In Appendix B, FDA provides further clarification and guidance to facilitate compliance with the requirements set forth in 21 CFR 807.92 and consistency in the information conveyed in the 510(k) Summaries which are available to the public on FDA’s website. As noted earlier in this guidance document, if during the course of review, additional testing or information are requested, the manufacturer should submit a revised 510(k) Summary to reflect the additional information. The following identifies the information that must be included in the 510(k) Summary under 21 CFR 807.92, information that we recommend be included in the 510(k) Summary, and other considerations.

· 807.92(a)(1): “The submitter's name, address, telephone number, a contact person, and the date the summary was prepared.”

o The “submitter” or manufacturer should be the holder of the 510(k), not a consultant or law firm.

· 807.92(a)(2): “The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known.”

o FDA recommends that the manufacturer list all applicable names and model numbers, if known.

o If the submission is bundled, the 510(k) Summary should list all applicable classification regulations and product codes.

· 807.92(a)(3): “An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process.”

o FDA recommends that the manufacturer provide the 510(k) number of the device used as the predicate device in support of the current 510(k) submission.

o If using an exempt device as a predicate, the manufacturer should list the classification regulation and the product code.

o If using a device that has been reclassified from Class III to II as a predicate, where a 510(k) has not been submitted, please list the PMA number.

o If the manufacturer lists an inappropriate predicate device, FDA will request that such information be removed and the 510(k) Summary updated accordingly by the manufacturer.

· 807.92(a)(4): “A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties.”

The description of the device attributes should include the following details:

o Device Identification:

§ List all key device components included in the submission (e.g., catheter, cable wire, leads)

§ List all model numbers (if known) and briefly explain the differences among models

o Device Characteristics (address all that apply):

§ Software 

§ Biologics 

§ Drugs 

§ any patient-contacting materials 

§ Coatings 

§ Additives 

§ single-use 

§ Sterile 

§ sterilization method [specify] 

o Environment of Use (address all that apply):

§ healthcare facility/hospital 

§ other [specify] 

o Brief Written Description of the Device:

§ Explanation of how the device works/principle of operation

§ Mechanism of action

§ Any necessary feature to determine SE or device performance

§ Energy source (if applicable)

o Materials of Use 

§ General type of material used (e.g., polysulfone, stainless steel)

§ If material conforms to an FDA recognized consensus standard for medical use, include the applicable number (e.g., ASTM FXXXX-last 2 numbers of the year)

§ Duration and type of contact

o Key Performance Specifications/Characteristics of the Device

· 807.92(a)(5): “A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph (a)(3) of this section, the 510(k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled.”

o The 510(k) Summary should include the Indications for Use, which should be identical to that proposed on the Indications for Use Sheet and the labeling.

o If the Indications for Use are different from those of the predicate device, a brief explanation is required to address why the differences in the Indications do not affect the safety and effectiveness of the device and do not alter the intended therapeutic, diagnostic, prosthetic, or surgical use of the device.

· 807.92(a)(6): “If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device identified in paragraph (a)(3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device identified in paragraph (a)(3) of this section.”

· 807.92(b): “510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment of performance data shall contain the following information:”

“(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence,”

o A high level summary of the tests that were used to demonstrate substantial equivalence should be included (e.g., fatigue testing, biocompatibility, etc.).

o If a guidance document was referenced/used for the testing, the guidance document should be referenced in this section.

o If an FDA recognized consensus standard (e.g., test method or guide) was used/relied upon for testing, please list the standard connotation (e.g., ASTM FXXXX-last 2 numbers of the year).

“(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence,”

o FDA is interested in collecting an appropriate degree of detail within this section to be informative regarding the level of evidence that was necessary to support an SE determination.

o As applicable, FDA recommends the following details be included regarding the clinical evidence provided to support an SE determination:

· Level of Evidence (identify one)

§ Randomized, multi-arm, “blinded” study with concurrent sham (placebo) control

§ Randomized, multi-arm, “blinded” study with concurrent (“active”) control

§ Randomized, multi-arm, un“blinded” study with a control (control that is either active or consists of no treatment)

§ Non-randomized study with concurrent (“active”) control

§ Single-arm study with patient serving as own control (include designed single- arm crossover)

§ Single-arm study with Historical Control (using patient-level data)

§ Single-arm study with Literature Control (historical control)

§ Single-arm study with Objective Performance Criteria

§ Single-arm study with Performance Goals

§ Registry

§ Observational study

§ Systematic review (meta-analysis with patient-level data)

§ Meta-analysis based on summary information only

§ Literature Summary

§ Uncertain

· Location of Study (specify one of the following)

o United States only 

o outside of United States only

o both in United States and outside of United States

o Identify applicable IDE number [Gxxxxxx]

· Primary Safety Endpoint Identified?

§ If Yes, describe

· Primary Effectiveness Endpoint Identified?

§ If Yes, describe

· Primary Composite Safety/Effectiveness Endpoint Identified, if applicable?

§ If Yes, describe

· Patient Accountability (Enter number of patients reported at each stage):

 

Stage	Investigational Device Arm Total	Control Arm Total	Total
Enrollment
Treatment
Primary Safety Endpoint Analysis
Primary Effectiveness Endpoint Analysis
Primary Composite Safety/Effectiveness (if app)

The content of the table may need to be modified depending upon the specifics of the clinical data provided and the endpoints studied.

· Identify whether the study met the primary endpoint

§ Whether Yes or No, describe

· Describe the study results in appropriate parameters

· Identify the adverse events and complications observed in the study, including those associated with the device.

“(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section.”

o A brief summary of why the device is substantially equivalent to the predicate.

· 807.92(c): “The summary should be in a separate section of the submission, beginning on a new page and ending on a page not shared with any other section of the premarket notification submission, and should be clearly identified as a ‘510(k) summary’.”

· 807.92(d): “Any other information reasonably deemed necessary by the agency.”

o If the FDA determines that other information needs to be included within the 510(k) Summary, such information must be included within this document.