The VF Gel Plus is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel Plus injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel Plus is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Device Description

Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principal durable component is synthetic calcium hydroxylapatite. The semi-solid nature is created by suspending the calcium hydroxylapatite particles in a high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the carbomer (NF). The calcium hydroxylapatite particles are 25 to 45 microns in size while being smooth but irregular in shape and are present in the product at 30% by volume.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "VF Gel Plus." It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one might find for an AI/ML device or a diagnostic accuracy study.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as it outlines a regulatory submission for a physical implant, not a data-driven model.

However, I can extract information related to the device's intended use and the general claim of performance based on comparison to a predicate device.

Here's a breakdown of the information that is available or derivable from the text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical trial for a diagnostic device. Instead, it claims substantial equivalence to a predicate device based on design, materials, function, intended use, and performance evaluations.

Category	Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use	Must be align with the predicate device and be substantiated by performance evaluations.	"The 'Indication Statement' for the VF Gel Plus is substantiated by the results of the performance evaluations and comparison testing to the predicate device."
Technological Characteristics	Must be substantially equivalent in design, materials, and fundamental scientific technology.	"The VF Gel Plus is substantially equivalent in design, materials and fundamental scientific technology to the predicate device."
Overall Safety & Effectiveness	Must not raise new issues regarding safety or effectiveness compared to the predicate device.	"No new issues of safety or effectiveness were raised for the VF Gel Plus Device. Therefore, safety and effectiveness are reasonably assured..."
Durability	Intended to be durable for a minimum of one month.	"The product is intended to be durable for a minimum of one month."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document refers to "performance evaluations and comparison testing" but does not detail a specific test set size or methodology for a clinical study with a control group. This is common for 510(k) submissions for physical implants where equivalence is demonstrated through non-clinical testing (e.g., material compatibility, degradation) and comparison to the predicate's known clinical performance, rather than a new large-scale clinical trial.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This type of information is relevant for studies involving human interpretation or data labeling, such as for AI/ML or diagnostic accuracy studies. The provided document is for a physical implant where ground truth would typically relate to material properties, biocompatibility, and functional outcomes in in vitro or in vivo (animal) models, or clinical observation, rather than expert consensus on a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical medical implant, not an AI-assisted diagnostic or decision support tool where "human readers" or AI assistance would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a physical medical implant, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implied Ground Truth: For this type of device, the "ground truth" would pertain to the physical and biological performance of the implant, such as:
- Biocompatibility (e.g., no adverse tissue reactions)
- Material properties (e.g., degradation rate, injectability, stability)
- Functional outcome (e.g., ability to augment vocal fold, leading to improved phonation, cough, airway protection) – these are assessed clinically but the study demonstrating equivalence likely relies on laboratory/pre-clinical data and existing knowledge of the predicate.
The document states "VF Gel Plus performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," implying that performance was measured against established benchmarks for similar devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/ML device that requires a training set.

In summary, the provided document is a 510(k) summary for a physical medical implant asserting substantial equivalence to an existing device. It does not contain the detailed study design, acceptance criteria, and performance metrics typically found in clinical trials for diagnostic devices or AI/ML products.

Summary

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12 510(k) SUMMARY

12.0 510(k) Summary

Coapt Systems is providing a summary of the safety and effectiveness information available for the VF Gel Plus. This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 and pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990.

SPONSOR/APPLICANT NAME AND ADDRESS

Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA 94303 Telephone: (650) 461-7600 Facsimile: (650) 213-9336

CONTACT INFORMATION

Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA 94303 Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: lruedy@coaptsystems.com

DATE OF PREPARATION OF 510(K) SUMMARY

February 6, 2008

DEVICE TRADE OR PROPRIETARY NAME

VF Gel Plus

DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Vocal Cord Medialization Implant Regulation Number: 874.3620 Class: II Product Code: MIX

IDENTIFICATION OF THE LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED

Name of Predicate Device	Product Code	Name of Manufacturer	510(k) or PMANumber
Radiesse Injectable LaryngealMedialization Implant	MIX	Bioform Medical	K033398

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DEVICE DESCRIPTION

INTENDED USE STATEMENT

SUBSTANTIAL EQUIVALANCE COMPARISON

1. Indications Summary

The "Indication Statement" for the VF Gel Plus is substantiated by the results of the performance evaluations and comparison testing to the predicate device. The differences between the Subject and the Predicate do not affect.the safety and effectiveness of the VF Gel Plus.

2. Technological Characteristics Summary

The VF Gel Plus is substantially equivalent in design, materials and fundamental scientific technology to the predicate device. Any differences between the Subject and the Predicate device are minor and do not raise issues regarding safety or effectiveness.

3. Performance Summary

The VF Gel Plus performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.

SUBSTANTIAL EQUIVALENCE CONCLUSION

Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the VF Gel Plus is substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness were raised for the VF Gel Plus Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style with thick, black lines. The text is also in black and appears to be in a sans-serif font.

Public Health Service

FEB 15 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Coapt Systems, Inc. c/o Ms. Linda Ruedy Director, Regulatory and Clinical Affairs 1820 Embarcadero Road Palo Alto, CA 94303

Re: K071663

Trade/Device Name: VF Gel Plus Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: MIX Dated: January 24, 2008 Received: January 25, 2008

Dear Ms. Ruedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -Ms. Linda Ruedy

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mating B. Septatis, und

Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(71662

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K071663

Device Name:

VF Gel Plus

The VF Gel Plus is indicated for vocal fold medialization in the Indications for Use: treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel Plus injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel Plus is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Prescription Use X (Part 21 CFR 801 Subpart D) And/Or

Over-the-Counter (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Daniel C. Clum

510(k) Number K071663

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.