The VF Gel 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 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 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, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.

AI/ML Overview

This document describes a 510(k) summary for a medical device called "VF Gel." The summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. Therefore, many of the requested data points (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or available in this type of submission.

Here's a breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not present a table of quantitative acceptance criteria or specific device performance metrics in the way one might expect for an AI/algorithm-based device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device, meaning the new device (VF Gel) is as safe and effective as the legally marketed predicate. The "reported device performance" is essentially that it meets the requirements of a substantially equivalent device.

The table below summarizes the comparison of "VF Gel Plus" (the subject device) to "VF Gel" (the predicate device) from Table 7: Substantial Equivalence Summary, which outlines the characteristics compared to establish equivalence. The "Impact on Safety and Effectiveness" column effectively serves as the "reported device performance" in this context, indicating that the new device does not raise new safety or effectiveness concerns.

Parameter	VF Gel (Predicate) Performance (Implied Acceptance Criteria for Subject Device)	VF Gel Plus (Subject) Performance (as reported)	Comparison
Indication for Use	Vocal fold medialization in the treatment of vocal fold insufficiency, to augment vocal fold size for improved glottal closure, allowing improved phonation, cough, and airway protection during swallowing. Temporary implant, durable for a minimum of one month.	Same	Equivalent
Target Population	Patients requiring temporary vocal fold medialization	Same	Equivalent
Surgical Approach	Percutaneous	Same	Equivalent
Design	Cohesive gel supplied in a syringe ready to use	Same	Equivalent
Materials	A gel of injection grade water, glycerin, mannitol and Carbopol 974P NF	Same as VF Gel with the addition of calcium hydroxylapatite particles	Equivalent
Biocompatibility	Meets ISO 10993	Same	Equivalent
Materials Standards	NF/USP requirements	Same	Equivalent
Mechanism of Action	Gel providing temporary space filling	Same	Equivalent
Human Factors/How Supplied	Supplied Sterile in a syringe premixed and ready for injection	Same	Equivalent
Human Factors/Quantity Supplied	Supplied pre-filled in a syringe filled to 0.5 and 1.3 cc for use in individual patients	Same	Equivalent
Sterility	Supplied sterile ready to use, Not to be resterilized	Same	Equivalent
Compatibility with other Devices	Syringe has Luer lock syringe that is compatible with needles with Luer fitting	Same	Equivalent

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

Sample Size for Test Set: This information is not provided in the 510(k) summary. The submission focuses on a comparison of characteristics to a predicate device, not a performance study with a test set of patient data.
Data Provenance: This information is not provided. As it's a device for vocal fold medialization, any "performance evaluations and comparison testing" mentioned are likely preclinical (e.g., benchtop, material characterization), or may refer to clinical experience with the predicate device, but specific data provenance for a test set is absent.

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

This information is not applicable/not provided. The submission does not detail a study involving expert-established ground truth for a test set in the context of an AI/algorithm. The "ground truth" for this medical device's approval is based on its physical and functional equivalence to a legally marketed predicate device.

4. Adjudication method for the test set:

This information is not applicable/not provided. There is no described test set or expert adjudication process for such a test set.

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:

This information is not applicable/not provided. This is a submission for a physical medical implant (gel), not an AI/algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This information is not applicable/not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the established safety and effectiveness of the predicate device. The VF Gel's "ground truth" is that its design, materials, function, and intended use are similar enough to the predicate device that it can be considered substantially equivalent. This is based on material properties, biocompatibility, and functional evaluations rather than expert consensus on patient outcomes or pathology from a dataset.

8. The sample size for the training set:

This information is not applicable/not provided. This is a physical medical device, not an AI/algorithm that requires a training set.

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

This information is not applicable/not provided. As above, there is no training set for a physical device.

Summary

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APR 2 5 2008 510(k) SUMMARY 10.0

10.1 510(k) Summary

Coapt Systems is providing a summary of the safety and effectiveness information available for the VF Gel. 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 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 Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: Iruedy@coaptsystems.com

DATE OF PREPARATION OF 510(K) SUMMARY

April 2, 2008

DEVICE TRADE OR PROPRIETARY NAME VF Gel

DEVICE COMMON OR CLASSIFICATION NAME

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

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

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DEVICE DESCRIPTION

INTENDED USE STATEMENT

SUBSTANTIAL EQUIVALANCE COMPARISON

1. Indications Summary

The "Indication Statement" for the VF Gel 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. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

2. Technological Characteristics Summary

The VF Gel is substantially equivalent in design, materials and fundamental scientific technology to the predicate devices. 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 performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.

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Parameter	VF Gel (Predicate)	VF Gel Plus (Subject)	Comparison	Impact onSafety andEffectiveness
Indication for Use	The VF Gel is indicated forvocal fold medialization inthe treatment of vocal foldinsufficiency, whereinsufficiency may beimproved by injection of asoft tissue bulking agent. VFGel injection augments thesize of the displaced ordeformed vocal fold so that itmay meet the opposing foldat the midline for improvedglottal closure. Improvedglottal closure may allowimproved phonation,improvement of cough, andan improved ability to protectthe airway duringswallowing. VF Gel is atemporary implant thatdegrades over time. Theproduct is intended to bedurable for a minimum ofone month.	The VF Gel Plus is indicatedfor vocal fold medializationin the treatment of vocal foldinsufficiency, whereinsufficiency may beimproved by injection of asoft tissue bulking agent. VFGel Plus injection augmentsthe size of the displaced ordeformed vocal fold so that itmay meet the opposing foldat the midline for improvedglottal closure. Improvedglottal closure may allowimproved phonation,improvement of cough, andan improved ability to protectthe airway duringswallowing. VF Gel Plus is atemporary implant thatdegrades over time. Theproduct is intended to bedurable for a minimum ofone month.	Equivalent	None
Target Population	Patients requiring temporaryvocal fold medialization	Same	Equivalent	None
Surgical Approach	Percutaneous	Same	Equivalent	None
Design	Cohesive gel supplied in asyringe ready to use	Same	Equivalent	None
Materials	A gel of injection gradewater, glycerin, mannitol andCarbopol 974P NF	Same as VF Gel with theaddition of calciumhydroxylapatite particles	Equivalent	None
Biocompatibility	Meets ISO 10993	Same	Equivalent	None
Materials Standards	NF/USP requirements	Same	Equivalent	None
Mechanism of Action	Gel providing temporaryspace filling	Same	Equivalent	None
Human Factors/HowSupplied	Supplied Sterile in a syringepremixed and ready forinjection	Same	Equivalent	None
Human Factors/Quantity Supplied	Supplied pre-filled in asyringe filled to 0.5 and 1.3cc for use in individualpatients	Same	Equivalent	None
Sterility	Supplied sterile ready to use,Not to be resterilized	Same	Equivalent	None
Compatibility withother Devices	Syringe has Luer locksyringe that is compatiblewith needles with Luer fitting	Same	Equivalent	None

Table 7: Substantial Equivalence Summary

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SUBSTANTIAL EQUIVALENCE CONCLUSION

Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the VF Gel 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 Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/4/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 logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2008

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

Re: K080956 Trade/Device Name: VF Gel Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: MIX Dated: April 2, 2008 Received: April 3, 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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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,

Zubir A. Malik

Malvina B. Eydelman, 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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Indications for Use

510(k) Number (if known): K080956

Device Name: VF Gel

Indications For Use: The VF Gel 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 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 is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

510(k) Number K080956

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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.