The VF LiquiGel 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 LiquiGel 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 LiquiGel 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

The provided document is a 510(k) Premarket Notification for the VF LiquiGel device by Coapt Systems, Inc. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data (such as those for novel devices or PMAs) that would typically include detailed information on acceptance criteria and specific study outcomes in the way requested.

The document states that "The VF LiquiGel performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," but does not provide the specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria. Instead, it relies on demonstrating substantial equivalence in design, materials, function, and intended use to a legally marketed predicate device (VF Gel, K080956).

Therefore, I cannot provide all the requested information because it is not contained within the provided text. The document is primarily a comparison to a predicate device to establish substantial equivalence.

Here's the information that can be extracted or inferred:

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

The document does not explicitly present acceptance criteria for performance in a quantitative way. Instead, it compares characteristics of the VF LiquiGel to its predicate, VF Gel, and states equivalency. The "reported device performance" is essentially that it is "Equivalent" to the predicate in all assessed parameters, implying it meets the same functional and safety profiles.

Parameter	VF Gel (Predicate) Performance / Acceptance	VF LiquiGel (Subject) Reported Performance	Comparison	Impact on Safety and Effectiveness
Indication for Use	Indicated for vocal fold medialization in treatment of vocal fold insufficiency; augments vocal fold size for improved glottal closure, phonation, cough, and airway protection. Temporary implant, durable for minimum one month.	Same	Equivalent	None
Target Population	Patients requiring temporary vocal fold medialization	Same	Equivalent	None
Surgical Approach	Percutaneous or transoral	Same	Equivalent	None
Design	Cohesive gel supplied in a syringe ready to use	Same	Equivalent	None
Materials	A gel of injection grade water, glycerin, mannitol, NaOH and Carbopol 974P NF	Same, with a slightly lower pH	Equivalent	None
Biocompatibility	Meets ISO 10993	Same (Implied: Meets ISO 10993)	Equivalent	None
Materials Standards	NF/USP requirements	Same (Implied: Meets NF/USP requirements)	Equivalent	None
Mechanism of Action	Gel providing temporary space filling	Same	Equivalent	None
Human Factors/How Supplied	Supplied Sterile in a syringe premixed and ready for injection	Same	Equivalent	None
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	None
Sterility	Supplied sterile ready to use, Not to be resterilized	Same	Equivalent	None
Compatibility with other Devices	Syringe has Luer lock syringe that is compatible with needles with Luer fitting	Same	Equivalent	None

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" in the context of a prospective or retrospective study on patients using the VF LiquiGel. The evaluation is based on performance evaluations and comparison testing to the predicate device (Section 10.1, Substantial Equivalence Comparison, 1. Indications Summary; 3. Performance Summary), likely bench testing and material characterization, rather than a clinical study with a patient sample size. Therefore, there's no information on data provenance from human subjects or study design (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As there is no described clinical test set for this 510(k) submission, there are no experts establishing ground truth for such a set. The "ground truth" for substantial equivalence is based on regulatory and scientific comparison to the predicate device's established safety and effectiveness.

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

Not applicable. There is no described clinical test set requiring adjudication.

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 device is a medical implant (a gel), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical implant (a gel), not an algorithm.

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

The "ground truth" in this 510(k) context is the established safety and effectiveness profile of the predicate device (VF Gel, K080956) and the scientific understanding of the materials and mechanism of action, validated through material characterization and biocompatibility testing (meeting ISO 10993 and NF/USP requirements). No clinical outcomes data for the subject device are presented to establish ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The "training set" doesn't apply here.

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

Not applicable. This is not an AI/machine learning device.

Summary

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Coapt Systems, Inc.

Special 510(k) Premarket Notific VF LiquiGel

SEP 1 1 2009

510(k) SUMMARY 10.0

510(k) Summary 10.1

Coapt Systems is providing a summary of the safety and effectiveness information available for the VF LiquiGel. 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

Louis-Pierre Marcoux Manager, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7651 Facsimile: (650) 213-9336 Email: Imarcoux(@coaptsystems.com

DATE OF PREPARATION OF 510(K) SUMMARY

December 11, 2008

DEVICE TRADE OR PROPRIETARY NAME VF LiquiGel

DEVICE COMMON OR CLASSIFICATION NAME

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

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Coapt Systems, Inc.

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
VF Gel	MIX	Coapt Systems	K080956

DEVICE DESCRIPTION

INTENDED USE STATEMENT

SUBSTANTIAL EQUIVALANCE COMPARISON

1. Indications Summary

The "Indication Statement" for the VF LiquiGel 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 LiquiGel. VF LiguiGel 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 LiquiGel 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 LiquiGel performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.

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・

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Parameter	VF Gel (Predicate)	VF LiquiGel (Subject)	Comparison	Impact on Safety and Effectiveness
Indication 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.	The VF LiquiGel 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 LiquiGel 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 LiquiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.	Equivalent	None
Target Population	Patients requiring temporary vocal fold medialization	Same	Equivalent	None
Surgical Approach	Percutaneous or transoral	Same	Equivalent	None
Design	Cohesive gel supplied in a syringe ready to use	Same	Equivalent	None
Materials	A gel of injection grade water, glycerin, mannitol, NaOH and Carbopol 974P NF	Same, with a slightly lower pH	Equivalent	None
Biocompatibility	Meets ISO 10993	Same	Equivalent	None
Materials Standards	NF/USP requirements	Same	Equivalent	None
Mechanism of Action	Gel providing temporary space filling	Same	Equivalent	None
Human Factors/How Supplied	Supplied Sterile in a syringe premixed and ready for injection	Same	Equivalent	None
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	None
Sterility	Supplied sterile ready to use, Not to be resterilized	Same	Equivalent	None
Compatibility with other Devices	Syringe has Luer lock syringe that is compatible with needles with Luer fitting	Same	Equivalent	None

Table 7: Substantial Equivalence Summarv

Image /page/2/Picture/4 description: The image shows a sequence of numbers, specifically "0000033". The numbers are printed in a simple, slightly distorted font, giving them a somewhat vintage or digitized appearance. The sequence consists of five zeros followed by two threes, with a small period at the end.

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000034

SUBSTANTIAL EQUIVALENCE CONCLUSION

Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the VF LiquiGel 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 LiquiGel 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 seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized image of an eagle with its wings spread.

SFP 1 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Coapt Systems, Inc. c/o Mr. Louis-Pierre Marcoux Regulatory Affairs Manager 1820 Embarcadero Road Palo Alto, CA 94303

Re: K083783

Trade/Device Name: VF LiquiGel™ Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: II Product Code: MIX Dated: August 21, 2009 Received: August 24, 2009

Dear Mr. Marcoux:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Louis-Pierre Marcoux

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

E. R. Rehm, MD

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

Enclosure

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Coapt Systems, Inc.

KOR 248.3 Special 510(k) Premarket Notification VF LiquiGel

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Not yet assigned

Device Name:

VF LiquiGel

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Daniel C. Clapp
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K083783

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

000013

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.