MODIFICATION TO VF GEL PLUS

K080956 · Coapt Systems, Inc. · MIX · Apr 25, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K080956
• Device Name: MODIFICATION TO VF GEL PLUS
• Applicant: Coapt Systems, Inc.
• Product Code: MIX · Ear, Nose, Throat
• Decision Date: Apr 25, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

VF Gel is a sterile, latex-free, non-pyrogenic, thixotropic, high-yield strength clear gel; functions as a soft tissue bulking agent for vocal fold medialization. Delivered via percutaneous injection using a Luer-lock syringe; thixotropic properties allow injection through fine needles with minimal force. Implant augments displaced or deformed vocal folds to facilitate midline contact, improving glottal closure, phonation, cough, and airway protection. Intended as a temporary, degradable implant with a minimum one-month durability. Used by clinicians in a medical setting; output is physical tissue augmentation observed via standard clinical assessment of vocal function.

Clinical Evidence

Bench testing only. Performance evaluations confirmed the device meets user specifications and applicable standards. No clinical data provided.

Technological Characteristics

Materials: injection-grade water, glycerin, mannitol, and Carbopol 974P NF. Thixotropic, high-yield strength gel. Supplied sterile in pre-filled Luer-lock syringes (0.5cc and 1.3cc). Biocompatibility meets ISO 10993. Materials comply with NF/USP requirements.

Indications for Use

Indicated for patients requiring temporary vocal fold medialization to treat vocal fold insufficiency. Augments displaced or deformed vocal folds to improve glottal closure, phonation, cough, and airway protection during swallowing.

Regulatory Classification

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.

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone]

## CONTACT INFORMATION

Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: [phone] Facsimile: [phone] Email: [e-mail]

### 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

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.

# INTENDED USE STATEMENT

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.

# 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 on<br>Safety and<br>Effectiveness |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------|
| Indication for Use | The VF Gel is indicated for<br>vocal fold medialization in<br>the treatment of vocal fold<br>insufficiency, where<br>insufficiency may be<br>improved by injection of a<br>soft tissue bulking agent. VF<br>Gel injection augments the<br>size of the displaced or<br>deformed vocal fold so that it<br>may meet the opposing fold<br>at the midline for improved<br>glottal closure. Improved<br>glottal closure may allow<br>improved phonation,<br>improvement of cough, and<br>an improved ability to protect<br>the airway during<br>swallowing. VF Gel is a<br>temporary implant that<br>degrades over time. The<br>product is intended to be<br>durable for a minimum of<br>one month. | The VF Gel Plus is indicated<br>for vocal fold medialization<br>in the treatment of vocal fold<br>insufficiency, where<br>insufficiency may be<br>improved by injection of a<br>soft tissue bulking agent. VF<br>Gel Plus injection augments<br>the size of the displaced or<br>deformed vocal fold so that it<br>may meet the opposing fold<br>at the midline for improved<br>glottal closure. Improved<br>glottal closure may allow<br>improved phonation,<br>improvement of cough, and<br>an improved ability to protect<br>the airway during<br>swallowing. VF Gel Plus is a<br>temporary implant that<br>degrades over time. The<br>product is intended to be<br>durable for a minimum of<br>one month. | Equivalent | None |
| Target Population | Patients requiring temporary<br>vocal fold medialization | Same | Equivalent | None |
| Surgical Approach | Percutaneous | Same | Equivalent | None |
| Design | Cohesive gel supplied in a<br>syringe ready to use | Same | Equivalent | None |
| Materials | A gel of injection grade<br>water, glycerin, mannitol and<br>Carbopol 974P NF | Same as VF Gel with the<br>addition of calcium<br>hydroxylapatite particles | Equivalent | None |
| Biocompatibility | Meets ISO 10993 | Same | Equivalent | None |
| Materials Standards | NF/USP requirements | Same | Equivalent | None |
| Mechanism of Action | Gel providing temporary<br>space filling | Same | Equivalent | None |
| Human Factors/How<br>Supplied | Supplied Sterile in a syringe<br>premixed and ready for<br>injection | Same | Equivalent | None |
| Human Factors/<br>Quantity Supplied | Supplied pre-filled in a<br>syringe filled to 0.5 and 1.3<br>cc for use in individual<br>patients | Same | Equivalent | None |
| Sterility | Supplied sterile ready to use,<br>Not to be resterilized | Same | Equivalent | None |
| Compatibility with<br>other Devices | Syringe has Luer lock<br>syringe that is compatible<br>with 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 [phone]. 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 [phone] or [phone] 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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