VF GEL PLUS

K071663 · Coapt Systems, Inc. · MIX · Feb 15, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K071663
• Device Name: VF GEL PLUS
• Applicant: Coapt Systems, Inc.
• Product Code: MIX · Ear, Nose, Throat
• Decision Date: Feb 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

VF Gel Plus is a sterile, semi-solid, cohesive subdermal implant used for vocal fold medialization. It consists of synthetic calcium hydroxylapatite particles (25-45 microns, 30% by volume) suspended in a thixotropic gel carrier (sterile water, glycerin, mannitol, and carbomer). The device is injected into the vocal fold to augment its size, enabling the displaced or deformed fold to meet the opposing fold at the midline. This improves glottal closure, phonation, cough, and airway protection during swallowing. It is a temporary, degradable implant intended to be durable for at least one month. The device is intended for clinical use by a physician.

Clinical Evidence

Bench testing only. Performance evaluations and comparison testing were conducted to substantiate the indications for use and demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Subdermal implant; synthetic calcium hydroxylapatite particles (25-45 microns) in a thixotropic gel carrier (sterile water, glycerin, mannitol, carbomer). Sterile, latex-free, non-pyrogenic. Semi-solid, cohesive form factor.

Indications for Use

Indicated for patients with vocal fold insufficiency requiring vocal fold medialization via soft tissue bulking agent injection to improve glottal closure, phonation, cough, and airway protection.

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.

Predicate Devices

• Radiesse Injectable Laryngeal Medialization Implant (K033398)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone]

#### CONTACT INFORMATION

Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA 94303 Telephone: [phone] Facsimile: [phone] Email: [e-mail]

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 PMA<br>Number |
|--------------------------------------------------------|--------------|----------------------|-------------------------|
| Radiesse Injectable Laryngeal<br>Medialization Implant | MIX | Bioform Medical | K033398 |

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## 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.

# INTENDED USE STATEMENT

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.

## 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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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 [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.

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