AOC SOLUBLE IMPLANT MATERIAL

K081531 · Ceremed , Inc. · KHJ · Jul 18, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K081531
• Device Name: AOC SOLUBLE IMPLANT MATERIAL
• Applicant: Ceremed , Inc.
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AGC "M is indicated for as a water-solubic implant material and as a water-soluble space occupying material, as an adjunct during the natural healing process.

Device Story

AOC is a water-soluble implant material used as a space-occupying agent to assist in the natural healing process. It is intended for surgical applications where a temporary, absorbable material is required to maintain space or support tissue during recovery. The device is applied by a clinician during surgical procedures. It functions as a physical barrier or filler that eventually dissolves, eliminating the need for secondary removal. The benefit to the patient is the facilitation of healing in the treated area through temporary space maintenance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Water-soluble synthetic polymer material. Classified as an ear, nose, and throat synthetic polymer material (21 CFR 874.3620).

Indications for Use

Indicated for use as a water-soluble implant material and space-occupying material to support the natural healing process.

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

• Ostene® Soluble Implant Material (K062280)
• AOC™ Porous Polyethylene Surgical Implants (K080507)

Submission Summary (Full Text)

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K081531
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Ceremed, Inc. 510 (k) Premarket Notification - AOC™ Soluble Implant Materia

## VII - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:

## Submitted by:

JUL 1 8 2008

Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: [phone] Fax: [phone]

Contact Person:

Date Prepared

Common/Usual Name:

Proprietary Names:

Classification Name:

Tadeusz Wellisz, M.D.

May 23, 2008

AOC™ Soluble Implant Material

AOC", AOC" Implant Material, Ceretene"", AOC"-ES, AOC"-LV

Ear, nose, and throat synthetic polymer material (per 21 CFR section 874.3620)

Product Code

KHI

## Predicate Devices

- 1. Ceremed, Inc. Ostene® Soluble Implant Material (K062280)
- Ceremed, Inc. 2. AOCTM Porous Polyethylene Surgical Implants (K080507)

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle emblem, with the eagle's head facing left and its wings forming a flowing, abstract shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ceremed, Inc. % Tadeusz Wellisz, M.D. President 3643 Lenawee Avenue Los Angeles, California 90016

JUL 1 8 2008

Re: K081531 Trade/Device Name: AOC™, AOC™ Implant Material, AOC™ Soluble Implant Material, Ceretene™, AOC™ -ES, AOC™ -LV Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: KHJ Dated: May 23, 2008 Received: June 5, 2008

Dear Dr. Wellisz:

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

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Page 2 - Tadeusz Wellisz, M.D.

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.

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 of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark M. Millican

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ceremed, Inc. 510 (k) Premarket Notification - AOC™ Soluble Implant Material

## XII. INDICATIONS FOR USE:

510 (k) Number (if known):

Device Name:

AOC™, AOC™ Implant Material, AOC™ Soluble Implant Material, Ceretene™, AOC™ ES, AOC™-LV

108153

Indications For Use:

AGC "M is indicated for as a water-solubic implant material and as a water-soluble space occupying material, as an adjunct during the natural healing process.

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)

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(Division Signes Division of General, Restorative, and Neurological Devices

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510(k) Number