ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI

K132198 · Ceremed , Inc. · KHJ · Sep 12, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K132198
• Device Name: ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
• Applicant: Ceremed , Inc.
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: Sep 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Adaptain™ is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Device Story

Adaptain is a sterile, water-soluble, wax-like surgical implant material composed of alkylene oxide copolymers. Supplied in various forms (bars, sticks, granules, sheets), it is applied by clinicians during surgery. The material softens when warmed and adheres to itself upon application of firm pressure; it becomes lubricious when wet and does not swell during dissolution. It serves as a space-occupying adjunct to support natural healing. The device is provided sterile via irradiation and is intended for single use.

Clinical Evidence

No clinical data; substantial equivalence determined via non-clinical evaluations including design, materials, and performance comparisons.

Technological Characteristics

Water-soluble alkylene oxide copolymers (AOC PolymerBlend™). Wax-like consistency; softens with heat. Supplied in various form factors (bars, sticks, granules, sheets). Sterile (irradiation). No additives or colorants.

Indications for Use

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

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

• Adaptain FastWrap™ (K122561)

Submission Summary (Full Text)

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#### K132198 1 of 2 Ceremed, Inc. Page 6 - 1 Traditional 510(k) - Adaptain FastWrap™, Envelock ", Page C

#### VI - 510 (K) SUMMARY

#### Submitted by:

Chelsea Mitchell Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: [phone] Fax: [phone]

**SEP** 12013

| Contact Person: | Chelsea Mitchell |
|--------------------|---------------------------------------------------|
| Date Prepared | July 12, 2013 |
| Common/Usual Name: | Soluble Synthetic Polymer Implant Material |
| Proprietary Name: | Adaptain™, Adaptain FastWrap™, Envelock™, Biowai™ |
| Regulation Number: | 21 CFR 874.3620 |
| Regulation Name: | Ear, nose and throat synthetic polymer material |
| Regulatory Class: | II |
| Product Code: | KHJ |
| Predicate Device: | Ceremed, Inc.<br>Adaptain FastWrap™, (K122561) |

#### Description of the device:

Adaptain™ is a water-soluble, wax-like surgical implant material that will adhere to itself utilized directly and a first application of firm pressure. Adaptain " is designed to be utilized directly out of the package. The implant will soften as it is warmed. The surface of the implant becomes lubricious when wet, and the implant does not swell as it dissolves.

Adaptain™ is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend™) and contains no other additives or colorants. Adaptain is supplied in a number of forms including bars, sticks, granules and sheets of various sizes with weights ranging from 0.5 to 5 grams each.

Adaptain™ is provided sterile by irradiation and must not be resterilized.

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# K132198

2 of 2

Traditional 510(k) -- Adaptain", Adaptain FastWrap", Envelock ", Biowai Page 6 - 2

### Intended use:

Adaptain™ is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

### Substantial equivalence:

The non-clinical evaluations used to determine substantial equi valence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this submission is identical in design, materials, indications, performance and sterilization to the predicate Adaptain FastWrap™ (K122561).

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an abstract human figure with three flowing lines extending from its arm, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring. MD 20993-0002

September 12, 2013

Ceremed, Incorporated Ms. Chelsea Mitchell Vice President, Regulatory Affairs 3643 Lenawec Avenue Los Angeles, California 90016

Re: K132198

Trade/Device Name: Adaptain ", Adaptain FastWrap", Envelock", Biowai" Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: July 12. 2013 Received: July 16. 2013

Dear Ms. Mitchell:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Chelsea Mitchell

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ceremed, Inc. Traditional 510(k) - Adaptain", Adaptain FastWrap", Envelock ", Page 5 - 1

# Y. INDICATIONS FOR USE:

510 (k) Number (if known): K132198

Device Name: Adaptain™, Adaptain FastWrap™, Envelock™, Biowai™

Indications For Use:

Adaptain" is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)

# CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

# David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132198

Division Sign-Off

510(k) Number_