Biopor, AOC Porous Polyethylene, Cerepor

K160988 · Ceremed , Inc. · KKY · Jul 14, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160988
• Device Name: Biopor, AOC Porous Polyethylene, Cerepor
• Applicant: Ceremed , Inc.
• Product Code: KKY · General, Plastic Surgery
• Decision Date: Jul 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biopor Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

Device Story

Biopor Porous Polyethylene Implants are porous high-density polyethylene (HDPE) surgical implants used for maxillofacial skeleton augmentation or reconstruction. The material features interconnecting pores to facilitate fibrovascular ingrowth. Implants are provided in various block, sheet, and anatomical shapes, which can be further contoured or carved by the surgeon to meet specific patient anatomical requirements. Optional features include a water-soluble alkylene oxide copolymer (AOC) coating and embedded titanium mesh. The device is intended for use by surgeons in a clinical/surgical setting. The implants are provided sterile and are for single use.

Clinical Evidence

Bench testing only. Biocompatibility and implantation studies were conducted per ISO 10993, including cytotoxicity, sensitization (LLNA), systemic toxicity, genotoxicity (Ames, chromosomal aberration, micronucleus), and muscle/bone implantation studies in rabbits. Hemolysis and pyrogen testing were also performed.

Technological Characteristics

Material: Porous high-density polyethylene (HDPE). Optional components: Water-soluble alkylene oxide copolymer (AOC) coating, embedded titanium mesh. Sterilization: Provided sterile. Biocompatibility: ISO 10993 compliant. Form factor: Blocks, sheets, and anatomical shapes.

Indications for Use

Indicated for augmentation or reconstruction of the maxillofacial skeleton in patients requiring surgical intervention.

Regulatory Classification

Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

Predicate Devices

• Biopor Porous Polyethylene Surgical Implants (K141880)
• Su-Por® Surgical Implants (K140437)
• Medpor® Surgical Implant Material (K922489)

Submission Summary (Full Text)

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

July 14, 2016

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

Re: K160988

Trade/Device Name: Biopor®, AOC™ Porous Polyethylene, Cerepor™ Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY Dated: June 8, 2016 Received: June 23, 2016

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, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does 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 devicerelated 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K160988

Device Name Biopor Porous Polyethylene Implants

Indications for Use (Describe)

Biopor Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: underline;"> </span> Exemption Under 21 CFR 58.1 Subpart D | <span style="text-decoration: underline;"> </span> For EPA-Specific Use (21 CFR 58.1(a)(2)) |
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary of Safety and Effectiveness

#### Submitted by:

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

| Contact Person: | Chelsea Mitchell |
|----------------------|--------------------------------------------------------------------------|
| Date Prepared: | March 31, 2016 |
| Common/Usual Name: | Porous High Density Polyethylene<br>(HDPE) Surgical Implant |
| Proprietary Name: | Biopor®, AOC™ Porous<br>Polyethylene, Cereport™ |
| Classification Name: | Polytetrafluoroethylene with carbon<br>fibers composite implant material |
| Product Code: | KKY |

## Predicate Devices:

- 1. Ceremed. Inc. Biopor Porous Polyethylene Surgical Implants (K141880)
- 2. Poriferous, LLC Su-Por® Surgical Implants (K140437)
- 3. Stryker® (Formerly Porex) Medpor® Surgical Implant Material (K922489)

## Description of the device:

Biopor Porous Polyethylene Implants are manufactured of porous high-density polyethylene, a biomaterial that is easily contoured or carved to suit the anatomical and functional requirements of the patient. The interconnecting pores of the Porous HDPE material permits fibrovascular ingrowth into the implant. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend and/or the option of embedded titanium mesh. AOC™ Porous Polyethylene Surgical Implants are provided STERILE and should not be resterilized.

## Intended use (Indications):

Biopor Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

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#### Substantial equivalence:

Biopor Porous Polyethylene Implants in this application represent a line extension of additional shapes and sizes, and have the same intended use and indications for use as the predicate Biopor® Porous Polyethylene Implants (K141880). The additional shapes and sizes are equivalent to those of the predicates Medpor® Surgical Implant Material (K922489) and Su-Por® Surgical Implants (K140437).

The biocompatibility of the alkylene oxide copolymer blend is in accordance with the standards set forth in ISO 10993 Biological Testing of Medical and Dental Materials and Devices.

The mechanical properties of AOC™ Porous Polyethylene Surgical Implants are substantially equivalent to the corresponding properties of the predicate devices made of porous polyethylene, and any minor differences raise no new issues of safety and efficacy.

#### Biocompatibility and Performance Testing:

Performance testing of the Biopor® Porous Polyethylene Implants was completed. Biocompatibility and Implantation studies were also conducted in accordance with ISO 10993. The test data reports are listed below:

Cytotoxicity Study Using the End-Point Titration Murine Local Lymph Node Assay (LLNA) ISO Modified Intracutaneous Study Solution USP and ISO Modified Systemic Toxicity Study Solution ISO Muscle Implantation Study Genotoxicity Mouse Bone Marrow Micronucleus Study Genotoxicity: Bacterial Reverse Mutation Study Genotoxicity: In Vitro Chromosomal Aberration Study Bone Implantation Study in the Femur of the Rabbit AOC Polymer Hemolysis Porous Polyethylene Post-irradiation Cytotoxicity ISO Intramuscular Implantation AOC Coated & Uncoated PPE Pyrogen Test in NZW Rabbits Suture Pullout from PPE