Biopor Porous Polyethylene Implants

K161446 · Ceremed , Inc. · GWO · Sep 27, 2016 · Neurology

Device Facts

• Record ID: K161446
• Device Name: Biopor Porous Polyethylene Implants
• Applicant: Ceremed , Inc.
• Product Code: GWO · Neurology
• Decision Date: Sep 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biopor Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.

Device Story

Biopor Porous Polyethylene Implants are porous high-density polyethylene (PPE) surgical implants; available in sheet configurations; optional water-soluble alkylene oxide copolymer (AOC) coating. Implants are contoured or carved by surgeons to meet patient-specific anatomical requirements for craniofacial augmentation or reconstruction. Provided sterile; intended for single use. Device functions as a structural scaffold for tissue ingrowth. Clinical benefit includes restoration of skeletal form and function in the craniofacial region.

Clinical Evidence

Bench testing only. Biocompatibility testing included cytotoxicity, LLNA sensitization, intracutaneous irritation, systemic toxicity, muscle implantation, and genotoxicity (Ames, chromosomal aberration, micronucleus). Performance testing included suture pull-out strength, flexibility, and porosity characterization (>40 µm). All tests met acceptance criteria.

Technological Characteristics

Material: Porous high-density polyethylene (PPE) with optional water-soluble alkylene oxide copolymer (AOC) coating. Form factor: Sheets. Sterilization: Electron beam irradiation. Porosity: >40 µm pore size. Mechanical properties: Suture pull-out strength and flexibility validated against predicate criteria.

Indications for Use

Indicated for augmentation or reconstruction of the craniofacial skeleton, including cranial skeleton, orbit, nasal bones, and zygoma in patients requiring surgical implantation.

Regulatory Classification

Identification

A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• Biopor® Porous Polyethylene Surgical Implants (K141880)

Reference Devices

• K043133

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 27, 2016

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

Re: K161446

Trade/Device Name: Biopor Porous Polyethylene Implants Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: August 2, 2016 Received: August 26, 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,

Carlos L. Pena SS

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K161446

#### Device Name Biopor Porous Polyethylene Implants

Indications for Use (Describe)

Biopor Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.

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

| <input type="checkbox"/> Research and/or Educational Use Only |
|---------------------------------------------------------------|
| <input type="checkbox"/> Commercial Use |

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:

### Submitted by:

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

| Contact Person: | Chelsea Mitchell |
|----------------------|----------------------------------------------------------------|
| Date Prepared | September 27, 2016 |
| Common/Usual Name: | Porous High Density Polyethylene<br>(HDPE) Surgical Implant |
| Proprietary Name: | Biopor® Porous Polyethylene Implants |
| Classification Name: | Plate, Cranioplasty, Preformed, Alterable<br>(21 CFR 882.5320) |
| Product Code: | GWO |

Predicate Device:

- 1. Ceremed, Inc. Biopor® Porous Polyethylene Surgical Implants (K141880)
### Description of the device:

Biopor® Porous Polyethylene Implants are manufactured of porous high-density polyethylene (PPE), a biomaterial that is contoured or carved to suit the anatomical and functional requirements of the patient. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend (AOC). Biopor® Porous Polyethylene Implants are provided STERILE and must not be resterilized.

### Intended use (Indications For Use):

Biopor® Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.

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# Comparison of Technology to Predicate Device:

The differences and similarities in technological characteristics and intended use between the subject and predicate devices are listed below:

| | Biopor® PPE | Biopor® PPE |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | K161446 | K141880 |
| Indications for<br>Use Statement | Biopor® Porous<br>Polyethylene Implants<br>in sheet configurations<br>are intended for the<br>augmentation or<br>reconstruction of the<br>craniofacial skeleton,<br>including the cranial<br>skeleton, orbit, nasal<br>bones and the zygoma. | Biopor® Porous Polyethylene Implants in block,<br>sheet, and anatomical shapes are intended for the<br>augmentation or reconstruction of the<br>"maxillofacial skeleton". |
| Materials | PPE with AOC option | PPE with Titanium and AOC options |
| Configuration | Sheets | Sheets and anatomical shapes |
| Sterility | Unchanged | Sterile via electron beam irradiation |
| Packaging | Unchanged | Inner packet, outer Tyvek pouch |

# Biocompatibility and Performance Testing:

Performance testing of the Biopor® Porous Polyethylene Implants was completed. The biocompatibility profile was leveraged from testing to support K043133 (a predicate ancestor of K141880). The endotoxin specification of the device is < 2.15 EU/device. These data are applicable to Preformed Cranioplasty Plate (21 CFR 882.5320) and support the substantial equivalence of the subject device to the predicate (K141880). The test data is summarized below:

| Test | Test Method Summary | Results |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Cytotoxicity<br>Study Using the<br>End-Point<br>Titration | An in vitro study of the AOC<br>coating used dilutions of an<br>extract on a confluent monolayer<br>of mouse fibroblast cells. | The extract tested negative after 24, 48<br>and 72 hours. No cytotoxicity detected. |
| Murine Local<br>Lymph Node<br>Assay (LLNA) | A study of the AOC coating for<br>delayed contract sensitization<br>using the LLNA mouse model | Under the conditions of the study, the<br>material was not considered sensitizing to<br>the mouse. |
| ISO Modified<br>Intracutaneous<br>Solution | A study of the AOC coating for<br>irritation and sensitization.<br>3 rabbits were injected into the<br>skin and observed for 72 hrs. | The primary irritation index<br>characterization for the test article was<br>negligible. |
| USP and ISO<br>Modified<br>Systemic<br>Toxicity | A study of the AOC coating for<br>systemic toxicity. 10 mice were<br>administered a dose of 50 ml/kg<br>and observed for 7 days. | There was no evidence of systemic<br>toxicity. |
| ISO Muscle<br>Implantation | The AOC coating for evaluated<br>for toxicity. Test articles were<br>implanted into the muscle of<br>rabbits. | After 2 weeks, the test article was<br>classified as a non-irritant. |
| Genotoxicity<br>Mouse Bone<br>Marrow<br>Micronucleus | The AOC coating for evaluated<br>for genotoxicity using the mouse<br>bone marrow micronucleus<br>model. | The coating showed no evidence of<br>cellular toxicity. |
| Genotoxicity:<br>Bacterial Reverse<br>Mutation | The AOC coating for evaluated<br>for genotoxicity using Bacterial<br>Reverse Mutation. | The coating showed no evidence of<br>cellular toxicity. |
| Genotoxicity: In<br>Vitro<br>Chromosomal<br>Aberration | The AOC coating for evaluated<br>for genotoxicity using In Vitro<br>Chromosomal Aberration. | The coating showed no evidence of<br>cellular toxicity. |
| Bone<br>Implantation<br>Study in the<br>Femur of the<br>Rabbit | The AOC coating was implanted<br>into the femurs of rabbits and<br>evaluated after 4 and 8 weeks. | The test article was absorbed and all sites<br>were healing normally. |
| AOC Polymer<br>Hemolysis | The AOC coating for evaluated<br>for hemolysis using In Vitro<br>rabbit red blood cells. | The test article was non-hemolytic. |
| PPE Post-<br>irradiation<br>Cytotoxicity | An <i>in vitro</i> study of the<br>irradiated PPE implant extract<br>using MEM Elution. | The test articles were non-cytotoxic. |
| ISO<br>Intramuscular<br>Implantation<br>AOC Coated &<br>Uncoated PPE | AOC Coated & Uncoated PPE<br>devices were implanted into<br>rabbit muscle and histopathology<br>was performed after 1, 2 and 4<br>weeks. | Fibrovascular ingrowth occurred into<br>coated and uncoated implants. |
| Suture Pull-out of<br>AOC-Coated<br>Biopor Porous<br>Polyethylene<br>Implant | Coated implants were evaluated<br>for strength using a suture pull-<br>out test method | The test articles met acceptance criteria. |
| Biopor Sheet<br>Performance<br>Qualification | Coated and uncoated implants<br>were evaluated for flexibility. | The test articles met acceptance criteria. |
| Porosity<br>Characterization<br>of Porous<br>Polyethylene<br>Implants | Coated and uncoated implants<br>were evaluated for porosity with<br>the criteria of pore size greater<br>than 40 µm. | The test articles met acceptance criteria. |

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# Substantial Equivalence:

The Biopor® Porous Polyethylene Implants in this submission represent a line extension of additional sheet configurations intended for use in the craniofacial skeleton, and have a comparable intended use and indications for use as the predicate Biopor® Porous Polyethylene Implants indicated for use in the maxillofacial skeleton (K141880). This submission contains implants for use in the craniofacial skeleton. They are similar to one type of implants currently marketed by Ceremed.

The biocompatibility profile of the subject devices is leveraged from that of the predicate device. The mechanical properties of subject Biopor® Porous Polyethylene Implants meet the same acceptance criteria as the predicate device sheet configurations.