(125 days)
No
The summary describes a passive implant made of porous polyethylene and focuses on biocompatibility and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "Biopor® Porous Polyethylene Implants" intended for "augmentation or reconstruction of the craniofacial skeleton". Augmentation or reconstruction for medical reasons is a therapeutic application.
No
The device is an implant used for augmentation or reconstruction, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made of porous high-density polyethylene, which is a hardware component. The performance studies also focus on the physical and biological properties of the material and coating.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the augmentation or reconstruction of the craniofacial skeleton. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description details a physical implant made of porous polyethylene.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties, and tissue integration, which are relevant to surgical implants, not IVDs.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples (like blood, urine, tissue) to provide diagnostic information. This device is a physical implant used in surgery.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
GWO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the Biopor® Porous Polyethylene Implants was completed. The test data is summarized below:
- Cytotoxicity Study Using the End-Point Titration: An in vitro study of the AOC coating used dilutions of an extract on a confluent monolayer of mouse fibroblast cells. Results: The extract tested negative after 24, 48 and 72 hours. No cytotoxicity detected.
- Murine Local Lymph Node Assay (LLNA): A study of the AOC coating for delayed contract sensitization using the LLNA mouse model. Results: Under the conditions of the study, the material was not considered sensitizing to the mouse.
- ISO Modified Intracutaneous Solution: A study of the AOC coating for irritation and sensitization. 3 rabbits were injected into the skin and observed for 72 hrs. Results: The primary irritation index characterization for the test article was negligible.
- USP and ISO Modified Systemic Toxicity: A study of the AOC coating for systemic toxicity. 10 mice were administered a dose of 50 ml/kg and observed for 7 days. Results: There was no evidence of systemic toxicity.
- ISO Muscle Implantation: The AOC coating for evaluated for toxicity. Test articles were implanted into the muscle of rabbits. Results: After 2 weeks, the test article was classified as a non-irritant.
- Genotoxicity Mouse Bone Marrow Micronucleus: The AOC coating for evaluated for genotoxicity using the mouse bone marrow micronucleus model. Results: The coating showed no evidence of cellular toxicity.
- Genotoxicity: Bacterial Reverse Mutation: The AOC coating for evaluated for genotoxicity using Bacterial Reverse Mutation. Results: The coating showed no evidence of cellular toxicity.
- Genotoxicity: In Vitro Chromosomal Aberration: The AOC coating for evaluated for genotoxicity using In Vitro Chromosomal Aberration. Results: The coating showed no evidence of cellular toxicity.
- Bone Implantation Study in the Femur of the Rabbit: The AOC coating was implanted into the femurs of rabbits and evaluated after 4 and 8 weeks. Results: The test article was absorbed and all sites were healing normally.
- AOC Polymer Hemolysis: The AOC coating for evaluated for hemolysis using In Vitro rabbit red blood cells. Results: The test article was non-hemolytic.
- PPE Post-irradiation Cytotoxicity: An in vitro study of the irradiated PPE implant extract using MEM Elution. Results: The test articles were non-cytotoxic.
- ISO Intramuscular Implantation AOC Coated & Uncoated PPE: AOC Coated & Uncoated PPE devices were implanted into rabbit muscle and histopathology was performed after 1, 2 and 4 weeks. Results: Fibrovascular ingrowth occurred into coated and uncoated implants.
- Suture Pull-out of AOC-Coated Biopor® Porous Polyethylene Implant: Coated implants were evaluated for strength using a suture pull-out test method. Results: The test articles met acceptance criteria.
- Biopor® Sheet Performance Qualification: Coated and uncoated implants were evaluated for flexibility. Results: The test articles met acceptance criteria.
- Porosity Characterization of Porous Polyethylene Implants: Coated and uncoated implants were evaluated for porosity with the criteria of pore size greater than 40 µm. Results: The test articles met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
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.(b)
Classification. Class II (performance standards).
0
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| Research and/or Educational Use Only |
|---|
| Commercial Use |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510 (K) SUMMARY:
Submitted by:
Chelsea Mitchell Ceremed. Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (424) 258-1888 Fax: (310) 815-2130
| Contact Person: | Chelsea Mitchell |
|---|---|
| Date Prepared | September 27, 2016 |
| Common/Usual Name: | Porous High Density Polyethylene |
| (HDPE) Surgical Implant | |
| Proprietary Name: | Biopor® Porous Polyethylene Implants |
| Classification Name: | Plate, Cranioplasty, Preformed, Alterable |
| (21 CFR 882.5320) | |
| Product Code: | GWO |
Predicate Device:
-
- 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.
4
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 | ||
| Use Statement | 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. | Biopor® Porous Polyethylene Implants in block, | |
| sheet, and anatomical shapes are intended for the | ||
| augmentation or reconstruction of the | ||
| "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 in vitro study of the
irradiated PPE implant extract
using MEM Elution. | The test articles were non-cytotoxic. |
| ISO
Intramuscular
Implantation
AOC Coated &
Uncoated PPE | AOC Coated & Uncoated PPE
devices were implanted into
rabbit muscle and histopathology
was performed after 1, 2 and 4
weeks. | Fibrovascular ingrowth occurred into
coated and uncoated implants. |
| Suture Pull-out of
AOC-Coated
Biopor Porous
Polyethylene
Implant | Coated implants were evaluated
for strength using a suture pull-
out test method | The test articles met acceptance criteria. |
| Biopor Sheet
Performance
Qualification | Coated and uncoated implants
were evaluated for flexibility. | The test articles met acceptance criteria. |
| Porosity
Characterization
of Porous
Polyethylene
Implants | Coated and uncoated implants
were evaluated for porosity with
the criteria of pore size greater
than 40 µm. | The test articles met acceptance criteria. |
5
6
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.