(279 days)
None
Not Found
No
The summary describes a physical implant made of porous polyethylene and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an implant intended for the augmentation or reconstruction of the maxillofacial skeleton, which indicates it is used for treatment purposes.
No
The device is described as an implant for augmentation or reconstruction, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it is a "Porous High Density Polyethylene (HDPE) Surgical Implant," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
- This device is an implant. It is a surgical implant intended to be placed within the human body for augmentation or reconstruction.
The description clearly states its purpose is for surgical implantation, not for testing or analyzing biological samples.
N/A
Intended Use / Indications for Use
Biopor® Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.
Product codes
KKY
Device Description
Porous High Density Polyethylene (HDPE) Surgical Implant
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, connected by a flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2015
Ceremed Incorporated Ms. Chelsea Mitchell Vice President of Regulatory Affairs 3643 Lenawee Avenue Los Angeles, California 90016
Re: K141880
Trade/Device Name: Biopor® Porous Polyethylene Implants Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY Dated: February 24, 2015 Received: March 6, 2015
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
1
device-related 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.
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/Resourcesfor You/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 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.
for
Sincerely yours,
David Krause -S
- 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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Ceremed, Inc. Page 5 - 1 (Revised 2/15) Traditional 510 (k) Premarket Notification - Biopor®
V. INDICATIONS FOR USE:
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Biopor® Porous Polyethylene Implants
Indications For Use:
Biopor® Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (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)
Division Sign-Off
510(k) Number_________________________________________________________________________________________________________________________________________________________________
3
Page 4 - 1 (Revised 4/15) Ceremed, Inc. Traditional 510 (k) Premarket Notification – Biopor®
IV. GENERAL INFORMATION:
A. DEVICE NAME:
| a. Common/Usual Name: | Porous High Density Polyethylene
(HDPE) Surgical Implant |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------|
| b. Proprietary Name: | Biopor®, AOC™ Porous
Polyethylene, Cerepor™,
In the future other brand names may
be used by individual licensees. |
| c. Classification Name: | Polytetrafluoroethylene with carbon
fibers composite implant material
(per 21 CFR section 878.3500) |
B. DEVICE SPONSOR:
| a. Manufacturer: | Ceremed, Inc.
3643 Lenawee Ave.
Los Angeles, California 90016
Tel: (310) 815-2125
Fax: (310) 815-2130 |
|------------------|-------------------------------------------------------------------------------------------------------------------|
| b. Establishment | 3004961344 |
| Registration No: | Owner/Operator # 9063721 |
c. Sterilization Sites:
Sterigenics IBA Advanced Materials Division San Diego, California 92121 Phone (858) 271-6330 Fax (858) 271-0957
C. CLASSIFICATION:
| a. Class: | II |
|---|---|
| b. Product Code: | KKY |
c. Panel: Restorative Devices Surgical, Orthopedic, and
D. PERFORMANCE STANDARDS: None established
- E. SHELF LIFE: 5 years