(56 days)
Not Found
No
The summary describes a physical implant made of porous polyethylene and titanium mesh, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended for the "augmentation or reconstruction of the craniomaxillofacial skeleton", which means it is used to repair or improve parts of the body structurally or functionally, fitting the definition of a therapeutic device.
No
The device is described as an implant for augmentation or reconstruction, not for identifying a disease or condition.
No
The device description clearly states that the device is provided as physical blocks, sheets, and anatomical shapes made of porous high-density polyethylene (HDPE), which are physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "augmentation or reconstruction of the craniomaxillofacial skeleton." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "surgical implant" made of porous polyethylene. This is a physical object implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the AOC™ Porous Polyethylene Surgical Implants are a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AOC™ Porous Polyethylene Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Product codes (comma separated list FDA assigned to the subject device)
KKY
Device Description
AOC™ Porous Polyethylene Surgical Implants are provided as blocks, sheets, and anatomical shapes, and are manufactured of porous high-density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years. 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 Implants are provided sterile by irradiation and must not be resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial skeleton
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)
Not Found
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.
Not Found
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
§ 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
Page 1 of 2
Ceremed, Inc. AOC Porous Polyethylene 510 (k) Submission
Page 7 - 1
YII - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitted by:
APR 2 1 2008
Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (310) 815-2125 Fax: (310) 815-2130
Contact Person: Tadeusz Wellisz, M.D. Date Prepared February 14, 2008 Common/Usual Name: Porous High Density Polyethylene (HDPE) Surgical Implants Proprietary Names: AOCTM Porous Polyethylene, AOC™ Porous HDPE, AOC™ Porous Polyethylene Surgical Implant, Cerepor, PPE, PPE, PPE C, PPE Ti, PPE C-Ti, Synpor™, Synpor™ C, Synpor™ Ti, Synpor™ C-Ti, Biopor™, Biopor™ C. Biopor™ Ti, Biopor™ C-Ti Polymer ENT Synthetic, Porous
Classification Name:
Polyethylene (per 21 CFR section 874.3620)
Predicate Devices
-
- Ceremed, Inc. AOC™ Porous Polyethylene Surgical Implants K043133
-
- · Porex Surgical Inc. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364
1
Ceremed, Inc. AOC Porous Polyethylene 510 (k) Submission
ise 2 of 2
Page 7 - 2
Description of the device:
AOC™ Porous Polyethylene Surgical Implants are provided as blocks, sheets, and anatomical shapes, and are manufactured of porous high-density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years. 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 Implants are provided sterile by irradiation and must not be resterilized.
Intended use:
AOC™ Porous Polyethylene Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Substantial equivalence:
AOC™ Porous Polyethylene Surgical Implants have the same intended use and indications for use as the predicate devices made of porous polyethylene. 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with its wings forming abstract shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2008
Ceremed, Inc. % Tad Wellisz, M.D. President 3643 Lenawee Avenue Los Angeles, California 90016
Re: K080507
Trade/Device Name: AOC Porous Polyethylene Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY Dated: February 14, 2008 Received: March 12, 2008
Dear Dr. Wellisz:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 -- Tad Wellisz, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ _ K080507
Device Name: AOC Porous Polyethylene
Indications For Use:
AOC™ Porous Polyethylene Surgical Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogle - fos mkm
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
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510(k) Number K010507