(56 days)
AOC™ Porous Polyethylene Surgical Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
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.
The provided text describes a 510(k) submission for the Ceremed, Inc. AOC Porous Polyethylene surgical implants. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Details about a study to prove the device meets acceptance criteria (as this is not required for a 510(k) submission in the same way it would be for a PMA).
- Sample size used for a test set or its data provenance.
- Number and qualifications of experts used to establish ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on:
- Device Description: AOC™ Porous Polyethylene Surgical Implants are made of porous high-density polyethylene (HDPE), used for craniofacial reconstruction. They can be coated with an alkylene oxide copolymer blend and/or have embedded titanium mesh. They are provided sterile by irradiation.
- Intended Use: Augmentation or reconstruction of the craniomaxillofacial skeleton.
- Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (Ceremed, Inc. AOC™ Porous Polyethylene Surgical Implants K043133 and Porex Surgical Inc. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364) based on:
- Same intended use and indications for use.
- Biocompatibility of the alkylene oxide copolymer blend in accordance with ISO-10993.
- Mechanical properties being substantially equivalent to predicate devices, with minor differences raising no new issues of safety and efficacy.
Conclusion:
This document is a 510(k) summary, which inherently focuses on demonstrating "substantial equivalence" to existing predicate devices rather than establishing de novo performance against acceptance criteria in the manner of a clinical trial. As such, the information requested in your prompt (specific acceptance criteria, study details, expert involvement for ground truth, AI performance metrics, etc.) is not applicable to or present in this type of regulatory submission.
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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
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Ceremed, Inc. AOC Porous Polyethylene 510 (k) Submission
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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.
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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.
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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
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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
§ 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.