(110 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 provided with a coating of a water-soluble alkylene oxide copolymer blend. AOC Porous Polyethylene Implants are provided sterile by irradiation and must not be resterilized.
The provided document is a 510(k) summary for the Ceremed, Inc. AOC Porous Polyethylene surgical implant. It focuses on establishing substantial equivalence to predicate devices and describes the device, its intended use, and regulatory classification.
However, the document does not contain any information regarding acceptance criteria, device performance metrics, study design, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about the study that proves the device meets the acceptance criteria based on the provided text. The document is a regulatory submission for premarket notification, not a detailed technical performance study report.
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Ceremed, Inc. AOC Porous Polyethylene 510 (k) Submission MAR 2 --
VII - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitted by:
Carl Children Children
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 November 8, 2004 Common/Usual Name: Porous High Density Polyethylene (HDPE) Surgical Implants Proprietary Names: AOCTM Porous Polyethylene, AOCTM Porous HDPE, AOC™ Porous Polyethylene Surgical Implant, Cerepor™ Classification Name: Polymer ENT Synthetic, Porous Polyethylene (per 21 CFR section 874.3620)
Predicate Devices
- ePor, Inc. l . Porous HDPE Surgical Implants K022665
-
- Ceremed, Inc. AOC™ Bone Wax K041363
-
- Porex Surgical Inc. MEDPOR® Surgical Implant Material: Preformed Cranial and Facial Implants K922489
-
- Porex Surgical Inc. MEDPOR® Plus Surgical Implant Biomaterial K012350
- Porex Surgical Inc. 5. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364
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Ceremed, Inc. AOC Porous Polyethylene 510 (k) Submission
343033 2/2
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 provided with a coating of a water-soluble alkylene oxide copolymer blend. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 - 2005
Tadeusz Wellisz, M.D. President Ceremed, Inc. 3643 Lenawee Avenue Los Angeles, California 90016
Re: K043133
Trade/Device Name: AOC Porous Polyethylene Regulation Number: 21 CFR 878.3500 Regulation Name: PTFE with carbon fibers implant Regulatory Class: II Product Code: KKY Dated: January 14, 2005 Received: January 21, 2005
Dear Dr. Wellisz:
We have reviewed your Section 510(k) premarket notification of intent to arrice the indication We have reviewed your Section 910(x) presidentially equivalent (for the indications
referenced above and have determined the device is substantially equivalent relerenced above and nave determined we marketed predicate devices marketed in interstate for use stated in the encrosury manated problem of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enatures with the provisions of the Federal Food. I'my, devices mar nave been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The You may, ulcrefore, market the device, exciter, excirements for annual registration, listing of general controls provisions of were ice, 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 If your device is classified (500 above) ans. Existing major regulations affecting your device can inay be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Councements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dr Fristians over device complies with other requirements of the Act that I DT has made a solo regulations administered by other Federal agencies. You must of any it cach statutes and regulations ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN I at 607), adomig (21 CFR Part 820), and if applicable, the clectronic north in the quality byticles (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Tadeusz Wellisz, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yours of substantial equivalence of your device to a legally premated 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 n you a the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golders, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ceremed, Inc. 510 (k) Premarket Notification - AOC Porous Polyethylene
XII. INDICATIONS FOR USE:
KO43133 510 (k) Number (if known):
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
(Per 21 CFR 801.109) X
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 EV ALUATION (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K043133
Division Sign-Off
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.