(46 days)
AOC "M is indicated for as a water-solubic implant material and as a water-soluble space occupying material, as an adjunct during the natural healing process.
Not Found
The provided text describes a 510(k) premarket notification for a medical device (AOC™ Soluble Implant Material) and its substantial equivalence to predicate devices. However, it does not contain any information about specific acceptance criteria, device performance metrics, or a study that proves the device meets such criteria.
The document is a regulatory submission for market clearance, focusing on:
- Identification of the device and its manufacturer.
- Classification and product codes.
- Identification of predicate devices.
- Formal FDA notification of clearance.
- Indications for Use statement.
Therefore, I cannot provide the requested table and study details based on the input text. The information required, such as specific performance metrics (sensitivity, specificity, accuracy, etc.), sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone performance, is not present in the provided excerpt.
To reiterate, the input does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance details.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Details about a standalone (algorithm only) performance study.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
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K081531
Page 7 - 1
Ceremed, Inc. 510 (k) Premarket Notification - AOC™ Soluble Implant Materia
VII - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitted by:
JUL 1 8 2008
Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (310) 815-2125 Fax: (310) 815-2130
Contact Person:
Date Prepared
Common/Usual Name:
Proprietary Names:
Classification Name:
Tadeusz Wellisz, M.D.
May 23, 2008
AOC™ Soluble Implant Material
AOC", AOC" Implant Material, Ceretene"", AOC"-ES, AOC"-LV
Ear, nose, and throat synthetic polymer material (per 21 CFR section 874.3620)
Product Code
KHI
Predicate Devices
-
- Ceremed, Inc. Ostene® Soluble Implant Material (K062280)
- Ceremed, Inc. 2. AOCTM Porous Polyethylene Surgical Implants (K080507)
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle emblem, with the eagle's head facing left and its wings forming a flowing, abstract shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ceremed, Inc. % Tadeusz Wellisz, M.D. President 3643 Lenawee Avenue Los Angeles, California 90016
JUL 1 8 2008
Re: K081531 Trade/Device Name: AOC™, AOC™ Implant Material, AOC™ Soluble Implant Material, Ceretene™, AOC™ -ES, AOC™ -LV Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: KHJ Dated: May 23, 2008 Received: June 5, 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
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Page 2 - Tadeusz Wellisz, M.D.
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.
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 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. Millican
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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Ceremed, Inc. 510 (k) Premarket Notification - AOC™ Soluble Implant Material
XII. INDICATIONS FOR USE:
510 (k) Number (if known):
Device Name:
AOC™, AOC™ Implant Material, AOC™ Soluble Implant Material, Ceretene™, AOC™ ES, AOC™-LV
108153
Indications For Use:
AGC "M is indicated for as a water-solubic implant material and as a water-soluble space occupying material, as an adjunct during the natural healing process.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
bb
(Division Signes Division of General, Restorative, and Neurological Devices
Page 1 of of
510(k) Number
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.