(126 days)
OSTENE® is indicated for use as a water-soluble implant material for use in the control of bleeding from bone surfaces and as a water-soluble space occupying material as an adjunct during the natural healing process.
Ostene® is a water-soluble odorless, opaque wax-like material consisting of a sterile mixture of alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Ostene® is provided sterile by irradiation and must not be resterilized.
This is a 510(k) premarket notification for a medical device (Ostene Implant Material), not a study report for an AI/ML powered device. As such, it does not contain the information required to answer your prompt regarding acceptance criteria and a study proving a device meets those criteria, particularly within the context of AI/ML performance.
The document discusses substantial equivalence to predicate devices based on intended use, fundamental scientific technology, and biocompatibility. It does not mention any performance metrics, studies with test sets, ground truth establishment, or human reader effectiveness with or without AI assistance.
Therefore, I cannot populate the table or provide the requested details because this K062280 document does not contain information about studies related to AI/ML device performance.
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K062280 Page 11
Ceremed, Inc. 510 (k) Premarket Notification - Ostene Implant Material
VII - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitted by:
Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (310) 815-2125 Fax: (310) 815-2130
DEC 1 1 2006
| Contact Person: | Tadeusz Wellisz, M.D. |
|---|---|
| Date Prepared | November 14, 2006 |
| Common/Usual Name: | Soluble Polymer Surgical Implant Material |
| Proprietary Names: | Ostene®, AOC™, Osteotene™, Ceretene™, Cerepor™, Aptene™, Apatene™, Actipaste™ |
| Classification Name: | Synthetic Polymer Material, (per 21 CFR 874.3620) |
Product Code:
KHJ, MTT
Predicate Devices
- 1 . Ceremed, Inc. AOC™ Porous Polyethylene Surgical Implants K043133
-
- Ceremed, Inc. AOC™ Bone Wax K041363
-
- Ceremed, Inc. AOC" Bone Wax (Ostene®) K052528
-
- Genzyme Corp. Sepragel™ ENT K043035
-
- Medtronic Xomed, Inc. MeroGel™ Injectable K002972
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K062280 Page 2/2
Page 8
Ceremed. Inc. 510 (k) Premarket Notification - Ostene Implant Material
Description of the device:
Ostene® is a water-soluble odorless, opaque wax-like material consisting of a sterile mixture of alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Ostene® is provided sterile by irradiation and must not be resterilized.
Intended use:
Ostene® is intended for use as a water-soluble space occupying material as an adjunct during the natural healing process and it provides for control of bleeding from bone surfaces by acting as a mechanical barrier.
Substantial equivalence:
The Ostene® in this application has the same intended use fundamental scientific technology as the legally marketed AOC™ Bone Wax (Ostene®) and the coating of AOC™ Porous Polyethylene Surgical Implants. The classification of the Ostene® as water-soluble synthetic polymer material for use as a space occupying material is supported by its comparison to the legally marketed device Sepragel (K043035) and MeroGel (K002972).
The Ostene® in this application as a bone hemostatic agent is identical to, and has the same intended use and indications for use as the predicate device AOC™ Bone Wax (Ostene®). 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.
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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 two main elements: a symbol and text. The symbol is a stylized representation of an eagle or bird, with three curved lines forming its body and wings. The text is arranged in a circular fashion around the symbol, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ceremed, Inc. DEC 1 1 2006 % Tad Wellisz, M.D. President 3643 Lenawee Avenue Los Angeles, California 90016 Re: K062280 R002280
Trade/Device Name: Ostene", AOC"", Osteotene™, Ceretene™, Aptene™",
Actipaste", Apatene™, Actipaste™ Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: KHJ, MTJ Dated: November 14, 2006 Received: November 16, 2006
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 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 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 vours,
Yol N
Mark N. Melkerson
DEP Director
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 – Ostene Implant Material
XII. INDICATIONS FOR USE:
510 (k) Number (if known): __________________________________________________________________________________________________________________________________________________
Device Name: Ostene®, AOC™, Osteotene™, Ceretene™, Cerepor™, Aptene™, Apatene™, Actipaste™
Indications For Use:
OSTENE® is indicated for use as a water-soluble implant material for use in the control of bleeding from bone surfaces and as a water-soluble space occupying material as an adjunct during the natural healing process.
Prescription Use
(Per 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Sign Off
(Division Sign-Off) Division of General, Restorative, Page 1 of and Neurological Devices
510(k) Number L062280
§ 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.