(42 days)
Not Found
No
The device description and intended use describe a physical implant material with no mention of software, algorithms, or data processing, which are typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is described as an implant material and a space-occupying material that acts as an adjunct during the natural healing process, but it does not actively treat or cure a disease or condition itself.
No
This device is described as an "aqueous water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process." Its intended use is therapeutic (implant and space-occupying material for healing), not for diagnosing a condition or disease.
No
The device is described as a physical, wax-like implant material comprised of a sterile aqueous mixture of water-soluble alkylene oxide copolymers. It is a tangible product, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as an "aqueous water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process." This indicates it is used in vivo (within the body) to support healing, not in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a material designed to be implanted or used as a space filler within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples of human origin (blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
Therefore, this device falls under the category of a medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
AOC" -L is indicated for use as an aqueous water-soluble implant material and as a water-soluble space occupying material, as an adjunct during the natural healing process.
Product codes (comma separated list FDA assigned to the subject device)
KHJ
Device Description
AOC" -L Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. 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.
AOC" -L Soluble Implant Material is comprised of a sterile aqueous mixture of watersoluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. AOC" -L Soluble Implant Material contains no other additives or colorants. AOC" -L Soluble Implant Material is formed of various weights ranging from 0.5 to 5 grams each.
AOC" -L Soluble Implant Material is 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
Not Found
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
§ 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.
0
KDS82245 Page 1/2
Ceremed, Inc. 510 (k) Premarket Notification - AOCTM -L Soluble 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
SEP 1 8 2008
| Contact Person: | Tadeusz Wellisz, M.D. |
|---|---|
| Date Prepared | September 14, 2008 |
| Common/Usual Name: | AOC™-L Soluble Implant Material |
| Proprietary Names: | AOC™, Ostene™, AOC™ Implant Material, Ccretene™, AOC™-LV |
| Regulation Number: | 21 CFR section 874.3620 |
| Regulation Name: | Synthetic polymer material |
| Regulatory Class | II |
| Product Code | KHJ |
| Predicate Device | Ceremed, Inc. |
| AOC™ Soluble Implant Material (K081531) |
Description of the device:
AOC" -L Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. 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.
AOC" -L Soluble Implant Material is comprised of a sterile aqueous mixture of watersoluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. AOC" -L Soluble Implant Material contains no other additives or colorants. AOC" -L Soluble Implant Material is formed of various weights ranging from 0.5 to 5 grams each.
AOC" -L Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
Intended use:
1
K082245 Page 2/2
Ceremed, Inc. Page 7 - 2 510 (k) Premarket Notification - AOCTM -L Soluble Implant Material
AOC" -L is indicated for use as an aqueous water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
Fundamental Technology:
AOC" -L Soluble Implant Material is comprised of a sterile aqueous mixture of watersoluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. The copolymers dissolve from the site of application, and are not metabolized, but are eliminated from the body unchanged in the urine and feces.
AOC" -L Soluble Implant Material differs from the predicate device in that water has been added to alter the handling properties of the device.
Substantial equivalence:
AOC" -L Soluble Implant Material has the same intended use fundamental scientific technology and indication for use as the legally marketed predicate, AOC" Soluble Implant Material (K081531).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2008
Ceremed. Inc. % Tadeusz Wellisz, M.D. 3643 Lenawee Avenue Los Angeles, California 90016
Re: K082245
Trade/Device Name: AOC™ -L Soluble Implant Material, AOC™, Oxtene™, AOC™ Implant Material, Ceretene", AOC'" -LV Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: KHJ Dated: July 28, 2008 Received: August 7, 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 (OS) 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 - Tadeusz 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 N. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ceremed, Inc. Page 12 - 1 510 (k) Premarket Notification - AOC" (m -L Soluble Implant Material
XII. INDICATIONS FOR USE:
510 (k) Number (if known):
Device Name:
AOC" -L Soluble Implant Material, AOC", Ostene", AOC" Implant Material, Ceretene™ AOC™-LV
Indications For Use:
AOC" -L is indicated for use as an aqueous water-soluble implant material and as a water-soluble space occupying material, as an adjunct during the natural healing process.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR 801.109)
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 EVALUATION (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number k08229
Peter Thiel
Division Sign-Off 510(k) Number