(27 days)
Not Found
No
The device description and intended use clearly describe a physical material (wax) used for mechanical hemostasis. There is no mention of any computational or data-driven components, let alone AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is used to control bleeding from bone surfaces by creating a physical barrier, which is a therapeutic function.
No
The document describes AOC Bone Wax as a material used to control bleeding from bone surfaces by creating a physical barrier, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a "wax-like material" and describes its physical properties and mechanism of action as a physical barrier. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control bleeding from bone surfaces by creating a physical barrier. This is a direct interaction with the patient's body during a surgical procedure.
- Device Description: The description details a physical material applied directly to bone.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.
Product codes
MTJ
Device Description
AOC Bone Wax 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 additional handling and manipulation, if so desired. AOC Bone Wax is provided sterile by irradiation and must not be resterilized.
Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
OCT 1 1 2005
Ceremed. Inc. AOC Bone Wax Special 510 (k) Submission
IX - 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
Contact Person: Date Prepared
Common/Usual Name:
Tadeusz Wellisz, M.D. August 29, 2005
Common/Usual Name:
Proprietary Name:
Classification Name:
Predicate Device:
Bone Wax
AOC Bone Wax Ostene TM, Osteotene TM, Ceretene тм
Unclassified
Ceremed, Inc. AOC Bone Wax K050440, K041363
Description of the device:
AOC Bone Wax 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 additional handling and manipulation, if so desired. AOC Bone Wax is provided sterile by irradiation and must not be resterilized.
Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Intended use:
AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.
Substantial equivalence:
The modified AOC Bone Wax has the same intended use fundamental scientific technology as the legally marketed AOC Bone Wax.
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Image /page/1/Picture/2 description: The image shows a circular logo for the Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the top half of the circle.
OCT 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tadeusz Wellisz, M.D. President Ceremed. Inc. 3643 Lenawec Avenue Los Angeles, California 90016
Re: K052528
Trade/Device Name: AOC'" Bone Wax, Ostenc", Osteotene", Ceretene" Regulatory Class: Unclassified Product Code: MTJ Dated: September 12, 2005 Received: September 14, 2005
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.
2
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
S. Mark Mullen
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ceremed, Inc. Special 510 (k) - AOC Bone Wax
YII. INDICATIONS FOR USE:
510 (k) Number (if known): _KOS2526
Device Name: AOC™ Bone Wax, Ostene™, Osteotene™, Ceretene™, Ceretene TM
Indications For Use: AOC Bone Wax is indicated for use in the control of bleeding from bone surfaces.
Prescription Use ﮯ (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)
200
Division Sign-Off) (Division Dig.)
Division of General, Restorative, and Neurological Devices
510(k) Number K052528
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