(27 days)
Not Found
No
The device description focuses on the physical properties and mechanism of action of a wax-like material for bone hemostasis, with no mention of AI or ML.
No.
The device description states OSTENE CT is indicated for use in the control of bleeding from bone surfaces, acting as a physical barrier to stop bleeding by plugging vascular openings. This function is not considered therapeutic, but rather a hemostatic agent.
No
Ostene CT is described as a water-soluble implant material and a hemostasis agent to control bleeding from bone surfaces by creating a physical barrier. It treats a condition rather than diagnosing it.
No
The device description clearly indicates that Ostene is a physical, wax-like material provided in sticks, intended for direct application to bone surfaces. It is a tangible implant material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a water-soluble implant material and for use in the control of bleeding from bone surfaces." This describes a device used in vivo (within the body) to physically stop bleeding.
- Device Description: The description details a "wax-like material" that is applied directly to bone surfaces to create a physical barrier. This is a mechanical action within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside of the body on biological samples. This device is used inside the body for a therapeutic purpose (hemostasis).
N/A
Intended Use / Indications for Use
OSTENE is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
OSTENE® CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device Description
Ostene 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.
Ostene is comprised of a sterile mixture of water-soluble alkylene oxide copolymers. derived from ethylene oxide and propylene oxide. Ostene contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.
As a bone hemostasis agent, Ostene stops 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. Ostene, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene 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
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 (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
N/A
0
SEP 2 4 2008
K082491
page 1/2
Ceremed, Inc. Special 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
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: | Tadeusz Wellisz, M.D. |
|---|---|
| Date Prepared | August 27, 2008 |
| Common/Usual Name: | Soluble Bone Hemostasis Implant Material |
| Proprietary Name: | Ostene ® CT, Ostene ® , AOC ™ CT, |
| AOC ™ , Osteotene ™ , Ceretene ™ | |
| Classification Name: | Polymer, Synthetic, Water-soluble |
| Predicate Device: | Ceremed, Inc. |
| Ostene ® Soluble Bone Hemostasis Implant | |
| Material (K070093) |
Description of the device:
Ostene 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.
Ostene is comprised of a sterile mixture of water-soluble alkylene oxide copolymers. derived from ethylene oxide and propylene oxide. Ostene contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.
As a bone hemostasis agent, Ostene stops 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. Ostene, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene is provided sterile by irradiation and must not be resterilized.
1
K082491 Page2/2
Ceremed, Inc. Page 9 - 2 Special 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
Intended use:
OSTENE is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Substantial equivalence:
The modified Ostene®CT Soluble Bone Hemostasis Implant has the same intended use fundamental scientific technology as the legally marketed Ostene® Soluble Bone Hemostasis Implant.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
SEP 2 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ceremed, Inc. % Tadeusz Wellisz, M.D. 3643 Lenawee Avenue Los Angeles, California 90016
Re: K082491
Trade/Device Name: Ostene® CT Soluble Bone Hemostasis Implant Material, AOC™ Ostene™, Osteotene™, Ceretenc Regulation Number: Unclassified
Product Code: MTJ Dated: August 27, 2008 Received: August 28, 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 cquivalent (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.
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 M. Wilkerson
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. Special 510 (k) - Ostenc®CT Soluble Bone Hemostasis Implant Material
VII. INDICATIONS FOR USE:
510 (k) Number (if known):
Device Name: Ostene®CT Soluble Bone Hemostasis Implant Material, AOC™CT, AOC™, Ostene™, Osteotene™, Ceretene™
Indications For Use:
OSTENE® CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number k Page 4 of 5
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