(18 days)
Not Found
No
The device description and intended use focus on the physical properties and function of a bone hemostasis material, with no mention of AI or ML.
No.
The device description clearly states its purpose is to control bleeding from bone surfaces by creating a physical barrier, which is a hemostasis agent, not a therapeutic treatment.
No
Explanation: The device is indicated for use as a water-soluble implant material and for controlling bleeding from bone surfaces, acting as a physical barrier to stop bleeding. It does not diagnose any condition.
No
The device is described as a "wax-like material" and a "sterile mixture of water-soluble alkylene oxide copolymers," which are physical substances, 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 that is applied directly to the body to achieve a physical effect (stopping bleeding).
- Device Description: The description details a physical material (wax-like) that acts as a "physical barrier" to plug vascular openings in bone. This is a mechanical action, not a diagnostic test performed on a sample from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device Description
Ostene®CT 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®CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. Ostene® CT 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®CT 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 CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene®CT is provided sterile by irradiation and must not be resterilized. A substitution has been made in a neutral excipient copolymer.
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
N/A
0
K09636
Ceremed. Inc. Special 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
IX - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitted by:
JUN 22 2009
Page 9
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 Name:
Regulatory Class:
Classification Name:
Product Code:
Predicate Device:
Tadeusz Wellisz, M.D.
June 1, 2009
Soluble Bone Hemostasis Implant Material
Ostene®CT, AOC™CT, Osteotene™, Ceretene
Unclassified
Wax, Bone
MTJ
Ceremed, Inc. Ostene® Soluble Bone Hemostasis Implant Material (K082491)
Description of the device:
Ostene®CT 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®CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. * Ostene® CT 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®CT 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 CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene®CT is provided sterile by irradiation and must not be resterilized. * A substitution has been made in a neutral excipient copolymer.
1
K091636 Page 7/2
Ceremed, Inc. Page 9 - 2 Special 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
Intended use:
Ostene®CT 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 and fundamental scientific technology as the legally marketed Ostene®CT Soluble Bone Hemostasis Implant.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines or strokes.
Public Health Service
JUN 22 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ceremed, Inc. % Tadeusz Wellisz, M.D. Chairman 3643 Lenawee Avenue Los Angeles, California 90016
Re: K091636
Trade/Device Name: Ostene®CT, AOC™CT, Osteotene™, Ceretene™ Regulatory Class: Unclassified Product Code: MTJ Dated: June 1, 2009 Received: June 4, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 A. Milken
Mark N.Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ceremed, Inc.
Special 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
VII. INDICATIONS FOR USE:
510 (k) Number (if known): Kog (1 (236
Device Name: Ostene®CT, AOC™CT, 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 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)
Daniel Krone for MXM
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091636
Division Sign-Off
510(k) Number