(77 days)
Not Found
No
The device description and performance studies focus on the physical properties and hemostatic function of a water-soluble implant material, with no mention of AI or ML.
Yes
The device is indicated for "control of bleeding from bone surfaces," which is a physiological treatment, classifying it as a therapeutic device.
No
The device is described as a water-soluble implant material used to control bleeding and act as a bone hemostasis agent, which are therapeutic functions, not diagnostic.
No
The device is described as a "water-soluble implant material" and a "wax-like material formed into sticks," which are physical components, 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 "for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces in cardiothoracic surgery surgery following sternotomy". This describes a device used in vivo (within the body) during surgery to control bleeding.
- Device Description: The description details a "water-soluble surgical implant material" that acts as a "bone hemostasis agent" by creating a "physical barrier" and "plugging the vascular openings in the bone". This is a physical action performed directly on the patient's tissue.
- 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.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical implant used directly on the surgical site to control bleeding.
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 in cardiothoracic surgery following sternotomy.
Product codes
MTJ
Device Description
Ostene® CT is a water-soluble surgical implant material for use in cardiothoracic surgery. 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces (in cardiothoracic surgery following sternotomy)
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)
The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this substantially equivalent in indications and intended use; and is identical in design, materials, sterilization, and performance to the predicate Ostene®CT (K091636).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K10207/
OCT - 8 2010
Ceremed, Inc. · Page 6 - 1 Rev b 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
VI - 510 (K) SUMMARY
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 | October 06, 2010 |
| Common/Usual Name: | Soluble Bone Hemostasis Implant Material |
| Proprietary Name: | Ostene®CT Bone Hemostasis Implant |
| Material, AOC™ CT, Osteotene™, | |
| Ceretene™ | |
| Regulatory Class: | Unclassified |
| Classification Name: | Wax, Bone |
| Product Code: | MTJ |
| Predicate Device: | Ceremed, Inc. |
| Ostene®CT Soluble Bone Hemostasis | |
| Implant Material (K091636) |
Description of the device:
Ostene® CT is a water-soluble surgical implant material for use in cardiothoracic surgery. 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. 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.
1
4102071
Page 6 - 2 Rev b Zo FZ Ceremed, Inc. 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 in cardiothoracic surgery following sternotomy.
Substantial equivalence:
The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this substantially equivalent in indications and intended use; and is identical in design, materials, sterilization, and performance to the predicate Ostene®CT (K091636).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an eagle or bird with three wing-like shapes extending upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ceremed, Inc. % Tadeusz Wellisz M.D. Chairman 3643 Lenawee Avenue Los Angeles, California 90016
OCT - 8 2010
Re: K102071
Trade/Device Name: Ostene®CT, AOC™ CT, Osteotene™, Ceretene™ Regulatory Class: Unclassified Product Code: MTJ Dated: September 24, 2010 Received: September 29, 2010
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Tadeusz Wellisz M.D.
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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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. Page 5 - 1 Rev 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
V. INDICATIONS FOR USE:
510 (k) Number (if known): K102071
OCT - 8 2010
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 in cardiothoracic surgery surgery following sternotomy .
| 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 Krane for UXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102071
Division Sign-Off
: : 510(k) Number_