(71 days)
Not Found
No
The device description and intended use focus on the physical properties and mechanical function of the bone putty. There is no mention of AI, ML, or any computational analysis of data.
No
Explanation: The device is intended for mechanical control of bleeding, acting as a barrier, rather than directly treating a disease or condition by restoring health or normal function.
No
The device is described as a hemostatic bone putty used to control bleeding, acting as a mechanical barrier. It does not provide any diagnostic information or assessment of a patient's condition.
No
The device description clearly states it is a "sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency" and mentions the addition of a spatula, indicating it is a physical medical device, 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 to control bleeding from bone by acting as a mechanical barrier. This is a therapeutic/surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical material applied directly to the bone during surgery. It does not involve analyzing biological samples (like blood, urine, tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description and performance studies do not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's condition
- Using reagents or assays
The device is a surgical hemostatic agent, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Hemasorb Resorbable Hemostatic Bone Putty is intended for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.
Product codes (comma separated list FDA assigned to the subject device)
MTI
Device Description
Orthocon Hemasorb Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material is a mixture of calcium stearate, vitamin E acetate and a liquid surfactant. The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. Hemasorb requires no kneading prior to application and does not soften appreciably at body temperature. The subject of this 510(k) is the addition of a spatula as an alternative method of Hemasorb application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures
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 in vitro tests performed were: simulated use and shipping (including mechanical tests of cyclic compression and tensile failure testing), finite element analysis, and stability (including sterile package integrity). The device was determined to be biocompatible and to demonstrate adequate integrity and performance characteristics.
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
K113627 68 1 64 5
FEB 1 7 2012
510(k) Summary
| Contact: | Rosemary Harry
Vice President, Regulatory and Quality Affairs
Orthocon, Inc
1 Bridge Street, Suite 121
Irvington, NY 10533
harry@orthocon.com
914-357-2600 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | January 18, 2012 |
| Device Trade Name: | Hemasorb® Resorbable Hemostatic Bone Putty |
| Manufacturer: | Orthocon, Inc.
1 Bridge Street
Suite 121
Irvington, NY 10533 |
| Common Name: | Wax, bone |
| Classification: | None applicable |
| Class: | Unclassified |
| Product Code: | MTI |
Indications For Use:
Hemasorb Resorbable Hemostatic Bone Putty is intended for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.
Device Description:
Orthocon Hemasorb Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material is a mixture of calcium stearate, vitamin E acetate and a liquid surfactant. The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. Hemasorb requires no kneading prior to application and does not soften appreciably at body temperature. The subject of this 510(k) is the addition of a spatula as an alternative method of Hemasorb application.
Predicate Devices:
Substantial equivalence was shown with the previously cleared devices in K043260 and K102762.
1
Summary of Non-Clinical Performance Testing
The in vitro tests performed were: simulated use and shipping (including mechanical tests of cyclic compression and tensile failure testing), finite element analysis, and stability (including sterile package integrity).
The device was determined to be biocompatible and to demonstrate adequate integrity and performance characteristics.
Conclusion:
The modification subject to this 510(k) was shown to be substantially equivalent to previously cleared devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 a stylized caduceus or a bird-like figure, composed of three curved lines.
Public Health Service
FEB 1 7 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthocon, Inc. % Ms. Rosemary Harry VP. RA/QA 1 Bridge Street, Suite 121 · Irvington, New York 10533
Re: K113627
Trade/Device Name: Hemasorb® Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified · Product Code: MTJ Dated: January 18, 2012 Received: January 20, 2012
Dear Ms. Harry:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have a row a your 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). and Cosmetic Fror (. 10.) has the device, subject to the general controls provisions of the Act. The I ou may, thereforminens of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Trease now. 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 that I Dri has made a and regulations administered by other Federal agencies. You must or uny 1 cithe 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 CI K I all 607), labornig (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Rosemary Harry
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 A. Milikurn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use
510(k) Number (if known): 长川3 627
Device Name: Hemasorb® Resorbable Hemostatic Bone Putty
Hemasorb Resorbable Hemostatic Bone Putty is intended for use in the control of Flemaboro Tesserouser Traged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
K11362
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Moore for NXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113627