(352 days)
Not Found
No
The device description focuses on the physical and chemical properties of the bone putty and its mechanical action as a hemostatic agent. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is described as a hemostatic bone putty used to control bleeding, which is a functional purpose rather than a therapeutic one aiming to treat or cure a disease or condition.
No
Explanation: The device is a hemostatic bone putty, indicated for controlling bleeding by acting as a mechanical barrier. It does not perform any diagnostic function.
No
The device description clearly states it is a "sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency" and a "mixture of calcium stearate, Vitamin E acetate, and liquid surfactant," indicating it is a physical 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 to control bleeding from bone surfaces during surgical procedures and traumatic injuries by acting as a mechanical barrier. This is a direct therapeutic intervention on the patient's body.
- Device Description: The device is a physical material applied to the bone surface. It does not analyze biological samples (like blood, urine, tissue) outside of the body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, providing diagnostic results, or any of the typical functions of an in vitro diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and therapeutic.
N/A
Intended Use / Indications for Use
Hemasorb Resorbable Hemostatic Bone Putty is indicated 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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
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 management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature. When applied manually to surgically incised or traumatically broken bone, Hemasorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty has been shown in animals to be dispersed and substantially absorbed within a period of 30 days.
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)
Pre-clinical testing included animal testing in a sternotomy model. Hemasorb was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and performance.
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.
K043260, K091121, K102762, K102071
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
KIII575 pg 1 of 2
MAY 2 3 2012
510 (k) Summary
Contact:
Rosemary Harry Consultant Orthocon, Inc 1 Bridge Street, Suite 121 Irvington, NY 10533 harry@orthocon.com 914-357-2600
Date Prepared:
May 16, 2012
Device Trade Name:
Manufacturer:
Orthocon, Inc. 1 Bridge Street Suite 121 Irvington, NY 10533
Common Name:
Bone wax
Classification:
None applicable
MTJ
Unclassified Class:
Product Code:
Indications For Use:
Hemasorb Resorbable Hemostatic Bone Putty is indicated 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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Hemasorb® Resorbable Hemostatic Bone Putty
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 management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature.
8
1
When applied manually to surgically incised or traumatically broken bone, Hemasorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty has been shown in animals to be dispersed and substantially absorbed within a period of 30 days.
Predicate Devices:
Hemasorb was shown to be substantially equivalent to previously cleared devices (K043260, K091121, K102762, and K102071).
Substantial Equivalence:
Hemasorb Resorbable Hemostatic Bone Putty is substantially equiyalent to predicate devices in indications, intended use, design, materials, sterilization, and performance. Pre-clinical testing included animal testing in a sternotomy model.
Conclusion
Hemasorb was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and performance.
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 two main elements: a circular text border and an abstract symbol in the center. The text border reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The central symbol is an abstract representation, possibly of a person or a bird, composed of curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthocon Incorporated % Ms. Rosemary Harry Consultant 1 Bridge Street Suite 121 Irvington, New York 10533
MAY 2 3 2012
Re: K111575
Trade/Device Name: Hemasorb Resorbable Hemostatic Bone Putty Regulation Class: Unclassified Product Code: MTJ Dated: May 16, 2012 Received: May 21, 2012
Dear Ms. Harry:
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. 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
3
Page 2 - Ms. Rosemary Harry
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.
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/CDRH0ffices/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 vours.
Mark N. Melkerson
Director
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
KIJ575
Indications for Use
510(k) Number (if known): K111575 ·
Device Name: Hemasorb Resorbable Hemostatic Bone Putty
Hemasorb Resorbable Hemostatic Bone Putty is indicated 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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kraefamm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K11575