(141 days)
No
The description focuses on the physical properties and mechanical function of a hemostatic bone putty and its applicator. There is no mention of AI, ML, or any computational analysis of data.
Yes
The device is a therapeutic device because its intended use is to control bleeding from bone by acting as a mechanical barrier or tamponade during surgical procedures and in treating traumatic injuries, which directly addresses a medical condition or symptom.
No
Explanation: The device, Hemasorb Resorbable Hemostatic Bone Putty Applicator, is described as an applicator for a putty that controls bleeding by acting as a mechanical barrier or tamponade. Its intended use is for controlling bleeding from cut or damaged bone during surgical procedures or in treating traumatic injuries. There is no mention of the device being used to identify or determine the nature of a disease, condition, or injury.
No
The device description clearly outlines a physical applicator (syringe-type) containing a physical substance (bone putty). This is a hardware device with a physical component and 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 by acting as a mechanical barrier. This is a direct therapeutic action on the patient's body.
- Device Description: The device is a putty applied directly to bone. It functions physically to stop bleeding.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) for a therapeutic purpose.
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
MTJ
Device Description
The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb® apply) is a syringe-type applicator containing Hemasorb Resorbable Hemostatic Bone Putty. Use of the applicator will allow convenient discharge of the putty into the surgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is beveled and made from a softer material than the applicator barrel to assist with spreading the material onto the bone.
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 bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of calcium stearate, Vitamin E acetate, and a liquid surfactant. 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces (cut, damaged, surgically incised, traumatically broken bone, 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)
In vitro testing demonstrated that the performance of the Hemasorb Resorbable Hemostatic Bone Putty Applicator was substantially equivalent to that of the predicate devices. The biocompatibility and extractable tests that demonstrate that the materials are safe and substantially equivalent to the predicate device are:
- . Cytotoxicity
- Irritation (Intracutaneous Injection) .
- Acute Systemic Injection .
- HPLC Analysis of putty in contact with the dyed plunger .
- Evaluation of Ignition Potential .
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
GIOK Summary
K12 1953
1 of 2
Contact: Howard Schraver Orthocon. Inc. 1 Bridge Street, Suite 121 Invington, NY 10533 Telephone: 914-357-2600 Fax: 914.231.7884 hs.ss@verizon.net Date Prepared: October 21, 2012 Hemasorb® Resorbable Hemostatic Bone Putty Device Trade Name: Applicator Manufacturer: Orthocon. Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 Common Name: Bone wax
Classification Name: Bone wax (unclassified)
Class: Unclassified
Product Code: MTJ
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.
Device Description:
The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb® apply) is a syringe-type applicator containing Hemasorb Resorbable Hemostatic Bone Putty. Use of the applicator will allow convenient discharge of the putty into the surgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is beveled and made from a softer material than the applicator barrel to assist with spreading the material onto the bone.
NOV 2 1 2012
1
VI 12 1953
2 of 2
47
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 bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of calcium stearate, Vitamin E acetate, and a liquid surfactant. 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).
Substantial Equivalence and Predicate Devices:
The Hemasorb Resorbable Hemostatic Bone Putty Applicator was shown to be substantially equivalent to the devices cleared under K102762, K111575, and K113627 with respect to intended use, technological characteristics and performance.
Performance Testing:
In vitro testing demonstrated that the performance of the Hemasorb Resorbable Hemostatic Bone Putty Applicator was substantially equivalent to that of the predicate devices. The biocompatibility and extractable tests that demonstrate that the materials are safe and substantially equivalent to the predicate device are:
- . Cytotoxicity
- Irritation (Intracutaneous Injection) .
- Acute Systemic Injection .
- HPLC Analysis of putty in contact with the dyed plunger .
- Evaluation of Ignition Potential .
Conclusion:
The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb apply) is substantially equivalent to the predicate device with respect to intended use, technological characteristics and performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 21, 2012
Orthocon. Incorporated % Richard Kronenthal, Ph.D. Chief Scientific Officer 1 Bridge Street, Suite 121 Irvington, New York 10533
Re: K121953
Trade/Device Name: Hemasorb Apply Regulatory Class: Unclassified Product Code: MTJ Dated: October 21, 2012 Received: October 23, 2012
Dear Dr. Kronenthal:
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 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 (OS) 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 - Richard Kronenthal, Ph.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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use
510(k) Number (if known): K121953
Device Name: Hemasorb Applicator
Hemasorb Resorbable Hemostatic Bone Putty Applicator 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 (Part 21 CFR 801 Subpart D)
CONFIDENTIAL
Over-The-Counter Use AND/OR (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)
David Krause
(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K121953