(26 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a bone putty, with no mention of AI or ML technologies.
Yes
The device is a therapeutic device because its intended use is to control bleeding during surgical procedures and in treating traumatic injuries by acting as a mechanical barrier or tamponade, which is a form of medical treatment.
No
Explanation: The device, Orthocon AHBPpress™ Absorbable Hemostatic Bone Putty, is indicated for controlling bleeding by acting as a mechanical barrier or tamponade. It does not extract or process information from the body to aid in diagnosis.
No
The device description clearly states it is a physical material (putty) intended for surgical use, not a software application.
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 or tamponade. This is a direct therapeutic action on the body.
- Device Description: The description details a physical material applied to the bone surface.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples (like blood, urine, tissue) outside of the body to diagnose or monitor conditions. This device is applied directly to the body for a therapeutic effect.
N/A
Intended Use / Indications for Use
Orthocon AHBPpress™ Absorbable 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.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device Description
Orthocon AHBP™ Absorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, water soluble and absorbable material of putty-like consistency intended for use in the control of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The material is a mixture of alkylene oxide polymer-based materials and carboxymethylcellulose sodium salt. 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.
When applied manually to surgically incised or traumatically broken bone, AHBP™ Absorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and substantially absorbed within a period of 8 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces; cut or damaged bone
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)
Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution and swelling properties. The following bench studies were completed: smearability stickiness, stiffness, temperature sensitivity, and dissolution and swelling.
Biocompatibility Testing: Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation / subacute toxicity, hemolysis, and pyrogenicity. Sterile mesh used in the packaging of the strip was also evaluated for cytotoxicity.
In Vivo Performance Testing: Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, ability to remove the device, and to characterize its safety and absorption time.
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
K140117
510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
FEB 1 1 2014
| Name: | Orthocon, Inc. |
|---|---|
| Contact: | Howard Schrayer |
| Regulatory Affairs Consultant | |
| Address: | 1 Bridge Street Suite 121 |
- 1 Bridge Street, Suite Address: Irvington, NY 10533
| Telephone: | (609) 924 - 9510 |
|---|---|
| Fax: | (732) 683 - 9476 |
- January 28, 2014 Date Prepared
General Device Information
| Product Name: | AHBPpressTM Absorbable Hemostatic Bone Putty |
|---|---|
| Classification: | "Bone Wax", Product code: MTJ |
- Unclassified Regulation:
Predicate Device
Orthocon, Inc. - AHBP™ Absorbable Hemostatic Bone Putty 510(k) Number K122156
Description
Orthocon AHBP™ Absorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, water soluble and absorbable material of putty-like consistency intended for use in the control of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The material is a mixture of alkylene oxide polymer-based materials and carboxymethylcellulose sodium salt. 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.
When applied manually to surgically incised or traumatically broken bone, AHBP™ Absorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and substantially absorbed within a period of 8 days.
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Intended Use (Indications)
Orthocon AHBPpress™ Absorbable Hemostatic Bone Putty is indicated for use as an absorbable implant material for the control of bleeding from bone surfaces.
Purpose of Submission
Orthocon intends to produce an alternate packaged configuration (strip) of its hemostatic bone putty as a product line extension to the AHBP™ Absorbable Hemostatic Bone Putty.
Substantial Equivalence
This submission supports the position that the Orthocon AHBP press™ Absorbable Hemostatic Bone Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, and is exactly the same as the predicate Orthocon AHBP™ Absorbable Hemostatic Bone Putty with the exception of the packaging configuration.
Performance Data
Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution and swelling properties. The following bench studies were completed: smearability stickiness, stiffness, temperature sensitivity, and dissolution and swelling.
Biocompatibility Testing
Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation / subacute toxicity, hemolysis, and pyrogenicity. Sterile mesh used in the packaging of the strip was also evaluated for cytotoxicity.
In Vivo Performance Testing
Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, ability to remove the device, and to characterize its safety and absorption time.
Conclusions
Orthocon. Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as Orthocon AHBPpress™ and that Substantial Equivalence to the predicate device has been established. The data presented demonstrate that the device is suitable for its indicated use. The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 11, 2014
Orthocon Incorporated Mr. Howard Schrayer Regulatory Affairs Consultant 1 Bridge Street, Suite 121 Irvinton. New York 10533
Re: K140117
Trade/Device Name: Orthocon AHBPpress™ Absorbably Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: January 14, 2014 Received: January 16, 2014
Dear Mr. Schrayer:
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
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Page 2 - Mr. Howard Schrayer
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K140117 510(k) Number (if known):
Device Name: Orthocon AHBPpress™ Absorbable Hemostatic Bone Putty
Indications For Use:
Orthocon AHBPpress™ Absorbable 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.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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