Orthocon HEMASORBpress 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. HEMASORBpress Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

Device Description

Orthocon HEMASORBpress™ Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, resorbable 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 (a wax-like tamponade), Vitamin E Acetate (for handling properties) and an alkylene oxide copolymer (a dispersing agent). 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 will be dispersed and resorbed within a period of 30 days.

AI/ML Overview

The provided text is a 510(k) summary for the Orthocon HEMASORBpress™ Resorbable Hemostatic Bone Putty. This document focuses on demonstrating substantial equivalence to predicate devices for a medical device and does not describe a study involving an AI algorithm or its performance against acceptance criteria for an AI-driven task like image analysis.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, the document details physical and biological testing conducted on the HEMASORBpress device and its predicate. Here's a summary of the device-specific testing mentioned, as it relates to demonstrating safety and effectiveness for a physical medical device, not an AI:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of quantitative acceptance criteria with corresponding reported device performance values in the format usually seen for AI or diagnostic devices. Instead, it lists the types of tests conducted to ensure the device's properties and safety/effectiveness are comparable to predicate devices. The implicit "acceptance criteria" here are that the device performs satisfactorily and similarly to predicate devices in these tests.

Acceptance Criteria Category (Implicit)	Reported Device Performance Summary
Material Properties:	* Handling Properties (Original Device): Tested for smearability, stickiness, stiffness, and temperature sensitivity. (Implicit: Satisfactory handling and stability over temperature range.) * Handling Properties (Strip Configuration): Usability testing performed to verify handling. (Implicit: Satisfactory handling for the new configuration.)* Dissolution & Swelling Properties (Original Device): Evaluated. (Implicit: Acceptable dissolution and swelling profile.)* Product Interface with Mesh (Strip Configuration): Tested. (Implicit: Satisfactory interaction between bone putty and polypropylene mesh.)
Biocompatibility:	* ISO 10993 Compliance (Original Device): Cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation/subacute toxicity, hemolysis, and pyrogenicity studies conducted on final, finished, gamma-irradiation sterilized device, in accordance with GLP requirements. (Implicit: Biocompatible, passes all specified tests per ISO 10993.)* Cytotoxicity (Strip Configuration): Cytotoxicity testing of the polypropylene mesh performed. (Implicit: Polypropylene mesh is biocompatible.)* Pyrogen Testing (Strip Configuration): USP and rabbit pyrogen testing performed. (Implicit: Non-pyrogenic.)
In Vivo Performance:	* Animal Studies (Original Device): Demonstrated intraoperative in vivo hemostasis, resistance to irrigation, ability to remove the device, and characterized safety and absorption time. (Implicit: Device effectively controls bleeding, is resistant to irrigation, removable, safe, and absorbs within an acceptable timeframe in vivo.)
Packaging Stability:	* Package Stability Testing (Strip Configuration): Performed. (Implicit: Packaging maintains device integrity and sterility over time.)

2. Sample size used for the test set and the data provenance:

No information provided regarding sample sizes for individual tests. The document only "Testing was conducted" or "Testing included animal studies."
Data Provenance: Not explicitly stated for each test, but generally, these are laboratory bench tests and animal studies conducted by or for the manufacturer (Orthocon, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the document describes a physical medical device, not an AI algorithm requiring expert ground truth for diagnostic or interpretative tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for the type of device testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the physical properties and biocompatibility, the "ground truth" is based on standardized test methods and validated measurements against defined parameters (e.g., ISO standards for biocompatibility, specific physical property measurements).
For in vivo performance, the "ground truth" is derived from direct observation and measurement in animal models (e.g., cessation of bleeding, absorption time).

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not an AI algorithm.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2014

Orthocon Incorporated Mr. Howard Schrayer Regulatory Affairs Consultant 1 Bridge Street, Suite 121 Irvington, New York 10533

Re: K142339

Trade/Device Name: HEMASORBpress™ Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: September 12, 2014 Received: September 15, 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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

Orthocon HEMASORBpress Resorbable Hemostatic Bone Putty

Indications for Use (Describe)

Orthocon HEMASORBpress Resorbable Hemostatic Bone Putty is 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. HEMASORBpress Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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510(k) SUMMARY (Per 21 CFR 807.92)

General Company Information

Name:Contact:	Orthocon, Inc.Howard SchrayerRegulatory Affairs Consultant
Address:	1 Bridge Street, Suite 121Irvington, NY 10533
Telephone:Fax:	(609) 924 - 9510(914) 231 - 7884
Date Prepared	September 19, 2014

General Device Information

Product Name:	HEMASORBpress™ Resorbable Hemostatic Bone Putty
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"Bone Wax", Product code: MTJ Classification: Regulation: Unclassified

Predicate Devices

Orthocon, Inc. - HEMASORB® Resorbable Hemostatic Bone Putty 510(k) Numbers K043260 and K111575

Orthocon, Inc. - AHBPpress™ Absorbable Hemostatic Bone Putty [510(k) Number K140117]

Description

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Intended Use (Indications)

Purpose of Submission

Orthocon intends to produce an alternate packaged configuration (strip) of its hemostatic bone putty as a product line extension to HEMASORB Resorbable Hemostatic Bone Putty.

Substantial Equivalence

This submission supports the position that the Orthocon HEMASORBpress Resorbable 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 HEMASORB Resorbable Hemostatic Bone Putty [cleared under 510(k) K043260 and K111575] with the exception of the shape and packaging configuration (i.e., a thin strip sandwiched between two lavers of polypropylene mesh versus a cvlindrical shape without a polypropylene mesh). The secondary predicate K140117 is a bone wax device that is packaged in the same strip configuration using the same packaging materials (including the polypropylene mesh) as this alternate configuration (HEMASORBpress) of the device.

Testing Completed on Original Configuration

The following testing was completed on the original (predicate) device and is referenced in the 510(k) Notice because the device formulation is unchanged;

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

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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.

Testing Completed on Strip Configuration

In accordance with design control procedures, Orthocon, Inc. performed a risk analysis for the proposed modifications based on an FMEA approach. Based on the results of the risk analysis, the following verification and validation activities were performed: cytotoxicity testing of the polypropylene mesh, USP and rabbit pyrogen testing, usability testing to verify the device's handling properties, testing to evaluate product interface with the mesh, and package stability testing.

Conclusions

Orthocon. Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as Orthocon HEMASORBpress and that Substantial Equivalence to the predicate devices 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.

Regulation Number and Section

N/A