Hemasorbplus 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.

Device Description

Orthocon HEMASORBPLUS press 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 or damaged surface of bone. The material contains a mixture of alkylene oxide polymer based materials, vitamin E acetate, granular calcium phosphate and sodium carboxymethylcellulose. 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 damaged bone, HEMASORBPLUS press Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

AI/ML Overview

The provided text describes the Hemasorbplus Press Resorbable Hemostatic Bone Putty. Because this is a medical device and not a diagnostic AI/ML algorithm or system, many of your requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information, ground truth types) are not applicable. The information focuses on device performance and testing for substantial equivalence to predicates, rather than the accuracy of a diagnostic output.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench/In Vivo)	Reported Device Performance
Original Configuration Testing (Predicate Device)
Device's handling properties (smearability, stickiness, stiffness)	Testing was conducted and verified the device's handling properties. (Specific results not detailed, but implied to be acceptable for substantial equivalence).
Device's performance over a range of temperatures (temperature sensitivity)	Testing was conducted to characterize performance over a range of temperatures. (Specific results not detailed, but implied to be acceptable for substantial equivalence).
Device's dissolution and swelling properties	Testing was conducted. (Specific results not detailed, but implied to be acceptable for substantial equivalence).
Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, hemolysis, pyrogenicity) for final, finished, gamma-irradiation sterilized device (ISO 10993 compliant, GLP)	Testing was conducted and found acceptable. (Specific results not detailed, but implied to be acceptable for substantial equivalence).
Intraoperative in vivo hemostasis	Demonstrated via animal studies.
Resistance to irrigation	Demonstrated via animal studies.
Ability to remove the device	Demonstrated via animal studies.
Safety and absorption time (in vivo)	Characterized via animal studies.
Strip Configuration Testing (New Device - Hemasorbplus Press)
Cytotoxicity of the polypropylene mesh	Testing was performed. (Implied to be acceptable in allowing substantial equivalence).
USP and rabbit pyrogen testing	Testing was performed. (Implied to be acceptable in allowing substantial equivalence).
Usability testing to verify the device's handling properties	Testing was performed. (Implied to be acceptable, as it was considered "suitable for its indicated use" and established substantial equivalence). The text specifically states the device is "soft, moldable," "can be spread easily with minimal adhesion to surgical gloves," and "requires no kneading prior to application and does not soften appreciably at body temperature," which are handling properties.
Testing to evaluate product interface with the mesh	Testing was performed. (Implied to be acceptable in allowing substantial equivalence).
Package stability testing	Testing was performed. (Implied to be acceptable in allowing substantial equivalence). The new product is in a "thin strip sandwiched between two layers of polypropylene mesh."
Maintain substantial equivalence to predicate devices for hemostasis by mechanical barrier/tamponade.	"Orthocon, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as Orthocon HEMASORBPLUS press 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 device achieves local control of bleeding by acting as a mechanical barrier (tamponade) in line with its predicate (HEMOSTATIC BONE PUTTY 3). The new configuration is also compared to AHBPpress™, which is packaged similarly with polypropylene mesh, further supporting the substantial equivalence argument for the new form factor.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The studies mentioned are "bench studies" (e.g., smearability), "biocompatibility testing" (in vitro and in vivo models), and "animal studies." For the "strip configuration," further "usability testing" and specific material tests were performed.
Data Provenance: Not specified. Animal studies and bench tests were performed by 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 device is a hemostatic bone putty, not a diagnostic AI/ML system that requires expert interpretation for a "ground truth" test set. Its performance is evaluated through physical, chemical, and biological tests.

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

Not applicable for the reasons mentioned above.

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. This device is a medical product, not a diagnostic AI system assisting human readers.

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

Not applicable. This is not an algorithm.

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

The "ground truth" here is established through well-defined scientific and regulatory standards:
- Benchmarking/Predicate Equivalence: Comparison to the established performance characteristics of the predicate devices.
- ISO 10993 Standards: For biocompatibility.
- GLP (Good Laboratory Practice) Requirements: For biocompatibility testing.
- Animal Models: For in vivo performance (hemostasis, resistance to irrigation, removal, safety, absorption).
- USP (United States Pharmacopeia) Norms: For pyrogenicity testing.
- Risk Analysis (FMEA approach): For validation of modifications to the device (new strip configuration).

8. The sample size for the training set

Not applicable as this is not an AI/ML algorithm.

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

Not applicable as this is not an AI/ML algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

December 22, 2014

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

Re: K143069

Trade/Device Name: Hemasorbplus Press Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: November 26, 2014 Received: November 28, 2014

Dear Mr. Schraver:

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

{1}------------------------------------------------

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/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 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,

Binita S.Ashar -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K143069

Device Name

Hemasorbplus Press Resorbable Hemostatic Bone Putty

Indications for Use (Describe)

Hemasorbplus 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.

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."

{3}------------------------------------------------

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	October 24, 2014

General Device Information

Product Name:	HEMASORB PLUS press Resorbable Hemostatic Bone Putty
---------------	-------------------------------------------------------------

Classification:	"Bone Wax", Product code: MTJ
Regulation:	Unclassified

Predicate Devices

Orthocon, Inc. - HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty 510(k) Number K123243

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

Description

{4}------------------------------------------------

Intended Use (Indications)

Orthocon HEMASORBPLUS press 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.

Purpose of Submission

Orthocon intends to produce an alternate packaged configuration (strip) of its hemostatic bone putty as a product line extension to HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty.

Substantial Equivalence

This submission supports the position that the Orthocon HEMASORBPLUS press Resorbable Hemostatic Bone Putty is substantially equivalent to a number of preenactment and previously cleared devices, and is exactly the same as the predicate Orthocon HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty [cleared under 510(k) K123243] with the exception of the shape and packaging configuration (i.e., a thin strip sandwiched between two layers of polypropylene mesh versus a cylindrical 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 (HEMASORBPLUS press) 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, genotoxicity, implantation / subacute toxicity, hemolysis, and pyrogenicity

{5}------------------------------------------------

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 HEMASORBPLUS press 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 quidelines.

Regulation Number and Section

N/A