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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Orthocon AHBPpress™ Absorbable Hemostatic Bone Putty, based on the provided text.

Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results for novel devices. Therefore, detailed acceptance criteria and specific study outcomes are presented in a manner typical for such submissions, which often relies on bench testing and animal studies.

Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence, meaning the new device (AHBPpress™) performs similarly to the predicate device (AHBP™). The acceptance criteria are implicitly tied to matching the predicate's performance in key areas and meeting general biocompatibility and safety standards.

Acceptance Criteria Category	Specific Tests/Properties Evaluated	Reported Device Performance (Summary)
Handling Properties	Smearability	Tested (results imply satisfactory)
	Stickiness	Tested (results imply satisfactory)
	Stiffness	Tested (results imply satisfactory)
Physical Performance	Temperature Sensitivity	Tested (results imply satisfactory over a range of temperatures)
	Dissolution Properties	Tested (implies satisfactory and consistent with "substantially absorbed within 8 days" as described for AHBP™)
	Swelling Properties	Tested (implies satisfactory)
Biocompatibility	Cytotoxicity	Conducted (implied acceptable per ISO 10993)
	Irritation	Conducted (implied acceptable per ISO 10993)
	Sensitization	Conducted (implied acceptable per ISO 10993)
	Acute Systemic Toxicity	Conducted (implied acceptable per ISO 10993)
	Implantation / Subacute Toxicity	Conducted (implied acceptable per ISO 10993)
	Hemolysis	Conducted (implied acceptable per ISO 10993)
	Pyrogenicity	Conducted (implied acceptable per ISO 10993)
In Vivo Performance	Intraoperative In Vivo Hemostasis	Demonstrated in animal studies
	Resistance to Irrigation	Demonstrated in animal studies
	Ability to Remove the Device	Demonstrated in animal studies
	Safety and Absorption Time	Characterized in animal studies ("substantially absorbed within 8 days" mentioned for predicate, likely matched)

Study Details

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

Test Set Sample Size: Not explicitly stated in terms of specific numbers for each bench or animal study. The document mentions "testing was conducted" and "animal studies to demonstrate," implying sufficient samples were used to generate the necessary data for a 510(k) submission.
Data Provenance: Not specified. Standard practice for such submissions would be studies performed in a certified laboratory (for bench tests) or animal facility. The document does not indicate country of origin or whether studies were retrospective or prospective, though animal studies would inherently be prospective.

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

Not applicable as this is not a study requiring expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for the bench and animal studies would be the objective measurements and observations made by laboratory personnel or veterinarians, adhering to study protocols.

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

Not applicable. This is not a study requiring human adjudication of results in the way a clinical trial for diagnostic accuracy might. The outcomes of the bench and animal studies are typically direct measurements or observations.

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

No. This is not a diagnostic device or an AI-assisted device. Therefore, MRMC studies and the concept of human reader improvement with AI are not relevant.

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

No. This is a medical device (hemostatic bone putty), not a software algorithm.

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

Bench Studies: Objective measurements of physical properties (smearability, stiffness, dissolution rate, swelling, temperature sensitivity).
Biocompatibility Studies: Established biological endpoints and observations based on ISO 10993 standards (e.g., cell viability for cytotoxicity, tissue reaction for implantation).
In Vivo Performance Studies (Animal): Direct observation of hemostasis, resistance to irrigation, ease of removal, and histological or gross assessment of absorption time and safety in animal models.

8. The sample size for the training set

Not applicable. This device does not use an algorithm that requires a training set.

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

Not applicable. This device does not use an algorithm that requires a training set.

Summary

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K140117

510(k) SUMMARY (Per 21 CFR 807.92)

General Company Information

FEB 1 1 2014

Name:	Orthocon, Inc.
Contact:	Howard SchrayerRegulatory 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

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K140117

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:

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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Regulation Number and Section

N/A