Orthocon 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.

AI/ML Overview

The provided text describes Orthocon Absorbable Hemostatic Bone Putty and its substantial equivalence to predicate devices, rather than a device that employs AI or requires complex performance metrics. Therefore, many of the requested categories (numbers 3, 4, 5, 6, 8, 9) regarding AI-specific evaluation methodologies are not applicable to this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Outcome	Reported Device Performance
Bench Testing	Handling Properties: Smearability, Stickiness, Stiffness, Temperature Sensitivity. Dissolution and Swelling Properties	"Bench 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." "All of the testing demonstrated that Orthocon Absorbable Hemostatic Bone Putty met its design criteria and, as relevant, performed in a manner equivalent to the predicate devices."
Biocompatibility Testing	ISO 10993 recommendations: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Genotoxicity, Implantation/Subacute Toxicity, Hemolysis, Pyrogenicity.	"Biocompatibility 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, sterilized device in accordance with GLP requirements: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, hemolysis, and pyrogenicity." "All of the testing demonstrated that Orthocon Absorbable Hemostatic Bone Putty met its design criteria and, as relevant, performed in a manner equivalent to the predicate devices."
In vivo Testing (Animal)	Intraoperative hemostasis, Resistance to irrigation, Ability to remove the device, Absorption time.	"In vivo Testing included comparative animal studies to demonstrate intraoperative hemostasis, resistance to irrigation, ability to remove the device, and to characterize its absorption time." "All of the testing demonstrated that Orthocon Absorbable Hemostatic Bone Putty met its design criteria and, as relevant, performed in a manner equivalent to the predicate devices."
Substantial Equivalence	Equivalence in technological characteristics (resorbable, water-soluble putty formulations, alkylene oxide polymers, carboxymethylcellulose component) and mechanism of action (mechanical tamponade) to predicate devices.	"The technological characteristics (i.e., resorbable, water-soluble putty formulations) are equivalent to the characteristics of the Ceremed and Synthes predicates. Both of these predicates and Orthocon Absorbable Hemostatic Bone Putty incorporate alkylene oxide polymers in the formulation. The Synthes predicate also shares a carboxymethylcellulose component. Each of these devices (and the predicate Ethicon bone wax) accomplish their clinical purpose through mechanical tamponade." "Orthocon, Inc. believes that it's the information provided establishes that similar legally-marketed devices have been used for the same clinical indications as Orthocon Absorbable Hemostatic Bone Putty and that the device is substantially equivalent to previously cleared bone wax devices."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state numerical sample sizes for bench, biocompatibility, or animal studies. It describes the types of tests conducted, but not the number of units tested, animals used, or subjects involved in any human studies (which are implied not to have been the primary method for this type of device clearance).

Provenance: This testing was conducted by Orthocon, Inc. to support their 510(k) submission. The exact location or 'country of origin' of the data isn't specified beyond being submitted to the US FDA. The studies are described in the context of device development and regulatory submission, implying they are prospective studies specifically designed to demonstrate safety and effectiveness for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is not an AI diagnostic tool and does not involve interpretation by human experts to establish "ground truth" in the way an AI medical imaging device would. Performance is demonstrated through physical, chemical, and biological testing.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable. No expert adjudication process is described as the device's performance is demonstrated through objective physical, chemical, and biological tests, not through interpretation of complex data by human experts.

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 is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance is defined by its ability to meet specific engineering, chemical, and biological criteria, as established by accepted standards (e.g., ISO 10993 for biocompatibility) and comparison to predicate devices. For instance:

Bench Testing: Engineering measurements and physical property characterization (e.g., specific values for smearability, dissolution rates).
Biocompatibility Testing: Regulatory standards (ISO 10993) defining acceptable biological responses.
In vivo Testing: Direct observation and measurement of physiological responses in animal models (e.g., cessation of bleeding, degree of absorption, ease of removal).

8. The sample size for the training set

Not applicable. This is not an AI device that relies on a "training set."

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

Not applicable. This is not an AI device.

Summary

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510(k) Summary 4.

Contact:

K122156

Howard Schrayer c/o Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 Telephone: 609-924-9510 Fax: 914-231-7884 hs.ss@verizon.net

Date Prepared:

December 21, 2012

Manufacturer:

Orthocon®, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533

Device Trade Name:

Orthocon Absorbable Hemostatic Bone Putty

Common Name: Bone wax

Classification:

Unclassified

MTJ

Product Code:

Predicate Devices

Ceremed, Inc. Ostene AOC Bone Wax K041363 and others

Synthes (USA) Synthes Hemostatic Bone Putty K113079 and others

Ethicon, Inc. Ethicon Bone Wax pre-amendment

JAN 2 8 2013

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Device Description:

Intended Use (Indications):

Orthocon Absorbable Hemostatic Bone Putty is indicated for use as an absorbable implant material for the control of bleeding from bone surfaces.

Substantial Equivalence and Predicate Devices:

The submission supports the position that Orthocon Absorbable Hemostatic Bone Putty is substantially equivalent to a number of previously cleared bone wax devices including Ceremed - Ostene AOC Bone Wax (K041363 and others), Synthes (USA) - Synthes Hemostatic Bone Putty (K113079 and others), and Ethicon Bone Wax (pre-amendment).

The technological characteristics (i.e., resorbable, water-soluble putty formulations) are equivalent to the characteristics of the Ceremed and Synthes predicates. Both of these predicates and Orthocon Absorbable Hemostatic Bone Putty incorporate alkylene oxide polymers in the formulation. The Synthes predicate also shares a carboxymethylcellulose component. Each of these devices (and the predicate Ethicon bone wax) accomplish their clinical purpose through mechanical tamponade.

Bench, biocompatibility and animal testing performed on the Orthocon Absorbable Hemostatic Bone Putty demonstrate the device is substantially equivalent to predicate devices in intended use and performance. This testing included the following:

Bench 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.

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Biocompatibility 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, sterilized device in accordance with GLP requirements: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, hemolysis, and pyrogenicity.

In vivo Testing included comparative animal studies to demonstrate intraoperative hemostasis, resistance to irrigation, ability to remove the device, and to characterize its absorption time.

All of the testing demonstrated that Orthocon Absorbable Hemostatic Bone Putty met its design criteria and, as relevant, performed in a manner equivalent to the predicate devices.

Conclusion:

Orthocon, Inc. believes that it's the information provided establishes that similar legally-marketed devices have been used for the same clinical indications as Orthocon Absorbable Hemostatic Bone Putty and thát the device is substantially equivalent to previously cleared bone wax devices. The device has been tested in accordance with all relevant standards and guidelines.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

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

January 28, 2013

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

Re: K122156

Trade/Device Name: Orthocon Absorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: December 28, 2012 Received: December 31, 2012

Dear Dr. 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

,在

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Page 2 - Mr. Howard Schraver

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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

510(k) Number (if known): K 122156 ·

Device Name: Orthocon Absorbable Hemostatic Bone Putty

Orthocon® Absorbable Hemostatic Bone Putty is indicated for use as an absorbable implant material in the control of bleeding from bone surfaces.

Prescription Use _ V (Part 21 CFR 801 Subpart D)

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: K122156

Regulation Number and Section

N/A