HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Device Description

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible formulation comprised of water soluble and resorbable materials in a putty-like consistency intended for use in the control of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of alkylene oxide polymer-based materials, vitamin E acetate, granular calcium phosphate, and carboxymethylcellulose sodium salt. The material is virtually odorless, off-white in color and can be spread easily onto bone with minimal adhesion to surgical gloves. The bone putty does not require kneading prior to application.

AI/ML Overview

This document describes a traditional 510(k) submission for a medical device called HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria or a comparative effectiveness study involving AI. Therefore, many of the requested details regarding acceptance criteria for AI-assisted devices or MRMC studies are not applicable.

Here's the breakdown of the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of benchmarks or thresholds that the device needed to meet for its performance. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to predicate devices through various tests. The reported performance is descriptive, indicating that the device "demonstrates" or "was shown" to meet the intended use and characteristics.

Acceptance Criteria (Inferred from Substantial Equivalence Goal)	Reported Device Performance
Handling properties similar to predicate devices	Bench testing verified handling properties (relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling).
Biocompatibility in accordance with ISO 10993	Biocompatibility testing conducted (irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, LAL, and pyrogenicity) on the final, finished, gamma-radiation sterilized device.
Intraoperative in vivo hemostasis	Animal studies demonstrated intraoperative in vivo hemostasis.
Resistance to irrigation	Animal studies demonstrated resistance to irrigation.
Ability to remove the device	Animal studies demonstrated ability to remove the device.
Characterize absorption time	Animal studies characterized absorption time.
Overall substantial equivalence to predicate devices in intended use, technological characteristics, and performance.	"HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is substantially equivalent to previously cleared and preamendment bone wax devices with respect to intended use, general technological characteristics and performance."

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

The document does not explicitly state specific sample sizes for each bench, biocompatibility, or animal test. It refers to "Bench Testing," "Biocompatibility Testing," and "Animal Testing" as categories. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a bone putty, and its performance is evaluated through physical, chemical, and biological tests, not by expert interpretation of data like medical imaging. Therefore, "experts" in the context of establishing ground truth for a test set (e.g., radiologists) are not relevant here.

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

This information is not applicable. Adjudication methods are typically used in clinical trials or studies involving human assessment where disagreements need resolution. The testing described for this bone putty does not involve such a process.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the HEMOSTATIC BONE PUTTY 3 is. The product is a physical bone hemostatic agent.

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

No, a standalone (algorithm-only) performance evaluation was not done. This metric is specific to AI algorithms and is not relevant for a physical medical device like bone putty.

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

The "ground truth" for this device's performance is established through established scientific and engineering principles measured by:

Bench Test Results: Physical properties like stiffness, spreadability, stickiness, temperature sensitivity, dissolution, and swelling are measured directly.
Biocompatibility Test Results: Measured outcomes in laboratory tests (e.g., irritation, sensitization levels).
Animal Study Observations: Direct observation of hemostasis, irrigation resistance, device removal, and absorption time in an animal model.

These are objective measurements and observations rather than subjective expert consensus or pathology reports in the traditional sense.

8. The sample size for the training set

This information is not applicable. The device is a physical product and does not involve AI algorithms that require a "training set."

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

This information is not applicable for the same reason as point 8.

Summary

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Traditional 510(K) HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty

510(k) Summary

Contact:	Howard SchrayerOrthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533Telephone: 914-357-2600Fax: 914-231-7884hs.ss@verizon.net	APR	5
Date Prepared:	October 15, 2012
Device Trade Name:	HEMOSTATIC BONE PUTTY 3Resorbable Hemostatic Bone Putty
Manufacturer:	Orthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533
Common Name:	Bone wax
Classification:	Unclassified
Product Code:	MTJ

Indications for Use:

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. ·

Device Description:

2013

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Substantial Equivalence and Predicate Devices:

The device was shown to be substantially equivalent to previously cleared bone wax devices including Ostene® AOC Bone Wax (K041363), US Surgical Auto Suture Bone Wax (K971680), and Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax (K111538), and traditional nonabsorbable bone wax devices, including CP Medical Bone Wax (K024372).

Traditional 510(K)

Performance Testing:

Bench testing; biocompatibility and animal functionality testing performed on the HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, 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 properties. The following bench studies were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution and swelling.

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, gamma-radiation sterilized device in accordance with GLP requirements: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, LAL and pyrogenicity.

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

Conclusion

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is substantially equivalent to previously cleared and preamendment bone wax devices with respect to intended use, general technological characteristics and performance.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: April 5, 2013

Orthocon, Inc. % Mr. Howard Schrayer One Bridge Street, Suite 121 Irvington, New York 10533

Re: K123243

Trade/Device Name: Hemostatic Bone Putty 3 Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: March 11, 2013 Received: March 12, 2013

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark Newelkerson -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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Traditional 510(K) HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty

Indications for Use

510(k) Number (if known): K123243

Device Name: HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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David Krause/g

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123243

CONFIDENTIAL

Regulation Number and Section

N/A