The Orthocon HemaSorb™ 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.

Device Description

Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, resorbable material of putty-like consistency intended for use it the management of bleeding from the cut surface of bone. The material is a mxture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling mroperties) and alkylene oxide copolymers (a dispersing agent). The material is virtualling proponicos, offwhite 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 60 days.

AI/ML Overview

The provided document is a 510(k) summary for the Orthocon HemaSorb Resorbable Hemostatic Bone Putty. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic or AI device.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not provided in this document, as it describes a medical device (hemostatic bone putty) and not a diagnostic algorithm or AI.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance Study for Orthocon HemaSorb Resorbable Hemostatic Bone Putty

The provided 510(k) summary for the Orthocon HemaSorb Resorbable Hemostatic Bone Putty does not detail specific quantitative acceptance criteria or a dedicated performance study with a test set, expert readers, or AI components. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device.

The "acceptance criteria" in this context are primarily related to the successful demonstration of substantial equivalence, which involves comparing the new device's intended use, technological characteristics, and performance data (if any) to those of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Substantial Equivalence Review)	Reported Device Performance / Justification
Intended Use	Must be the same as or very similar to the predicate device.	Identical: "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." (Same as predicate, Orthocon OrthoStat).
Technological Characteristics	Materials, composition, mechanism of action, performance attributes (e.g., resorbability, handling properties) must be substantially equivalent.	Similar: Composed of calcium stearate, Vitamin E Acetate, and alkylene oxide copolymers. Mechanism: acts as a mechanical barrier (tamponade) to achieve local control of bleeding. "Virtually non-pyrogenic, 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." Resorbs within 60 days. The submission states it "contains summaries of studies conducted to demonstrate substantial equivalence and a description of the modification made to the composition."
Safety and Effectiveness	Device must be as safe and effective as the predicate device.	The 510(k) summary concludes: "The data presented demonstrate that the device is suitable for its indicated use." And "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."

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

Not Applicable / Not Provided: This submission is for a medical device (hemostatic bone putty) and does not involve a "test set" of data or images in the context of an AI/diagnostic device. The "studies" mentioned refer to those demonstrating substantial equivalence, likely bench testing, material characterization, and potentially animal or historical data, rather than a clinical reader study.
Data Provenance: Not specified, but generally, substantial equivalence relies on physicochemical testing, biocompatibility data, and comparison to the predicate device's established performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable: There is no mention of experts establishing "ground truth" in the context of diagnostic interpretation for this type of device.

4. Adjudication Method for the Test Set

Not Applicable: No test set or expert adjudication related to diagnostic performance is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: This type of study is not relevant for a hemostatic bone putty and was not conducted or reported in this summary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable: This device is not an algorithm or AI.

7. The Type of Ground Truth Used

Not Applicable: The concept of "ground truth" in the context of pathology or outcomes data for a diagnostic algorithm is not relevant here. The "truth" for this device relates to its material properties, biocompatibility, and ability to stop bone bleeding, which would be assessed through standard materials science, in vitro, and potentially in vivo (animal or historical human use) testing.

8. The Sample Size for the Training Set

Not Applicable: There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: No training set exists for this device.

Summary

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

K063330 page 1/2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

General Company Information

Name:	Orthocon, Inc.			Nov 2 2006
Contact:	Howard SchrayerRegulatory Affairs Consultant
Address:	167 Stone Hill RoadColts Neck, NJ 07722
Telephone:	(732) 683 - 9304
Fax:	(732) 683 - 9476
Date Prepared	November 1, 2006
General Device Information
Product Name:	HemaSorb™ Resorbable Hemostatic Bone Putty
Classification:	"Bone Wax", Product code: MTJ

Predicate Device

Unclassified

Orthocon, Inc. - OrthoStat Resorbable Hemostatic Bone Putty 510(k) Number K043260

Description

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

K063330 Page 2/2

Intended Use (Indications)

Orthocon HemaSorb™ 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.

Substantial Equivalence

This submission supports the position that the Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, including:

Orthocon, Inc. – OrthoStat Resorbable Hemostatic Bone Putty - 510(k) Number K043260

The 510(k) Notice contains summaries of studies conducted to demonstrate substantial equivalence and a description of the modification made to the composition.

The data presented demonstrate that the device is suitable for its indicated use.

Conclusions

Orthocon, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty. 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.

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthocon, Inc. % Mr. Howard L. Schrayer 167 Stone Hill Road Colts Neck, New Jersey 07722

NOV 2 2 2006

Re: K063330

Trade/Device Name: Orthocon, HemaSorb™ Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: November 2, 2006 Received: November 3, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Page 2 – Mr. Howard L. Schrayer

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE

510(k) Number (if known): KO63330

Device Name: Orthocon, HemaSorb™ Resorbable 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)

Pelotmo

eral, Restorative. and Neurological Devices

510(k) Number L06336

Regulation Number and Section

N/A