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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

Device Description

Orthocon Hemasorb Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. 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 broken bone, Hemasorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty has been shown in animals to be dispersed and substantially absorbed within a period of 30 days.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Hemasorb Resorbable Hemostatic Bone Putty." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing specific acceptance criteria and detailed study results as one might find for a novel device undergoing clinical trials with defined endpoints.

Therefore, for many of the requested categories, the information is not explicitly provided in the document. However, I can extract the relevant information that is present.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance was based on demonstrating "substantial equivalence" to predicate devices. This implies that the performance accepted was that which is comparable to already marketed devices for the same intended use.
Reported Device Performance:
- Mechanism of Action: Achieves local control of bleeding by acting as a mechanical barrier (tamponade) when applied manually to surgically incised or traumatically broken bone.
- Absorption in Animals: Shown in animals to be dispersed and substantially absorbed within a period of 30 days.

Feature	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Indicated Use	Comparable to predicate devices: control of bleeding from cut/damaged bone (mechanical barrier/tamponade); use during surgical procedures and traumatic injuries; control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.	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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Mechanical Bleeding Control	Effective as a mechanical barrier/tamponade (comparable to predicate devices).	Achieves local control of bleeding by acting as a mechanical barrier (tamponade).
Resorbability (in vivo)	Resorbable within a clinically acceptable timeframe (comparable to predicate devices).	Shown in animals to be dispersed and substantially absorbed within a period of 30 days.
Biocompatibility	Biocompatible (implicit for a resorbable implantable material).	Described as "biocompatible."
Physical Characteristics (user experience)	Soft, moldable, putty-like consistency; virtually odorless, off-white; spreadable with minimal adhesion to surgical gloves; no kneading; does not soften appreciably at body temperature (comparable to predicate devices).	Sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency. Mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. Virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. Requires no kneading prior to application and does not soften appreciably at body temperature.
Sterilization	Compatible with established sterilization methods (comparable to predicate devices).	Stated to be "sterile" and "substantially equivalent ... in sterilization" to predicate devices.
Materials	Safe and effective materials (comparable to predicate devices).	Mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. Stated to be "substantially equivalent ... in materials" to predicate devices.
Overall Performance	Substantial equivalence to predicate devices (K043260, K091121, K102762, K102071).	Hemasorb was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and performance. Pre-clinical testing included animal testing in a sternotomy model. Hemasorb was shown to be substantially equivalent to previously cleared devices (K043260, K091121, K102762, and K102071) in indications, intended use, design, materials, sterilization, and performance.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "animal testing in a sternotomy model" as part of pre-clinical testing but does not provide the number of animals or specific details of the study design or sample size.
Data Provenance: The study was pre-clinical, involving animal testing. No country of origin is specified for the study data. It is inherently prospective from the perspective of the animal study.

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

Not applicable/Not provided. This type of submission relies on pre-clinical data (animal studies) and comparison to predicate devices, not human expert consensus for a diagnostic AI. The "ground truth" for the animal study would be the observable control of bleeding and subsequent absorption.

4. Adjudication method for the test set

Not applicable/Not provided. This is relevant for studies involving human interpretation or clinical endpoints that require review, typically in diagnostic imaging or clinical trials. The animal study would have direct physiological outcomes.

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 a medical device for hemostasis, not a diagnostic AI system.

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

Not applicable. This is a medical device for hemostasis. The "performance" is inherent to the material properties and how it interacts with bone to stop bleeding, not an algorithm.

7. The type of ground truth used

For the animal study: Physiological outcomes related to hemostasis (control of bleeding) and material absorption (e.g., visual assessment, histological analysis) would serve as the ground truth.
For the substantial equivalence claim: The "ground truth" is established by comparing the device's characteristics (indications, intended use, design, materials, sterilization, performance) against those of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set. The "development" would involve material science, formulation, and in vitro/in vivo testing, not algorithm training.

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

Not applicable. As above, this is not an AI/ML device.

Summary

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KIII575 pg 1 of 2

MAY 2 3 2012

510 (k) Summary

Contact:

Rosemary Harry Consultant Orthocon, Inc 1 Bridge Street, Suite 121 Irvington, NY 10533 harry@orthocon.com 914-357-2600

Date Prepared:

May 16, 2012

Device Trade Name:

Manufacturer:

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

Common Name:

Bone wax

Classification:

None applicable

MTJ

Unclassified Class:

Product Code:

Indications For Use:

Hemasorb® Resorbable Hemostatic Bone Putty

Device Description:

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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 has been shown in animals to be dispersed and substantially absorbed within a period of 30 days.

Predicate Devices:

Hemasorb was shown to be substantially equivalent to previously cleared devices (K043260, K091121, K102762, and K102071).

Substantial Equivalence:

Hemasorb Resorbable Hemostatic Bone Putty is substantially equiyalent to predicate devices in indications, intended use, design, materials, sterilization, and performance. Pre-clinical testing included animal testing in a sternotomy model.

Conclusion

Hemasorb was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text border and an abstract symbol in the center. The text border reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The central symbol is an abstract representation, possibly of a person or a bird, composed of curved lines.

Public Health Service

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

Orthocon Incorporated % Ms. Rosemary Harry Consultant 1 Bridge Street Suite 121 Irvington, New York 10533

MAY 2 3 2012

Re: K111575

Trade/Device Name: Hemasorb Resorbable Hemostatic Bone Putty Regulation Class: Unclassified Product Code: MTJ Dated: May 16, 2012 Received: May 21, 2012

Dear Ms. Harry:

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

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Page 2 - Ms. Rosemary Harry

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 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/CDRH0ffices/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.

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

Enclosure

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KIJ575

Indications for Use

510(k) Number (if known): K111575 ·

Device Name: Hemasorb Resorbable Hemostatic Bone Putty

Prescription Use V (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kraefamm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K11575

Regulation Number and Section

N/A