HEMASORB APPLY

K121953 · Orthocon, Inc. · MTJ · Nov 21, 2012 · SU

Device Facts

• Record ID: K121953
• Device Name: HEMASORB APPLY
• Applicant: Orthocon, Inc.
• Product Code: MTJ · SU
• Decision Date: Nov 21, 2012
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

Hemasorb Applicator is a syringe-type device containing Hemasorb Resorbable Hemostatic Bone Putty; a sterile, moldable, absorbable mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. Used in surgical or trauma settings by surgeons to manage bone bleeding. Applicator allows manual discharge of putty onto surgeon's hand, instrument, or directly onto bone. Beveled tip assists in spreading material. Acts as mechanical barrier/tamponade to achieve local hemostasis. Benefits patient by providing absorbable hemostatic control.

Clinical Evidence

Bench testing only. In vitro performance testing, biocompatibility, and extractable studies (cytotoxicity, irritation, acute systemic injection, HPLC analysis, ignition potential) demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Syringe-type applicator with beveled tip. Putty composition: calcium stearate, Vitamin E acetate, liquid surfactant. Sterile, absorbable, biocompatible material. Manual operation.

Indications for Use

Indicated for control of bleeding from cut or damaged bone via mechanical barrier/tamponade in surgical procedures, traumatic injuries, and cardiothoracic surgery following sternotomy.

Predicate Devices

• K102762
• K111575
• K113627

Submission Summary (Full Text)

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GIOK Summary

K12 1953

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Contact: Howard Schraver Orthocon. Inc. 1 Bridge Street, Suite 121 Invington, NY 10533 Telephone: [phone] Fax: [phone] [e-mail] Date Prepared: October 21, 2012 Hemasorb® Resorbable Hemostatic Bone Putty Device Trade Name: Applicator Manufacturer: Orthocon. Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 Common Name: Bone wax

Classification Name: Bone wax (unclassified)

Class: Unclassified

Product Code: MTJ

## Indications for Use:

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:

The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb® apply) is a syringe-type applicator containing Hemasorb Resorbable Hemostatic Bone Putty. Use of the applicator will allow convenient discharge of the putty into the surgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is beveled and made from a softer material than the applicator barrel to assist with spreading the material onto the bone.

NOV 2 1 2012

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VI 12 1953

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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 bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of calcium stearate, Vitamin E acetate, and a liquid surfactant. 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).

## Substantial Equivalence and Predicate Devices:

The Hemasorb Resorbable Hemostatic Bone Putty Applicator was shown to be substantially equivalent to the devices cleared under K102762, K111575, and K113627 with respect to intended use, technological characteristics and performance.

## Performance Testing:

In vitro testing demonstrated that the performance of the Hemasorb Resorbable Hemostatic Bone Putty Applicator was substantially equivalent to that of the predicate devices. The biocompatibility and extractable tests that demonstrate that the materials are safe and substantially equivalent to the predicate device are:

- . Cytotoxicity
- Irritation (Intracutaneous Injection) .
- Acute Systemic Injection .
- HPLC Analysis of putty in contact with the dyed plunger .
- Evaluation of Ignition Potential .

## Conclusion:

The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb apply) is substantially equivalent to the predicate device with respect to intended use, technological characteristics and performance.

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## 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: November 21, 2012

Orthocon. Incorporated % Richard Kronenthal, Ph.D. Chief Scientific Officer 1 Bridge Street, Suite 121 Irvington, New York 10533

Re: K121953

Trade/Device Name: Hemasorb Apply Regulatory Class: Unclassified Product Code: MTJ Dated: October 21, 2012 Received: October 23, 2012

Dear Dr. Kronenthal:

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 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.

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## Page 2 - Richard Kronenthal, Ph.D.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Mark N. Melkerson

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): K121953

Device Name: Hemasorb Applicator

Hemasorb Resorbable Hemostatic Bone Putty Applicator 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.

Prescription Use (Part 21 CFR 801 Subpart D)

CONFIDENTIAL

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: K121953