HEMOSORB

K021581 · On Site Gas Systems, Inc. · QSY · Jul 12, 2002 · SU

Device Facts

• Record ID: K021581
• Device Name: HEMOSORB
• Applicant: On Site Gas Systems, Inc.
• Product Code: QSY · SU
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

Device Story

Hemosorb is a bulk granular hemostatic agent applied topically to bleeding wounds; functions via physical adsorption of water from blood; concentrates platelets to accelerate natural coagulation; acts as a sponge to reduce liquid volume in the wound; packaged for one-handed application; used in clinical or field settings to achieve hemostasis; aids healthcare providers by reducing bleeding time and blood loss; benefits patients by improving survival in hemorrhage scenarios.

Clinical Evidence

Bench and animal testing performed. In vitro and in vivo studies (rats, rabbits, large mammals) compared Hemosorb to collagen-based agents and standard dressings. Large animal model of lethal uncontrolled hemorrhage showed 0% mortality with Hemosorb vs 33.4% with standard dressing and 80% with no dressing. Biocompatibility testing (ISO 17025) included cytotoxicity, skin sensitization, skin irritation, intracutaneous testing, and muscle implantation. Toxicity studies showed low histopathology scores.

Technological Characteristics

Bulk granular hemostatic agent; physical adsorption mechanism; non-chemical; biocompatible materials; packaged for single-handed application.

Indications for Use

Indicated for local management of bleeding wounds, including minor cuts, lacerations, and abrasions in patients requiring topical hemostasis.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Sorbastace (K-965034)

Submission Summary (Full Text)

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On Site Gas Systems, Inc. Francis X. Hursey President 35 Budney Road Newington, Connecticut 06111 June 11, 2023

Re: K021581 Trade/Device Name: Hemosorb Regulatory Class: Unclassified Product Code: QSY

Dear Francis X. Hursey:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 12, 2002. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, [e-mail].

Image /page/0/Picture/7 description: The image shows the closing of a letter, including the signature of Julie A. Morabito, Ph.D., who is the Assistant Director. The letter is from DHT4B: Division of Infection Control and Plastic Surgery Devices. It also mentions OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and the Center for Devices and Radiological Health.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are connected by a flowing line that suggests movement and unity.

JUL 12 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Francis X. Hursey President On Site Gas Systems, Inc. 35 Budney Road Newington, Connecticut 06111

Re: K021581

Trade/Device Name: Hemosorb Regulatory Class: Unclassified Product Code: FRO Dated: May 9, 2002 Received: May 14, 2002

Dear Mr. Hursey:

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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Mr. Francis X. Hursey

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Aztyt Rlwdn
Celia M! Witten, Ph.D., M.D.

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

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

Stupt Rurdia

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K021581 510(k) Number --

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'JUL 12 2002

. 17. s

K021581

page 1 of 4

# 510(k) Summary

### Z-MEDICA, LLC 35 BUDNEY ROAD

NEWINGTON, CT 06111 860.667.8888

CONTACT PERSON

BART GULLONG VICE-PRESIDENT

> REVISED: JUNE 28, 2002

> > 4-1 Revised 6/28/02

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K021581
page 2 of 4

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### 510(k) Summary

| Trade Name | Hemosorb |
|----------------------|-----------------------------------------------|
| Device Class | Unclassified |
| Classification Panel | General and Plastic Surgery |
| Common Name | Traumatic Wound Dressing |
| Predicate Device | Sorbastace<br>K-965034<br>Company: Hemostace |
| Contact Person | Bart Gullong, Vice-President |
| Company Name | Z-Medica, LLC |
| Company Address | 35 Budney Road<br>Newington, CT 06111 |
| Company Phone # | 860.667.2201 |
| Revised | June 28, 2002 |

### Statement of Indications for Use

Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

### Device Description

Hemosorb is a bulk granular hemostatic agent, which is placed on or into a wound to effect adsorption, and coagulation of same.

The effect of Hemosorb is purely physical, not chemical in nature. Hemosorb has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.

4-2 Revised 6/28/02

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The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for wounds, to create hemostasis by coagulation.

Hemosorb has been tested in-house at On Site, at Hartford Hospital, by Johnson & Johnson, and at the University of Connecticut by Micro Test Laboratories, and at USUHS for the military. Testing and results are enclosed.

In Invitro and Invivo testing on rats, rabbits and larger mammals at the University of Connecticut. Hemosorb consistently performed well above a cologen-based hemostatic agent in rate of coagulation and reduction of bleeding time.

Tests of Hemosorb by the UConn Chemistry Department showed a lower toxicity score of rat histopathology following application of compound to stop bleeding than other hemostatic agents. Toxicity was only 10% higher than the inert control device used.

Tests by the Chief of Surgery at VAMC. Newington, CT, conducted at Hartford Hospital on rats and pigs' livers and skin, found Hemosorb was superior to other hemostatic agents in its ability to stop bleeding.

During March 2002, testing on large mammals (animals) was completed. USUHS and the Office of Naval Research developed a large animal model of lethal uncontrolled hemorrhage. This was used to test whether the use of various hemostatic agents (in addition to standard dressing) would decrease bleeding and improve early survival. The study was highly controlled. The following is a brief summary of Hemosorb's successful results:

| | Mortality Rate: No Dressing = 80% |
|------------|----------------------------------------|
| | Standard Dressing = 33.4% |
| | Standard Dressing with Hemosorb = 0% |
| Blood Loss | Hemosorb = lowest volume of blood loss |
| | of tested hemostatic agents. |

Biocompatibility testing was completed by ISO 17025 Certified MicroTest Laboratories, Inc., of Agawam, Mass. The tests included:

| Test | Sample # | Dated |
|--------------------------------|----------|----------|
| Agar Overlay Cytotoxicity Test | 02-00480 | 01/29/02 |
| Water Adsorption Rate | 02-00254 | 01/21/02 |
| Skin Sensitization | 01-06556 | 12/21/01 |
| Skin Irritation | 01-06555 | 12/07/01 |
| Intracutaneous Test | 01-06554 | 11/30/01 |
| MEM Elution Cytotoxicity Test | 01-06492 | 11/08/01 |
| Muscle Implant | 01-06476 | 01/08/01 |

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K021581

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In summary, Hemosorb performed extremely well.

Hemosorb is a safe, effective, low cost wound dressing which is substantially alike in purpose, characteristic, process, and result to Sorbastace, and thereby eligible for approval under 510(k).

4-4 Revised 6/28/02