TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM

K070211 · Hemostasis, LLC · QSY · Apr 5, 2007 · SU

Device Facts

• Record ID: K070211
• Device Name: TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
• Applicant: Hemostasis, LLC
• Product Code: QSY · SU
• Decision Date: Apr 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds. Prescription: TraumArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at perculaneous needle access, vascular access and percutaneous catheter access sites. OTC: BleedArrest™ particles and foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

Device Story

Topical hemostatic dressing consisting of plant-based starch particles and lyophilized starch foam with hydroxypropylmethylcellulose (HPMC) binder. Applied to bleeding wounds; particles dehydrate blood cells; causes rapid hemoconcentration of platelets, serum proteins, and fibrinogen; accelerates clotting. Used in clinical settings (Rx) or home/point-of-care (OTC) for bleeding control. Benefits patient by limiting blood loss in surgical, traumatic, or access-site wounds.

Clinical Evidence

Bench testing and comparative performance testing in a porcine model. Biocompatibility testing conducted per ISO 10993 and FDA G95-1 guidance. No human clinical trial data reported.

Technological Characteristics

Plant-based starch particles and lyophilized starch foam with HPMC binder. Hemostatic mechanism via blood cell dehydration. Provided sterile. Biocompatibility per ISO 10993.

Indications for Use

Indicated for management of bleeding wounds. TraumArrest (Rx): temporary treatment of moderate to severe bleeding wounds (surgical, donor sites, dermatological, cuts, lacerations) and control of bleeding at percutaneous needle, vascular, and catheter access sites. BleedArrest (OTC): minor bleeding wounds (cuts, lacerations, abrasions) and minor nose bleeds.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Medafor HemaDerm (K033666)
• Medafor Bleed-X (K013225)

Submission Summary (Full Text)

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June 11, 2023

Hemostasis, LLC c/o Keith A. Roberts 5000 Township Parkway St. Paul, Minnesota 55110

Re: K070211 Trade/Device Name: TraumArrest™ and BleedArrest (OTC) Regulatory Class: Unclassified Product Code: OSY, LYA

Dear Keith A. Roberts:

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 April 5, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.

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].

> Sincerely, Julie A. Morabito -S Julie Morabito, Ph.D.

Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 5 - 2007

Hemostasis, LLC % Mr. Keith A. Roberts 5000 Township Parkway St. Paul, Minnesota 55110

Re: K070211

Trade/Device Name: TraumArrest™ and BleedArrest Regulatory Class: Unclassified Product Code: FRO Dated: January 16, 2007 Received: January 22, 2007

Dear Mr. Roberts:

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.

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.

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Page 2 - Mr. Keith A. Roberts

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

for

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

Enclosure

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#### Intended Use/ Indications for Use

510(k) Number (if known): K070211

Device Name: Indications for Use:

The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.

Prescription: TraumArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, · dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at perculaneous needle access, vascular access and percutaneous catheter access sites.

OTC: BleedArrest™ particles and foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

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 OF NEEDED)

Concurrence of Office of Device Evaluation (ODE)

8

Revision Sign-Off

(Division Sign-Off) (Division Sign-Orr). Restorative,
Division of General. Restorative, Division of Neurologica. Devices

510(k) Number

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APR 5 - 2016

510(k) Summary

#### APPLICANT

Hemostasis, LLC Corporation 5000 Township Parkway, St. Paul, MN 55110 Telephone: [phone] Fax: [phone] Contact: Keith Roberts Title: Technical Business Development

Company Name: Hemostasis, LLC

Classification Name: Dressing, Unclassified, Product Code - FRO

Common/Usual Name: Topical hemostatic particles and foam

Proprietary Name: TraumArrest™ (Rx) particle and foam and BleedArrest (OTC) particle and foam.

Establishment Registration Number and Manufacturing Location: To be Assigned Hemostasis, LLC is located at 5000 Township Parkway, St. Paul, MN 55110.

#### Performance Standards: N/A

Substantial Equivalence: The Hemostasis, LLC TraumArrest™ and BleedArrest particles and foam are substantially equivalent to the Medafor HemaDerm and Bleed-X products which were the subject of premarket notification numbers K033666 and K013225. Hemostasis, LLC believes we have demonstrated that our hemostat devices have performed as well as the above predicate devices. A list of additional predicate devices including their subsequent labeling claims is provided in the summary table titled Matrix of Predicate Devices in Section 12.

# COMPARATIVE TESTING OF SUBSTANTIALLY EQUIVALENT DEVICES

Hemostasis, LLC has performed biocompatibility testing on our devices as well as comparative testing using a Porcine Model.

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# DESCRIPTION

As described above, the Hemostasis, LLC hemostats are comprised of plant based starch particles. The particles consist in two forms; one is starch particles and one is starch particles processed into a foam using a lyophylization process and include a polysaccharide binder hydroxypropylmethylcellulose (HPMC). Starch is a polysaccharide that is a well known hemostatic agent due to its ability to hold moisture. The Hemostasis hemostatic particles and foam quickly dehydrate blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations,

### INDICATIONS FOR USE

The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.

Prescription: TraumArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

OTC: BleedArrest™ particles and foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

#### PREDICATE DEVICE

Medafor HemaDerm and Bleed-X products which were the subject of Premarket Notification numbers K033666 and K013225.

## BIOCOMPATIBILITY

The classification and applicable testing of the Hemostasis devices were determined using guidelines of ISO 10993 - Biological Evaluation of Medical Devices and FDA guidance document Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1). The criteria have been satisfied for biocompatibility.

#### PORCINE MODEL FOR COMPARATIVE PERFORMANCE TESTING

Comparative testing was performed using a Porcine Model and the devices met the performance criteria.

The Hemostasis, LLC products will be provided sterile.

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# CONCLUSION

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Through the data and information presented, Hemostasis, LLC considers the devices r rrough the aquivalent to legally marketed predicated devices cited in this Premarket Notification.

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