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 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,

AI/ML Overview

The provided text is a 510(k) summary for the TraumArrest™ and BleedArrest™ devices. It describes the devices, their intended use, and establishes substantial equivalence to predicate devices. However, this document does not report on a study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Instead, it states that:

"Comparative testing was performed using a Porcine Model and the devices met the performance criteria." This indicates a study was done, and it was successful, but the specific acceptance criteria and the results are not detailed.
"Hemostasis, LLC believes we have demonstrated that our hemostat devices have performed as well as the above predicate devices." This is a statement of belief based on the comparative testing, but again, without specific data.
"Performance Standards: N/A" This means there are no formal, recognized performance standards for this type of device that the manufacturer had to meet.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth are not present in the provided document.

Here's an attempt to answer the questions based on the limited information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance
Performance in a porcine model equivalent to predicate devices.	"the devices met the performance criteria" in a Porcine Model.
Biocompatibility according to ISO 10993 and FDA guidance.	"The criteria have been satisfied for biocompatibility."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: The study was a "Porcine Model," indicating an animal study rather than human clinical data. The location of the study (country) is not specified. It would be prospective since it's an experimental study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The nature of a porcine model study typically involves veterinary experts or researchers, but this is not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

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

No. This device is a topical hemostat, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding human reader improvement with AI is not applicable.

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

This question is not applicable as the device is a physical hemostat, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Porcine Model," the ground truth would likely be direct observation of hemostasis, measurement of blood loss, or time to hemostasis, as assessed by the researchers or veterinary staff involved in the study. This constitutes "outcomes data" in an animal model context.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable as there is no training set for this type of physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue.

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, Julie.Morabito@fda.hhs.gov.

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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.

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 (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

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.

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)

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: 651-855-1466 Fax: 651-651-855-1465 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

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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K070211 Page 3/3

CONCLUSION

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.

Regulation Number and Section

N/A