Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, do noralites, 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: ExcelArrest™ is 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 modified chitin particles and polysaccharide binders. The particles are dissolved in water, poured into appropriate trays and using a lyophylization process, the water is removed to form a foam bandage. Chitin has well known hemostasis properties and when combined with the sodium carboxymethylcellulose and hydroxyethylcellulose binders, has an affinity to hold water. The Hemostasis foam quickly dehydrates 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 a medical device called ExcelArrest™ Foam Hemostat Bandage. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with reported numerical performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in this document.

However, I can extract the information that is present:

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

This document does not provide a table of specific numerical acceptance criteria for performance metrics (e.g., clotting time, blood loss reduction). Instead, it states that the device "met the performance criteria" in a porcine model. The acceptance criteria are implicitly defined by the performance of the predicate devices.

Acceptance Criteria	Reported Device Performance
Implicit: Performance comparable to legally marketed predicate devices in a relevant animal model for hemostasis.	"Comparative testing was performed using a Porcine Model and the devices met the performance criteria."
Biocompatibility: Meet guidelines of ISO 10993 and FDA guidance G95-1.	"The criteria have been satisfied for biocompatibility."

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

Sample Size for Test Set: Not specified. The document only mentions "a Porcine Model" without detailing the number of animals or trials.
Data Provenance: Porcine Model (animal study). Specific country of origin is not mentioned, but it's likely a controlled laboratory setting. The study appears to be prospective as it's comparative testing being performed for the submission.

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

Not specified. Animal studies typically rely on veterinary assessment or quantitative measurements, rather than human expert consensus for "ground truth" in the way clinical studies do.

4. Adjudication method for the test set:

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The performance testing was conducted in a porcine model, not involving human readers.

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

This device is a physical medical device (hemostatic bandage), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here.

7. The type of ground truth used:

The ground truth for the performance testing in the porcine model would be based on direct physiological measurements of hemostasis (e.g., time to hemostasis, blood loss volume) as observed and measured by researchers during the animal study.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 11, 2023

Hemostasis, LLC Corporation % Keith Roberts Technical Business Development 5000 Township Parkway St. Paul, Minnesota 55110

Re: K072900 Trade/Device Name: ExcelArrest™ Foam Hemostat Bandage Regulatory Class: Unclassified Product Code: QSY, LYA

Dear Keith 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 October 26, 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.

Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is listed as an Assistant Director. The signature block includes the office she works in, DHT4B: Division of Infection Control and Plastic Surgery Devices. It also includes OHT4: Office of Surgical and Infection Control Devices, and the 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hemostasis, LLC Corporation % Mr. Keith Roberts Technical Business Development 5000 Township Parkway St. Paul, MN 55110

OCT 26 2007

Re: K072900

Trade/Device Name: ExcelArrest™ Foam Hemostat Bandage Regulatory Class: Unclassified Product Code: FRO Dated: November 6, 2007 Received: November 11, 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.

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Page 2 - Mr. Keith Roberts

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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):

Device Name: Indications for Use:

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

OTC: ExcelArrest™ is 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)

a see and service and superior and consistences

ion Sign-Off Division of General. Resto and Neurological Devices

510(k) Number L072900

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K072900
page 1/2

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

36 2 6 7001

Company Name: Hemostasis, LLC

Classification Name: Dressing, Unclassified, Product Code - FRO

Common/Usual Name: Topical hemostatic foam

Proprietary Name: ExcelArrest™ (Rx) and (OTC) 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 ExcelArrest™ foam hemostat is Substantially Equivalent to the Hemostasis, LLC products that were the subject of premarket notification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of premarket notification K050511.

DESCRIPTION

INDICATIONS FOR USE

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

Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative a ) tradities, 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: ExcelArrest™ foam is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

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K072900
page 2/2

PREDICATE DEVICES

Hemostasis, LLC bandages subject of premarket notification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of premarket notification K050511.

BIOCOMPATIBILITY

The classification and applicable testing of the Hemostasis device was 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 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.

CONCLUSION

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

Regulation Number and Section

N/A