Non-absorbable hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required.

Device Description

BloodSTOP and BloodSTOP iX Hemostatic Gauze are made from regenerated cotton cellulose, chemically treated to become water-soluble. When contacting blood and exudates, they expand into clear gel, thereby adhering and creating pressure to seal the wound.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "BloodSTOP and BloodSTOP iX Hemostatic Gauze" and its substantial equivalence determination. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the specific study that proves the device meets those criteria.

The document is a US FDA 510(k) clearance letter (K072681) from 2007, and an administrative update letter from 2023. It states that the device is substantially equivalent to a predicate device, "Seal-On Hemostatic Powder Spray" (K010933). It mentions that "Animal studies included in this submission show that BloodSTOP and BloodSTOP iX are equivalent or faster than the predicate Seal-On Powder Spray in time to hemostasis."

Based on the provided information, here's what can be answered:

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

The document does not explicitly state acceptance criteria in a quantitative manner for performance. It broadly states: "Animal studies included in this submission show that BloodSTOP and BloodSTOP iX are equivalent or faster than the predicate Seal-On Powder Spray in time to hemostasis."

Acceptance Criteria (Implicit): Time to hemostasis for BloodSTOP/BloodSTOP iX should be equivalent to or faster than the predicate device (Seal-On Hemostatic Powder Spray).
Reported Device Performance: BloodSTOP/BloodSTOP iX demonstrated performance that was "equivalent or faster" than the predicate device in terms of time to hemostasis in animal studies.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified in the provided text. The document only mentions "Animal studies."
Data Provenance: "Animal studies" were used. The country of origin and whether it was retrospective or prospective is not specified.

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

This information is not provided in the document. For animal studies evaluating hemostasis, "ground truth" would typically be objective measurements of bleeding cessation, rather than expert consensus on an image or clinical observation.

4. Adjudication method for the test set

This information is not provided in the document.

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

This is not applicable. The device is a hemostatic gauze, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

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

This is not applicable. The device is a physical product, not an algorithm.

7. The type of ground truth used

For hemostasis studies, the ground truth would be objective measurements of bleeding cessation, typically observed directly during the animal procedure. The document doesn't specify the exact metrics but implies direct observation of "time to hemostasis."

8. The sample size for the training set

This information is not provided. As this is not an AI/ML device, a "training set" in the computational sense is not directly relevant. The "training" or development of the device would involve research and development, but not an algorithmic training set.

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

This information is not provided and is not directly applicable in the context of a physical medical device. The "ground truth" for developing such a device would relate to the chemical properties and physical performance observed during its formulation and testing, aiming to achieve the desired hemostatic effect.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 11, 2023

LifeScience PLUS, Inc. Audry Vitale Consultant 22 Stony Hill Drive Mystic, Connecticut 06355

Re: K072681

Trade/Device Name: BloodSTOP and BloodSTOP iX Hemostatic Gauze Regulatory Class: Unclassified Product Code: QSY

Dear Audry Vitale:

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 November 2, 2007. 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, Julie.Morabito@fda.hhs.gov.

Image /page/0/Picture/8 description: The image shows the signature of Julie A. Morabito, Ph.D., who is the Assistant Director of DHT4B: Division of Infection Control and Plastic Surgery Devices. It also mentions OHT4: Office of Surgical and Infection Control Devices. The signature is followed by the word "Sincerely,", which indicates that this is the closing of a formal letter or document.

Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LifeScience PLUS, Inc. % Ms. Audrey Vitalc 22 Stony Hill Drive Mystic, Connecticut 06355

NOV - 2 2007

Re: K072681

Trade/Device Name: BloodSTOP and BloodSTOP iX Hemostatic Gauze Regulatory Class: Unclassified Product Code: FRO Dated: September 19, 2007 Received: September 21, 2007

Dear Ms. Vitale:

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 (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.

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 - Ms. Audrey Vitale

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,

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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3. Indications for Use

510(k) Number (if known):

Device Name: BloodSTOP and BloodSTOP iX Hemostatic Gauze

Indications For Use:

Non-absorbable hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required.

Prescription Use AND/OR Over-The-Counter Use V (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDF if if the ma Division of Ge and Neurolog 510(k) I

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LifeScience PLU Palo Alto, CA 943

K072681

510(k) Summary

NOV - 2 2007

1. Submitter/Owner: LifeScience PLUS, Inc. 473 Sapena Court, Suite #7 Santa Clara, CA 95054 (Tel) 1-650-565-8172 (Toll free) 1-877-587-5433 (fax) 1-440-445-2752
  P.O. BOX 60783 Palo Alto, CA 94306
1. Contact Person: Vicky Feng
1. Date: September 11, 2007
1. Device Name

Trade Name: BloodSTOP and BloodSTOP iX Hemostatic Gauze Common Name: Hemostatic wound dressing Product Code: FRO, unclassified

1. Predicate Device: Seal-On Hemostatic Powder Spray, K010933
1. Device Description and Intended Use:

Intended Use: Non-absorbable hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required.

1. Substantial Equivalence:
  BloodSTOP and BloodSTOP iX Hemostatic Gauze are used to control bleeding, as is the predicate device. They are of similar composition as the predicate device, being made from chemically treated plant-source cellulose. They are similar in principle of operation in that both transform into a gel, covering and protecting the wound while hemostasis is achieved. They differ in presentation and method of application, as the predicate is a microdispersed cellulose in aerosol form. Animal studies included in this submission show that BloodSTOP and BloodSTOP iX are equivalent or faster than the predicate Seal-On Powder Spray in time to hemostasis. BloodSTOP and BloodSTOP iX are biocompatible, as demonstrated by test results included in this premarket submission. BloodSTOP and BloodSTOP iX Hemostatic Gauze are substantially equivalent to the cited predicate device in intended use and technological characteristics. Differences in technological characteristics do not raise new issues of safety.

473 Sapena Court, Suite 7, Santa Clara, California 95054 Tel. 877.587.5433 Tel: 650-565-8172

Regulation Number and Section

N/A