BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 by LIFESCIENCE PLUS, INC.

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 document is a 510(k) premarket notification for the BloodSTOP and BloodSTOP iX Hemostatic Gauze. It is not a study that describes acceptance criteria and proves the device meets them in the context of an AI/ML medical device.

The 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Seal-On Hemostatic Powder Spray, K010933) for its intended use, which is "Topical control of bleeding from minor cuts and abrasions of the skin surface."

Therefore, based on the provided document, I cannot fulfill your request for the following reasons:

No Acceptance Criteria for AI/ML performance: The document does not define performance acceptance criteria for an AI/ML device, as it is not an AI/ML device. It's a wound dressing.
No Reported Device Performance relevant to AI/ML: The performance reported is related to hemostasis time in animal studies, comparing it to the predicate device. This is not performance data for an AI/ML system (e.g., sensitivity, specificity, accuracy).
No Test Set/Data Provenance for AI/ML: There is no mention of test sets, data provenance, or ground truth for an AI/ML model.
No Expert Ground Truth establishment: The document does not discuss experts establishing ground truth for a test set.
No Adjudication Method: Adjudication methods are not applicable here.
No MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case study, as this device does not involve human readers interpreting outputs.
No Standalone Algorithm Performance: The concept of standalone algorithm performance is irrelevant for a hemostatic gauze.
No Ground Truth Type relevant to AI/ML: The "ground truth" for this device would be direct observation of hemostasis, not expert consensus, pathology, or outcomes data in the context of an AI/ML model.
No Training Set Size/Ground Truth for Training Set: Since it's not an AI/ML device, there are no training sets or ground truth established for training.

What the document does describe (and how it relates to your request's concepts, even if not directly fulfilling it):

Device Performance (not for AI/ML): "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." This is the primary "performance" discussed.
Ground Truth (implicitly for animal studies): The concept of "time to hemostasis" in animal studies implies direct observation or measurement of when bleeding stops, which would serve as the "ground truth" for that specific performance metric.
Comparison to Predicate Device: The study's "acceptance criteria" can be implicitly understood as demonstrating substantial equivalence to the predicate device, particularly regarding safety and effectiveness (hemostasis time and biocompatibility).

In summary, the provided FDA 510(k) notification for BloodSTOP and BloodSTOP iX Hemostatic Gauze is for a physical medical device and therefore does not contain information about acceptance criteria, study design, or performance metrics relevant to an AI/ML-driven device.

Summary

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June 11, 2023

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

Re: K071578

Trade/Device Name: BloodSTOP And BloodSTOP iX Hemostatic Gauze Regulatory Class: Unclassified Product Code: OSY

Dear Audrey 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 September 27, 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.

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 & Human Services. The logo consists of a stylized eagle or bird-like symbol with three trailing lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 2 7 2007

Re: K071578

Trade/Device Name: BloodSTOP and BloodSTOP iX Hemostatic Gauze Regulatory Class: Unclassified Product Code: FRO Dated: September 13, 2007 Received: September 20, 2007

Dear Ms. Audrey 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 (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

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Page 2 – Ms. Audrey Vitale

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 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 DoloN
Oct 6, 2012

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

K071578 510(k) Number (if known):

Device Name: BloodSTOP and BloodSTOP iX Hemostatic Gauze

Indications For Use:

Topical control of bleeding from minor cuts and abrasions of the skin surface

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number [K071578](https://510k.innolitics.com/search/K071578)

Prescription Use Over-The-Counter Use AND/OR (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 CDRH, Office of Device Evaluation (ODE)

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LifeScience PLUS, Inc.

510(k) Summary

1. Submitter/Owner: LifeScience PLUS. Inc. P.O. BOX 60783 473 Sapena Court, Suite #7 Palo Alto, CA 94306 Santa Clara, CA 95054 (Tel) 1-650-565-8172 (Toll free) 1-877-587-5433 (fax) 1-440-445-2752
  SEF 2 7 2007
2, Contact Person: Vicky Feng
1. Date: June 4, 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: OTC topical control of bleeding from minor cuts and abrasions of the skin surface.

1. Substantial Equivalence:
  BloodSTOP and BloodSTOP iX Hemostatic Gauze have the same intended use as 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

Fax. 440.445.2752 www.lifescienceplus.com; www.blood-stop.com

Regulation Number and Section

N/A