BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17

• K Number: K071578
• Device Name: BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17
• Manufacturer: LIFESCIENCE PLUS, INC.
• Date Cleared: 2007-09-27 ( 111 days)
• Product Code: QSY FRO OSY UNC
• Regulation Number: N/A

Intended Use

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

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.

Predicate Devices

K010933

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and hemostatic function of the gauze, with no mention of AI or ML.

Therapeutic

Yes
The device is intended for "topical control of bleeding from minor cuts and abrasions of the skin surface," which addresses a medical condition (bleeding) and provides a therapeutic effect (hemostasis).

Diagnostic

No

The device is described as a hemostatic gauze intended for topical control of bleeding from minor cuts and abrasions. Its function is to stop bleeding, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Hemostatic Gauze" made from "regenerated cotton cellulose," which is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "Topical control of bleeding from minor cuts and abrasions of the skin surface." This describes a direct therapeutic action on the body, not a diagnostic test performed on samples taken from the body.
• Device Description: The description explains how the device works by interacting with blood and exudates on the wound surface to form a gel and seal the wound. This is a physical and chemical interaction for hemostasis, not a diagnostic analysis of a biological sample.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring specific substances (analytes) in those samples
  • Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is a topical hemostatic agent, which is a type of medical device used to stop bleeding.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

OSY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

skin surface

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Seal-On Hemostatic Powder Spray, K010933

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

0

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 is in blue and includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION".

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, [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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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 [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 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

p

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

• 3. Date: June 4, 2007
• 4. Device Name

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

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

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.

Intended Use: OTC topical control of bleeding from minor cuts and abrasions of the skin surface.

• 7. 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. [phone] Tel: [phone]

Fax. [phone] www.lifescienceplus.com; www.blood-stop.com