BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE

• K Number: K072681
• Device Name: BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE
• Manufacturer: LIFESCIENCE PLUS, INC.
• Date Cleared: 2007-11-02 ( 42 days)
• Product Code: QSY FRO UNC
• Regulation Number: N/A

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.

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 summary describes a physical hemostatic gauze and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The "Intended Use / Indications for Use" states "emergency and therapeutic use in the control of bleeding". The "Intended User / Care Setting" also mentions "therapeutic use".

Diagnostic

No
Explanation: The device is described as hemostatic gauze used for controlling bleeding, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Non-absorbable hemostatic gauze" made from "regenerated cotton cellulose," which are physical materials, 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 for controlling bleeding from skin and surface wounds. This is a direct application to the body for therapeutic purposes.
• Device Description: The device is a hemostatic gauze that interacts with blood and exudates on the wound surface to form a gel and stop bleeding. This is a physical interaction with bodily fluids outside of a laboratory setting for diagnostic purposes.
• Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) to provide diagnostic information about a patient's condition. The device's function is purely therapeutic (stopping bleeding).

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

QSY, FRO

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 and other surface wounds.

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

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

Not Found

Predicate Device(s)

Seal-On Hemostatic Powder Spray, K010933

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 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, [e-mail].

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 [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,

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

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
• 2. Contact Person: Vicky Feng
• 3. Date: September 11, 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: 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.

• 7. 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. [phone] Tel: [phone]