(161 days)
BloodSTOP iX Battle Matrix is indicated for external temporary control of minor to moderate bleeding of traumatic wounds.
BloodSTOP iX Battle Matrix is a biocompatible, non-irritating, woven matrix of fibers made from cellulose. Using a proprietary process, regenerated cellulose is etherified and oxidized to make a watersoluble, hemostatic matrix. When applied to a wound, BloodSTOP® iX Battle Matrix absorbs blood and other body fluids, transforms into a gel, actively aids in blood coagulation, and adheres to the wound with a protective translucent layer. BloodSTOP iX exerts its pro-coagulant activity by activating the intrinsic coagulation pathway, accelerating clot formation. Its water solubility allows for easy removal through rinsing without disruption of the clotted wound surface. BloodSTOP iX Battle Matrix is provided sterile in a simple to use format that readily conforms to a wound: 3"x24" strip, z-folded to an 8-layer 3"x3" pad.
The provided text describes the BloodSTOP iX Battle Matrix device and its substantial equivalence to predicate devices, particularly focusing on biocompatibility and hemostatic efficacy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the input text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Biocompatibility: | BloodSTOP iX Battle Matrix results: |
| Cytotoxicity | Non-cytotoxic |
| Intracutaneous Reactivity | Non-irritating |
| Sensitization/Hypersensitivity | Non-sensitizing |
| Primary Skin Irritation | Non-irritating |
| Systemic Injection, Acute Systemic Toxicity | Non-toxic |
| Systemic Injection, Subchronic/Chronic Toxicity | Non-toxic |
| Subcutaneous Implantation | Non-reactive |
| Hemostatic Efficacy (compared to QuikClot eX combat gauze): | Achieved equivalent (or better) hemostasis in every measure evaluated. |
| Time to hemostasis | Equivalent (or better) |
| Blood loss | Equivalent (or better) |
| Maintenance of MAP | Equivalent (or better) |
| 3-hour survival | Equivalent (or better) |
| Hematological measures of clot stability in simulated walking test | Equivalent (or better) |
| Absence of conclusive distant adverse effects | Achieved |
2. Sample size used for the test set and the data provenance:
- Biocompatibility Testing: The text does not specify the sample size for individual biocompatibility tests. It states that tests were performed "for evaluation of devices in contact with breached or compromised surfaces for a limited duration." These are generally standardized in vitro and in vivo tests, but specific animal or cell line numbers are not provided.
- Data Provenance: Not explicitly stated, but typically these tests are conducted in certified laboratories according to ISO standards.
- Hemostatic Efficacy (In vivo testing):
- Test Set: "a widely recognized 6mm femoral artery injury model in swine." The exact number of swine used is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin), but it's an in vivo animal model, implying prospective (experimental) data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The text does not provide information about the number of experts or their qualifications for establishing ground truth for either biocompatibility or hemostatic efficacy testing. These types of studies typically follow established scientific protocols and endpoint measurements rather than relying on expert consensus for ground truth on the test itself.
4. Adjudication method for the test set:
The text does not mention an adjudication method (like 2+1, 3+1) for the test set. For the types of studies described (biocompatibility and animal hemostasis model), results are usually objectively measured and interpreted by laboratory personnel and veterinary scientists, rather than clinical experts adjudicating outcomes from images or patient data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The studies described are laboratory and animal model-based, not human reader-based evaluations. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device, BloodSTOP iX Battle Matrix, is a physical hemostatic dressing, not an algorithm or an AI-powered device. Therefore, the concept of "standalone performance" for an algorithm without human intervention does not apply here.
7. The type of ground truth used:
- Biocompatibility Testing: The ground truth for these tests is established by standardized laboratory assays and observations as defined by ISO 10993-1 and FDA Blue Book Memo, G95-1 (e.g., cell viability for cytotoxicity, skin reaction scores for irritation/sensitization).
- Hemostatic Efficacy (In vivo testing): The ground truth for hemostatic efficacy in the swine model is based on direct physiological measurements and observations of objective endpoints, such as:
- Measured time to hemostasis (actual time until bleeding stops).
- Quantified blood loss.
- Measured Mean Arterial Pressure (MAP).
- Survival rate (3-hour survival).
- Hematological analysis of clot stability.
- Pathological examination for adverse effects (absence of conclusive distant adverse effects).
8. The sample size for the training set:
This question is not applicable. The BloodSTOP iX Battle Matrix is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
This question is not applicable for the same reason as #8.
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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 words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 21, 2023
LifeScience PLUS Inc. Audrey Vitale Director of QA/QMS 2520A Wyandotte St. Mountain View, California 94043
Re: K160130 Trade/Device Name: BloodSTOP iX Battle Matrix Regulatory Class: Unclassified Product Code: QSY
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 June 29, 2016. 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 contains a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized representation of three human profiles facing right, arranged in a way that they appear interconnected. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2016
LifeScience Plus, Inc. Ms. Audrey Vitale Director of QA/QMS 2520A Wyandotte St. Mountain View, CA 94043
Re: K160130
Trade/Device Name: BloodSTOP iX Battle Matrix Regulatory Class: Unclassified Product Code: FRO Dated: May 24, 2016 Received: May 26, 2016
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160130
Device Name BloodSTOP iX Battle Matrix
Indications for Use (Describe)
BloodSTOP iX Battle Matrix is indicated for external temporary control of minor to moderate bleeding of traumatic wounds.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the logo for LifeScience PLUS, a company that specializes in revolutionary wound care. The words "LifeScience" are in blue, while "PLUS" is in orange. To the right of the word "PLUS" is a white and orange medical cross.
510(k) Summary:
1. Submitter/510(k) Owner:
LifeScience PLUS, Inc. 2520A Wvandotte Street Mountain View, CA 94043
Contact Person: Audrey Vitale Telephone: 650-565-8172 Fax: 650-336-1130 Date prepared: June 29, 2016
2. Device:
Device Proprietary Name: BloodSTOP iX Battle Matrix Device Common Name: Hemostatic Dressing Classification: Unclassified Classification Name: Dressing Product Code: FRO
3. Predicate Devices:
- Primary: K072474 QuikClot eX (also marketed as QuikClot Combat Gauze)
- . K072681 BloodSTOP iX Hemostatic Gauze
4. Device Description:
BloodSTOP iX Battle Matrix is a biocompatible, non-irritating, woven matrix of fibers made from cellulose. Using a proprietary process, regenerated cellulose is etherified and oxidized to make a watersoluble, hemostatic matrix. When applied to a wound, BloodSTOP® iX Battle Matrix absorbs blood and other body fluids, transforms into a gel, actively aids in blood coagulation, and adheres to the wound with a protective translucent layer. BloodSTOP iX exerts its pro-coagulant activity by activating the intrinsic coagulation pathway, accelerating clot formation. Its water solubility allows for easy removal through rinsing without disruption of the clotted wound surface. BloodSTOP iX Battle Matrix is provided sterile in a simple to use format that readily conforms to a wound: 3"x24" strip, z-folded to an 8-layer 3"x3" pad.
5. Indications For Use:
BloodSTOP iX Battle Matrix is indicated for external temporary control of minor to moderate bleeding of traumatic wounds.
6. Technological Characteristics and Substantial Equivalence:
Two predicate devices have been selected to support substantial equivalence of BloodSTOP iX Battle Matrix:
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Image /page/5/Picture/0 description: The image shows the logo for LifeScience PLUS. The words "LifeScience" are in blue, and the word "PLUS" is in orange. Below the words is the phrase "REVOLUTIONARY WOUND CARE" in a smaller font. To the right of the word "PLUS" is a graphic of a plus sign, with one plus sign in white and another in orange, slightly offset.
- QuikClot eX (K072474. also marketed as QuikClot Combat Gauze): same intended use and a) similar technological characteristics.
BloodSTOP iX Battle Matrix and QuikClot eX (Combat Gauze) have the same intended use: temporary external use for the control of bleeding of traumatic wounds.
BloodSTOP iX Battle Matrix is technologically similar to the predicate device QuikClot eX (Combat Gauze) in design in that both products are in presented in an intuitive, easy-to-use, sterile, dressing format that readily conforms to a wound. Both are free of animal-derived components. They have the same principle of operation in that, when applied to a wound with pressure, they exert hemostatic action to control bleeding. BloodSTOP iX Battle Matrix, upon contact with blood, transforms into a gel, adheres to the wound, and activates the intrinsic coagulation pathway, accelerating clot formation. The mechanism of QuikClot eX (Combat Gauze), containing the hemostatic mineral agent kaolin in a gauze matrix, is similar: when contacting blood, it initiates the clotting process by activating the intrinsic coagulation pathway.
The products are technologically different in hemostatic agent. In QuikClot eX, the agent is kaolin mineral powder. With BloodSTOP iX Battle Matrix, the etherified, oxidized, regenerated cellulose matrix itself initiates hemostasis. Although the hemostatic components of these two products are different, their mechanism of action and outcome is substantially similar.
- b) BloodSTOP iX Hemostatic Gauze (K072681): similar intended use and same technological characteristics
BloodSTOP iX Battle Matrix and BloodSTOP iX Hemostatic Gauze have similar indication statements as both are for temporary external use to control surface bleeding. The intended use of BloodSTOP iX Battle Matrix also includes bleeding of traumatic wounds.
BloodSTOP iX Battle Matrix and BloodSTOP iX Hemostatic Gauze are identical in format and chemical composition, both being etherified, oxidized, regenerated cellulose dressings produced by LifeScience PLUS, Inc., in the identical manufacturing process. BloodSTOP iX Battle Matrix is larger in size.
7. Performance Data
Performance testing included in this submission demonstrates that BloodSTOP iX Battle Matrix is as safe and as effective as the legally marketed predicates:
- Biocompatibility testing for the intended body contact and duration
- . In-vivo testing in a severe bleed wound model
Biompatibility Testing a)
Biocompatibility testing recommended in ISO 10993-1 and additional tests recommended in FDA Blue Book Memo, G95-1, for evaluation of devices in contact with breached or compromised surfaces for a limited duration, were undertaken for BloodSTOP iX products. Test results demonstrate BloodSTOP iX Battle Matrix safety in that it is biocompatible for the intended use:
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Image /page/6/Picture/0 description: The image shows the logo for LifeScience PLUS. The words "LifeScience" are in blue, and the word "PLUS" is in orange. Below the words "LifeScience" is the phrase "REVOLUTIONARY WOUND CARE" in a smaller font. To the right of the word "PLUS" is a graphic of a plus sign, with one layer in white and the other in orange.
| Test | Result |
|---|---|
| Cytotoxicity | Non-cytotoxic |
| Intracutaneous Reactivity | Non-irritating |
| Sensitization/Hypersensitivity | Non-sensitizing |
| Primary Skin Irritation | Non-irritating |
| Systemic Injection, Acute Systemic Toxicity | Non-toxic |
| Systemic Injection, Subchronic/ ChronicToxicity | Non-toxic |
| Subcutaneous Implantation | Non-reactive |
b) Hemostatic Efficacy
In vivo testing demonstrates the safety and efficacy of BloodSTOP iX Battle Matrix for the intended use, using a widely recognized 6mm femoral artery injury model in swine. The results demonstrate that the new device is as safe and as effective as QuikClot eX (Combat Gauze) in achieving hemostasis as measured by time to hemostasis, blood loss, maintenance of MAP, 3-hour survival, hematological measures of clot stability in simulated walking test, and absence of conclusive distant adverse effects.
8. Conclusion
BloodSTOP iX Battle Matrix has the same intended use as QuikClot eX (Combat Gauze) and is similar in technological characteristics. Both products are sterile wound dressings, a widely and intuitively used format. They are applied and removed in the same way and have the same principle of operation. The difference in technological characteristics is in the hemostatic agent. BloodSTOP iX Battle Matrix has been shown to be equivalently biocompatible for the contact and duration, to achieve equivalent (or better) hemostasis in every measure evaluated in the benchmark animal model, with equivalent clot stability during animal movement. In an abundance of caution, labeling contains a warning about potential risk of embolism in areas of exposed vasculature.
BloodSTOP iX Battle Matrix has a similar intended use and the same technological characteristics as BloodSTOP iX Hemostatic Gauze.
BloodSTOP iX Battle Matrix is substantially equivalent to the predicate devices based on technological characteristics and performance data including bench, pre-clinical and usability testing.
N/A