NuStat XR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.

Device Description

The NuStat® range of hemostatic wound dressings are textiles composed of continuous filament silica and bamboo cellulose. This submission adds a radiopaque filament to the NuStat XR models of the legally marketed dressing. The dressings are produced in various sizes to accommodate different wound sizes, ranging from a width of 2" to 8" and length of 2" to 60". The dressings are either z-folded or rolled into a medical grade Tyvek pouch which is then sterilized using gamma irradiation to a SAL of 10-6. The NuStat® range of hemostatic wound dressings have a number of hemostatic properties which enhance the ability of the dressing to temporarily control bleeding. The cellulose and continuous filament silica influence the contact activation pathway of the coagulation cascade by absorbing blood fluids, resulting in the localized concentration of platelets and clotting factors. The negatively charged fibers of the continuous filament silica simulate the negative ions secreted by activated platelets, which further influence the coagulation cascade. The radiopaque element allows for detection via x-ray.

AI/ML Overview

The provided text describes the NuStat® Hemostatic Dressing, an unclassified medical device. While it mentions performance data, this primarily pertains to biocompatibility, sterility, and radiopacity, and does not include a study proving the device meets acceptance criteria related to its primary function of controlling bleeding. The document explicitly states that efficacy testing was not required for this submission.

Therefore, many of the requested sections about acceptance criteria and a study proving device performance in that context cannot be directly extracted from the provided text. However, I can provide information based on what is available:

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

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Biocompatibility	Cytotoxicity	Passed (conducted in accordance with ISO 10993)
	Sensitization	Passed (conducted in accordance with ISO 10993)
	Irritation	Passed (conducted in accordance with ISO 10993)
Sterility	Sterilization Validation	Demonstrated a 10⁻⁶ SAL (Sterility Assurance Level) using the VDmax25 method (following ISO 11137:2006 requirements)
Radiopacity (for NuStat® XR)	ASTM F640-07 Method C	Equivalent to radiopacity of 1.73 ± 0.13 mm thickness 99+% 110 alloy aluminum sheet; determined to be acceptable.

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

The document does not provide specific sample sizes for the biocompatibility, sterility, or radiopacity tests. It implies these were standard tests performed according to recognized international standards. Data provenance is not specified, but these are likely laboratory tests conducted for regulatory submission.

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. The tests described (biocompatibility, sterility, radiopacity) are typically performed in a laboratory setting by qualified technicians following established protocols, rather than requiring expert consensus on a ground truth in the way a diagnostic AI model might.

4. Adjudication method for the test set

Not applicable for the types of tests described (biocompatibility, sterility, radiopacity). These are objective measurements against defined standards.

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

No. An MRMC study is not mentioned. This device is a hemostatic dressing, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical hemostatic dressing, not an algorithm or AI product.

7. The type of ground truth used

For the biocompatibility, sterility, and radiopacity tests, the "ground truth" would be the established scientific and regulatory standards/benchmarks as defined by ISO and ASTM, against which the device's performance was measured. For example, for sterility, the ground truth is a 10⁻⁶ SAL.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device.

Key Clarification from the Document Regarding Efficacy:

The document explicitly states: "In vivo and in vitro testing to evaluate the efficacy of the NuStat® range of dressings was not required as the addition of a radiopaque element does not affect the performance of the device as a hemostatic wound dressing." This indicates that for this specific 510(k) submission (K142363), the efficacy of the hemostatic function was considered established through the predicate device (Stasilon FR K072890), and the new submission focused on the safety aspects related to the radiopaque element and general device properties. Therefore, the document does not contain a study "proving the device meets acceptance criteria" for its primary hemostatic function.

Summary

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April 21, 2023

Beeken Biomedical Mr. Richard Kendall President and CEO 127 West Hargett Street, Suite 300 Raleigh, North Carolina 27601

Re: K142363 Trade/Device Name: Nustat® Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY

Dear Mr. Richard Kendall:

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 January 9, 2015. 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/7 description: The image shows the signature of Julie A. Morabito. The signature is followed by a dash and the letter S. The word "Sincerely" is written above the signature.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2015

Beeken Biomedical Mr. Richard Kendall President and Chief Executive Officer 127 West Hargett Street, Suite 300 Raleigh, North Carolina 27601

Re: K142363

Trade/Device Name: NuStat Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 7, 2014 Received: November 21, 2014

Dear Mr. Richard Kendall:

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

510(k) Number (if known)

K142363

Device Name NuStat Hemostatic Dressing

Indications for Use (Describe)

NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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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Indications for Use

510(k) Number (if known)

K142363

Device Name NuStat XR Hemostatic Dressing

Indications for Use (Describe)

NuStat XR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.

Type of Use (Select one or both, as applicable)

쓰 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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510(k) Summary

Date Summary Prepared:	August 22, 2014
510(k) Owner:	Beeken Biomedical127 West Hargett St., Suite 300Raleigh, NC 27601
Contact Person:	Richard KendallPresident and CEO(919) 267-3428rkendall@beekenbiomedical.com
Device Name:	NuStat®
Trade Name:	NuStat® and NuStat® XR
Common Name:	Hemostatic Wound Dressing
Classification:	Wound Dressing, Drug
Class:	Unclassified
Product Code:	FRO
Predicate Device(s):	Primary PredicateK072890 Stasilon FRTMThis device has not been subject to adesign-related recall.Secondary PredicateK102546 ChitoGauzeTM XRThis device has not been subject to adesign-related recall.
Device Description:	The NuStat® range of hemostatic wound dressings aretextiles composed of continuous filament silica and bamboocellulose. This submission adds a radiopaque filament to theNuStat XR models of the legally marketed dressing. Thedressings are produced in various sizes to accommodatedifferent wound sizes, ranging from a width of 2" to 8" andlength of 2" to 60". The dressings are either z-folded orrolled into a medical grade Tyvek pouch which is thensterilized using gamma irradiation to a SAL of 10-6. The
	NuStat® range of hemostatic wound dressings have a numberof hemostatic properties which enhance the ability of thedressing to temporarily control bleeding. The cellulose andcontinuous filament silica influence the contact activationpathway of the coagulation cascade by absorbing bloodfluids, resulting in the localized concentration of platelets andclotting factors. The negatively charged fibers of thecontinuous filament silica simulate the negative ions secretedby activated platelets, which further influence the coagulationcascade. The radiopaque element allows for detection via x-ray.
Statement of Intended Use:	(Over-The-Counter Use):
	NuStat® is indicated to temporarily control bleeding in minorcuts, lacerations, punctures, abrasions and incisions.
	(Prescription Use):
	NuStat® XR is a single-use hemostatic wound dressingapplied externally with mechanical compression totemporarily control bleeding in lacerations, punctures,abrasions and incisions.
Comparison of TechnologicalCharacteristics with PredicateDevices:	NuStat® range of dressings are technologically identical tothe currently marketed predicate Stasilon FR device(K072890). The addition of the radiopaque filament to thedressing is the similar type of filament in the predicateChitoGauze XR (K102546) and does not affect thefundamental scientific technological characteristics of theoriginal Stasilon FR. NuStat® dressings and both predicatesare hemostatic wound dressings. All three are substantiallyequivalent in that they contain a hemostatic agent thatfunctions to temporarily control bleeding. NuStat® dressingsand Stasilon FR are identical; the hemostatic agent iscontinuous filament silica, which triggers an electrostaticinteraction when in contact with blood to promote clotting.ChitoGauze XR uses a different hemostatic agent, chitosan,which is a polymer that also works by electrostatic interactionto promote clotting. Although the hemostatic components aredifferent, their mechanism of action and outcome issubstantially equivalent.
Performance Data:	The biocompatibility evaluation for NuStat® dressings wasconducted in accordance with the FDA Blue BookMemorandum #G95-1 "Use of International Standard ISO10993, 'Biological Evaluation of Medical Device Part 1:Evaluation and Testing'" May 1, 1995, and InternationalStandard ISO 10993-1 “Biological Evaluation of MedicalDevices - Part 1L Evaluation and Testing Within a RiskManagement Process” as recognized by FDA. The battery of

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testing included the following tests as determined for an article determined to be a surface device in contact with breached or compromised surfaces with a prolonged contact duration:

Cvtotoxicity -
-Sensitization
-Irritation

A sterility validation for NuStat® was completed following ISO 11137:2006 requirements to demonstrate a 10to SAL using the VDmax25 method.

The radiopacity of the radiopaque filament in NuStat® XR was determined via testing performed in accordance with ASTM F640-07 Method C (Standard Test Methods for Determining the Radiopacity for Medical Use). The product was found to be equivalent to the radiopacity of 1.73 ± 0.13 mm thickness 99+% 110 alloy aluminum sheet and was therefore determined to be acceptable.

In vivo and in vitro testing to evaluate the efficacy of the NuStat® range of dressings was not required as the addition of a radiopaque element does not affect the performance of the device as a hemostatic wound dressing. The results of bench safety testing indicate that the new device is as safe as the predicate devices.

Assessment of Clinical Data: Based upon the substantial equivalence determination for the predicate devices, no clinical data was required for evaluation of NuStat® dressings.

Overall Conclusions: Based on the indications for use, technological characteristics, and comparison to predicate devices, the NuStat® range of hemostatic wound dressing is demonstrated to be substantially equivalent to the predicates and is safe and effective for its intended use.

Regulation Number and Section

N/A