NUSTAT, NUSTAT XR

K142363 · Beeken Biomedical · QSY · Jan 9, 2015 · SU

Device Facts

• Record ID: K142363
• Device Name: NUSTAT, NUSTAT XR
• Applicant: Beeken Biomedical
• Product Code: QSY · SU
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

NuStat and NuStat XR are hemostatic wound dressings composed of continuous filament silica and bamboo cellulose. The device is applied externally to wounds; it functions by absorbing blood fluids to concentrate platelets and clotting factors. Negatively charged silica fibers simulate activated platelets to trigger the contact activation pathway of the coagulation cascade, promoting clot formation. NuStat XR includes a radiopaque filament for X-ray detection. The dressings are provided in various sizes, z-folded or rolled in Tyvek pouches, and sterilized via gamma irradiation. The device is used to temporarily control bleeding in minor wounds; it is intended for both over-the-counter and prescription use. The output is a physical barrier and chemical trigger for hemostasis, which aids the healthcare provider or patient in managing bleeding and potentially reducing blood loss.

Clinical Evidence

Bench testing only. No clinical data was required. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, irritation). Sterility validated per ISO 11137. Radiopacity tested per ASTM F640-07.

Technological Characteristics

Textile dressing composed of continuous filament silica and bamboo cellulose. Radiopaque filament added to XR models. Sterilization: Gamma irradiation (SAL 10^-6) per ISO 11137. Radiopacity tested per ASTM F640-07. Hemostatic principle: Electrostatic interaction via negatively charged silica fibers.

Indications for Use

Indicated for temporary control of bleeding in minor cuts, lacerations, punctures, abrasions, and incisions. NuStat XR is for use with mechanical compression.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Stasilon FR (K072890)
• ChitoGauze XR (K102546)

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] or [phone] 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 [phone] or [phone] 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.*

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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# 510(k) Summary

| Date Summary Prepared: | August 22, 2014 |
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| 510(k) Owner: | Beeken Biomedical<br>127 West Hargett St., Suite 300<br>Raleigh, NC 27601 |
| Contact Person: | Richard Kendall<br>President and CEO<br>[phone]<br>[e-mail] |
| 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 Predicate<br>K072890 Stasilon FRTM<br>This device has not been subject to a<br>design-related recall.<br><br>Secondary Predicate<br>K102546 ChitoGauzeTM XR<br>This device has not been subject to a<br>design-related recall. |
| Device Description: | The NuStat® range of hemostatic wound dressings are<br>textiles composed of continuous filament silica and bamboo<br>cellulose. This submission adds a radiopaque filament to the<br>NuStat XR models of the legally marketed dressing. The<br>dressings are produced in various sizes to accommodate<br>different wound sizes, ranging from a width of 2" to 8" and<br>length of 2" to 60". The dressings are either z-folded or<br>rolled into a medical grade Tyvek pouch which is then<br>sterilized using gamma irradiation to a SAL of 10-6. The |
| | NuStat® range of hemostatic wound dressings have a number<br>of hemostatic properties which enhance the ability of the<br>dressing to temporarily control bleeding. The cellulose and<br>continuous filament silica influence the contact activation<br>pathway of the coagulation cascade by absorbing blood<br>fluids, resulting in the localized concentration of platelets and<br>clotting factors. The negatively charged fibers of the<br>continuous filament silica simulate the negative ions secreted<br>by activated platelets, which further influence the coagulation<br>cascade. The radiopaque element allows for detection via x-<br>ray. |
| Statement of Intended Use: | (Over-The-Counter Use): |
| | NuStat® is indicated to temporarily control bleeding in minor<br>cuts, lacerations, punctures, abrasions and incisions. |
| | (Prescription Use): |
| | NuStat® XR is a single-use hemostatic wound dressing<br>applied externally with mechanical compression to<br>temporarily control bleeding in lacerations, punctures,<br>abrasions and incisions. |
| Comparison of Technological<br>Characteristics with Predicate<br>Devices: | NuStat® range of dressings are technologically identical to<br>the currently marketed predicate Stasilon FR device<br>(K072890). The addition of the radiopaque filament to the<br>dressing is the similar type of filament in the predicate<br>ChitoGauze XR (K102546) and does not affect the<br>fundamental scientific technological characteristics of the<br>original Stasilon FR. NuStat® dressings and both predicates<br>are hemostatic wound dressings. All three are substantially<br>equivalent in that they contain a hemostatic agent that<br>functions to temporarily control bleeding. NuStat® dressings<br>and Stasilon FR are identical; the hemostatic agent is<br>continuous filament silica, which triggers an electrostatic<br>interaction when in contact with blood to promote clotting.<br>ChitoGauze XR uses a different hemostatic agent, chitosan,<br>which is a polymer that also works by electrostatic interaction<br>to promote clotting. Although the hemostatic components are<br>different, their mechanism of action and outcome is<br>substantially equivalent. |
| Performance Data: | The biocompatibility evaluation for NuStat® dressings was<br>conducted in accordance with the FDA Blue Book<br>Memorandum #G95-1 "Use of International Standard ISO<br>10993, 'Biological Evaluation of Medical Device Part 1:<br>Evaluation and Testing'" May 1, 1995, and International<br>Standard ISO 10993-1 “Biological Evaluation of Medical<br>Devices - Part 1L Evaluation and Testing Within a Risk<br>Management 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.