Nustat XR

K160578 · Beeken Biomedical, LLC · QSY · Jun 29, 2016 · SU

Device Facts

• Record ID: K160578
• Device Name: Nustat XR
• Applicant: Beeken Biomedical, LLC
• Product Code: QSY · SU
• Decision Date: Jun 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

OTC: NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions. Rx: NuStat is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions, surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

Device Story

NuStat Hemostatic Dressing is a single-use, sterile, hemostatic wound dressing composed of continuous filament silica and bamboo cellulose fibers (65% silica, 35% cellulose). It is applied externally to wounds by clinicians or patients (OTC) with mechanical compression. The dressing functions via a physical structure that absorbs blood fluids, concentrating platelets and clotting factors; the negatively charged silica fibers trigger an electrostatic interaction with blood to promote coagulation. Available in various sizes and configurations (z-folded or rolled) in Tyvek or LDPE pouches. Optional radiopaque polypropylene thread allows for X-ray detection. The device aids in temporary bleeding control, potentially reducing blood loss and facilitating wound management in clinical or home settings.

Clinical Evidence

Animal study (swine femoral artery injury model, n=15) compared hemostatic performance. Primary endpoints: immediate hemostasis at release of manual pressure (T0), hemostasis at 60 minutes, and re-bleeding. Bench testing included biocompatibility (ISO 10993), aPTT laboratory verification, accelerated aging (ASTM F2096), and radiopacity (ASTM F640-07). Results demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Composition: 65% continuous filament silica, 35% bamboo cellulose. Optional radiopaque element: polypropylene thread coated with barium sulfate (ASTM F640-07). Sensing/Actuation: Passive physical absorption and electrostatic coagulation trigger. Form factor: Z-folded or rolled in Tyvek/LDPE pouches. Sterilization: Gamma irradiation (SAL 10^-6). Connectivity: None.

Indications for Use

Indicated for temporary control of bleeding in minor cuts, lacerations, punctures, abrasions, incisions, surgical wounds, and traumatic injuries in patients requiring external hemostatic dressing with mechanical compression.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Nustat Hemostatic Dressing (K142363)

Reference Devices

• HemCon Guardacare XR (K103641)
• Quickclot Hemostatic Gauze (K123387)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

Beeken Biomedical, LLC % Susan Finneran Regulatory Compliance Experts, Inc. 186 Old Farm Rd Abington, Massachusetts 02351

April 21, 2023

Re: K160578 Trade/Device Name: Nustat XR Regulatory Class: Unclassified Product Code: QSY

Dear Susan Finneran:

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

June 29, 2016

Beeken Biomedical, LLC % Ms. Susan Finneran Regulatory Compliance Experts, Inc. 186 Old Farm Road Abington, Massachusetts 02351

Re: K160578

Trade/Device Name: Nustat XR Regulatory Class: Unclassified Product Code: FRO Dated: May 6, 2016 Received: May 9, 2016

Dear Ms. Finneran:

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) K160578

Device Name Nustat Hemostatic Dressing

Indications for Use (Describe) OTC:

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

Rx:

NuStat is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions, surgical wounds (operative, dermatological, etc.) and traumatic injuries.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 5.1<br>Statement | This summary of 510(k) safety and effectiveness information is being submitted<br>in accordance with the requirements of SMDA 1990 and CFR 807.92 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.2<br>Submitter | Beeken Biomedical, LLC.<br>292-G Page Street<br>Stoughton, MA. 02072<br>Establishment registration number: 3009348684 |
| 5.3<br>Company<br>Contact | Richard Kendall<br>President & CEO<br>Beeken Biomedical, LLC<br>292 Page Street, Unit G<br>Stoughton, MA 02072 |
| 5.4<br>Device Name | Proprietary Name: Nustat Hemostatic Dressing<br>Common Name: Hemostatic Wound Dressing<br>Classification Name: Dressing, wound, Drug, FRO |
| 5.5<br>Predicate<br>Legally<br>Marketed<br>Devices | Nustat Hemostatic Dressing, which is the subject of this submission, is<br>substantially equivalent to the previously cleared Nustat XR cleared via<br>K142363. Reference predicate devices have also been included in table 5.1<br>below; HemCon Guardacare XR and the Quickclot Hemostatic Gauze, which<br>were cleared via K103641 and K123387 respectively. |

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#### 5.6 The Nustat XR Hemostatic Dressing is a hemostatic wound dressing that Device composed of continuous filament silica and bamboo cellulose. The Description distribution of cellulose and silica fibers in each dressing is 65% silica fiber, 35% cellulose.

The dressings are available in various sizes in either Tyvek or LDPE pouched configurations and are available with or without the Radiopaque thread.

| Size | Packaging<br>configuration |
|-----------|----------------------------|
| 2" x 36" | LDPE pouch |
| 4 x 4" | LDPE pouch |
| 12" x 12" | Tyvek pouch |
| 3" x 48" | Tyvek pouch |
| 4" x 48" | Tyvek pouch |
| 6" x 60" | Tyvek pouch |
| 4" x 8" | Tyvek pouch |
| 8" x 12" | Tyvek pouch |
| 2" x 2" | Tyvek pouch |

The dressings are either z-folded or rolled into a medical grade Tyvek pouch or LDPE pouch which is then sterilized using gamma irradiation to a sterility assurance level 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.

| 5.7<br>Device<br>Indications and<br>Intended use | OTC:<br>NuStat is indicated to temporarily control bleeding in minor cuts, lacerations,<br>punctures, abrasions and incisions. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | Rx:<br>NuStat is a single-use hemostatic wound dressing applied externally with<br>mechanical compression to temporarily control bleeding in lacerations,<br>punctures, abrasions, surgical wounds (operative, postoperative,<br>dermatological, etc.) and traumatic injuries |

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#### 5.8 Performance Testing

Performance testing, including biocompatibility testing, laboratory verification testing, packaging validation, and sterilization validation has been completed to demonstrate substantial equivalence to the cited predicate device/ reference device.

#### Biocompatibility Testing

Biocompatibility testing was conducted in accordance with ISO 10993-1 and the following tests were conducted with passing results

ISO10993-5:Cytotoxicity (MEM Elution) ISO 10993- 10: Sensitization (Guinea Pig Maximization) ISO 10993-10:Irritation (Intracutaneous Reactivitiy Test) ISO 10993-4: Hemolysis ISO 10993-11: Acute Systemic Toxicity

#### Laboratory Verification Testing

Laboratory Verification Testing was conducted to verify the performance of the Nustat Hemostatic Dressing compared to the predicate device.

The objective of this evaluation was to compare the activated Partial Thromboplastin Time (aPTT) of the Nustat material to the aPTT of the predicate devices.

As part of this evaluation the aPTT time for the Nustat was compared to two predicate devices. The result demonstrated that the NuStat Dressing was substantially equivalent.

#### Age-Testing

Testing was completed to demonstrate that after subjecting the packaging and product to accelerated aging conditions that the package remained intact as demonstrated by package integrity testing conducted in accordance with ASTM F2096. Testing on the aged product was also tested for aPTT to demonstrate that the product was functioning and was substantially equivalent to the predicate device.

#### Radiopacity:

Imaging analysis was completed to demonstrate that the radiopaque thread would meet the requirements of ASTM F640-07.

#### Animal Testing (Swine femoral model):

A complex penetrating femoral artery groin injury was made using a 5.5mm vascular punch followed by 45 seconds of uncontrolled hemorrhage in 15 swine. The hemostatic dressings were randomized using a random sequence generator and then assigned to the animals.

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Three minutes of manual pressure was applied with each agent after the free bleed. Primary end points included immediate hemostasis upon release of manual pressure (T0), hemostasis at 60 minutes, and re-bleeding during the 60-minute observation period.

Performance testing was adequate to demonstrate substantial equivalence of the subject device to the predicate for the conditions tested.

## TABLE 5.1 TABLE OF SUSTANTIAL EQUIVALENCE

| Feature | NuStat® Hemostatic<br>Dressing<br>Proposed Device | Nustat Hemostatic<br>Dressing<br>Primary predicate<br>K142363 | HemCon<br>GuardaCare XR<br>Reference Predicate<br>K103641 | QuickClot-<br>Reference Predicate<br>K123387 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | OTC:<br>NuStat is a single-use<br>hemostatic wound dressing<br>applied externally with<br>mechanical compression to<br>temporarily control bleeding<br>in lacerations, punctures,<br>abrasions and incisions.<br><br>Rx:<br>NuStat is a single-use<br>hemostatic wound dressing<br>applied externally with<br>mechanical compression to<br>temporarily control bleeding<br>in lacerations, punctures,<br>abrasions, surgical wounds<br>(operative, postoperative,<br>dermatological, etc.) and<br>traumatic injuries. | OTC:<br>Nustat is indicated to<br>temporarily control<br>bleeding in minor cuts,<br>lacerations, punctures,<br>abrasions, and incisions<br><br>Rx:<br>Nustat XR is a single-use<br>hemostatic wound<br>dressing applied<br>externally with<br>mechanical compression<br>to temporarily control<br>bleeding in lacerations,<br>punctures, abrasions, and<br>incisions. | HemCon<br>GuardaCare XR is a<br>hemostatic dressing<br>intended for the<br>temporary control of<br>severely bleeding<br>wounds such as<br>surgical wounds and<br>traumatic injuries. | Quickclot<br>Hemostatic Dressing<br>is intended for use as<br>a topical dressing for<br>local management of<br>bleeding wounds<br>such as cuts,<br>lacerations and<br>abrasions. It may<br>also be used for<br>temporary treatment<br>of severely bleeding<br>wounds such as<br>surgical wounds<br>(operative,<br>postoperative,<br>dermatological, etc.)<br>and traumatic injuries |
| Feature | NuStat® Hemostatic<br>Dressing<br>Proposed Device | Nustat Hemostatic<br>Dressing<br>Primary predicate<br>K142363 | HemCon<br>GuardaCare XR<br>Reference Predicate<br>K103641 | QuickClot-<br>Reference Predicate<br>K123387 |
| Mechanism<br>of Action for<br>Hemostasis | Knitted material forms a<br>physical structure which acts<br>as a fluid absorbent,<br>aggregating platelets and<br>Red Blood Cells<br><br>Properties of the continuous<br>filament silica trigger an<br>electrostatic interaction<br>when in contact with blood<br>to promote clotting. | Knitted material forms a<br>physical structure which<br>acts as a fluid absorbent,<br>aggregating platelets and<br>Red Blood Cells<br><br>Properties of the<br>continuous filament silica<br>trigger an electrostatic<br>interaction when in<br>contact with blood to<br>promote clotting. | Knitted material<br>forms a physical<br>structure which acts<br>as a fluid absorbent,<br>aggregating platelets<br>and Red Blood Cells<br><br>Properties of the<br>chitosan trigger an<br>electrostatic<br>interaction when in<br>contact with blood<br>to promote clotting. | Knitted material<br>forms a physical<br>structure which acts<br>as a fluid absorbent,<br>aggregating platelets<br>and Red Blood Cells<br><br>Properties of the<br>kaolin, a mineral<br>which triggers<br>electrostatic<br>interaction when in a<br>contact with blood to<br>promote clotting |
| Method of<br>Use | Placed or packed over<br>wound. Compressed until<br>bleeding is controlled.<br>Removed within 24 hours. | Placed or packed over<br>wound. Compressed until<br>bleeding is controlled.<br>Removed within 24<br>hours. | Placed or packed<br>over wound.<br>Compressed until<br>bleeding is<br>controlled.<br>Removed within 24<br>hours. | Placed or packed<br>over wound.<br>Compressed until<br>bleeding is<br>controlled.<br>Removed within 24<br>hours. |
| Composition | Knitted cellulose and<br>continuous filament silica<br>Cellulose (rayon, edge<br>sealant)<br>Optional Radiopaque<br>element - Polypropylene<br>thread coated with barium<br>sulfate | Knitted cellulose and<br>continuous filament silica<br>Cellulose (rayon, edge<br>sealant)<br>Optional Radiopaque<br>element - Polypropylene<br>thread coated with | Knitted cellulose<br>and polyester/ rayon<br>blend coated with<br>Chitosan<br>Radiopaque element | Knitted cellulose and<br>kaolin.<br><br>Radiopaque element |
| Form Factor | Folded or rolled<br>4" x 4" , 2" x 36"<br>12 x 12"<br>3" x 48"<br>4"x 48"<br>6" x 60"<br>4" x 8"<br>8" x12"<br>2" x 2" | Folded or rolled<br>4" x 4"<br>2" x 36"<br>12 x 12"<br>3" x 48"<br>4"x 48"<br>6' x 60"<br>4" x 8"<br>8" x12" | Rectangular, z-<br>folded<br>8-ply 2" x 2"<br>8-ply 4" x 4"<br>4" x 2 yrds, Z folded<br>4"x 4" | Available in 1 inch<br>and 5/8th inch<br>diameter in the<br>following<br>configurations:<br>2"x 2 , 4"x 4", 12"x<br>12", 3"x 4 yrds, 4" x4<br>yrds. |
| Packaging | LDPE or Tyvek pouch | Tyvek peel pouch | PET Foil peel pouch | Pouch, not specified |
| Sterilization<br>Method | Gamma Irradiation | Gamma irradiation | Gamma Irradiation | Gamma irradiation |

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