Who is the manufacturer of NuStat?

Beeken Biomedical, LLC filed the 510(k) submission for NuStat (K183190).

What is the FDA product code for NuStat?

POD. It is classified under 21 CFR 878.4454 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for NuStat?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NuStat?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NuStat

Q: What are the predicate devices for NuStat?

Z-Medica, LLC's D2 Dressing (DEN160012).

K183190 · Beeken Biomedical, LLC · POD · Sep 25, 2019 · General, Plastic Surgery

Device Facts

Record ID	K183190
Device Name	NuStat
Applicant	Beeken Biomedical, LLC
Product Code	POD · General, Plastic Surgery
Decision Date	Sep 25, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4454
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.

Device Story

NuStat is a hemostatic wound dressing composed of 65% continuous filament silica and 35% bamboo cellulose rayon fibers, incorporating a radiopaque thread for X-ray detection. Used in clinical settings by healthcare providers, the device is applied to bleeding sites (internal organ spaces, surgical wounds, traumatic injuries). Its principle of operation is physical: the cellulose component absorbs excess fluid, facilitating the physical aggregation of blood cells and clotting factors at the application site. The silica fibers further influence the coagulation cascade via contact activation. The dressing provides temporary hemostasis, aiding in the management of severe bleeding. It is provided sterile in various sizes and configurations (foil, Tyvek, or LDPE pouches). The device is intended for prescription use.

Clinical Evidence

No human clinical data. Evidence includes bench testing and GLP animal studies (pig liver resection model). Hemostasis achieved within 3 minutes. Radiographic visualization confirmed at placement and 48 hours. No evidence of vascular obstruction, embolization, or infection. Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity) showed no adverse findings. In-vitro clot assessment (PT/aPTT) showed accelerated clotting. Particulate release was substantially equivalent to the predicate.

Technological Characteristics

Hemostatic gauze composed of 65% silica fiber and 35% bamboo cellulose rayon fiber. Includes radiopaque thread (PP-BaSO4). Dimensions range from 2"x2" to 12"x12". Sterilized via gamma radiation. Mechanism: physical fluid absorption and contact activation of the coagulation cascade. Biocompatibility per ISO 10993. Packaging: Tyvek or LDPE pouches.

Indications for Use

Indicated for patients with class III or class IV bleeding requiring temporary control of internal organ space bleeding, and for control of severely bleeding wounds and traumatic injuries.

Regulatory Classification

Identification

A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must: (i) Demonstrate that the device is able to achieve hemostasis; (ii) Demonstrate that the device can be radiographically detected; and (iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation. (2) The device must be demonstrated to be biocompatible. (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed: (i) In vitro clot assessment; (ii) Particulate release testing; (iii) Physical characterization, including swelling percent and particulate size; (iv) Chemical characterization; (v) Radiopacity testing; and (vi) Mechanical integrity testing, including tensile strength and tear strength. (4) Performance data must demonstrate the sterility of the device. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Labeling must include the following: (i) Instructions for use, including an instruction to remove all visible device components by irrigation; (ii) The maximum amount of time the device may be left within the body; (iii) A shelf life; (iv) A contraindication for intravascular use of the device; and (v) A warning regarding the potential for adhesion formation.

In combination with the general controls of the FD&C Act, the non-absorbable, hemostatic gauze for temporary internal use is subject to the following special controls: 1. Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must: a) Demonstrate that the device is able to achieve hemostasis; b) Demonstrate that the device can be radiographically detected; and c) Assess pertinent safety endpoints including vascular obstruction and adhesion formation. 2. The device must be demonstrated to be biocompatible. 3. Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed: a) In vitro clot assessment; b) Particulate release testing; c) Physical characterization, including swelling percent and particulate size; d) Chemical characterization; e) Radiopacity testing; and f) Mechanical integrity testing, including tensile strength and tear strength. 4. Performance data must demonstrate the sterility of the device. 5. Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. 6. Labeling must include the following: a) Instructions for use, including an instruction to remove all visible device components by irrigation; b) The maximum amount of time the device may be left within the body; c) A shelf life; d) A contraindication for intravascular use of the device; and e) A warning regarding the potential for adhesion formation.

Predicate Devices

Z-Medica, LLC's D2 Dressing (DEN160012)

Reference Devices

Beeken Biomedical, LLC's NuStat XR (K160578)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 25, 2019 Beeken Biomedical, LLC % Mary McNamara Vice President of Regulatory Affairs Alira Health 1 Grant Street, Suite 400 Framingham, MA 01702 Re: K183190 Trade/Device Name: NuStat Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze for Temporary Internal Use Regulatory Class: Class II Product Code: POD Dated: August 29, 2019 Received: August 30, 2019 Dear Mary McNamara: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Cindy Chowdhury, Ph.D., M.B.A. Acting 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 Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K183190 Device Name NuStat Indications for Use (Describe) NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries. | 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. 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." {3}------------------------------------------------ ## 510(k) Summary | 510(k) Number: | K183190 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Beeken Biomedical, LLC 378 Page Street, Suite 201 Stoughton, MA 02072 | | Contact Person: | Richard A. Kendall | | Preparation Date: | September 23, 2019 | | Device Name: | NuStat® | | Device Classification: | Common Name: Temporary, Internal Use Hemostatic Wound Dressing Generic Name: Non-absorbable, hemostatic gauze for temporary internal use Device Classification: Class II Regulation Number: 21 CFR 878.4454 Product Code: POD | | Special Controls: | Complies with the Non-absorbable, hemostatic gauze for temporary internal use as identified in 21 CFR 878.4454 | | Intended Use / | NuStat is indicated for temporary control of internal organ space bleeding | | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Indications for Use: | for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. | | | Device Description: | The NuStat is a hemostatic wound dressing that is composed of continuous filament silica and bamboo cellulose rayon fiber and is provided with radiopaque thread. The distribution of cellulose and silica fibers in each dressing is 65% silica fiber and 35% bamboo cellulose rayon fiber. The dressings are available in various sizes and provided sterile in either foil, Tyvek, or LDPE pouched configurations. The NuStat hemostatic wound dressings have a number of hemostatic properties that enhance the ability of the dressing to temporarily control bleeding. NuStat Hemostatic Dressing's mode of action is via absorption of fluid, which results in a physical aggregation of blood cells and clotting factors at the site of application. The radiopaque element allows for detection via x-ray. | | | Predicate Device: | Z-Medica, LLC's D2 Dressing (DEN160012), decision date June 30, 2017. | | | Beeken Biomedical 510k) Summary | NuStat K183190 | 1 Page | | Reference Device: | Beeken Biomedical, LLC's NuStat XR (K160578), decision date June 29, 2016. | | | Special Controls: | The performance testing demonstrates the device performs as intended under anticipated conditions of use, per the special controls for the non- absorbable, hemostatic gauze for temporary internal use as identified in 21 CFR 878.4454 | | | Mechanism of Action: | The principle of operation for NuStat is via absorption of fluid, resulting in a physical aggregation of blood cells and clotting factors. The cellulose component absorbs excess fluid which results in a physical aggregation of blood cells and clotting factors at the site of application. | | | Comparison of Technological Characteristics: | Fundamental scientific technology, including design, are equivalent to the predicate device D2 Dressing (DEN160012) and identical to reference device NuStat XR (K160578). The key technological and performance similarities examined among devices are as follows: | | | | Mechanism of Action - Equivalent to the predicate device and identical to the reference device. | | | | Packaging Materials – Identical to the reference device and equivalent to the predicate device. | | | | Sterilization Method - Identical to the predicate and reference devices. | | | Substantial Equivalence: | Predicate device, Z-Medica, LLC's D2 Dressing (DEN160012), is a class II device per decision date June 30, 2017. Reference device, Beeken Biomedical, LLC's NuStat XR (K160578) is the exact same identical device as the subject device. Substantial equivalence to the predicate device is based on intended use, physical and technological characteristics, and comparative device information. This submission seeks to expand the Rx indication for use for the NuStat device. Table 1 below demonstrates the substantial equivalence between NuStat and the predicate and reference device. | | {4}------------------------------------------------ {5}------------------------------------------------ | Substantial Equivalence | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate Device | Reference Device | Equivalence | | Applicant | Beeken Biomedical, LLC | Z-Medica, LLC | Beeken Biomedical, LLC | N/A | | Device Name | NuStat | D2 Dressing | NuStat XR | N/A | | 510(k)/De Novo Number | TBD | DEN160012 | K160578 | N/A | | Decision Date | TBD | June 30, 2017 | June 29, 2016 | N/A | | Device Classification Name | Non-absorbable, hemostatic gauze for temporary internal use; | Non-absorbable, hemostatic gauze for temporary internal use | Dressing, Wound, Drug | Equivalent | | Regulation Number | 878.4454; | 878.4454 | Unclassified | Equivalent | | Product Code | POD | POD | FRO | Equivalent | | 510(k) Review Panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Identical | | Device Description | | | Equivalent. | | | The NuStat is a hemostatic wound dressing that is composed of continuous filament silica and bamboo cellulose with radiopaque thread. The distribution of cellulose and silica fibers in each dressing is 65% silica fiber and 35% cellulose. The dressings are available in various sizes in either Tyvek or LDPE pouched configurations. The NuStat range of hemostatic wound dressings have a number of hemostatic properties that enhance the ability of the dressing to temporarily control bleeding. The radiopaque element allows for detection via x-ray. The principle of operation for NuStat is via absorption of fluid, resulting in a physical aggregation of blood cells and clotting factors. The cellulose component absorbs excess fluid which results in a physical aggregation of blood cells and clotting factors at the site of application. | QuikClot Control+ consists of a white to off-white to yellow sterile, x-ray detectable hemostatic dressing and is packaged for aseptic removal. QuikClot Control+ is impregnated with kaolin, a naturally occurring, inorganic mineral that accelerates the body's natural clotting process. It's the same active ingredient used in QuikClot Combat Gauze®. Because kaolin contains no animal or human proteins, no thrombin, fibrinogen, botanicals, or shellfish products, there is no risk of allergic responses. Biocompatibility studies have shown that it is safe and has no negative effect on tissues. Integrated double X-ray indicators facilitate detection and removal, reducing the risk of lost or retained product. | The NuStat is a hemostatic wound dressing that is composed of continuous filament silica and bamboo cellulose, and are available with or without radiopaque thread. The distribution of cellulose and silica fibers in each dressing is 65% silica fiber and 35% cellulose. The dressings are available in various sizes in either Tyvek or LDPE pouched configurations. The NuStat range of hemostatic wound dressings have a number of hemostatic properties that 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 | Both are hemostatic wound dressings that utilize a matrix of fibers to absorb blood and accelerate the clotting process. Both use hemostatic material that may enhance hemostasis by physical means. This difference does not raise any new issues of safety or effectiveness. | | | Intended Use / | Rx: | Rx: | Rx: | Equivalent. | | Indications for Use | NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. | D2 Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. | 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. OTC: NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions. | Subject device uses both intended use / indications for use of predicate and reference device. Additional testing was performed in support of expanding the Rx indication for use in this submission. | | Mechanism of Action | The gauze is knit from silica and cellulose fibers, hemostatic material that may enhance hemostasis by physical means. Knitted material forms a physical structure which acts as a fluid absorbent, aggregating platelets and red blood cells. | The gauze is impregnated with kaolin, hemostatic material that may enhance hemostasis by physical means.…

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