(310 days)
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.
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.
The document describes a 510(k) premarket notification for a medical device called NuStat®, a non-absorbable, hemostatic gauze for temporary internal use. The submission seeks to expand the prescription (Rx) indication for use for the device. The study proves the device's substantial equivalence to a legally marketed predicate device (Z-Medica, LLC's D2 Dressing, DEN160012) and its identity to a reference device (Beeken Biomedical, LLC's NuStat XR, K160578).
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria or pass/fail thresholds for each test, but rather describes the performance evaluated against the "special controls for the non-absorbable, hemostatic gauze for temporary internal use as identified in 21 CFR 878.4454" and substantial equivalence to the predicate/reference devices. Therefore, the "acceptance criteria" are implied by the successful testing results and determination of substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance and Outcome of Study |
|---|---|---|
| Hemostasis | Achieve hemostasis of a moderate to significant bleeding surface, substantially equivalent to predicate device. | Achieved hemostasis of a moderate to significant bleeding surface within 3 minutes in a Pilot study and Pivotal GLP study (liver resection in pig model). Substantially equivalent to the predicate device. |
| Radiographic Detection | Easily visualized radiographically at time of placement and at 48 hours. | The device was rated as being easily visualized radiographically at the time of placement and at 48 hours in a Pilot study and Pivotal GLP study (liver resection in pig model). |
| Vascular Obstruction & Downstream Embolization | No evidence of vascular obstruction or embolization, substantially equivalent to predicate device. | No evidence of vascular obstruction or embolization was observed in either the Pilot study or Pivotal GLP study (liver resection in pig model). In the GLP study, this was substantially equivalent to the predicate device. |
| Sterility | Device is sterile; no evidence of infection. | Validated sterilization testing shows the device is sterile. No evidence of infection was noted in either the Pilot study or Pivotal GLP study (liver resection in pig model). |
| Biocompatibility | Device is biocompatible per ISO 10993-1. | Results show the device is biocompatible based on testing per ISO 10993-1 for prolonged patient contact (>24 hours to 30 days) with blood path and circulating blood. |
| Cytotoxicity | Device is non-cytotoxic per ISO 10993-5. | Device is considered non-cytotoxic per ISO 10993-5 (ISO elution method). |
| Sensitization | Device is non-sensitizing per ISO 10993-10. | Device is considered non-sensitizing per ISO 10993-10 (Magnusson-Kligman method). |
| Irritation | Device is non-irritant per ISO 10993-11. | Device is considered non-irritant per ISO 10993-11 (intracutaneous reactivity testing). |
| Systemic Toxicity (Acute) | Device shows no acute systemic toxicity per ISO 10993-11. | Device showed no acute systemic toxicity based on testing in mice per ISO 10993-11. |
| Pyrogenicity | Device is non-pyrogenic per ISO 10993-11 and USP <151>. | Device is considered non-pyrogenic per ISO 10993-11 and USP <151> (rabbit pyrogen test). |
| Endotoxin | Device conforms to FDA and USP requirements for end-product release of medical devices. | Device conforms to FDA and USP requirements for end-product release of medical devices based on LAL Kinetic Turbidimetric Assay. |
| Interaction with Blood | Device performs as expected for a hemostatic device; activated complement. | Device performed as expected for a hemostatic device; activated complement, based on ISO 10993-4 (SC5b-9 Complement Assay). |
| Sub-acute Systemic Toxicity | Device shows no signs of systemic toxicity per ISO 10993-11. | Device showed no signs of systemic toxicity based on implantation in rabbit abdomen per ISO 10993-11. |
| Sub-chronic Systemic Toxicity | Device shows no signs of subchronic toxicity per ISO 10993-11. | Device showed no signs of subchronic toxicity based on the Pivotal Study "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS, per ISO 10993-11. |
| Genotoxicity | Device shows no signs of genotoxicity per ISO 10993-5. | Device showed no signs of genotoxicity based on Ames test and Mouse lymphoma assay per ISO 10993-5. |
| Local Effects after Implantation | Expected irritation for non-absorbable device; no adverse events in pivotal study. | In the rabbit muscle study (ISO 10993-6), the device was considered an irritant, as expected for a non-absorbable device. In the Pivotal GLP Study, the device showed no adverse events. |
| Inflammation, Adhesions, Systemic and Local Toxicity | No signs of systemic/local toxicity; inflammation and adhesions as expected for surgery and substantially equivalent to predicate. | The device showed no signs of systemic or local toxicity. Inflammation and adhesions associated with the device were as expected for this type of surgery (laparotomy and liver resection) and were substantially equivalent to those of the predicate device, per ISO 10993-6, 10993-11 and customized assessments in the Pivotal GLP study. |
| In-vitro Clot Assessment | Device accelerates clotting times from baseline. | Device accelerated clotting times from baseline based on testing PT and aPTT in bench tests. |
| Particulate Release Testing | Substantially equivalent to predicate device, even if numerous. | Tested under worst-case scenario, the device released silica particulates in quantities that were too numerous to count. This was substantially equivalent to the predicate device. Particulate sizes were not enumerated for either device. |
| Swell Percent | Minimal swell. | The swell of the device was minimal, tested as part of absorption capacity. |
| Tensile Strength Testing | Pass according to specifications. | Tested and passed according to specifications. |
| Tear Strength | Pass according to specifications. | Tested and passed according to specifications. |
| Stability | Support a one-year expiration date. | Testing was performed to support a one-year expiration date. |
2. Sample Sizes and Data Provenance
-
Sample Size for Test Set (Pre-market Studies):
- Pilot Study: "Pilot study to Develop and Refine a Survival Mode of Severe Hemorrhage for the Evaluation of the NuStat Internal Hemostatic Dressing (NuStat XR)" - ANS 2319 (number of animals not specified)
- Pivotal GLP Study: "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS (number of animals not specified, but GLP implies rigorous standards)
- Biocompatibility/Toxicity Tests: Various ISO 10993 tests (number of animals or in vitro samples not specified, but these are standardized tests).
- In-vitro Clot Assessment: (number of bench tests not specified).
- Particulate Release Testing: (number of tests not specified).
- Swell Percent/Tensile/Tear Strength/Stability: (number of tests not specified).
-
Data Provenance:
- The animal studies (Pilot and Pivotal GLP studies) were conducted using a pig model of liver resection.
- Other tests include standardized ISO 10993 biocompatibility and toxicity tests (e.g., mice for acute systemic toxicity, rabbits for pyrogenicity and sub-acute systemic toxicity/implantation).
- The studies were prospective for the purpose of demonstrating safety and effectiveness for a 510(k) submission.
- The country of origin is not explicitly stated, but as a US FDA submission, it's typically expected that these studies conform to international good laboratory practices (GLP) and are conducted in reputable facilities, often in the US or internationally accepted sites.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of human experts to establish ground truth in the context of device performance, as this device (hemostatic gauze) is assessed directly through in-vivo (animal model) and in-vitro laboratory testing for its physical and biological performance characteristics. The "ground truth" is established by direct measurement and observation of the device's hemostatic capabilities, radiographic visibility, biological interactions, and physical properties in these controlled experimental settings.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, often by multiple human readers or experts, to resolve discrepancies and establish a consensus ground truth. This is not applicable here as the device's performance is determined by direct physiological and material science measurements in animal models and laboratory settings, rather than subjective human assessment of ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study is specifically designed for diagnostic devices, particularly those involving medical imaging where human interpretation of AI outputs is a key component. NuStat is a therapeutic hemostatic device, not a diagnostic AI system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. NuStat is a physical medical device (hemostatic gauze), not an algorithm or AI system. Its performance is inherent to its physical properties and biological interactions, not a computational output that would require a "standalone" algorithmic evaluation.
7. Type of Ground Truth Used
The "ground truth" for evaluating NuStat's performance was established through:
- Direct Physiological Measurement/Observation (in-vivo): In the pig model studies, the ability of the device to achieve hemostasis within a specific time (3 minutes), the absence of vascular obstruction/embolization, and the lack of infection were directly observed and measured. Radiographic visibility was visually assessed.
- Pathology/Histology: Likely used in the pivotal GLP study and local effects after implantation study to assess inflammation, adhesions, local toxicity, and the presence or absence of issues like vascular obstruction or embolization. The document mentions "assessments customized to the intended use" in the pivotal GLP study.
- Standardized Laboratory Testing (in-vitro): For biocompatibility, cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, endotoxin, interaction with blood, genotoxicity, in-vitro clot assessment, particulate release, swell percent, tensile strength, tear strength, and stability, the ground truth was established by adherence to recognized international standards (ISO, USP) and the measured outcomes of these tests.
8. Sample Size for the Training Set
Not applicable. NuStat is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI development. The "training" for this device would refer to the research and development phases where the material composition and design were optimized.
9. How Ground Truth for the Training Set Was Established
Not applicable, as explained in point 8.
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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
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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
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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) |
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510(k) Summary
| 510(k) Number: | K183190 |
|---|---|
| Submitter: | Beeken Biomedical, LLC378 Page Street, Suite 201Stoughton, MA 02072 |
| Contact Person: | Richard A. Kendall |
| Preparation Date: | September 23, 2019 |
| Device Name: | NuStat® |
| Device Classification: | Common Name: Temporary, Internal Use Hemostatic Wound DressingGeneric Name: Non-absorbable, hemostatic gauze for temporaryinternal useDevice Classification: Class IIRegulation Number: 21 CFR 878.4454Product Code: POD |
| Special Controls: | Complies with the Non-absorbable, hemostatic gauze for temporaryinternal 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 usedfor control of severely bleeding wounds such as surgical wounds andtraumatic injuries. | |
| Device Description: | The NuStat is a hemostatic wound dressing that is composed ofcontinuous filament silica and bamboo cellulose rayon fiber and isprovided with radiopaque thread. The distribution of cellulose and silicafibers in each dressing is 65% silica fiber and 35% bamboo celluloserayon fiber. The dressings are available in various sizes and providedsterile in either foil, Tyvek, or LDPE pouched configurations. The NuStathemostatic wound dressings have a number of hemostatic properties thatenhance 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 factorsat the site of application. The radiopaque element allows for detection viax-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 June29, 2016. | |
| Special Controls: | The performance testing demonstrates the device performs as intendedunder anticipated conditions of use, per the special controls for the non-absorbable, hemostatic gauze for temporary internal use as identified in21 CFR 878.4454 | |
| Mechanism of Action: | The principle of operation for NuStat is via absorption of fluid, resultingin a physical aggregation of blood cells and clotting factors.The cellulose component absorbs excess fluid which results in aphysical aggregation of blood cells and clotting factors at the site ofapplication. | |
| Comparison ofTechnologicalCharacteristics: | Fundamental scientific technology, including design, are equivalent tothe predicate device D2 Dressing (DEN160012) and identical toreference device NuStat XR (K160578). The key technological andperformance similarities examined among devices are as follows: | |
| Mechanism of Action - Equivalent to the predicate device and identicalto the reference device. | ||
| Packaging Materials – Identical to the reference device and equivalent tothe predicate device. | ||
| Sterilization Method - Identical to the predicate and reference devices. | ||
| SubstantialEquivalence: | Predicate device, Z-Medica, LLC's D2 Dressing (DEN160012), is a classII device per decision date June 30, 2017. Reference device, BeekenBiomedical, LLC's NuStat XR (K160578) is the exact same identicaldevice as the subject device. Substantial equivalence to the predicatedevice is based on intended use, physical and technologicalcharacteristics, and comparative device information. This submissionseeks to expand the Rx indication for use for the NuStat device. Table 1below demonstrates the substantial equivalence between NuStat and thepredicate and reference device. |
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| 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 NovoNumber | TBD | DEN160012 | K160578 | N/A |
| Decision Date | TBD | June 30, 2017 | June 29, 2016 | N/A |
| Device ClassificationName | Non-absorbable,hemostatic gauze fortemporary internaluse; | Non-absorbable,hemostatic gauze fortemporary 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 & PlasticSurgery | General & PlasticSurgery | General & PlasticSurgery | Identical |
| Device Description | Equivalent. | |||
| The NuStat is ahemostatic wounddressing that iscomposed ofcontinuous filamentsilica and bamboocellulose withradiopaque thread.The distribution ofcellulose and silicafibers in eachdressing is 65% silicafiber and 35%cellulose. Thedressings areavailable in varioussizes in either Tyvekor LDPE pouchedconfigurations. TheNuStat range ofhemostatic wounddressings have anumber of hemostaticproperties thatenhance the ability ofthe dressing totemporarily controlbleeding. Theradiopaque elementallows for detectionvia x-ray. Theprinciple of operationfor NuStat is viaabsorption of fluid,resulting in a physicalaggregation of bloodcells and clottingfactors.The cellulosecomponent absorbsexcess fluid whichresults in a physicalaggregation of bloodcells and clottingfactors at the site ofapplication. | QuikClot Control+consists of a white tooff-white to yellowsterile, x-raydetectable hemostaticdressing and ispackaged for asepticremoval.QuikClot Control+ isimpregnated withkaolin, a naturallyoccurring, inorganicmineral thataccelerates the body'snatural clottingprocess. It's the sameactive ingredient usedin QuikClot CombatGauze®. Becausekaolin contains noanimal or humanproteins, no thrombin,fibrinogen, botanicals,or shellfish products,there is no risk ofallergic responses.Biocompatibilitystudies have shownthat it is safe and hasno negative effect ontissues. Integrateddouble X-rayindicators facilitatedetection and removal,reducing the risk oflost or retainedproduct. | The NuStat is ahemostatic wounddressing that iscomposed ofcontinuous filamentsilica and bamboocellulose, and areavailable with orwithout radiopaquethread. Thedistribution ofcellulose and silicafibers in each dressingis 65% silica fiber and35% cellulose. Thedressings areavailable in varioussizes in either Tyvekor LDPE pouchedconfigurations. TheNuStat range ofhemostatic wounddressings have anumber of hemostaticproperties thatenhance the ability ofthe dressing totemporarily controlbleeding. Thecellulose andcontinuous filamentsilica influence thecontact activationpathway of thecoagulation cascadeby absorbing bloodfluids, resulting in thelocalizedconcentration ofplatelets and clottingfactors. Thenegatively chargedfibers of thecontinuous filamentsilica simulate thenegative ions secretedby activated platelets,which furtherinfluence thecoagulation cascade.The radiopaqueelement allows for | Both are hemostaticwound dressings thatutilize a matrix offibers to absorb bloodand accelerate theclotting process. Bothuse hemostaticmaterial that mayenhance hemostasisby physical means.This difference doesnot raise any newissues of safety oreffectiveness. | |
| Intended Use / | Rx: | Rx: | Rx: | Equivalent. |
| Indications for Use | NuStat is indicatedfor temporary controlof internal organspace bleeding forpatients displayingclass III or class IVbleeding. It may alsobe used for control ofseverely bleedingwounds such assurgical wounds andtraumatic injuries. | D2 Dressing isindicated fortemporary control ofinternal organ spacebleeding for patientsdisplaying class III orclass IV bleeding. Itmay also be used forcontrol of severelybleeding wounds suchas surgical woundsand traumatic injuries. | NuStat is a single-usehemostatic wounddressing appliedexternally withmechanicalcompression totemporarily controlbleeding inlacerations, punctures,abrasions, surgicalwounds (operative,postoperative,dermatological, etc.)and traumatic injuries.OTC:NuStat is indicated totemporarily controlbleeding in minorcuts, lacerations,punctures, abrasionsand incisions. | Subject device usesboth intended use /indications for use ofpredicate andreference device.Additional testingwas performed insupport of expandingthe Rx indication foruse in thissubmission. |
| Mechanism ofAction | The gauze is knitfrom silica andcellulose fibers,hemostatic materialthat may enhancehemostasis byphysical means.Knitted materialforms a physicalstructure which actsas a fluid absorbent,aggregating plateletsand red blood cells. | The gauze isimpregnated withkaolin, hemostaticmaterial that mayenhance hemostasis byphysical means. | Knitted materialforms a physicalstructure which actsas a fluid absorbent,aggregating plateletsand red blood cells.Properties of thecontinuous filamentsilica trigger anelectrostaticinteraction when incontact with blood topromote clotting. | Equivalent.The devices share thesame physicalmechanism of action;contact activation ofthe clotting cascade.The predicate,reference, and subjectdevices areconstructed withhemostatic materialwhich may enhancehemostasis byphysical means.This difference doesnot raise any newissues of safety oreffectiveness. |
| Target Population | Rx:Patients displayingclass III or class IVbleeding. | Rx:Patients displayingclass III or class IVbleeding. | Rx:Patients displayingbleeding inlacerations, punctures,abrasions, surgicalwounds (operative,postoperative,dermatological, etc.)and traumatic injuries.OTC:Patients displayingminor cuts,lacerations, punctures,abrasions andincisions. | Equivalent.The subject devicecombines the targetpopulation of thepredicate andreference device asappropriate to the Rxindication.This difference doesnot raise any newissues of safety oreffectiveness. |
| Anatomical Site | Rx:Internal organ space,surgical wounds, andtraumatic injuries. | Rx:Internal organ space,surgical wounds, andtraumatic injuries. | Rx:Bleeding inlacerations, punctures,abrasions, surgicalwounds (operative,postoperative,dermatological, etc.)and traumatic injuries.OTC:Minor cuts,lacerations, punctures,abrasions andincisions. | Equivalent.The subject devicecombines theanatomical sites ofthe predicate andreference device asappropriate to the Rxindication.This difference doesnot raise any newissues of safety oreffectiveness. |
| Materials | 65% silica fiber35% cellulose rayonfiberPP-BaSO4radiopaque thread | Hydrophilic gauzeimpregnated withkaolinRadiopaque material | 65% silica fiber35% cellulose rayonfiberOptional PP-BaSO4radiopaque thread | Equivalent.Subject, predicate,and reference devicescontain hemostaticmaterial.Subject and predicatedevices provideradiopaque material. |
| Physical Presentation | Knit gauze | Non-woven gauze | Knit gauze | Equivalent. |
| Knit gauze is onecontinuous loopedyarn to form a fabricmatrix. Woven gauzeis multiple yarnscrossing each other toform a fabric matrix. | ||||
| Subject, predicate,and reference devicesare non-wovendressings that create afabric matrix withspace between theyarns to absorb blood. | ||||
| This difference doesnot raise any newissues of safety oreffectiveness. | ||||
| Device Dimensions | 2" x 2"2" x 36"3" x 48"4" x 4"4" x 8"4" x 48"6" x 60"8" x 12"12" x 12" | 3" x 72"5" x 5"8" x 8"12" x 12" | 2" x 2"2" x 36"3" x 48"4" x 4"4" x 8"4" x 48"6" x 60"8" x 12"12" x 12" | Equivalent.Subject and referencedevices have theexact same dimensionconfigurations.Subject device offerssimilar dimensions asthe predicate devicedimensions.This difference does |
| not raise any newissues of safety oreffectiveness. | ||||
| Sterilization Method | Gamma radiation | Gamma radiation | Gamma radiation | Identical. |
| Packaging | Tyvek or LDPEpouch in a paperboardbox | Foil peel pouch in apaperboard box | Tyvek or LDPEpouch in a paperboardbox | Equivalent.These packagingmaterials are commonwith these devices.This difference doesnot raise any newissues of safety oreffectiveness. |
| Shelf Life | 1 year | Unknown | 3 years for Tyvek5 years for LDPE | The subject andreference deviceshave the exact sameshelf life.The shelf life of thepredicate device isunknown. |
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Beeken Biomedical 510k) Summary
NuStat K183190
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Performance Testing: The performance testing demonstrates the device performs as intended under anticipated conditions of use, per the special controls for the nonabsorbable, hemostatic gauze for temporary internal use as identified in 21 CFR 878.4454 and is described below:
- Hemostasis: Assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. Hemostasis of a moderate to significant bleeding surface was achieved within 3 minutes, substantially equivalent to the predicate device.
- Radiographic Detection: Assessed in a Pilot study and Pivotal ● GLP study of liver resection in the pig model. The device was rated as being easily visualized radiographically at the time of placement and at 48 hours.
- . Vascular obstruction and downstream embolization: Assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. No evidence of vascular obstruction or embolization was observed in either study. In the GLP study, this was substantially equivalent to the predicate device.
- Sterility: Validated sterilization testing shows that the device is ● sterile. Performance testing was assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. No evidence of infection was noted in either study.
- . Biocompatibility: The device was tested per ISO 10993-1 a device with prolonged duration of patient contact (>24 hours to 30 days) in contact with the blood path and circulating blood. The results show the device is biocompatible.
- Cytotoxicity: Performed per ISO 10993-5 (ISO elution method), device is considered non-cytotoxic.
- Sensitization: Performed per ISO 10993-10 (Magnusson-● Kligman method), device is considered non-sensitizing.
- Irritation: Performed per ISO 10993-11 (intracutaneous reactivity ● testing), device is considered non-irritant.
- Systemic toxicity, acute: Performed per ISO 10993-11 (acute ● systemic toxicity in mice), device showed no acute systemic toxicity.
- Pyrogenicity: Performed per ISO 10993-11 and USP <151>, (rabbit pyrogen test) device is considered non-pyrogenic.
- Endotoxin: Performed per LAL Kinetic Turbidimetric Assay, device conforms to FDA and USP requirements for end-product release of medical devices.
- Interaction with blood: Performed per ISO 10993-4 (SC5b-9 ● Complement Assay, device performed as expected for a hemostatic device; activated complement.
- Sub-acute systemic toxicity: Performed per ISO 10993-11 ● (implantation in rabbit abdomen), device showed no signs of systemic toxicity/
- Sub-chronic systemic toxicity: Performed per ISO 10993-11 (Pivotal Study "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS), device showed no signs of subchronic toxicity.
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- Genotoxicity: Performed per ISO 10993-5 (Ames test, Mouse lymphoma assay), device showed no signs of genotoxicity.
- . Local effects after implantation: Performed per ISO 10993-6 (rabbit muscle implant and Pivotal GLP Study. In the rabbit muscle study the device was considered an irritant, as expected for a non-absorbable device. In the pivotal study, the device showed no adverse events.
- Inflammation, adhesions, systemic and local toxicity: Performed ● per ISO 10993-6, 10993-11 and assessments customized to the intended use in the Pivotal GLP study (Pivotal Study "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day'- FP-SS). The device showed no signs of systemic, or local toxicity. Inflammation and adhesions associated with the device were as expected for this type of surgery (laparotomy and liver resection) and were substantially equivalent to those of the predicate device.
- Pilot Pig Study- "Pilot Study to Develop and Refine a Survival ● Mode of Severe Hemorrhage for the Evaluation of the NuStat Internal Hemostatic Dressing (NuStat XR)" - ANS 2319
- Pivotal Pig Study- "Evaluation of the NuStat Trauma Pad XR ● Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS
- In-vitro clot assessment: Assessed by testing PT and aPTT in ● bench tests. Device accelerated clotting times from baseline.
- . Particulate release testing: Tested under worst-case scenario, the device released silica particulates in quantities that were too numerous to count. This was substantially equivalent to the predicate device. Particulate sizes were not enumerated for either device.
- Swell percent: Tested as part of absorption capacity. The swell ● of the device was minimal.
- Tensile strength testing: Tested and passed according to specifications
- Tear strength: Tested and passed according to specifications ●
- Stability: Testing was performed to support a one-year expiration ● date
- Conclusion: The subject device is equivalent to the predicate device and identical to the reference device. These conclusions are based upon the facts that the subject device is the exact same, identical device as the reference device, and the subject device has identical intended use and equivalent technological characteristics as the predicate device. These differences do not raise new types of questions of safety and effectiveness.
§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
(a)
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.(b)
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.