(120 days)
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.
The Nustat XR Hemostatic Dressing is a hemostatic wound dressing that composed of continuous filament silica and bamboo cellulose. The 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.
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.
The provided text describes the Nustat XR Hemostatic Dressing and its substantial equivalence to predicate devices, but does not explicitly state specific acceptance criteria or a dedicated study proving the device meets those criteria in a quantitative manner.
Instead, the performance testing section details various tests conducted to demonstrate substantial equivalence to predicate devices. This means the device is considered safe and effective because it performs as well as or similarly to a device already legally marketed.
However, based on the provided text, I can extract and infer information to address your request as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not provided, I will construct a table based on the performance tests described, indicating what was evaluated and the general outcome (which is "passing" or "substantially equivalent" in relation to predicate devices).
| Acceptance Criteria Category (Inferred) | Specific Test Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5: Cytotoxicity (MEM Elution) | Passing results |
| ISO 10993-10: Sensitization (Guinea Pig Maximization) | Passing results | |
| ISO 10993-10: Irritation (Intracutaneous Reactivity Test) | Passing results | |
| ISO 10993-4: Hemolysis | Passing results | |
| ISO 10993-11: Acute Systemic Toxicity | Passing results | |
| Hemostatic Effectiveness | Activated Partial Thromboplastin Time (aPTT) comparison | Demonstrated substantial equivalence to two predicate devices, indicating similar performance in influencing the coagulation cascade. |
| Animal Testing (Swine femoral model) - Primary Endpoints: | Demonstrated adequate performance to show substantial equivalence to the predicate for the conditions tested. - Immediate hemostasis upon release of manual pressure (T0) - Hemostasis at 60 minutes - Re-bleeding during the 60-minute observation period | |
| Product Stability/Integrity | Age-Testing (Packaging integrity per ASTM F2096) | Package remained intact after accelerated aging conditions. |
| Age-Testing (aPTT on aged product) | Demonstrated that the product was functioning and was substantially equivalent to the predicate device after accelerated aging. | |
| Radiopacity | Imaging analysis for radiopaque thread | Met the requirements of ASTM F640-07. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The text does not specify sample sizes (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation).
- Laboratory Verification Testing (aPTT): The text does not specify the number of samples tested for aPTT.
- Animal Testing (Swine femoral model): 15 swine were used. The data provenance is a "complex penetrating femoral artery groin injury" model, which is a common experimental model for hemostatic devices. The country of origin for the study is not specified but is presumably where the company is based or where the contract research organization operates. This is a prospective study since devices were randomized and assigned to animals and observed for specific endpoints.
- Age-Testing & Radiopacity: Sample sizes are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information provided about experts establishing "ground truth" in the classical sense for this type of submission.
- For biocompatibility and laboratory verification, the "ground truth" is typically defined by established laboratory standards and predicate device performance.
- For the animal study, the "ground truth" for endpoints like hemostasis and re-bleeding would be directly observed by the study personnel (e.g., veterinarians, researchers) involved in the experiment. Their qualifications are not explicitly mentioned but would be assumed to be appropriate for conducting animal studies and assessing physiological responses.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for any of the performance tests. The animal study results would likely be determined by direct observation and measurement by the study team.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices, especially those involving AI for image analysis, where human readers interpret results. The Nustat XR is a physical hemostatic dressing, so MRMC studies involving AI assistance are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This concept is relevant for AI-powered diagnostic or interpretive algorithms. The Nustat XR is a physical medical device.
7. The Type of Ground Truth Used
- Biocompatibility: Established ISO standards and laboratory methods define successful outcomes.
- Laboratory Verification (aPTT): Comparison against the performance of legally marketed predicate devices serves as the "ground truth" for substantial equivalence.
- Animal Testing: Direct physiological observation (immediate hemostasis, hemostasis at 60 minutes, re-bleeding) in the swine model serves as the ground truth.
- Age-Testing: ASTM F2096 standards for packaging integrity and comparison to predicate device aPTT for product function.
- Radiopacity: ASTM F640-07 requirements for radiopaque elements.
Essentially, the "ground truth" for this device's performance demonstration is based on established scientific methods, biological responses in a live animal model, engineering standards, and direct comparison to predicate devices, rather than human expert consensus on interpretations of data.
8. The Sample Size for the Training Set
There is no mention of a "training set" as this device is not an AI/machine learning algorithm. The closest equivalent would be the data generated during the product development and manufacturing process, but this is not organized as a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical device.
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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, Julie.Morabito@fda.hhs.gov.
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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) 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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| 5.1Statement | This summary of 510(k) safety and effectiveness information is being submittedin accordance with the requirements of SMDA 1990 and CFR 807.92 |
|---|---|
| 5.2Submitter | Beeken Biomedical, LLC.292-G Page StreetStoughton, MA. 02072Establishment registration number: 3009348684 |
| 5.3CompanyContact | Richard KendallPresident & CEOBeeken Biomedical, LLC292 Page Street, Unit GStoughton, MA 02072 |
| 5.4Device Name | Proprietary Name: Nustat Hemostatic DressingCommon Name: Hemostatic Wound DressingClassification Name: Dressing, wound, Drug, FRO |
| 5.5PredicateLegallyMarketedDevices | Nustat Hemostatic Dressing, which is the subject of this submission, issubstantially equivalent to the previously cleared Nustat XR cleared viaK142363. Reference predicate devices have also been included in table 5.1below; HemCon Guardacare XR and the Quickclot Hemostatic Gauze, whichwere 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 | Packagingconfiguration |
|---|---|
| 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.
| 5.7DeviceIndications andIntended 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 withmechanical compression to temporarily control bleeding in lacerations,punctures, abrasions, surgical wounds (operative, postoperative,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® HemostaticDressingProposed Device | Nustat HemostaticDressingPrimary predicateK142363 | HemConGuardaCare XRReference PredicateK103641 | QuickClot-Reference PredicateK123387 |
|---|---|---|---|---|
| Intended Use | OTC:NuStat is a single-usehemostatic wound dressingapplied externally withmechanical compression totemporarily control bleedingin lacerations, punctures,abrasions and incisions.Rx:NuStat is a single-usehemostatic wound dressingapplied externally withmechanical compression totemporarily control bleedingin lacerations, punctures,abrasions, surgical wounds(operative, postoperative,dermatological, etc.) andtraumatic injuries. | OTC:Nustat is indicated totemporarily controlbleeding in minor cuts,lacerations, punctures,abrasions, and incisionsRx:Nustat XR is a single-usehemostatic wounddressing appliedexternally withmechanical compressionto temporarily controlbleeding in lacerations,punctures, abrasions, andincisions. | HemConGuardaCare XR is ahemostatic dressingintended for thetemporary control ofseverely bleedingwounds such assurgical wounds andtraumatic injuries. | QuickclotHemostatic Dressingis intended for use asa topical dressing forlocal management ofbleeding woundssuch as cuts,lacerations andabrasions. It mayalso be used fortemporary treatmentof severely bleedingwounds such assurgical wounds(operative,postoperative,dermatological, etc.)and traumatic injuries |
| Feature | NuStat® HemostaticDressingProposed Device | Nustat HemostaticDressingPrimary predicateK142363 | HemConGuardaCare XRReference PredicateK103641 | QuickClot-Reference PredicateK123387 |
| Mechanismof Action forHemostasis | Knitted material forms aphysical structure which actsas a fluid absorbent,aggregating platelets andRed Blood CellsProperties of the continuousfilament silica trigger anelectrostatic interactionwhen in contact with bloodto promote clotting. | Knitted material forms aphysical structure whichacts as a fluid absorbent,aggregating platelets andRed Blood CellsProperties of thecontinuous filament silicatrigger an electrostaticinteraction when incontact with blood topromote clotting. | Knitted materialforms a physicalstructure which actsas a fluid absorbent,aggregating plateletsand Red Blood CellsProperties of thechitosan trigger anelectrostaticinteraction when incontact with bloodto promote clotting. | Knitted materialforms a physicalstructure which actsas a fluid absorbent,aggregating plateletsand Red Blood CellsProperties of thekaolin, a mineralwhich triggerselectrostaticinteraction when in acontact with blood topromote clotting |
| Method ofUse | Placed or packed overwound. Compressed untilbleeding is controlled.Removed within 24 hours. | Placed or packed overwound. Compressed untilbleeding is controlled.Removed within 24hours. | Placed or packedover wound.Compressed untilbleeding iscontrolled.Removed within 24hours. | Placed or packedover wound.Compressed untilbleeding iscontrolled.Removed within 24hours. |
| Composition | Knitted cellulose andcontinuous filament silicaCellulose (rayon, edgesealant)Optional Radiopaqueelement - Polypropylenethread coated with bariumsulfate | Knitted cellulose andcontinuous filament silicaCellulose (rayon, edgesealant)Optional Radiopaqueelement - Polypropylenethread coated with | Knitted celluloseand polyester/ rayonblend coated withChitosanRadiopaque element | Knitted cellulose andkaolin.Radiopaque element |
| Form Factor | Folded or rolled4" x 4" , 2" x 36"12 x 12"3" x 48"4"x 48"6" x 60"4" x 8"8" x12"2" x 2" | Folded or rolled4" x 4"2" x 36"12 x 12"3" x 48"4"x 48"6' x 60"4" x 8"8" x12" | Rectangular, z-folded8-ply 2" x 2"8-ply 4" x 4"4" x 2 yrds, Z folded4"x 4" | Available in 1 inchand 5/8th inchdiameter in thefollowingconfigurations:2"x 2 , 4"x 4", 12"x12", 3"x 4 yrds, 4" x4yrds. |
| Packaging | LDPE or Tyvek pouch | Tyvek peel pouch | PET Foil peel pouch | Pouch, not specified |
| SterilizationMethod | Gamma Irradiation | Gamma irradiation | Gamma Irradiation | Gamma irradiation |
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N/A