(137 days)
Not Found
No
The device description and performance studies focus on the material properties and physical mechanisms of hemostasis, with no mention of AI or ML.
Yes.
The device is indicated to temporarily control bleeding, which is a therapeutic function.
No
This device is a hemostatic wound dressing for controlling bleeding, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a textile composed of physical materials (silica and bamboo cellulose) and is a wound dressing, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions." This is a direct therapeutic action on the body's surface, not a test performed in vitro (outside the body) on a sample to provide diagnostic information.
- Device Description: The description details a wound dressing that works by absorbing blood fluids and influencing the coagulation cascade through physical and chemical properties. This is a topical hemostatic device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.
NuStat XR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The NuStat® range of hemostatic wound dressings are textiles composed of continuous filament silica and bamboo cellulose. This submission adds a radiopaque filament to the NuStat XR models of the legally marketed dressing. The dressings are produced in various sizes to accommodate different wound sizes, ranging from a width of 2" to 8" and length of 2" to 60". The dressings are either z-folded or rolled into a medical grade Tyvek pouch which is then sterilized using gamma irradiation to a SAL 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility evaluation for NuStat® dressings was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Device Part 1: Evaluation and Testing'" May 1, 1995, and International Standard ISO 10993-1 “Biological Evaluation of Medical Devices - Part 1L Evaluation and Testing Within a Risk Management Process” as recognized by FDA. The battery of testing included the following tests as determined for an article determined to be a surface device in contact with breached or compromised surfaces with a prolonged contact duration: Cvtotoxicity, Sensitization, Irritation.
A sterility validation for NuStat® was completed following ISO 11137:2006 requirements to demonstrate a 10to SAL using the VDmax25 method.
The radiopacity of the radiopaque filament in NuStat® XR was determined via testing performed in accordance with ASTM F640-07 Method C (Standard Test Methods for Determining the Radiopacity for Medical Use). The product was found to be equivalent to the radiopacity of 1.73 ± 0.13 mm thickness 99+% 110 alloy aluminum sheet and was therefore determined to be acceptable.
In vivo and in vitro testing to evaluate the efficacy of the NuStat® range of dressings was not required as the addition of a radiopaque element does not affect the performance of the device as a hemostatic wound dressing. The results of bench safety testing indicate that the new device is as safe as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 blue and white.
April 21, 2023
Beeken Biomedical Mr. Richard Kendall President and CEO 127 West Hargett Street, Suite 300 Raleigh, North Carolina 27601
Re: K142363 Trade/Device Name: Nustat® Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY
Dear Mr. Richard Kendall:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 9, 2015. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Image /page/0/Picture/7 description: The image shows the signature of Julie A. Morabito. The signature is followed by a dash and the letter S. The word "Sincerely" is written above the signature.
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face in profile, with three overlapping profiles creating a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2015
Beeken Biomedical Mr. Richard Kendall President and Chief Executive Officer 127 West Hargett Street, Suite 300 Raleigh, North Carolina 27601
Re: K142363
Trade/Device Name: NuStat Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 7, 2014 Received: November 21, 2014
Dear Mr. Richard Kendall:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
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
3
Indications for Use
510(k) Number (if known)
Device Name NuStat Hemostatic Dressing
Indications for Use (Describe)
NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
본 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known)
Device Name NuStat XR Hemostatic Dressing
Indications for Use (Describe)
NuStat XR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.
Type of Use (Select one or both, as applicable)
쓰 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
| Date Summary Prepared: | August 22, 2014 |
|---|---|
| 510(k) Owner: | Beeken Biomedical |
| 127 West Hargett St., Suite 300 | |
| Raleigh, NC 27601 | |
| Contact Person: | Richard Kendall |
| President and CEO | |
| (919) 267-3428 | |
| rkendall@beekenbiomedical.com | |
| Device Name: | NuStat® |
| Trade Name: | NuStat® and NuStat® XR |
| Common Name: | Hemostatic Wound Dressing |
| Classification: | Wound Dressing, Drug |
| Class: | Unclassified |
| Product Code: | FRO |
| Predicate Device(s): | Primary Predicate |
| K072890 Stasilon FRTM | |
| This device has not been subject to a | |
| design-related recall. |
Secondary Predicate
K102546 ChitoGauzeTM XR
This device has not been subject to a
design-related recall. |
| Device Description: | The NuStat® range of hemostatic wound dressings are
textiles composed of continuous filament silica and bamboo
cellulose. This submission adds a radiopaque filament to the
NuStat XR models of the legally marketed dressing. The
dressings are produced in various sizes to accommodate
different wound sizes, ranging from a width of 2" to 8" and
length of 2" to 60". The dressings are either z-folded or
rolled into a medical grade Tyvek pouch which is then
sterilized using gamma irradiation to a SAL 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. |
| Statement of Intended Use: | (Over-The-Counter Use): |
| | NuStat® is indicated to temporarily control bleeding in minor
cuts, lacerations, punctures, abrasions and incisions. |
| | (Prescription Use): |
| | NuStat® XR is a single-use hemostatic wound dressing
applied externally with mechanical compression to
temporarily control bleeding in lacerations, punctures,
abrasions and incisions. |
| Comparison of Technological
Characteristics with Predicate
Devices: | NuStat® range of dressings are technologically identical to
the currently marketed predicate Stasilon FR device
(K072890). The addition of the radiopaque filament to the
dressing is the similar type of filament in the predicate
ChitoGauze XR (K102546) and does not affect the
fundamental scientific technological characteristics of the
original Stasilon FR. NuStat® dressings and both predicates
are hemostatic wound dressings. All three are substantially
equivalent in that they contain a hemostatic agent that
functions to temporarily control bleeding. NuStat® dressings
and Stasilon FR are identical; the hemostatic agent is
continuous filament silica, which triggers an electrostatic
interaction when in contact with blood to promote clotting.
ChitoGauze XR uses a different hemostatic agent, chitosan,
which is a polymer that also works by electrostatic interaction
to promote clotting. Although the hemostatic components are
different, their mechanism of action and outcome is
substantially equivalent. |
| Performance Data: | The biocompatibility evaluation for NuStat® dressings was
conducted in accordance with the FDA Blue Book
Memorandum #G95-1 "Use of International Standard ISO
10993, 'Biological Evaluation of Medical Device Part 1:
Evaluation and Testing'" May 1, 1995, and International
Standard ISO 10993-1 “Biological Evaluation of Medical
Devices - Part 1L Evaluation and Testing Within a Risk
Management Process” as recognized by FDA. The battery of |
6
7
testing included the following tests as determined for an article determined to be a surface device in contact with breached or compromised surfaces with a prolonged contact duration:
- Cvtotoxicity -
- -Sensitization
- -Irritation
A sterility validation for NuStat® was completed following ISO 11137:2006 requirements to demonstrate a 10to SAL using the VDmax25 method.
The radiopacity of the radiopaque filament in NuStat® XR was determined via testing performed in accordance with ASTM F640-07 Method C (Standard Test Methods for Determining the Radiopacity for Medical Use). The product was found to be equivalent to the radiopacity of 1.73 ± 0.13 mm thickness 99+% 110 alloy aluminum sheet and was therefore determined to be acceptable.
In vivo and in vitro testing to evaluate the efficacy of the NuStat® range of dressings was not required as the addition of a radiopaque element does not affect the performance of the device as a hemostatic wound dressing. The results of bench safety testing indicate that the new device is as safe as the predicate devices.
Assessment of Clinical Data: Based upon the substantial equivalence determination for the predicate devices, no clinical data was required for evaluation of NuStat® dressings.
- Overall Conclusions: Based on the indications for use, technological characteristics, and comparison to predicate devices, the NuStat® range of hemostatic wound dressing is demonstrated to be substantially equivalent to the predicates and is safe and effective for its intended use.