(120 days)
No
The device description and performance studies focus on the material properties and mechanical action of the dressing, with no mention of AI or ML.
Yes.
The device description and intended use clearly state that the NuStat dressing is used to "temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions," which is a therapeutic function. The mechanism of action described (influencing the coagulation cascade) directly contributes to this therapeutic effect.
No
Explanation: The device is a hemostatic wound dressing intended to control bleeding, not to diagnose a medical condition.
No
The device description clearly states it is a "hemostatic wound dressing" composed of physical materials (silica and bamboo cellulose) and available in various physical configurations (pouches, z-folded, rolled). 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 clearly states that the device is applied externally to control bleeding in various types of wounds. This is a direct therapeutic action on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a wound dressing made of fibers that interact with blood in situ to promote clotting. It does not describe a test kit, reagent, or instrument used to analyze a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device's function is purely mechanical and biochemical interaction with blood at the wound site.
Therefore, the NuStat XR Hemostatic Dressing is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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)
Product codes
QSY, FRO
Device Description
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.
| Size | Packaging configuration |
|---|---|
| 2" x 36" | LDPE pouch |
| 4 x 4" | LDPE pouch |
| 12" x 12" | Tyvek pouch |
| 3" x 48" | Tyvek pouch |
| 4" x 48" | Tyvek pouch |
| 6" x 60" | Tyvek pouch |
| 4" x 8" | Tyvek pouch |
| 8" x 12" | Tyvek pouch |
| 2" x 2" | Tyvek pouch |
The dressings are either z-folded or rolled into a medical grade Tyvek pouch or LDPE pouch which is then sterilized using gamma irradiation to a sterility assurance level of 10-6.
The NuStat® range of hemostatic wound dressings have a number of hemostatic properties which enhance the ability of the dressing to temporarily control bleeding. The cellulose and continuous filament silica influence the contact activation pathway of the coagulation cascade by absorbing blood fluids, resulting in the localized concentration of platelets and clotting factors. The negatively charged fibers of the continuous filament silica simulate the negative ions secreted by activated platelets, which further influence the coagulation cascade. The radiopaque element allows for detection via x-ray.
Mentions image processing
Radiopacity:
Imaging analysis was completed to demonstrate that the radiopaque thread would meet the requirements of ASTM F640-07.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
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
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) 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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4
| 5.1
Statement | This summary of 510(k) safety and effectiveness information is being submitted
in accordance with the requirements of SMDA 1990 and CFR 807.92 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.2
Submitter | Beeken Biomedical, LLC.
292-G Page Street
Stoughton, MA. 02072
Establishment registration number: 3009348684 |
| 5.3
Company
Contact | Richard Kendall
President & CEO
Beeken Biomedical, LLC
292 Page Street, Unit G
Stoughton, MA 02072 |
| 5.4
Device Name | Proprietary Name: Nustat Hemostatic Dressing
Common Name: Hemostatic Wound Dressing
Classification Name: Dressing, wound, Drug, FRO |
| 5.5
Predicate
Legally
Marketed
Devices | Nustat Hemostatic Dressing, which is the subject of this submission, is
substantially equivalent to the previously cleared Nustat XR cleared via
K142363. Reference predicate devices have also been included in table 5.1
below; HemCon Guardacare XR and the Quickclot Hemostatic Gauze, which
were cleared via K103641 and K123387 respectively. |
5
5.6 The Nustat XR Hemostatic Dressing is a hemostatic wound dressing that Device composed of continuous filament silica and bamboo cellulose. The Description distribution of cellulose and silica fibers in each dressing is 65% silica fiber, 35% cellulose.
The dressings are available in various sizes in either Tyvek or LDPE pouched configurations and are available with or without the Radiopaque thread.
| Size | Packaging
configuration |
|-----------|----------------------------|
| 2" x 36" | LDPE pouch |
| 4 x 4" | LDPE pouch |
| 12" x 12" | Tyvek pouch |
| 3" x 48" | Tyvek pouch |
| 4" x 48" | Tyvek pouch |
| 6" x 60" | Tyvek pouch |
| 4" x 8" | Tyvek pouch |
| 8" x 12" | Tyvek pouch |
| 2" x 2" | Tyvek pouch |
The dressings are either z-folded or rolled into a medical grade Tyvek pouch or LDPE pouch which is then sterilized using gamma irradiation to a sterility assurance level of 10-6.
The NuStat® range of hemostatic wound dressings have a number of hemostatic properties which enhance the ability of the dressing to temporarily control bleeding. The cellulose and continuous filament silica influence the contact activation pathway of the coagulation cascade by absorbing blood fluids, resulting in the localized concentration of platelets and clotting factors. The negatively charged fibers of the continuous filament silica simulate the negative ions secreted by activated platelets, which further influence the coagulation cascade. The radiopaque element allows for detection via x-ray.
| 5.7
Device
Indications and
Intended use | OTC:
NuStat is indicated to temporarily control bleeding in minor cuts, lacerations,
punctures, abrasions and incisions. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | Rx:
NuStat is a single-use hemostatic wound dressing applied externally with
mechanical compression to temporarily control bleeding in lacerations,
punctures, abrasions, surgical wounds (operative, postoperative,
dermatological, etc.) and traumatic injuries |
6
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.
7
Three minutes of manual pressure was applied with each agent after the free bleed. Primary end points included immediate hemostasis upon release of manual pressure (T0), hemostasis at 60 minutes, and re-bleeding during the 60-minute observation period.
Performance testing was adequate to demonstrate substantial equivalence of the subject device to the predicate for the conditions tested.
TABLE 5.1 TABLE OF SUSTANTIAL EQUIVALENCE
| Feature | NuStat® Hemostatic
Dressing
Proposed Device | Nustat Hemostatic
Dressing
Primary predicate
K142363 | HemCon
GuardaCare XR
Reference Predicate
K103641 | QuickClot-
Reference Predicate
K123387 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | OTC:
NuStat is a single-use
hemostatic wound dressing
applied externally with
mechanical compression to
temporarily control bleeding
in lacerations, punctures,
abrasions and incisions.
Rx:
NuStat is a single-use
hemostatic wound dressing
applied externally with
mechanical compression to
temporarily control bleeding
in lacerations, punctures,
abrasions, surgical wounds
(operative, postoperative,
dermatological, etc.) and
traumatic injuries. | OTC:
Nustat is indicated to
temporarily control
bleeding in minor cuts,
lacerations, punctures,
abrasions, and incisions
Rx:
Nustat XR is a single-use
hemostatic wound
dressing applied
externally with
mechanical compression
to temporarily control
bleeding in lacerations,
punctures, abrasions, and
incisions. | HemCon
GuardaCare XR is a
hemostatic dressing
intended for the
temporary control of
severely bleeding
wounds such as
surgical wounds and
traumatic injuries. | Quickclot
Hemostatic Dressing
is intended for use as
a topical dressing for
local management of
bleeding wounds
such as cuts,
lacerations and
abrasions. It may
also be used for
temporary treatment
of severely bleeding
wounds such as
surgical wounds
(operative,
postoperative,
dermatological, etc.)
and traumatic injuries |
| Feature | NuStat® Hemostatic
Dressing
Proposed Device | Nustat Hemostatic
Dressing
Primary predicate
K142363 | HemCon
GuardaCare XR
Reference Predicate
K103641 | QuickClot-
Reference Predicate
K123387 |
| Mechanism
of Action for
Hemostasis | Knitted material forms a
physical structure which acts
as a fluid absorbent,
aggregating platelets and
Red Blood Cells
Properties of the continuous
filament silica trigger an
electrostatic interaction
when in contact with blood
to promote clotting. | Knitted material forms a
physical structure which
acts as a fluid absorbent,
aggregating platelets and
Red Blood Cells
Properties of the
continuous filament silica
trigger an electrostatic
interaction when in
contact with blood to
promote clotting. | Knitted material
forms a physical
structure which acts
as a fluid absorbent,
aggregating platelets
and Red Blood Cells
Properties of the
chitosan trigger an
electrostatic
interaction when in
contact with blood
to promote clotting. | Knitted material
forms a physical
structure which acts
as a fluid absorbent,
aggregating platelets
and Red Blood Cells
Properties of the
kaolin, a mineral
which triggers
electrostatic
interaction when in a
contact with blood to
promote clotting |
| Method of
Use | Placed or packed over
wound. Compressed until
bleeding is controlled.
Removed within 24 hours. | Placed or packed over
wound. Compressed until
bleeding is controlled.
Removed within 24
hours. | Placed or packed
over wound.
Compressed until
bleeding is
controlled.
Removed within 24
hours. | Placed or packed
over wound.
Compressed until
bleeding is
controlled.
Removed within 24
hours. |
| Composition | Knitted cellulose and
continuous filament silica
Cellulose (rayon, edge
sealant)
Optional Radiopaque
element - Polypropylene
thread coated with barium
sulfate | Knitted cellulose and
continuous filament silica
Cellulose (rayon, edge
sealant)
Optional Radiopaque
element - Polypropylene
thread coated with | Knitted cellulose
and polyester/ rayon
blend coated with
Chitosan
Radiopaque element | Knitted cellulose and
kaolin.
Radiopaque element |
| Form Factor | Folded or rolled
4" 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 rolled
4" x 4"
2" x 36"
12 x 12"
3" x 48"
4"x 48"
6' x 60"
4" x 8"
8" x12" | Rectangular, z-
folded
8-ply 2" x 2"
8-ply 4" x 4"
4" x 2 yrds, Z folded
4"x 4" | Available in 1 inch
and 5/8th inch
diameter in the
following
configurations:
2"x 2 , 4"x 4", 12"x
12", 3"x 4 yrds, 4" x4
yrds. |
| Packaging | LDPE or Tyvek pouch | Tyvek peel pouch | PET Foil peel pouch | Pouch, not specified |
| Sterilization
Method | Gamma Irradiation | Gamma irradiation | Gamma Irradiation | Gamma irradiation |
8