← Product Code [POD](/submissions/SU/subpart-e%E2%80%94surgical-devices/POD) · K183190
# NuStat (K183190)
_Beeken Biomedical, LLC · POD · Sep 25, 2019 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/POD/K183190
## Device Facts
- **Applicant:** Beeken Biomedical, LLC
- **Product Code:** [POD](/submissions/SU/subpart-e%E2%80%94surgical-devices/POD.md)
- **Decision Date:** Sep 25, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4454
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic
## Intended Use
NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.
## Device Story
NuStat is a hemostatic wound dressing composed of 65% continuous filament silica and 35% bamboo cellulose rayon fibers, incorporating a radiopaque thread for X-ray detection. Used in clinical settings by healthcare providers, the device is applied to bleeding sites (internal organ spaces, surgical wounds, traumatic injuries). Its principle of operation is physical: the cellulose component absorbs excess fluid, facilitating the physical aggregation of blood cells and clotting factors at the application site. The silica fibers further influence the coagulation cascade via contact activation. The dressing provides temporary hemostasis, aiding in the management of severe bleeding. It is provided sterile in various sizes and configurations (foil, Tyvek, or LDPE pouches). The device is intended for prescription use.
## Clinical Evidence
No human clinical data. Evidence includes bench testing and GLP animal studies (pig liver resection model). Hemostasis achieved within 3 minutes. Radiographic visualization confirmed at placement and 48 hours. No evidence of vascular obstruction, embolization, or infection. Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity) showed no adverse findings. In-vitro clot assessment (PT/aPTT) showed accelerated clotting. Particulate release was substantially equivalent to the predicate.
## Technological Characteristics
Hemostatic gauze composed of 65% silica fiber and 35% bamboo cellulose rayon fiber. Includes radiopaque thread (PP-BaSO4). Dimensions range from 2"x2" to 12"x12". Sterilized via gamma radiation. Mechanism: physical fluid absorption and contact activation of the coagulation cascade. Biocompatibility per ISO 10993. Packaging: Tyvek or LDPE pouches.
## Regulatory Identification
A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.
## Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i) Demonstrate that the device is able to achieve hemostasis;
(ii) Demonstrate that the device can be radiographically detected; and
(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2) The device must be demonstrated to be biocompatible.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(i) In vitro clot assessment;
(ii) Particulate release testing;
(iii) Physical characterization, including swelling percent and particulate size;
(iv) Chemical characterization;
(v) Radiopacity testing; and
(vi) Mechanical integrity testing, including tensile strength and tear strength.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) Instructions for use, including an instruction to remove all visible device components by irrigation;
(ii) The maximum amount of time the device may be left within the body;
(iii) A shelf life;
(iv) A contraindication for intravascular use of the device; and
(v) A warning regarding the potential for adhesion formation.
In combination with the general controls of the FD&C Act, the non-absorbable, hemostatic gauze for temporary internal use is subject to the following special controls:
1. Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
a) Demonstrate that the device is able to achieve hemostasis;
b) Demonstrate that the device can be radiographically detected; and
c) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
2. The device must be demonstrated to be biocompatible.
3. Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
a) In vitro clot assessment;
b) Particulate release testing;
c) Physical characterization, including swelling percent and particulate size;
d) Chemical characterization;
e) Radiopacity testing; and
f) Mechanical integrity testing, including tensile strength and tear strength.
4. Performance data must demonstrate the sterility of the device.
5. Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
6. Labeling must include the following:
a) Instructions for use, including an instruction to remove all visible device components by irrigation;
b) The maximum amount of time the device may be left within the body;
c) A shelf life;
d) A contraindication for intravascular use of the device; and
e) A warning regarding the potential for adhesion formation.
## Predicate Devices
- Z-Medica, LLC's D2 Dressing ([DEN160012](/device/DEN160012.md))
## Reference Devices
- Beeken Biomedical, LLC's NuStat XR ([K160578](/device/K160578.md))
## Submission Summary (Full Text)
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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, LLC
378 Page Street, Suite 201
Stoughton, MA 02072 |
| Contact Person: | Richard A. Kendall |
| Preparation Date: | September 23, 2019 |
| Device Name: | NuStat® |
| Device Classification: | Common Name: Temporary, Internal Use Hemostatic Wound Dressing
Generic Name: Non-absorbable, hemostatic gauze for temporary
internal use
Device Classification: Class II
Regulation Number: 21 CFR 878.4454
Product Code: POD |
| Special Controls: | Complies with the Non-absorbable, hemostatic gauze for temporary
internal use as identified in 21 CFR 878.4454 |
| Intended Use / | NuStat is indicated for temporary control of internal organ space bleeding | |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Indications for Use: | for patients displaying class III or class IV bleeding. It may also be used
for control of severely bleeding wounds such as surgical wounds and
traumatic injuries. | |
| Device Description: | The NuStat is a hemostatic wound dressing that is composed of
continuous filament silica and bamboo cellulose rayon fiber and is
provided with radiopaque thread. The distribution of cellulose and silica
fibers in each dressing is 65% silica fiber and 35% bamboo cellulose
rayon fiber. The dressings are available in various sizes and provided
sterile in either foil, Tyvek, or LDPE pouched configurations. The NuStat
hemostatic wound dressings have a number of hemostatic properties that
enhance the ability of the dressing to temporarily control bleeding.
NuStat Hemostatic Dressing's mode of action is via absorption of fluid,
which results in a physical aggregation of blood cells and clotting factors
at the site of application. The radiopaque element allows for detection via
x-ray. | |
| Predicate Device: | Z-Medica, LLC's D2 Dressing (DEN160012), decision date June 30,
2017. | |
| Beeken Biomedical 510k) Summary | NuStat K183190 | 1 Page |
| Reference Device: | Beeken Biomedical, LLC's NuStat XR (K160578), decision date June
29, 2016. | |
| Special Controls: | The performance testing demonstrates the device performs as intended
under anticipated conditions of use, per the special controls for the non-
absorbable, hemostatic gauze for temporary internal use as identified in
21 CFR 878.4454 | |
| Mechanism of Action: | The principle of operation for NuStat is via absorption of fluid, resulting
in a physical aggregation of blood cells and clotting factors.
The cellulose component absorbs excess fluid which results in a
physical aggregation of blood cells and clotting factors at the site of
application. | |
| Comparison of
Technological
Characteristics: | Fundamental scientific technology, including design, are equivalent to
the predicate device D2 Dressing (DEN160012) and identical to
reference device NuStat XR (K160578). The key technological and
performance similarities examined among devices are as follows: | |
| | Mechanism of Action - Equivalent to the predicate device and identical
to the reference device. | |
| | Packaging Materials – Identical to the reference device and equivalent to
the predicate device. | |
| | Sterilization Method - Identical to the predicate and reference devices. | |
| Substantial
Equivalence: | Predicate device, Z-Medica, LLC's D2 Dressing (DEN160012), is a class
II device per decision date June 30, 2017. Reference device, Beeken
Biomedical, LLC's NuStat XR (K160578) is the exact same identical
device as the subject device. Substantial equivalence to the predicate
device is based on intended use, physical and technological
characteristics, and comparative device information. This submission
seeks to expand the Rx indication for use for the NuStat device. Table 1
below demonstrates the substantial equivalence between NuStat and the
predicate and reference device. | |
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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 Novo
Number | TBD | DEN160012 | K160578 | N/A |
| Decision Date | TBD | June 30, 2017 | June 29, 2016 | N/A |
| Device Classification
Name | Non-absorbable,
hemostatic gauze for
temporary internal
use; | Non-absorbable,
hemostatic gauze for
temporary internal use | Dressing, Wound,
Drug | Equivalent |
| Regulation Number | 878.4454; | 878.4454 | Unclassified | Equivalent |
| Product Code | POD | POD | FRO | Equivalent |
| 510(k) Review Panel | General & Plastic
Surgery | General & Plastic
Surgery | General & Plastic
Surgery | Identical |
| Device Description | | | Equivalent. | |
| The NuStat is a
hemostatic wound
dressing that is
composed of
continuous filament
silica and bamboo
cellulose with
radiopaque thread.
The distribution of
cellulose and silica
fibers in each
dressing is 65% silica
fiber and 35%
cellulose. The
dressings are
available in various
sizes in either Tyvek
or LDPE pouched
configurations. The
NuStat range of
hemostatic wound
dressings have a
number of hemostatic
properties that
enhance the ability of
the dressing to
temporarily control
bleeding. The
radiopaque element
allows for detection
via x-ray. The
principle of operation
for NuStat is via
absorption of fluid,
resulting in a physical
aggregation of blood
cells and clotting
factors.
The cellulose
component absorbs
excess fluid which
results in a physical
aggregation of blood
cells and clotting
factors at the site of
application. | QuikClot Control+
consists of a white to
off-white to yellow
sterile, x-ray
detectable hemostatic
dressing and is
packaged for aseptic
removal.
QuikClot Control+ is
impregnated with
kaolin, a naturally
occurring, inorganic
mineral that
accelerates the body's
natural clotting
process. It's the same
active ingredient used
in QuikClot Combat
Gauze®. Because
kaolin contains no
animal or human
proteins, no thrombin,
fibrinogen, botanicals,
or shellfish products,
there is no risk of
allergic responses.
Biocompatibility
studies have shown
that it is safe and has
no negative effect on
tissues. Integrated
double X-ray
indicators facilitate
detection and removal,
reducing the risk of
lost or retained
product. | The NuStat is a
hemostatic wound
dressing that is
composed of
continuous filament
silica and bamboo
cellulose, and are
available with or
without radiopaque
thread. The
distribution of
cellulose and silica
fibers in each dressing
is 65% silica fiber and
35% cellulose. The
dressings are
available in various
sizes in either Tyvek
or LDPE pouched
configurations. The
NuStat range of
hemostatic wound
dressings have a
number of hemostatic
properties that
enhance the ability of
the dressing to
temporarily control
bleeding. The
cellulose and
continuous filament
silica influence the
contact activation
pathway of the
coagulation cascade
by absorbing blood
fluids, resulting in the
localized
concentration of
platelets and clotting
factors. The
negatively charged
fibers of the
continuous filament
silica simulate the
negative ions secreted
by activated platelets,
which further
influence the
coagulation cascade.
The radiopaque
element allows for | Both are hemostatic
wound dressings that
utilize a matrix of
fibers to absorb blood
and accelerate the
clotting process. Both
use hemostatic
material that may
enhance hemostasis
by physical means.
This difference does
not raise any new
issues of safety or
effectiveness. | |
| Intended Use / | Rx: | Rx: | Rx: | Equivalent. |
| Indications for Use | NuStat is indicated
for temporary control
of internal organ
space bleeding for
patients displaying
class III or class IV
bleeding. It may also
be used for control of
severely bleeding
wounds such as
surgical wounds and
traumatic injuries. | D2 Dressing is
indicated for
temporary control of
internal organ space
bleeding for patients
displaying class III or
class IV bleeding. It
may also be used for
control of severely
bleeding wounds such
as surgical wounds
and traumatic injuries. | NuStat is a single-use
hemostatic wound
dressing applied
externally with
mechanical
compression to
temporarily control
bleeding in
lacerations, punctures,
abrasions, surgical
wounds (operative,
postoperative,
dermatological, etc.)
and traumatic injuries.
OTC:
NuStat is indicated to
temporarily control
bleeding in minor
cuts, lacerations,
punctures, abrasions
and incisions. | Subject device uses
both intended use /
indications for use of
predicate and
reference device.
Additional testing
was performed in
support of expanding
the Rx indication for
use in this
submission. |
| Mechanism of
Action | The gauze is knit
from silica and
cellulose fibers,
hemostatic material
that may enhance
hemostasis by
physical means.
Knitted material
forms a physical
structure which acts
as a fluid absorbent,
aggregating platelets
and red blood cells. | The gauze is
impregnated with
kaolin, hemostatic
material that may
enhance hemostasis by
physical means.…
---
**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/POD/K183190](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/POD/K183190)
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