(310 days)
No
The device description and performance studies focus on the material composition and physical properties of the hemostatic dressing, with no mention of AI or ML algorithms for analysis, prediction, or decision-making. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device, NuStat, is a hemostatic wound dressing indicated for temporary control of bleeding in organ spaces, surgical wounds, and traumatic injuries. Its mode of action involves physical aggregation of blood cells and clotting factors, which is a direct therapeutic intervention to manage bleeding in patients.
No
Explanation: The NuStat device is a hemostatic wound dressing used for temporary control of bleeding, not for diagnosing conditions. Its primary function is to stop bleeding, and while it contains a radiopaque thread for detection via x-ray, this is for locating the dressing, not for diagnostic imaging of the patient's condition.
No
The device description clearly states it is a hemostatic wound dressing composed of physical materials (silica and bamboo cellulose rayon fiber) and includes a radiopaque thread. This is a physical medical device, not software.
Based on the provided information, the NuStat device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- NuStat's Function: NuStat is a hemostatic wound dressing applied directly to bleeding sites (internal organ space, surgical wounds, traumatic injuries) to physically control bleeding. It works by absorbing fluid and promoting blood cell aggregation.
- Lack of Specimen Examination: The device does not involve the collection or examination of specimens from the body in a laboratory setting. Its action is direct and physical at the site of bleeding.
- Radiopaque Thread: While it has a radiopaque thread for detection via x-ray, this is a feature for locating the dressing within the body, not for analyzing a specimen.
Therefore, NuStat falls under the category of a medical device used for wound management and hemostasis, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
POD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Internal organ space, surgical wounds, and traumatic injuries.
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
- Hemostasis: Assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. Hemostasis of a moderate to significant bleeding surface was achieved within 3 minutes, substantially equivalent to the predicate device.
- Radiographic Detection: Assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. The device was rated as being easily visualized radiographically at the time of placement and at 48 hours.
- Vascular obstruction and downstream embolization: Assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. No evidence of vascular obstruction or embolization was observed in either study. In the GLP study, this was substantially equivalent to the predicate device.
- Sterility: Validated sterilization testing shows that the device is sterile. Performance testing was assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. No evidence of infection was noted in either study.
- Biocompatibility: The device was tested per ISO 10993-1 a device with prolonged duration of patient contact (>24 hours to 30 days) in contact with the blood path and circulating blood. The results show the device is biocompatible.
- Cytotoxicity: Performed per ISO 10993-5 (ISO elution method), device is considered non-cytotoxic.
- Sensitization: Performed per ISO 10993-10 (Magnusson-Kligman method), device is considered non-sensitizing.
- Irritation: Performed per ISO 10993-11 (intracutaneous reactivity testing), device is considered non-irritant.
- Systemic toxicity, acute: Performed per ISO 10993-11 (acute systemic toxicity in mice), device showed no acute systemic toxicity.
- Pyrogenicity: Performed per ISO 10993-11 and USP , (rabbit pyrogen test) device is considered non-pyrogenic.
- Endotoxin: Performed per LAL Kinetic Turbidimetric Assay, device conforms to FDA and USP requirements for end-product release of medical devices.
- Interaction with blood: Performed per ISO 10993-4 (SC5b-9 Complement Assay, device performed as expected for a hemostatic device; activated complement.
- Sub-acute systemic toxicity: Performed per ISO 10993-11 (implantation in rabbit abdomen), device showed no signs of systemic toxicity/
- Sub-chronic systemic toxicity: Performed per ISO 10993-11 (Pivotal Study "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS), device showed no signs of subchronic toxicity.
- Genotoxicity: Performed per ISO 10993-5 (Ames test, Mouse lymphoma assay), device showed no signs of genotoxicity.
- Local effects after implantation: Performed per ISO 10993-6 (rabbit muscle implant and Pivotal GLP Study. In the rabbit muscle study the device was considered an irritant, as expected for a non-absorbable device. In the pivotal study, the device showed no adverse events.
- Inflammation, adhesions, systemic and local toxicity: Performed per ISO 10993-6, 10993-11 and assessments customized to the intended use in the Pivotal GLP study (Pivotal Study "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day'- FP-SS). The device showed no signs of systemic, or local toxicity. Inflammation and adhesions associated with the device were as expected for this type of surgery (laparotomy and liver resection) and were substantially equivalent to those of the predicate device.
- Pilot Pig Study- "Pilot Study to Develop and Refine a Survival Mode of Severe Hemorrhage for the Evaluation of the NuStat Internal Hemostatic Dressing (NuStat XR)" - ANS 2319
- Pivotal Pig Study- "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS
- In-vitro clot assessment: Assessed by testing PT and aPTT in bench tests. Device accelerated clotting times from baseline.
- Particulate release testing: Tested under worst-case scenario, the device released silica particulates in quantities that were too numerous to count. This was substantially equivalent to the predicate device. Particulate sizes were not enumerated for either device.
- Swell percent: Tested as part of absorption capacity. The swell of the device was minimal.
- Tensile strength testing: Tested and passed according to specifications
- Tear strength: Tested and passed according to specifications
- Stability: Testing was performed to support a one-year expiration date
Key Metrics
Not Found
Predicate Device(s)
Z-Medica, LLC's D2 Dressing (DEN160012)
Reference Device(s)
Beeken Biomedical, LLC's NuStat XR (K160578)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
(a)
Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i) Demonstrate that the device is able to achieve hemostasis;
(ii) Demonstrate that the device can be radiographically detected; and
(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2) The device must be demonstrated to be biocompatible.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(i) In vitro clot assessment;
(ii) Particulate release testing;
(iii) Physical characterization, including swelling percent and particulate size;
(iv) Chemical characterization;
(v) Radiopacity testing; and
(vi) Mechanical integrity testing, including tensile strength and tear strength.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) Instructions for use, including an instruction to remove all visible device components by irrigation;
(ii) The maximum amount of time the device may be left within the body;
(iii) A shelf life;
(iv) A contraindication for intravascular use of the device; and
(v) A warning regarding the potential for adhesion formation.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 25, 2019
Beeken Biomedical, LLC % Mary McNamara Vice President of Regulatory Affairs Alira Health 1 Grant Street, Suite 400 Framingham, MA 01702
Re: K183190
Trade/Device Name: NuStat Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze for Temporary Internal Use Regulatory Class: Class II Product Code: POD Dated: August 29, 2019 Received: August 30, 2019
Dear Mary McNamara:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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, |
-
| |
| 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. | 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. | Equivalent.
The devices share the
same physical
mechanism of action;
contact activation of
the clotting cascade.
The predicate,
reference, and subject
devices are
constructed with
hemostatic material
which may enhance
hemostasis by
physical means.
This difference does
not raise any new
issues of safety or
effectiveness. |
| Target Population | Rx:
Patients displaying
class III or class IV
bleeding. | Rx:
Patients displaying
class III or class IV
bleeding. | Rx:
Patients displaying
bleeding in
lacerations, punctures,
abrasions, surgical
wounds (operative,
postoperative,
dermatological, etc.)
and traumatic injuries.
OTC:
Patients displaying
minor cuts,
lacerations, punctures,
abrasions and
incisions. | Equivalent.
The subject device
combines the target
population of the
predicate and
reference device as
appropriate to the Rx
indication.
This difference does
not raise any new
issues of safety or
effectiveness. |
| Anatomical Site | Rx:
Internal organ space,
surgical wounds, and
traumatic injuries. | Rx:
Internal organ space,
surgical wounds, and
traumatic injuries. | Rx:
Bleeding in
lacerations, punctures,
abrasions, surgical
wounds (operative,
postoperative,
dermatological, etc.)
and traumatic injuries.
OTC:
Minor cuts,
lacerations, punctures,
abrasions and
incisions. | Equivalent.
The subject device
combines the
anatomical sites of
the predicate and
reference device as
appropriate to the Rx
indication.
This difference does
not raise any new
issues of safety or
effectiveness. |
| Materials | 65% silica fiber
35% cellulose rayon
fiber
PP-BaSO4
radiopaque thread | Hydrophilic gauze
impregnated with
kaolin
Radiopaque material | 65% silica fiber
35% cellulose rayon
fiber
Optional PP-BaSO4
radiopaque thread | Equivalent.
Subject, predicate,
and reference devices
contain hemostatic
material.
Subject and predicate
devices provide
radiopaque material. |
| Physical Presentation | Knit gauze | Non-woven gauze | Knit gauze | Equivalent. |
| | | | | Knit gauze is one
continuous looped
yarn to form a fabric
matrix. Woven gauze
is multiple yarns
crossing each other to
form a fabric matrix. |
| | | | | Subject, predicate,
and reference devices
are non-woven
dressings that create a
fabric matrix with
space between the
yarns to absorb blood. |
| | | | | This difference does
not raise any new
issues of safety or
effectiveness. |
| Device Dimensions | 2" x 2"
2" x 36"
3" x 48"
4" x 4"
4" x 8"
4" x 48"
6" x 60"
8" x 12"
12" x 12" | 3" x 72"
5" x 5"
8" x 8"
12" x 12" | 2" x 2"
2" x 36"
3" x 48"
4" x 4"
4" x 8"
4" x 48"
6" x 60"
8" x 12"
12" x 12" | Equivalent.
Subject and reference
devices have the
exact same dimension
configurations.
Subject device offers
similar dimensions as
the predicate device
dimensions.
This difference does |
| | | | | not raise any new
issues of safety or
effectiveness. |
| Sterilization Method | Gamma radiation | Gamma radiation | Gamma radiation | Identical. |
| Packaging | Tyvek or LDPE
pouch in a paperboard
box | Foil peel pouch in a
paperboard box | Tyvek or LDPE
pouch in a paperboard
box | Equivalent.
These packaging
materials are common
with these devices.
This difference does
not raise any new
issues of safety or
effectiveness. |
| Shelf Life | 1 year | Unknown | 3 years for Tyvek
5 years for LDPE | The subject and
reference devices
have the exact same
shelf life.
The shelf life of the
predicate device is
unknown. |
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Beeken Biomedical 510k) Summary
NuStat K183190
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Performance Testing: The performance testing demonstrates the device performs as intended under anticipated conditions of use, per the special controls for the nonabsorbable, hemostatic gauze for temporary internal use as identified in 21 CFR 878.4454 and is described below:
- Hemostasis: Assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. Hemostasis of a moderate to significant bleeding surface was achieved within 3 minutes, substantially equivalent to the predicate device.
- Radiographic Detection: Assessed in a Pilot study and Pivotal ● GLP study of liver resection in the pig model. The device was rated as being easily visualized radiographically at the time of placement and at 48 hours.
- . Vascular obstruction and downstream embolization: Assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. No evidence of vascular obstruction or embolization was observed in either study. In the GLP study, this was substantially equivalent to the predicate device.
- Sterility: Validated sterilization testing shows that the device is ● sterile. Performance testing was assessed in a Pilot study and Pivotal GLP study of liver resection in the pig model. No evidence of infection was noted in either study.
- . Biocompatibility: The device was tested per ISO 10993-1 a device with prolonged duration of patient contact (>24 hours to 30 days) in contact with the blood path and circulating blood. The results show the device is biocompatible.
- Cytotoxicity: Performed per ISO 10993-5 (ISO elution method), device is considered non-cytotoxic.
- Sensitization: Performed per ISO 10993-10 (Magnusson-● Kligman method), device is considered non-sensitizing.
- Irritation: Performed per ISO 10993-11 (intracutaneous reactivity ● testing), device is considered non-irritant.
- Systemic toxicity, acute: Performed per ISO 10993-11 (acute ● systemic toxicity in mice), device showed no acute systemic toxicity.
- Pyrogenicity: Performed per ISO 10993-11 and USP , (rabbit pyrogen test) device is considered non-pyrogenic.
- Endotoxin: Performed per LAL Kinetic Turbidimetric Assay, device conforms to FDA and USP requirements for end-product release of medical devices.
- Interaction with blood: Performed per ISO 10993-4 (SC5b-9 ● Complement Assay, device performed as expected for a hemostatic device; activated complement.
- Sub-acute systemic toxicity: Performed per ISO 10993-11 ● (implantation in rabbit abdomen), device showed no signs of systemic toxicity/
- Sub-chronic systemic toxicity: Performed per ISO 10993-11 (Pivotal Study "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS), device showed no signs of subchronic toxicity.
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- Genotoxicity: Performed per ISO 10993-5 (Ames test, Mouse lymphoma assay), device showed no signs of genotoxicity.
- . Local effects after implantation: Performed per ISO 10993-6 (rabbit muscle implant and Pivotal GLP Study. In the rabbit muscle study the device was considered an irritant, as expected for a non-absorbable device. In the pivotal study, the device showed no adverse events.
- Inflammation, adhesions, systemic and local toxicity: Performed ● per ISO 10993-6, 10993-11 and assessments customized to the intended use in the Pivotal GLP study (Pivotal Study "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day'- FP-SS). The device showed no signs of systemic, or local toxicity. Inflammation and adhesions associated with the device were as expected for this type of surgery (laparotomy and liver resection) and were substantially equivalent to those of the predicate device.
- Pilot Pig Study- "Pilot Study to Develop and Refine a Survival ● Mode of Severe Hemorrhage for the Evaluation of the NuStat Internal Hemostatic Dressing (NuStat XR)" - ANS 2319
- Pivotal Pig Study- "Evaluation of the NuStat Trauma Pad XR ● Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS
- In-vitro clot assessment: Assessed by testing PT and aPTT in ● bench tests. Device accelerated clotting times from baseline.
- . Particulate release testing: Tested under worst-case scenario, the device released silica particulates in quantities that were too numerous to count. This was substantially equivalent to the predicate device. Particulate sizes were not enumerated for either device.
- Swell percent: Tested as part of absorption capacity. The swell ● of the device was minimal.
- Tensile strength testing: Tested and passed according to specifications
- Tear strength: Tested and passed according to specifications ●
- Stability: Testing was performed to support a one-year expiration ● date
- Conclusion: The subject device is equivalent to the predicate device and identical to the reference device. These conclusions are based upon the facts that the subject device is the exact same, identical device as the reference device, and the subject device has identical intended use and equivalent technological characteristics as the predicate device. These differences do not raise new types of questions of safety and effectiveness.