K Number

Device Name

Axiostat Patch

Manufacturer

Advamedica Inc.

Date Cleared

2021-04-15

(202 days)

Product Code

QSY FRO

Regulation Number

N/A

Intended Use

The Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites. vascular procedure sites and sites involving percutaneous catheters, tubes and pins.

Device Description

The Axiostat Patch is a sterile, single use, non-absorbable hemostatic dressing. It is composed of chitosan a well-known natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied directly to a wound with firm pressure, the dressing controls bleeding and provides a barrier against bacterial penetration. The hemostatic dressing can be removed after the clotting has occurred but should not remain on for more than 24 hours. The hemostatic dressing is not intended to be implanted. The Axiostat Patch is individually packaged in moisture proof packs and terminally sterilized using gamma irradiation.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K150916, K102944

Reference Devices

K172324

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and physical function of the hemostatic dressing, with no mention of AI or ML.

Therapeutic

Yes
The device is described as a hemostatic dressing intended for local management of bleeding wounds and to provide a barrier to bacterial penetration, which are therapeutic actions.

Diagnostic

The device description and intended use clearly state that the Axiostat Patch is a hemostatic dressing intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration. Its function is to control bleeding and protect the wound, not to diagnose any condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a sterile, single-use, non-absorbable hemostatic dressing composed of chitosan, which is a physical material. The performance studies also focus on the physical and biological properties of this material. There is no mention of software components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Axiostat Patch is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the local management of bleeding wounds and to provide a barrier to bacterial penetration. This is a direct therapeutic and protective function applied to the body.
Device Description: The device is a sterile, single-use, non-absorbable hemostatic dressing applied directly to a wound.
Mechanism of Action: It controls bleeding and provides a barrier against bacterial penetration through direct contact with the wound.
No mention of in vitro testing: The description and performance studies focus on the device's interaction with the wound and its ability to control bleeding and act as a barrier in vivo (in the body) or in simulated in vivo conditions (animal studies). There is no indication that the device is used to test samples outside of the body to diagnose a condition or provide information about a patient's health status.

IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Axiostat Patch does not perform this function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, surgical debridement sites, skin surface puncture sites, vascular sites and sites involving percutaneous catheters, tubes and pins.

Product codes (comma separated list FDA assigned to the subject device)

QSY, FRO

Device Description

When applied directly to a wound with firm pressure, the dressing controls bleeding and provides a barrier against bacterial penetration. The hemostatic dressing can be removed after the clotting has occurred but should not remain on for more than 24 hours. The hemostatic dressing is not intended to be implanted.

The Axiostat Patch is equivalent in material, design, composition, manufacturing, intended use, sterilization, and biocompatibility to the legally marketed Axiostat Chitosan Hemostatic Dressing (K172324, cleared on 23th Feb 2018). The only differences are the Indication for Use and the variations in size for this use.

The Axiostat Patch is individually packaged in moisture proof packs and terminally sterilized using gamma irradiation. The product may be cut to any size, and the company anticipates introducing the following sizes:

4 in x 4 in (10 cm x 10 cm)
3 in x 3 in (8 cm x 8 cm) .
3 in x 2 in (8 cm x 5 cm) .
2 in x 2 in (5 cm x 5 cm) .
2 in x 1 in (5 cm x 2.5 cm) ●
1.4 in x 1.4 in (3.5 cm x 3.5 cm)
1 in x 1 in (2.5 cm x 2.5 cm) .
0.8 in x 0.8 in (2 cm x 2 cm) .
. 0.4 in x 3 in (1 cm x 8 cm)
0.4 in x 1.5 in (1 cm x 4 cm) .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites. vascular procedure sites and sites involving percutaneous catheters, tubes and pins.

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 Subject Device has been evaluated through a series of nonclinical studies:
a. Biocompatibility testing: Performed per ISO 10993-1:2009, section "Surface devices used on Breached or compromised surface with limited contact duration (≤24 hrs)". Tests included Cytotoxicity (ISO 10993-5, non-cytotoxic), Skin Sensitization (ISO 10993-10, non-toxic), Intracutaneous Reactivity (ISO 10993-10, non-toxic), Acute Systemic Toxicity (ISO 10993-11, non-toxic), Material-Mediated Pyrogenicity (ISO 10993-11, non-pyrogenic), and Bacterial Endotoxin Test (USP 85, complies).
b. Heavy metal testing: Subject Device met USP-232 limits for elemental impurities.
c. Bench performance testing: Evaluated for Appearance, Moisture Content, Absorbency, pH, Integrity test, Tensile strength of product, and In vitro blood clotting test using in house protocols.
d. Barrier to bacteria testing: Axiostat Patch (n=3) and gauze (n=3) were challenged with 10^6 cells of Pseudomonas aeruginosa (ATCC 9027), Staphylococcus aureus (ATCC 6538), Escherichia coli (ATCC 14169), Enterococcus faecalis (ATCC 29212), Proteus mirabilis (ATCC 12453), and Staphylococcus epidermidis (ATCC 12228) for 24 hours. No bacterial growth was observed on plates with Axiostat Patch, while all plates with cotton gauze showed bacterial growth. This demonstrated the device's capacity as a bacterial barrier.
e. Animal studies: Evaluated using procedures described in "Safety Evaluation of New Hemostatic Agents, Smectite Granules, and Kaolin-Coated Gauze in a Vascular Injury Wound Model in Swine; Kheirabadi, et al., J Trauma. 2010 Feb:68(2):269-78." The Subject Device successfully achieved hemostasis in under 5 minutes in all test animals, with no rebleeding observed during a two-hour observation period. No thrombi or blood clots were found in the lumens of blood vessels at the repair site in Axiostat treated animals.

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.

K150916, K102944

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.

K172324

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

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 21, 2023

Advamedica Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, California 92108

Re: K202830 Trade/Device Name: Axiostat Patch Regulatory Class: Unclassified Product Code: QSY

Dear Alan Donald:

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 April 15, 2021. 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

April 15, 2021

Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Advamedica Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, California 92108

Re: K202830

Trade/Device Name: Axiostat Patch Regulatory Class: Unclassified Product Code: FRO Dated: September 7, 2020 Received: September 25, 2020

Dear Alan Donald:

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 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 mediation-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,

Lixin Liu -S

Lixin Liu. Ph.D. 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

Indications for Use

510(k) Number (if known) K202830

Device Name Axiostat Patch

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 81 CFR 201, Subpart D)
☐ Over-The-Counter Use (21 CFR 201, Subpart G)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

510(k) SUMMARY - K202830 AXIOSTAT PATCH

1. ADMINISTRATIVE INFORMATION

Date of preparation: 10 March 2021 a.

| b. | Submitter: | Advamedica Inc.
Harvard Square, 1 Mifflin Place,
Suite 400, Cambridge,
Massachusetts 02138, USA
Phone: +1 973-718-7575
Fax: +1 888-584-8237 |
|----|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| c. | Contact Person: | Mr. Leo Mavely,
President, Advamedica Inc.
Email: office@advamedica.com
Web: www.advamedica.com |
| d. | Prepared By: | Mr. Leo Mavely, President
Advamedica. Inc. |

2. DEVICE NAME AND CLASSIFICATION

a. Trade/ Proprietary Name	: Axiostat Patch
b. Common Name	: Hemostatic dressing
c. Classification Name	: Dressing, Wound, Drug
d. Regulatory Class	: Unclassified
e. Product code	: FRO
f. Classification Panel	: General and Plastic Surgery

3. IDENTIFICATION OF PREDICATE DEVICE

PREDICATES	PREDICATE 1	PREDICATE 2
510(k) Number	K150916	K102944
Trade/Proprietary	HemCon® Bandage PRO,	Coreleader Hemo-Pad

| Name | HemCon® Patch PRO,
HemCon® Strip PRO,
HemCon® ChitoFlex PRO | |
|---------------------|-------------------------------------------------------------------|-----------------------------|
| Manufacturer | HemCon Medical
Technologies, Inc. | Coreleader Biotech Co. Ltd. |
| Classification Name | Dressing, Wound, Drug | Dressing, Wound, Drug |
| Regulatory Class | Unclassified | Unclassified |
| Product Code | FRO | FRO |
| Panel | General & Plastic Surgery | General & Plastic Surgery |

4. DEVICE DESCRIPTION

4 in x 4 in (10 cm x 10 cm)
3 in x 3 in (8 cm x 8 cm) .
3 in x 2 in (8 cm x 5 cm) .
2 in x 2 in (5 cm x 5 cm) .
2 in x 1 in (5 cm x 2.5 cm) ●
1.4 in x 1.4 in (3.5 cm x 3.5 cm)
1 in x 1 in (2.5 cm x 2.5 cm) .
0.8 in x 0.8 in (2 cm x 2 cm) .
. 0.4 in x 3 in (1 cm x 8 cm)
0.4 in x 1.5 in (1 cm x 4 cm) .

Advamedica Inc.

5. INDICATIONS FOR USE (Prescription use)

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF SUBJECT AND PREDICATE DEVICES

The Axiostat Patch is technologically similar to the HemCon Patch Pro and the Coreleader Hemo-Pad. The Subject Device has the following similarities to one or both proposed predicate devices:

Intended use .
Indications for use .
Mechanism of action .
Primary material .
. Patient contacting material (chitosan)
Biocompatibility .
Bacterial Barrier .
Sterilization method .

Table 1: Comparison of technological characteristics of Subject and Predicate Devices

PARAMETER	SUBJECT DEVICE	PREDICATE 1	PREDICATE 2	SE
Manufacturer	Advamedica Inc.	HemCon, Inc.	Coreleader Biotech
Co. Ltd.	-
Model/Trade
Name	Axiostat Patch	HemCon Bandage
PRO, HemCon Patch
PRO, HemCon Strip
PRO, Hemcon
ChitoFlex PRO	Coreleader Hemo-
Pad	-
510(k) Number	K202830	K150916	K102944	-
Product Code	FRO	FRO	FRO	Same
Common name	Hemostatic dressing	Wound dressing	Topical
Hemostasis Pad	Same
Classification	Unclassified	Unclassified	Unclassified	Same
Primary
Material	Chitosan	Chitosan	Chitosan	Same
Intended Use	Wound
management	Wound management	Wound
management	Same
Indications for
Use	The Axiostat Patch is
intended for local
management of
bleeding wounds and
to provide a barrier to
bacterial penetration
of the dressing for
patients and for the
rapid control of
moderate to severe
bleeding. The
dressing is indicated
for the following
wounds: lacerations,
abrasions, surgical
debridement sites,
skin surface puncture
sites, vascular
procedure sites and
sites involving
percutaneous
catheters, tubes and
pins.	The HemCon®
prescription devices
are intended for local
management of
bleeding wounds and
to provide a barrier to
bacterial penetration of
the dressing in all
patients and for the
promotion of rapid
control (hemostasis) of
bleeding in patients
following
hemodialysis and for
those on
anticoagulation
therapy. The dressing
is indicated for the
following wounds:
lacerations, abrasions,
nose-bleeds, surgical
debridement sites, skin
surface puncture sites,
vascular procedure
sites and sites
involving
percutaneous
catheters, tubes and
pins.	The Coreleader
Hemo-Pad is a
dressing indicated
for topical wound
management and
for the external
topical temporary
control of
moderate to severe
bleeding. The
dressing is
indicated for the
following wounds:
abrasions,
lacerations, skin
surface puncture
sites for vascular
procedures
(arteries and veins)	See Note
1
OTC/
Prescription	Prescription Only	OTC and Prescription	Prescription Only	Similar
Single Use	Yes	Yes	Yes	Same
Packaging	Moisture proof pouch	Foil Bags	Foil pouch	Similar.
See Note
2
Sterilization	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	Same
Shelf life	5 years	3 years	3 years	Different.
See Note
				3
Biocompatibility
Tests	Compliant to ISO
10993	Compliant to ISO
10993	Compliant to ISO
10993	Same
Size	Various	Various	Various	Same

TRADITIONAL 510(k) Axiostat Patch

Note 1:

Technologically, the Subject Device is similar to both the predicate devices. The Subject Device and the Predicate Device 1 have similar Indications for Use. Additionally, the Subject Device also includes indications for management of moderate to severely bleeding wounds. Hence, Predicate Device 2 is identified for this additional Indication for Use.

Note 2:

Differences in the packaging material do not raise any different device safety and performance issues. Additionally, the shelf life and package integrity of the product has been validated through real time stability studies.

Note 3:

The Subject Device has a shelf life of 5 years. This has been evaluated through real-time stability studies.

7. PERFORMANCE DATA

The Subject Device has been evaluated through a series of nonclinical studies to determine whether Axiostat meets the acceptance criteria for its intended applications. These tests are summarized below.

a. Biocompatibility testing
Biocompatibility tests have been performed per the requirements of ISO 10993-1:2009, under the section "Surface devices used on Breached or compromised surface with limited contact duration (≤24 hrs)". The following tests have been performed as per these requirements.

Biocompatibility test	Standard followed	Outcome
Cytotoxicity	ISO 10993-5	Non-cytotoxic
Skin Sensitization	ISO 10993-10	Non-toxic

Table 2: Biocompatibility test details

Intracutaneous Reactivity	ISO 10993-10	Non-toxic
Acute Systemic Toxicity	ISO 10993-11	Non-toxic
Material-Mediated
Pyrogenicity	ISO 10993-11	Non-pyrogenic
Bacterial Endotoxin Test	USP 85	Complies

b. Heavy metal testing

The Subject Device was tested for heavy metal contamination in the finished, sterilized product, which met USP-232 limits [(232) ELEMENTAL IMPURITIES-LIMITS].

c. Bench performance testing
The Subject Device was evaluated through following bench tests.

	Test	Test Method
1.	Appearance	In house protocol
2.	Moisture Content	In house protocol
3.	Absorbency	In house protocol
4.	pH	In house protocol
5.	Integrity test	In house protocol
6.	Tensile strength of product	In house protocol
7.	In vitro blood clotting test	In house protocol

Table 3: Bench performance testing

d. Barrier to bacteria testing

This study was performed to evaluate the barrier to bacteria property of the Axiostat Patch. In this test, the Axiostat Patch (n=3) was used as a test sample and a similarly sized gauze (n=3) was used as the control sample. Samples were challenged with 106 cells of three gram-positive and three gram-negative bacterial species.

After challenging for the maximum use-life (i.e. 24 hrs.), the dressings were removed. Then, the plates without the dressing were incubated to observe for the presence/absence of bacterial growth. The following organisms were used:

Pseudomonas aeruginosa (ATCC 9027)
9 Staphylococcus aureus (ATCC 6538)
Escherichia coli (ATCC 14169)

. Enterococcus faecalis (ATCC 29212)
. Proteus mirabilis (ATCC 12453)
. Staphylococcus epidermidis (ATCC 12228)

No bacterial growth was observed in the plates containing Axiostat Patch, whereas all plates containing cotton gauze showed bacterial growth. These results demonstrate the capacity of the Axiostat Patch to act as a barrier to bacterial penetration through the device.

e. Animal studies

The Axiostat Patch was evaluated using the animal testing procedures described in "Safety Evaluation of New Hemostatic Agents, Smectite Granules, and Kaolin-Coated Gauze in a Vascular Injury Wound Model in Swine; Kheirabadi, et al., J Trauma. 2010 Feb:68(2):269-78." This study was performed at an outside independent laboratory.

The Subject Device successfully achieved hemostasis in under 5 minutes in all test animals, and no rebleeding was observed in any animals during the observation period of two hours. Further, there were no thrombi or blood clots in the lumens of blood vessels at the repair site in the Axiostat treated animals.

8. STERILIZATION AND PACKAGING

The Axiostat Patch is packaged in moisture proof packs. The product is terminally sterilized using gamma radiation to a sterility assurance level (SAL) of 10-6. The dose of gamma radiation has been optimized and validated per ISO 11137-2.

Following gamma sterilization, the package integrity was subjected to sterile barrier testing to validate a shelf life of 5 years. The stability and effectiveness of packaging of the sterilized product during the shelf life was confirmed by real time (to support 5-year shelf life) and accelerated stability studies.

The following tests were performed periodically in the validation of 5-year shelf life.

Seal strength test as per ASTM F88. .
. Dye penetration test as per ASTM F1929-15.
Sterility test as per US Pharmacopeia . .
Bacterial endotoxin test per US Pharmacopeia . .
Bench performance tests to validate the shelf life of the product .
- i. Appearance
- ii. Absorbency
- iii. pH testing
- iv. Moisture content
. Tensile strength for Patch

9. CONCLUSION

The Axiostat Patch is substantially equivalent to the predicate devices with respect to intended use, Indications for Use, design, material, sterilization, and biocompatibility.

Advamedica Inc.

The non-clinical testing data provided support the safety and performance of the device for the claimed Indications for Use statement. Hence, the minor differences between the Subject Device and the predicates do not raise any different device safety or performance issues.