(193 days)
Not Found
No
The device description and performance studies focus on the material properties and physical mechanism of action of the hemostatic gauze, with no mention of AI or ML.
Yes
The device is intended to control bleeding and manage wounds, which are therapeutic actions.
No
This device is a hemostatic gauze intended to control bleeding and manage external wounds, not to diagnose medical conditions.
No
The device description clearly states it is a physical gauze made of non-woven fabric, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
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.
- Axiostat Gauze Function: The Axiostat Gauze is a topical hemostatic dressing applied directly to external wounds to control bleeding. It works by interacting with the blood at the wound site, not by analyzing a specimen taken from the body in a laboratory setting.
- Intended Use: The intended use clearly states it's for "temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations" and "local management of bleeding wounds." This is a direct therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the material (chitosan) and its mechanism of action (controlling bleeding when applied to a wound). There is no mention of analyzing bodily fluids or tissues.
- Performance Studies: The performance studies described are related to biocompatibility, bench performance (like clotting time and index, which are measured in a lab but are assessing the device's ability to clot blood, not diagnosing a condition), and animal studies demonstrating its hemostatic effect on a wound. These are not diagnostic performance studies.
In summary, the Axiostat Gauze is a therapeutic device used to manage bleeding on external wounds, not a diagnostic device used to analyze specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
Prescription:
The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.
Over-the-Counter:
The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Axiostat Gauze is a single-use, non-absorbable non-woven hemostatic gauze. It is made of non-woven fabric derived from chitosan, which is a naturalpolymer. Chitosan is known for its mucoadhesiveand hemostatic properties.
When applied directly to a wound the dressing controls bleeding and can be removed after the clotting has occurred. The dressing should be removed within 24 hours. The dressing is not intended to be implanted.
The Axiostat Gauze is individually packed in a moisture proof packaging and terminally sterilized by gamma radiation to a sterility assurance level (SAL) of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External Wounds
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 to determine whether Axiostat Gauze meets the acceptance criteria for its intended applications. These tests are summarized below.
7.1. Biocompatibility testing
The Biocompatibility tests have been performed as 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 carried out as per these requirements-
- Cytotoxicity, Standard followed: ISO 10993-5, Outcome: Non-cytotoxic
- Skin Sensitization, Standard followed: ISO 10993-10, Outcome: Non-toxic
- Acute Dermal Irritation, Standard followed: ISO 10993-10, Outcome: Non-toxic
- Acute Systemic Toxicity, Standard followed: ISO 10993-11, Outcome: Non-toxic
- Hemolysis, Standard followed: ISO 10993-4, Outcome: Non-hemolytic
- Bacterial Endotoxin Test, Standard followed: USP 161, Outcome: Complies
7.2. Heavy metal testing
The Subject Device was tested for the heavy metal contamination in the finished sterilized product, which met USP-232 limits ((232) ELEMENTAL IMPURITIES-LIMITS).
7.3. Residual solvent testing
The subject device was tested for the presence of residual solvents - isopropyl alcohol (IPA) and acetic acid in the device as per USP 30 . This test is intended to assess the performance and safety of the device. It was found that the Axiostat Gauze is entirely composed of chitosan acetate and the level of residual isopropyl alcohol and acetic acid in the Axiostat Gauze are within the safety limit.
7.4. Bench performance testing
The Subject Device is evaluated through following bench tests.
- Appearance, Acceptance Criteria: Color - Cream/off yellow Foreign particle/undesired physical appearances No loose fibers, no holes/tears, no dust particles.
- Moisture content, Acceptance Criteria: Not more than 35% in the test device.
- Absorbency, Acceptance Criteria: Not less than 15 times of product weight.
- pH, Acceptance Criteria: 5 to 7.
- Tensile strength, Acceptance Criteria: Dry - >5N/25mm Wet - >1N/25mm.
- Integrity (dispersion test), Acceptance Criteria: Product remain intact.
- In-vitro clot assessment, Acceptance Criteria: Blood clotting time: Clotting time with Axiostat Gauze should be not more than 60% average clotting of control (recalcified blood). Blood clotting index: The BCI of Axiostat Gauze should be not more than 5% Blood clotting Index.
7.5. Animal studies
Animal testing was conducted to evaluate the hemostatic efficiency of the Axiostat Gauze in extremity arterial hemorrhage model in swine at an external laboratory as necessitated by FDA standards.
Advamedica has performed the animal testing as 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 and no rebleeding was observed in any animals during the observation period of two hours.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 7, 2023
Advamedica Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive. Suite 800 San Diego, California 92108
Re: K222909 Trade/Device Name: Axiostat Gauze Regulatory Class: Unclassified Product Code: FRO Dated: March 2, 2023 Received: March 2, 2023
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
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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Axiostat Gauze
Indications for Use (Describe)
Prescription:
The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.
Over-the-Counter:
The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized teal-colored icon resembling two overlapping triangles, followed by the word "ADVAMEDICA" in gray, sans-serif font. The icon is positioned to the left of the text, creating a balanced and professional visual identity.
510(k) SUMMARY
AXIOSTAT GAUZE
1. ADMINISTRATIVE INFORMATION
- Date of preparation: 4/7/2023 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.
DEVICE NAME AND CLASSIFICATION 2.
| a. | Trade/ Proprietary Name : | Axiostat Gauze |
|---|---|---|
| b. | Common Name : | Wound dressing |
| c. | Classification Name : | Dressing, Wound, Drug |
| d. | Regulatory Class : | Unclassified |
| e. | Product code : | FRO |
| f. | Classification Panel : | General and Plastic Surgery |
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Image /page/4/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized teal-colored symbol resembling a mountain range or interconnected triangles on the left. To the right of the symbol is the company name "ADVAMEDICA" in a gray, sans-serif font. The overall design is clean and modern.
IDENTIFICATION OF PREDICATE DEVICE 3.
| Parameters | Predicate Device | Proposed Device |
|---|---|---|
| 510(k) Number | K143462 | K222909 |
| Trade/Proprietary | ||
| Name | Anscare ChitoClot Gauze | Axiostat Gauze |
| Manufacturer | BenQ Materials Corporation | Advamedica Inc. |
| Regulatory Class | Unclassified | Unclassified |
| Classification Name | Dressing, Wound, Drug | Dressing, Wound, Drug |
| Product Code | FRO | FRO |
| Panel | General & Plastic Surgery | General & Plastic Surgery |
Table. 1: Predicate Device Details
DEVICE DESCRIPTION 4.
The Axiostat Gauze is a single-use, non-absorbable non-woven hemostatic gauze. It is made of non-woven fabric derived from chitosan, which is a naturalpolymer. Chitosan is known for its mucoadhesiveand hemostatic properties.
When applied directly to a wound the dressing controls bleeding and can be removed after the clotting has occurred. The dressing should be removed within 24 hours. The dressing is not intended to be implanted.
The Axiostat Gauze is individually packed in a moisture proof packaging and terminally sterilized by gamma radiation to a sterility assurance level (SAL) of 10-6.
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Image /page/5/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized letter "M" in teal, followed by the word "ADVAMEDICA" in gray. The "M" is made up of three connected lines that form a mountain-like shape.
Image /page/5/Picture/2 description: In the image, two hands wearing white gloves are holding several sheets of white paper. The hands are positioned on either side of the paper, with one hand holding the top sheets and the other holding the bottom sheets. The paper appears to be thin and delicate, and the hands are holding it carefully to avoid tearing it. There is a stack of paper below the sheets that are being held.
Fig 1: Axiostat Gauze
The Axiostat Gauze can be cut to any size within the permissible size limit and packed in three different folds,
- a) Folded gauze in the form of single ply, 2-ply, or 4-ply folds,
- b) Z-folded gauze in the form of zig-zag pattern
- c) Rolled gauze in the form of a roll.
Axiostat Gauze is currently available in the following sizes.
Folded single ply, 2 ply, 4 ply
2"x2" (5 cm x 5cm) 3"x3" (7.5cmx 7.5cm) 4"x4" (10cm x10cm) 6"x6" (15cm x15cm) 8"x8" (20cm x 20cm) 12"x12" (30cm x30cm) 16"x16" (40cm x 40cm)
Z folded
3" x 59" (7.6cm x 150cm) 3" x 78" (7.6cm x 200cm) 3" x 98" (7.6cm x 250cm)
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Image /page/6/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized letter "M" in teal, followed by the word "ADVAMEDICA" in gray. The "M" is made up of three connected lines that form a peak in the center. The text is in a sans-serif font and is aligned to the right of the "M" symbol.
- 3" x 118" (7.6cm x 300cm) 3" x 137" (7.6cm x 350 cm) 3" x 156" (7.6cm x 400cm)
Rolled
3" x 19" (7.6cm x 50cm)
3"x 39" (7.6cm x 100cm)
3" x 59" (7.6cm x 150cm)
3" x 78" (7.6cm x 200cm)
3" x 98" (7.6cm x 250cm)
3" x 118" (7.6cm x 300cm)
INDICATIONS FOR USE 5.
5.1 Prescription Use:
The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.
5.2 Over the Counter Use:
The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF SUBJECT 6. AND PREDICATE DEVICES
The Axiostat Gauze is technologically similar to Anscare ChitoClot Gauze. The subject device has the following similarities to the predicate device:
- Indication for use .
- Mechanism of action .
- Active material .
- Sterility .
- Biocompatibility
- Packaging .
- Contact duration and anatomical site .
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Image /page/7/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized teal-colored symbol resembling a stylized letter 'M' or a mountain range. To the right of the symbol, the word "ADVAMEDICA" is written in a dark gray, sans-serif font. The logo appears to be for a medical or healthcare-related company.
Table 2: Comparison of technological characteristics of the Predicate Device and Subject Device
| Parameters | Predicate Device | Subject Device | Notes |
|---|---|---|---|
| 510(k) Number | K143462 | K222909 | -- |
| Trade/Proprietary | |||
| Name | Anscare | ||
| Gauze | ChitoClot | ||
| Axiostat Gauze | -- | ||
| Manufacturer | BenQ | ||
| Materials | |||
| Corporation | Advamedica Inc. | -- | |
| Regulatory Class | Unclassified | Unclassified | Same |
| Product Code | FRO | FRO | Same |
| Indication for use | |||
| (prescription use) | For use as a temporary | ||
| external dressing to | |||
| control moderate to | |||
| severe bleeding and | |||
| manage external | |||
| abrasions, lacerations. | The Axiostat Gauze is | ||
| intended for use as a | |||
| temporary external | |||
| dressing to control | |||
| moderate to severe | |||
| bleeding and manage | |||
| external abrasions, | |||
| lacerations. | Same | ||
| Indication for use | |||
| (OTC) | To control bleeding of | ||
| lacerations, minor cuts, | |||
| and abrasions. | To control bleeding of | ||
| lacerations, cuts, and | |||
| abrasions. | Same | ||
| Anatomical Site | External Wounds | External Wounds | Same |
| Physical | |||
| composition | Soft absorbent, non- | ||
| woven gauze | Soft absorbent, non- | ||
| woven gauze | Same | ||
| Material | Chitosan | Chitosan | Same |
| Indicated | |||
| for | |||
| control | |||
| of | |||
| bleeding? | Yes | Yes | Same |
| Contact Duration | Up to 24 hours | Up to 24 hours | Same |
| Mechanism | |||
| of | |||
| Action | When applied directly on a wound with firm pressure, the AnsCare ChitoClot Gauze will turn into a gel-like condition to absorb the blood and seal the wound. | When applied on the bleeding site with firm pressure, the Axiostat Gauze acts as a mechanical barrier against bleeding. | Similar |
| Shelf life | 36 months | 30 months | Similar |
| Biocompatibility | |||
| (ISO 10993) | Yes | Yes | Same |
| Sterility | Gamma-Sterilized | Gamma-Sterilized | Same |
| Packaging | Foil-Pouch | Foil-Pouch | Same |
| Sizes | Various | Various | Same |
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Image /page/8/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized teal-colored symbol on the left, resembling a mountain range or an abstract letter 'A'. To the right of the symbol is the word "ADVAMEDICA" in gray, with each letter clearly visible and evenly spaced. The overall design is clean and professional.
7. PERFORMANCE DATA
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Image /page/9/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized, teal-colored symbol resembling two overlapping triangles, followed by the word "ADVAMEDICA" in gray, sans-serif font. The logo is simple and modern, with a focus on the company name.
The Subject Device has been evaluated through a series of nonclinical studies to determine whether Axiostat Gauze meets the acceptance criteria for its intended applications. These tests are summarized below.
7.1. Biocompatibility testing
The Biocompatibility tests have been performed as 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 carried out as per these requirements-
| S.No. | Biocompatibility test | Standard
followed | Outcome |
|-------|--------------------------|----------------------|---------------|
| 1. | Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| 2. | Skin Sensitization | ISO 10993-10 | Non-toxic |
| 3. | Acute Dermal Irritation | ISO 10993-10 | Non-toxic |
| 4. | Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| 5. | Hemolysis | ISO 10993-4 | Non-hemolytic |
| 6. | Bacterial Endotoxin Test | USP 161 | Complies |
Table 3: Biocompatibility test details
7.2. Heavy metal testing
The Subject Device was tested for the heavy metal contamination in the finished sterilized product, which met USP-232 limits ((232) ELEMENTAL IMPURITIES-LIMITS).
7.3. Residual solvent testing
The subject device was tested for the presence of residual solvents - isopropyl alcohol (IPA) and acetic acid in the device as per USP 30 . This test is intended to assess the performance and safety of the device. It was found that the Axiostat Gauze is entirely composed of chitosan acetate and the level of residual isopropyl alcohol and acetic acid in the Axiostat Gauze are within the safety limit.
7.4. Bench performance testing
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Image /page/10/Picture/1 description: The image features the logo for Advamedica. The logo consists of a stylized letter "M" in teal, positioned to the left of the company name, "ADVAMEDICA," which is written in gray, sans-serif font. The overall design is clean and modern.
The Subject Device is evaluated through following bench tests.
Table 4: Bench performance testing
| S.No | Test | Acceptance Criteria | Reference/Justification |
|---|---|---|---|
| 1. | Appearance | Color - Cream/off | |
| yellow | |||
| Foreign | |||
| particle/undesired | |||
| physical appearances | |||
| No loose fibers, no | |||
| holes/tears, no dust | |||
| particles | The product is visually checked before | ||
| packing to ensure it meets the set | |||
| criteria. | |||
| 2. | Moisture | ||
| content | Not more than 35% in | ||
| the test device | Moisture from the manufacturing | ||
| process may be retained in the finished | |||
| product. | |||
| Moisture content results in the stability | |||
| study are less than 35% at all time | |||
| points, with no change in the desired | |||
| properties. | |||
| 3. | Absorbency | Not less than 15 times | |
| of product weight | Traditional laparotomy sponges absorb | ||
| 5 times their weight in fluid. Axiostat | |||
| Gauze is an advanced hemostat that | |||
| absorbs fluids up to 15 times its own | |||
| weight. | |||
| 4. | pH | 5 to 7 | A mildly acidic to neutral pH is required |
| for adhesion and hemostatic activity. | |||
| 5. | Tensile | ||
| strength | Dry - >5N/25mm | ||
| Wet - >1N/25mm | The adhesive strength to | ||
| the | |||
| tissue/application site is less than the set | |||
| acceptance criteria for Tensile strength. | |||
| This prevents the product from breaking | |||
| during removal from the application | |||
| site. | |||
| 6. | Integrity | ||
| (dispersion | |||
| test) | Product remain intact | The outcome demonstrates the integrity | |
| of Axiostat Gauze on the application | |||
| site. | |||
| BS EN 13726-1:2002 | |||
| 7. | In-vitro clot | ||
| assessment | Blood clotting time: | ||
| Clotting time with | |||
| Axiostat Gauze should | |||
| be not more than 60% | |||
| average clotting of | |||
| control | |||
| (recalcified | |||
| blood) | |||
| Blood clotting index: | |||
| The BCI of Axiostat | |||
| Gauze should be not | |||
| more than 5% Blood | |||
| clotting Index | Blood clotting time: The faster the | ||
| blood clots compared to recalcified | |||
| blood (control), the better the | |||
| hemostatic efficacy of Axiostat Gauze. | |||
| Blood clotting index: represents the | |||
| percentage of non-coagulated blood in | |||
| the Axiostat Gauze, and the lower the | |||
| BCI, the better the clotting. |
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Image /page/11/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a teal-colored abstract symbol on the left, resembling a stylized letter 'M' or a mountain range. To the right of the symbol is the word "ADVAMEDICA" in a gray, sans-serif font. The overall design is clean and modern.
7.5. Animal studies
Animal testing was conducted to evaluate the hemostatic efficiency of the Axiostat Gauze in extremity arterial hemorrhage model in swine at an external laboratory as necessitated by FDA standards.
Advamedica has performed the animal testing as 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 and no rebleeding was observed in any animals during the observation period of two hours.
8. Sterilization and Shelf life
The Axiostat Gauze is packaged in moisture proof packs. The product is terminally sterilized using gamma radiation to a sterility assurance level (SAL) of 106. The dose of gamma radiation has been optimized and validated per ISO 11137-2.
12
Image /page/12/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized letter "M" in teal, followed by the word "ADVAMEDICA" in gray. The font is sans-serif and the logo is simple and modern.
Following gamma sterilization, the package integrity was subjected to sterile barrier testing to validate a shelf life of 30 months. The stability and effectiveness of packaging of the sterilized product during the shelf-life was confirmed by real time (to support 30 months shelf life) and accelerated stability studies.
The following tests were performed periodically in the validation of 30 months shelf life.
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Image /page/13/Picture/1 description: The image shows the logo for Advamedica. The logo consists of a stylized teal-colored symbol on the left, resembling a stylized letter "M" or a mountain range. To the right of the symbol is the word "ADVAMEDICA" in a gray, sans-serif font. The overall design is clean and modern, suggesting a company in the medical or technology field.
Product tests to validate the shelf life are as mentioned below -
- Appearance visual check .
- Moisture content as per ASTM E1868-10 .
- Absorbency as per BS EN 13726-1:2002 .
- pH as per BS EN 13726-1:2002 .
- Dispersion or integrity test as per BS EN 13726-1:2002 .
- Tensile strength test as per BS EN 29073-3:1992 and ISO 9073-18 .
Package tests to validate the shelf life are as mentioned below -
- Seal strength test as per ASTM F88 .
- Dye penetration test as per ASTM F3039-15 .
- . Sterility test as per US Pharmacopeia
- Bacterial Endotoxin Test as per US Pharmacopeia .
9. Conclusion
The Axiostat Gauze is substantially equivalent to the predicate device with respect to the risk-based classification, product code as defined by US FDA, intended use & indications for use, application site, physical composition, design material, method of sterilization, and biocompatibility. The non-clinical testing data provided supports the safety and performance of the device for the claimed Indications for Use statement. Hence, the minor differences between the subject devices and the predicates do not raise any new device safety or performance issues.