(206 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of the hemostatic dressing, with no mention of AI or ML.
Yes
The device is indicated to "control bleeding of lacerations, minor cuts and abrasions," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a hemostatic dressing intended to control bleeding of lacerations, minor cuts, and abrasions. Its function is to act as a mechanical barrier to stop bleeding, not to diagnose a condition or disease.
No
The device description clearly states it is a physical dressing made of chitosan, intended to be applied to wounds. It undergoes biocompatibility and bench performance testing, which are characteristic of physical medical devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "control bleeding of lacerations, minor cuts and abrasions." This is a direct therapeutic action on the body to stop bleeding.
- Device Description: The description explains how the dressing acts as a "mechanical barrier against bleeding" when applied to the bleeding site. This is a physical interaction with the wound.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any such specimens.
The Axiostat Chitosan Hemostatic Dressing is a medical device used for wound care and hemostasis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO, QSY
Device Description
Axiostat is a single use, hemostatic dressing made of 100% chitosan is a wellknown natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied on the bleeding site with firm pressure, the Axiostat Chitosan Hemostatic Dressing acts as a mechanical barrier against bleeding. The Axiostat is intended for a maximum duration of use of 24 hours, including bandage changes that may be needed.
Axiostat is individually packaged in foil bags and sterilized using gamma irradiation. Axiostat is provided in six different sizes for over the counter use as listed below.
Axiostat Sizes
10 x 10 cm
8 x 8 cm
8 x 5 cm
5 x 5 cm
3.5 x 3.5 cm
2 x 2 cm
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.
A. Biocompatibility testing:
Biocompatibility tests have been performed per the requirements of ISO 10993-1:2009, under the section "surface devices used in breached and compromised surfaces with limited exposure (.
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 contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "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: K172324
Trade/Device Name: Axiostat Chitosan Hemostatic Dressing 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 February 23, 2018. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains 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 box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2018
Advamedica Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, California 92108
Re: K172324
Trade/Device Name: Axiostat Chitosan Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 22, 2018 Received: January 23, 2018
Dear Alan Donald:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may; therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K172324
Device Name
Axiostat Chitosan Hemostatic Dressing
Indications for Use (Describe)
Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions.
Type of Use (Select one or both, as applicable)
__ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/2 description: The image shows the logo for Advamedica. The logo consists of a stylized teal-colored mountain range to the left of the company name. The company name "ADVAMEDICA" is written in a gray sans-serif font, with all letters capitalized.
510(k) Summary
5
K172324 p 2/6
510(k) SUMMARY - K172324
Advamedica, Inc.
AXIOSTAT CHITOSAN HEMOSTATIC DRESSING
ADMINISTRATIVE INFORMATION
- Date of Preparation: February 23, 2018 a.
| b. | Submitter: | Advamedica Inc.
485 Massachusetts Avenue,
Suite 300, Cambridge,
Massachusetts 02139, USA
Tel: +1 973-718-7575
Fax: +1 888-584-8237 |
|----|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| C. | Official Contact: | Mr. Leo Mavely, President
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 Names: | Axiostat Chitosan Hemostatic Dressing |
|---|---|---|
| b. | Common Name: | Hemostatic Dressing |
| c. | Classification Name: | Dressing, Wound, Drug |
| d. | Device Class: | Unclassified |
| e. | Product Codes: | FRO |
| f. | Classification Panel: | General and Plastic Surgery |
3. PREDICATE DEVICE
| Proprietary/Trade name | Chito-SAM™ Active |
|---|---|
| Manufacturer | SAM Medical Products |
| Classification Name | Dressing, Wound, Drug |
| Device Class | Unclassified |
| Panel | General & Plastic Surgery |
| Product Code | FRO |
| 510(k) Number | K133121 |
DEVICE DESCRIPTION 4.
Axiostat is a single use, hemostatic dressing made of 100% chitosan is a wellknown natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied on the bleeding site with firm pressure, the Axiostat
6
Chitosan Hemostatic Dressing acts as a mechanical barrier against bleeding. The Axiostat is intended for a maximum duration of use of 24 hours, including bandage changes that may be needed.
Axiostat is individually packaged in foil bags and sterilized using gamma irradiation. Axiostat is provided in six different sizes for over the counter use as listed below.
| Axiostat Sizes |
|---|
| 10 x 10 cm |
| 8 x 8 cm |
| 8 x 5 cm |
| 5 x 5 cm |
| 3.5 x 3.5 cm |
| 2 x 2 cm |
INDICATIONS FOR USE ડ.
Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions.
NON-CLINICAL TESTING 6.
The subject device has been evaluated through a series of nonclinical studies.
A. Biocompatibility testing:
Biocompatibility tests have been performed per the requirements of ISO 10993-1:2009, under the section "surface devices used in breached and compromised surfaces with limited exposure (.
SUBSTANTIAL EQUIVALENCE DETERMINATION 8.
The Axiostat Chitosan Hemostatic Dressing is substantially equivalent in intended use, indications for use, technology, material, design, packaging, sterilization, and performance claims to the predicate device, Chito-SAM™ Active (K133121). The following tables show the key characteristics of the subject and predicate devices.
| Subject device | Predicate device | Notes | |
|---|---|---|---|
| Manufacturer | Advamedica Inc. | SAM Medical Products | -- |
| Model/Trade | |||
| Name | Axiostat Chitosan Hemostatic | ||
| Dressing | Chito-SAM™ Active | -- | |
| 510K Identifier | New device | K133121 | -- |
| Common Name | Hemostatic dressing | Hemostatic Dressing | Same |
| Classification | Unclassified | Unclassified | Same |
| Product Code | FRO | FRO | Same |
| Material | Chitosan | Chitosan | Same |
| Intended Use | Hemostasis | Hemostasis | Same |
| Indications for use | Axiostat Chitosan Hemostatic | ||
| Dressing is indicated to control | |||
| bleeding of lacerations, minor cuts | |||
| and abrasions. | Chito-SAM™ Active is indicated | ||
| to control bleeding of lacerations, | |||
| minor cuts and abrasions. | Same |
Table 1: Comparison of technological characteristics of subject and predicate devices
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Image /page/8/Picture/1 description: The image shows the words "TRADITIONAL 510K" in bold, uppercase letters. Below that, the words "Axiostat Chitosan Hemostatic Dressing" are also in bold. The text appears to be advertising a traditional product called Axiostat Chitosan Hemostatic Dressing.
MEDICA
| OTC/ Prescription | OTC | OTC | Same |
|---|---|---|---|
| Anatomical Site | External wounds | External wounds | Same |
| Package material | Foil Bag | Foil bag | Same |
| Sterilization | Gamma irradiation | Gamma irradiation | Same |
| Sizes | Axiostat: | ||
| 10x10cm | |||
| 8x8cm | |||
| 8x5cm | |||
| 5x5cm | |||
| 3.5x3.5cm | |||
| 2x2cm | 4 x 4-inch | ||
| 3-inch x 6-foot Z-fold | -- |
Table 2: Comparison of biocompatibility tests on subject and predicate devices
| Biocompatibility Tests | Subject device
Axiostat Chitosan Hemostatic
Dressing | Predicate device
Chito-SAM™ Active
(K133121) |
|--------------------------------------------------|------------------------------------------------------------|----------------------------------------------------|
| Cytotoxicity Test | Non-cytotoxic | Non-cytotoxic |
| Skin Irritation Study | Negative | Negative |
| Skin Sensitization Study | Negative | Negative |
| Acute Intravenous Systemic
Toxicity Study | Negative | Negative |
| Acute Intraperitoneal Systemic
Toxicity Study | Negative | Negative |
| Hemolysis | Negative | Negative |
| Pyrogenicity Test | Negative | -- |
The intended use and "Indications for Use" for the predicate device are identical to those of the Axiostat Chitosan Hemostatic Dressing. The chemical composition of the chitosan material in both products is the same. The technological and performance characteristics of the Axiostat are equivalent to the predicate device. No new issues regarding safety or efficacy are introduced by the Axiostat Chitosan Hemostatic Dressing.
9. SIMILARITY AND DIFFERENCES
The subject device has the following similarities to the predicate devices:
-
the same intended use
- V the same material (chitosan)
-
same indications of use
-
identical biocompatibility characteristics
-
same sterilization method.
The minor differences in dimensions and form between the proposed device and predicate device do not affect the performance of proposed device or raise any safety concerns.
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Image /page/9/Picture/1 description: The image shows the logo for ADVAMEDICA. The logo consists of a stylized "M" shape in teal, followed by the word "ADVAMEDICA" in gray. Above the logo, the text "K172324 p 6/6" is displayed in black.
10. CONCLUSION
The Axiostat Chitosan Hemostatic Dressing shares its chemical composition and performance characteristics with the predicate device. The results of the performance testing confirm that the Axiostat Chitosan Hemostatic Dressing functions to its specifications, performs as intended, and exhibits the appropriate characteristics of a hemostatic dressing. The Axiostat is substantially equivalent to the predicate device in terms of materials, technological characteristics, intended use, indications for use, and performance. No new issues of safety or effectiveness are raised by the Axiostat Chitosan Hemostatic Dressing.