(234 days)
Not Found
No
The device description and performance studies focus on the material properties and hemostatic function of the chitosan-based gauze, with no mention of AI or ML technology.
Yes.
The device is intended to control bleeding and manage external abrasions and lacerations, which are therapeutic actions.
No
Explanation: The device is a hemostatic gauze used to control bleeding and manage external abrasions and lacerations. Its function is therapeutic, not diagnostic.
No
The device is a physical gauze made of chitosan fibers, designed to be applied directly to wounds. It is a tangible medical device, not software.
Based on the provided information, 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 therapeutic or wound management function, not a diagnostic one.
- Device Description: The device is a gauze made of chitosan fibers that helps absorb blood and control bleeding when applied directly to a wound. This is a physical barrier and hemostatic agent, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on functional characteristics (absorption, strength, pH), biocompatibility, and in-vivo hemostasis. These are relevant to the safety and effectiveness of a wound dressing, not to the accuracy of a diagnostic test.
- Lack of Diagnostic Metrics: There are no mentions of diagnostic metrics like sensitivity, specificity, PPV, NPV, or AUC, which are typical for IVD performance evaluation.
In summary, the Chito-SAM Gauze is a medical device intended for external wound management and bleeding control, not for performing diagnostic tests on in vitro specimens.
N/A
Intended Use / Indications for Use
Chito-SAM™ Active 100% Chitosan Hemostatic Dressing
To control bleeding of lacerations, minor cuts and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The Chito-SAM" Gauze (refers to both the Chito-SAM" 100 for prescription use and Chito-SAM" Active for over-the-counter use) is made of a non-woven fabric derived from chitosan fibers. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Chito-SAM Gauze will turn into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Chito-SAM Gauze is provided in three (3) different sizes for prescription use and two (2) different sizes for over-the-counter use to accommodate a variety of treatment regions. The Chito-SAM Gauze is individually packaged in a foil pouch and is gamma-sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench performance testing included functional testing for:
- . Liquid Absorption
- . pH
- Tensile Strength (wet and dry) .
- Platelet Aggregation .
- . Comparison to predicate devices for each of the above functional characteristics
Biocompatibility testing per ISO 10993-1 was performed for:
- . Cytotoxicity
- . Skin Irritation
- Skin Sensitization .
- . Hemolysis
- . Acute Systemic Toxicity (intraperitoneal and intravenous)
In-vivo hemostasis testing using the swine model was performed to demonstrate the performance of the Chito-SAM product vs. the predicate devices.
Shelf-life testing, including sterilization validation and packaging testing, confirmed a three-year shelf life for packaged, sterilized product.
The collective results of the bench and animal testing demonstrate that the materials chosen, the manufacturing processes, and design of the Chito-SAM Gauze meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates that the Chito-SAM Gauze does not raise new questions of safety or effectiveness for its intended use when compared to the predicate devices.
Clinical testing was not required for this submission.
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 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 21, 2023
Sam Medical Products Jack McCutcheon Quality Assurance and Regulatory Affairs Manager 27350 SW 95th Avenue, Suite 3038 Wilsonville, Oregon 97070
Re: K133121 Trade/Device Name: Chito-Sam™ Active Regulatory Class: Unclassified Product Code: QSY
Dear Jack Mccutcheon:
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 May 22, 2014. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2014
SAM Medical Products Mr. Jack McCutcheon Quality Assurance and Regulatory Affairs Manager 27350 Southwest 95th Avenue, Suite 3038 Wilsonville, Oregon 97070
Re: K133121
Trade/Device Name: Chito-SAM" Active Regulatory Class: Unclassified Product Code: FRO Dated: April 3, 2014 Received: April 7, 2014
Dear Ms. Griffin:
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. 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 (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
Page 2 - Mr. Jack McCutcheon
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K133121
Device Name: Chito-SAM™ Active
Indications For Use:
Chito-SAM™ Active 100% Chitosan Hemostatic Dressing
To control bleeding of lacerations, minor cuts and abrasions.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
4
510(k) SUMMARY, K133121
510(k) Summary
This 510(k) Summary for the Chito-SAM" Gauze (Chito-SAM™ 100 for prescription use and Chito-SAM" Active for over-the-counter use) is submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.
1.0 GENERAL INFORMATION
Applicant:
SAM Medical Products® 27350 SW 95th Avenue, Suite 3038 Wilsonville, OR 97070 U.S.A. Phone: 503-639-5474 FAX: 503-639-5425
Contact Person:
Kasey Griffin Quality Assurance and Regulatory Affairs Manager SAM Medical Products® 27350 SW 95th Avenue, Suite 3038 Wilsonville, OR 97070 U.S.A. Phone: 503-639-5474 FAX: 503-639-5425
Date Prepared: April 3, 2014
2.0 DEVICE INFORMATION
Trade Name: Chito-SAM™ 100 (Prescription use)
Chito-SAM™ Active (Over-the-counter use)
Generic/Common Name: Hemostatic Dressing
Classification: Unclassified
Product Code: FRO
5
3.0 PREDICATE DEVICES
Each of the following predicate devices is cleared for prescription use and over-thecounter use.
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|------------------|-----------------|-----------------------------------------------------------------------------------------------------|---------------------------|
| K080097 | FRO | CELOX Hemostatic Granules on
Sheet | Medtrade Products
Ltd. |
| K091795 | FRO | CELOX Trauma Gauze | Medtrade Products
Ltd. |
| K113560 | FRO | CELOX Gauze PRO
CELOX Gauze PRO OTC
CELOX PRO Hemostatic Gauze
OMNI-STAT Granules on Gauze | Medtrade Products
Ltd. |
4.0 DEVICE DESCRIPTION
The Chito-SAM" Gauze (refers to both the Chito-SAM" 100 for prescription use and Chito-SAM" Active for over-the-counter use) is made of a non-woven fabric derived from chitosan fibers. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Chito-SAM Gauze will turn into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Chito-SAM Gauze is provided in three (3) different sizes for prescription use and two (2) different sizes for over-the-counter use to accommodate a variety of treatment regions. The Chito-SAM Gauze is individually packaged in a foil pouch and is gamma-sterilized.
5.0 INDICATIONS FOR USE
Chito-SAM™ 100 (prescription use):
For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations.
Chito-SAM™ Active (over-the-counter use):
To control bleeding of lacerations, minor cuts and abrasions.
6.0 SUBSTANTIAL EQUIVALENCE COMPARISON
The indications for use for the predicate devices is substantially equivalent to the proposed indications for use for the Chito-SAM Gauze. The technological characteristics of the Chito-SAM Gauze are similar to the predicate devices. A vailable performance data support the determination of substantial equivalence. Any differences in the
6
510(k) Summary, K133121
technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Chito-SAM Gauze is substantially equivalent to the predicate devices.
7.0 NON-CLINICAL TESTING
Bench performance testing included functional testing for:
- . Liquid Absorption
- . pH
- Tensile Strength (wet and dry) .
- Platelet Aggregation .
- . Comparison to predicate devices for each of the above functional characteristics
Biocompatibility testing per ISO 10993-1 was performed for:
- . Cytotoxicity
- . Skin Irritation
- Skin Sensitization .
- . Hemolysis
- . Acute Systemic Toxicity (intraperitoneal and intravenous)
In-vivo hemostasis testing using the swine model was performed to demonstrate the performance of the Chito-SAM product vs. the predicate devices.
Shelf-life testing, including sterilization validation and packaging testing, confirmed a three-year shelf life for packaged, sterilized product.
The collective results of the bench and animal testing demonstrate that the materials chosen, the manufacturing processes, and design of the Chito-SAM Gauze meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates that the Chito-SAM Gauze does not raise new questions of safety or effectiveness for its intended use when compared to the predicate devices.
8.0 CLINICAL TESTING -
Clinical testing was not required for this submission.
9.0 CONCLUSIONS
The Chito-SAM Gauze shares its design and mechanism of action with the identified predicate devices. The results of the bench testing confirm that the Chito-SAM Gauze functions to its specifications, performs as intended, and exhibits the appropriate characteristics of a wound dressing. The Chito-SAM Gauze is substantially equivalent to the predicate devices in terms of technological characteristics, intended use, and performance. No new issues of safety or effectiveness are raised by the Chito-SAM Gauze.