Chito-SAM™ 100 (prescription use):
For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations.

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.

AI/ML Overview

Please note: The provided FDA 510(k) summary for the Chito-SAM™ Active device does not explicitly state acceptance criteria or direct device performance against those criteria in a table format. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, the response below will synthesize information regarding "acceptance criteria" from the described non-clinical tests and the "reported device performance" will be derived from the general statements of a successful outcome in these tests. Information that is not present in the provided document will be explicitly stated as "Not provided in the document."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Non-Clinical Testing)	Reported Device Performance (Summary from Non-Clinical Testing)
Liquid Absorption performance	Performed adequately; comparison to predicate devices showed similar functional characteristics.
pH within established range	Maintained appropriate pH levels; comparison to predicate devices showed similar functional characteristics.
Tensile Strength (wet and dry) maintained	Met established specifications; comparison to predicate devices showed similar functional characteristics.
Platelet Aggregation performance	Demonstrated appropriate platelet aggregation; comparison to predicate devices showed similar functional characteristics.
Biocompatibility (Cytotoxicity)	Passed according to ISO 10993-1.
Biocompatibility (Skin Irritation)	Passed according to ISO 10993-1.
Biocompatibility (Skin Sensitization)	Passed according to ISO 10993-1.
Biocompatibility (Hemolysis)	Passed according to ISO 10993-1.
Biocompatibility (Acute Systemic Toxicity)	Passed (intraperitoneal and intravenous) according to ISO 10993-1.
Hemostatic Efficacy (in-vivo)	Demonstrated performance comparable to predicate devices in the swine model.
Shelf-life	Confirmed a three-year shelf life for packaged, sterilized product through sterilization validation and packaging testing.
New Safety/Effectiveness Issues	No new issues of safety or effectiveness were raised compared to predicate devices, based on non-clinical testing results.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not explicitly provided. The document mentions "non-clinical testing" which includes functional testing, biocompatibility testing (per ISO 10993-1), in-vivo hemostasis testing, and shelf-life testing. The specific number of samples or animals used for each test is not detailed.
Data provenance:
- Country of origin: Not explicitly stated for specific tests.
- Retrospective or prospective: The non-clinical tests described (functional testing, biocompatibility, in-vivo hemostasis, shelf-life) are generally prospective studies designed to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. For non-clinical (bench and animal) testing, "ground truth" is typically established by objective measurements, laboratory analyses, and physiological observation, rather than expert consensus on subjective data. The document does not mention the involvement of experts for "ground truth" establishment in the context of these non-clinical tests.

4. Adjudication method for the test set

Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there is potential for disagreement in subjective assessments. The non-clinical tests described do not involve such a process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a hemostatic dressing, not an AI software/algorithm requiring human interpretation or assistance. Therefore, an MRMC study related to AI assistance for human readers was not performed or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hemostatic dressing, not an AI algorithm. Its performance is evaluated through direct physical, chemical, and biological testing, not by an algorithm.

7. The type of ground truth used

For non-clinical testing:
- Functional Testing (Liquid Absorption, pH, Tensile Strength, Platelet Aggregation): Ground truth is based on established laboratory standards, specifications, and comparison against predicate devices' known performance.
- Biocompatibility Testing (ISO 10993-1): Ground truth is determined by the specific criteria and endpoints defined in the ISO standard for cytotoxicity, irritation, sensitization, hemolysis, and systemic toxicity.
- In-vivo Hemostasis Testing: Ground truth is established by physiological outcomes (e.g., control of bleeding, time to hemostasis) observed in the animal model, often compared to an untreated control or predicate device.
- Shelf-life Testing: Ground truth is based on physical, chemical, and microbiological stability over time, validated through accelerated and real-time aging studies against predefined acceptance limits.

8. The sample size for the training set

Not applicable. This is a medical device (hemostatic dressing), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As stated above, this is not an AI algorithm requiring a training set.

Summary

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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

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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.

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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

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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

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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

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3.0 PREDICATE DEVICES

Each of the following predicate devices is cleared for prescription use and over-thecounter use.

510(k)Number	ProductCode	Trade Name	Manufacturer
K080097	FRO	CELOX Hemostatic Granules onSheet	Medtrade ProductsLtd.
K091795	FRO	CELOX Trauma Gauze	Medtrade ProductsLtd.
K113560	FRO	CELOX Gauze PROCELOX Gauze PRO OTCCELOX PRO Hemostatic GauzeOMNI-STAT Granules on Gauze	Medtrade ProductsLtd.

4.0 DEVICE DESCRIPTION

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

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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.

Regulation Number and Section

N/A