CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT

K133121 · Sam Medical Products · QSY · May 22, 2014 · SU

Device Facts

• Record ID: K133121
• Device Name: CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
• Applicant: Sam Medical Products
• Product Code: QSY · SU
• Decision Date: May 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

To control bleeding of lacerations, minor cuts and abrasions.

Device Story

Chito-SAM Active is a non-woven hemostatic dressing composed of chitosan fibers derived from shellfish; intended for over-the-counter use. Device applied directly to wound with firm pressure; chitosan absorbs blood and transforms into gel-like state to assist in temporary bleeding control. Packaged in foil pouches and gamma-sterilized. Used by patients or caregivers in home or point-of-care settings for minor injuries. Provides physical barrier and hemostatic support to facilitate clotting; aids in management of lacerations, cuts, and abrasions.

Clinical Evidence

No clinical data. Evidence consists of bench performance testing (liquid absorption, pH, tensile strength, platelet aggregation) and in-vivo hemostasis testing using a swine model compared to predicate devices. Biocompatibility testing (cytotoxicity, irritation, sensitization, hemolysis, acute systemic toxicity) and shelf-life/sterilization validation were performed.

Technological Characteristics

Non-woven fabric dressing made of chitosan fibers. Gamma-sterilized. Provided in various sizes in foil pouches. Hemostatic mechanism via blood absorption and gel formation. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for over-the-counter use to control bleeding of lacerations, minor cuts, and abrasions in the general population.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• CELOX Hemostatic Granules on Sheet (K080097)
• CELOX Trauma Gauze (K091795)
• CELOX Gauze PRO (K113560)
• CELOX Gauze PRO OTC (K113560)
• CELOX PRO Hemostatic Gauze (K113560)
• OMNI-STAT Granules on Gauze (K113560)

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] FAX: [phone]

#### 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: [phone] FAX: [phone]

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)<br>Number | Product<br>Code | Trade Name | Manufacturer |
|------------------|-----------------|-----------------------------------------------------------------------------------------------------|---------------------------|
| K080097 | FRO | CELOX Hemostatic Granules on<br>Sheet | Medtrade Products<br>Ltd. |
| K091795 | FRO | CELOX Trauma Gauze | Medtrade Products<br>Ltd. |
| K113560 | FRO | CELOX Gauze PRO<br>CELOX Gauze PRO OTC<br>CELOX PRO Hemostatic Gauze<br>OMNI-STAT Granules on Gauze | Medtrade Products<br>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

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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.