(85 days)
Not Found
No
The device description and performance studies focus on the material properties and hemostatic function of the gauze, with no mention of AI or ML.
No
The device is a hemostatic wound dressing intended to stop bleeding, which falls under wound care rather than therapeutic treatment of a disease or condition.
No.
The device is a hemostatic wound dressing, used for controlling bleeding, not for diagnosing medical conditions.
No
The device description clearly states it is a "dressing composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to be a hemostatic wound dressing for controlling bleeding from external wounds. This is a direct application to the body for therapeutic purposes, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The device is a physical dressing applied to a wound.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing or monitoring a disease or condition through in vitro testing.
- Performance Studies: The performance studies focus on biocompatibility, in vivo efficacy (stopping bleeding in a trauma model), reduction of microorganisms, and sterility – all relevant to a wound dressing, not an IVD.
In summary, ChitoGauze is a medical device intended for direct application to external wounds to control bleeding, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use (Rx):
ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Indications for Use (OTC):
ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. The four inch by four yard (4" x 4 yds) dressing is z-folded and packaged in a peelable foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.
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)
Biocompatibility
Biocompatibility has been demonstrated per ISO 10993.
In Vivo Efficacy
In vivo testing evaluated the efficacy of ChitoGauze versus lap sponges, uncoated gauze and coated gauze (competitive) in an extreme trauma model. ChitoGauze exhibited substantially equivalent efficaciy.
Reduction of Microorganisms:
ChitoGauze™ was tested for reduction of microorganisms against the following species. The log reduction data demonstrates the level of antibacterial effectiveness. The cinical utility of these results is unknown.
| Microorganism | Gram Stain | Log Reduction |
|---|---|---|
| Staphylococcus aureus (MRSA) ATCC 33591 | + | >4.1 |
| Staphylococcus aureus (MRSA) ATCC BAA-1556 | + | >4.2 |
| Staphylococcus epidermidis ATCC 12228 | + | >4.2 |
| Pseudomonas aeruginosa ATCC 9027 | - | >4.1 |
| Enterococcus faecalis (VRE) ATCC 51299 | + | >4.0 |
| Acinetobacter baumanii ATCC 15308 | - | >4.4 |
| Citrobacter freundii ATCC 8090 | - | >4.3 |
| Enterobacter cloacae ATCC 13047 | - | >4.1 |
| Streptococcus mutans ATCC 25175 | + | >4.0 |
| Streptococcus pneumoniae ATCC 10015 | + | >5.1 |
| Escherichia coli ATCC 8739 | - | >4.1 |
| Klebsiella pneumoniae ATCC 4352 | - | >4.0 |
| Streptococcus pyogenes ATCC 19615 | + | >4.2 |
| Salmonella choleraesius ATCC 10708 | - | >4.1 |
| Stenotrophomonas maltophilia ATCC 12714 | - | >4.0 |
| Citrobacter koseri ATCC 25408 | - | >4.1 |
| Proteus mirabilis ATCC 4630 | - | >4.2 |
| Proteus vulgaris ATCC 12454 | - | >4.3 |
| Moraxella catarrhalis ATCC 8193 | - | >4.1 |
| Clostridium difficile ATCC 9689 | + | >4.0 |
| Shigella species ATCC 11126 | - | >4.0 |
| Micrococcus luteus ATCC 49732 | + | >4.0 |
| Vibrio cholerae ATCC 11558 | - | >4.1 |
| Enterobacter aerogenes ATCC 13048 | - | 4.8 |
| Enterococcus faecalis (VRE) ATCC 700802 | + | 2.6 |
| Serratia marcescens ATCC 13880 | - | 5.0 |
Sterility
A sterility validation for ChitoGauze was completed following ISO 11137:2006 requirements to demonstrate a 10-6 SAL using the VDmax® method.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
HemCon Medical Technologies, Inc. c/o Kevin Hawkins Director - Quality and Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
July 28, 2023
Re: K090026 Trade/Device Name: ChitoGauze™ Regulatory Class: Unclassified Product Code: QSY
Dear Kevin Hawkins:
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 March 31, 2009. 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 features a stylized eagle with its wings forming a protective shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HemCon Medical Technologies, Inc. % Mr. Kevin Hawkins Director, Quality and Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223
Re: K090026
Trade/Device Name: ChitoGauze™ Regulatory Class: Unclassified Product Code: FRO Dated: December 30, 2008 Received: January 5, 2009
Dear Mr. Hawkins:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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, This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
MAR 3 1 2009
2
Page 2 - Mr. Kevin Hawkins
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K090026 510(k) Number (if known):
ChitoGauze™ Device Name:
Indications For Use:
Indications for Use (Rx):
ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Indications for Use (OTC):
ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Daniel Kone for MXM 3/13/2009
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K090026
4
510(k) Summarv
Trade Name: Common Name: Classification Name: Product Code: Predicate Device(s):
Company Name:
Contact Person:
Contact Phone:
Contact Fax:
Company Address:
MAR 3 1 2009
ChitoGauze™ Wound Dressing Dressing FRO HemCon® Bandage (K072486) QuikClot® eX™ (K072474)
HemCon Medical Technologies, Inc. 10575 SW Cascade Avenue, Suite 130 Portland, OR 97223 Kevin Hawkins Director - Quality & Regulatory (503)245.0459 x114 (503)245.1326
Date of Preparation:
20 March 2009
Description of the Device:
The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. The four inch by four yard (4" x 4 yds) dressing is z-folded and packaged in a peelable foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10° The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.
Intended Use:
ChitoGauze™ is intended to be a hemostatic wound dressing.
Indications for Use (Rx):
ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Indications for Use (OTC):
ChitoGauze is intended for temporary external use to stop bleeding of minor wounds. minor cuts and minor abrasions.
Technological Characteristics:
ChitoGauze is technologically similar to at least two predicate devices. The HemCon Bandage has demonstrated the safety and efficacy of a chitosan based hemostatic dressing. QuikClot® eX™has demonstrated the safety and efficacy of a standard, nonwoven medical gauze coated with a hemostatic material. ChitoGauze combines the
5
K090026 page 2/3
HemCon ChitoGauze™ 510(k) Summary Page 2 of 3
chitosan material of one predicate with the coated gauze of the other and is therefore technologically similar to both.
Non-Clinical Performance Data:
Biocompatibility
Biocompatibility has been demonstrated per ISO 10993.
In Vivo Efficacy
In vivo testing evaluated the efficacy of ChitoGauze versus lap sponges, uncoated gauze and coated gauze (competitive) in an extreme trauma model. ChitoGauze exhibited substantially equivalent efficaciy.
Reduction of Microorganisms:
ChitoGauze™ was tested for reduction of microorganisms against the following species. The log reduction data demonstrates the level of antibacterial effectiveness. The cinical utility of these results is unknown.
| Microorganism | Gram Stain | Log Reduction |
|---|---|---|
| Staphylococcus aureus (MRSA) ATCC 33591 | + | >4.1 |
| Staphylococcus aureus (MRSA) ATCC BAA-1556 | + | >4.2 |
| Staphylococcus epidermidis ATCC 12228 | + | >4.2 |
| Pseudomonas aeruginosa ATCC 9027 | - | >4.1 |
| Enterococcus faecalis (VRE) ATCC 51299 | + | >4.0 |
| Acinetobacter baumanii ATCC 15308 | - | >4.4 |
| Citrobacter freundii ATCC 8090 | - | >4.3 |
| Enterobacter cloacae ATCC 13047 | - | >4.1 |
| Streptococcus mutans ATCC 25175 | + | >4.0 |
| Streptococcus pneumoniae ATCC 10015 | + | >5.1 |
| Escherichia coli ATCC 8739 | - | >4.1 |
| Klebsiella pneumoniae ATCC 4352 | - | >4.0 |
| Streptococcus pyogenes ATCC 19615 | + | >4.2 |
| Salmonella choleraesius ATCC 10708 | - | >4.1 |
| Stenotrophomonas maltophilia ATCC 12714 | - | >4.0 |
| Citrobacter koseri ATCC 25408 | - | >4.1 |
| Proteus mirabilis ATCC 4630 | - | >4.2 |
| Proteus vulgaris ATCC 12454 | - | >4.3 |
| Moraxella catarrhalis ATCC 8193 | - | >4.1 |
| Clostridium difficile ATCC 9689 | + | >4.0 |
| Shigella species ATCC 11126 | - | >4.0 |
| Micrococcus luteus ATCC 49732 | + | >4.0 |
| Vibrio cholerae ATCC 11558 | - | >4.1 |
| Enterobacter aerogenes ATCC 13048 | - | 4.8 |
| Enterococcus faecalis (VRE) ATCC 700802 | + | 2.6 |
| Serratia marcescens ATCC 13880 | - | 5.0 |
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K090026 Page 3/3
HemCon ChitoGauze™ 510(k) Summary Page 3 of 3
Sterility
ചാന്തു
A sterility validation for ChitoGauze was completed following ISO 11137:2006
requirements to demonstrate a 10° SAL using the VDmax® method.
Clinical Performance Data:
No clinical data was required for evaluation of this device.
Substantial Equivalence:
The conclusion drawn from the technological characteristics and non-clinical performance data is that the device is as safe and effective as the predicate devices.