(75 days)
Not Found
No
The device description focuses on the material composition and physical properties of the dressing, with no mention of AI or ML capabilities. The radiopaque filament is a passive feature for detection via x-ray, not an AI/ML-driven image analysis tool.
Yes
The device is a hemostatic dressing intended for the "external, temporary control of severely bleeding wounds," which is a therapeutic function.
No
Explanation: The device is described as a hemostatic dressing for controlling bleeding, and the radiopaque filament is for detection (to prevent it from being left behind), not for diagnosing a condition or disease.
No
The device is a physical dressing made of gauze coated with chitosan and a radiopaque filament. It is a hardware 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 "hemostatic dressing for the external, temporary control of severely bleeding wounds." This describes a device used directly on a patient's body to control bleeding, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a physical dressing applied to a wound. While it has a radiopaque filament for detection, this is a feature for safety during treatment, not for diagnostic testing of a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
- Being used in a laboratory setting
The device is a therapeutic device used for wound management. The radiopaque filament is a safety feature related to the application and removal of the dressing, not a diagnostic function.
N/A
Intended Use / Indications for Use
ChitoGauze™XR is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
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. This submission for ChitoGauze™XR adds a radiopaque filament to models of various dimensions of the legally marketed dressing. The ChitoGauze™XR dressings are z-folded to the appropriate size and packaged in a single heat-sealed 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. The radiopaque filament allows for easy detection via x-ray to prevent the dressing from being inadvertently left on the wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
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)
Non-Clinical Performance Data:
Biocompatibility: Biocompatibility has been demonstrated per ISO 10993. Addition of the radiopaque filament to the dressing has no effect upon the biocompatibility.
In Vivo Efficacy: Two separate in vivo studies were designed and conducted to establish the hemostatic efficacy of the product in different injury types created to represent the likely use of the different product sizes. In both studies the device was tested side-by-side against a competitive hemostatic dressing. The first study tested the ability of the 4 inch by 4 yard size to control bleeding in 6mm femoral perforation injury in a swine. The second study measured the ability of a two inch by two inch 8-ply size to control bleeding in a splenic capsular strip injury in a swine. In both cases, the device proved to successfully control bleeding at least as well as the competitive product used as a reference.
Reduction of Microorganisms: ChitoGauze™ was tested for reduction of microorganisms against various species. The log reduction data demonstrates the level of antibacterial effectiveness; see table 2 below. The clinical utility of these results is unknown.
Sterility: A sterility validation for ChitoGauze™XR was completed following ISO 11137:2006 requirements to demonstrate a 10-6 SAL using the VDmax 5 method.
Radiopacity: The radiopacity of ChitoGauze™XR was determined via testing performed in accordance with ASTM F640-07 Method C (Standard Test methods for Determining the Radiopacity for Medical Use). The product was found to be equivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 mm 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Log Reduction for various microorganisms (see Table 2 in document for specific values).
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 & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
HemCon Medical Technologies, Inc. c/o Kendra Rathkey Regulatory Affairs Lead 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
July 28, 2023
Re: K102546 Trade/Device Name: ChitoGauze™ XR Regulatory Class: Unclassified Product Code: QSY
Dear Kendra Rathkey:
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 November 17, 2010. 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an image of a stylized eagle or bird-like figure with outstretched wings. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
HemCon Medical Technologies, Inc. % Ms. Kendra Rathkey Regulatory Affairs Lead 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
NOV 1 7 2010
Re: K102546
Trade/Device Name: HemCon Medical Technologies, Inc. Regulatory Class: Unclassified Product Code: FRO Dated: November 24, 2010 Received: November 24, 2010
Dear Ms. Rathkey:
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
2
Page 2 - Ms. Kendra Rathkey
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
For Peter Pan
Mark N. Mellon
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 5: Indications for Use Statement
| Applicant: | HemCon Medical Technologies, Inc. |
|---|---|
| 510(k) Number: | |
| Device Name: | ChitoGauze™ XR |
| NOV 1 7 2010 |
Indications for Use (Rx):
ChitoGauze™XR is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
1 510(k) = HemCon ChitoGauzeXR = =
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kune for MXM
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102546
150
4
Section 6: 510(k) Summary
NOW 1: 7 2010
| Trade Name: | ChitoGauze™ XR |
|---|---|
| Common Name: | Wound Dressing |
| Classification Name: | Dressing |
| Product Code: | FRO |
| Predicate Device(s): | Modification to ChitoGauze™ (K090026 K092357) |
| Company Name: | HemCon Medical Technologies, Inc. |
| Company Address: | 10575 SW Cascade Avenue, Suite 130 |
| Portland, OR 97223 | |
| Contact Person: | Kendra Rathkey |
| Regulatory Affairs Lead | |
| Contact Phone: | (503) 245.0459 x139 |
| Contact Fax: | (971) 327.5725 |
| Date of Preparation: | 01 September 2010 |
Description of the Device:
The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. This submission for ChitoGauze™XR adds a radiopaque filament to models of various dimensions of the legally marketed dressing. The ChitoGauze™XR dressings are z-folded to the appropriate size and packaged in a single heat-sealed 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. The radiopaque filament allows for easy detection via x-ray to prevent the dressing from being inadvertently left on the wound.
Intended Use:
ChitoGauze™XR is intended to be a hemostatic wound dressing.
Indications for Use (Rx):
ChitoGauze™XR is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Technological Characteristics:
ChitoGauze™XR is technologically equivalent to the currently marketed ChitoGauze dressing. Addition of the radiopaque filament to the dressing does not affect the fundamental scientific technological characteristics of the original ChitoGauze.
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Non-Clinical Performance Data:
Biocompatibility
Biocompatibility has been demonstrated per ISO 10993. Addition of the radiopaque filament to the dressing has no effect upon the biocompatibility.
In Vivo Efficacy
Two separate in vivo studies were designed and conducted to establish the hemostatic efficacy of the product in different injury types created to represent the likely use of the different product sizes. In both studies the device was tested side-by-side against a competitive hemostatic dressing. The first study tested the ability of the 4 inch by 4 yard size to control bleeding in 6mm femoral perforation injury in a swine. The second study measured the ability of a two inch by two inch 8-ply size to control bleeding in a splenic capsular strip injury in a swine. In both cases, the device proved to successfully control bleeding at least as well as the competitive product used as a reference.
Reduction of Microorganisms:
ChitoGauze™ was tested for reduction of microorganisms against the following species. The log reduction data demonstrates the level of antibacterial effectiveness; see table 2 below. The clinical utility of these results is unknown.
| Microorganism | Gram Stain | Log
Reduction |
|--------------------------------------------|------------|------------------|
| Staphylococcus aureus (MRSA) ATCC 33591 | + | >5.0 |
| Staphylococcus aureus (MRSA) ATCC BAA-1556 | + | >5.1 |
| Staphylococcus epidermidis ATCC 12228 | + | >4.4 |
| Pseudomonas aeruginosa ATCC 9027 | - | >5.1 |
| Enterococcus faecalis (VRE) ATCC 51299 | + | >5.4 |
| Acinetobacter baumanii ATCC 15308 | - | >5.2 |
| Citrobacter freundii ATCC 8090 | - | >5.2 |
| Enterobacter cloacae ATCC 13047 | - | >4.9 |
| Streptococcus mutans ATCC 25175 | + | >4.7 |
| Streptococcus pneumoniae ATCC 10015 | + | >5.4 |
| Escherichia coli ATCC 8739 | - | >4.9 |
| Klebsiella pneumoniae ATCC 4352 | - | >5.2 |
| Streptococcus pyogenes ATCC 19615 | + | 5.0 |
| Salmonella choleraesius ATCC 10708 | - | >4.6 |
| Stenotrophomonas maltophilia ATCC 12714 | - | >5.1 |
| Citrobacter koseri ATCC 25408 | - | >4.7 |
| Proteus mirabilis ATCC 4630 | - | >5.0 |
| Proteus vulgaris ATCC 12454 | - | >4.6 |
| Moraxella catarrhalis ATCC 8193 | - | >4.9 |
| Clostridium difficile ATCC 9689 | + | >5.0 |
| Shigella species ATCC 11126 | - | >4.3 |
| Micrococcus luteus ATCC 49732 | + | >5.0 |
| Vibrio cholerae ATCC 11558 | - | >4.0 |
| Enterobacter aerogenes ATCC 13048 | - | >5.0 |
| Enterococcus faecalis (VRE) ATCC 700802 | + | >5.3 |
| Serratia marcescens ATCC 13880 | - | >4.5 |
Table 2: Log reduction of microorganisms demonstrating level of antibacterial effectiveness of ChitoGauze™
Sterility
A sterility validation for ChitoGauze™XR was completed following ISO 11137:2006 requirements to demonstrate a 10-6 SAL using the VDmax 5 method.
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K102546 page 3/3
Radiopacity:
The radiopacity of ChitoGauze™XR was determined via testing performed in accordance with ASTM F640-07 Method C (Standard Test methods for Determining the Radiopacity for Medical Use). The product was found to be equivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 mm 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable.
Clinical Performance Data:
No clinical data was required for evaluation of this device.
Conclusion:
The modification to ChitoGauze to add the radiopaque filament is neither a change to the intended use, nor an alteration of the fundamental scientific technology of the device.