(337 days)
Not Found
No
The device is a hemostatic dressing made of chitosan with antibacterial properties, and the submission focuses on expanding the antibacterial claims based on in vitro testing. There is no mention of AI or ML in the description, intended use, or performance studies.
Yes.
The device is described as a "hemostatic dressing for the external temporary control of severely bleeding wounds" and for "local management of bleeding," which directly addresses and treats a physical condition (bleeding).
No
The device is a hemostatic dressing and antibacterial barrier that controls bleeding in wounds, not a device used to diagnose a condition or disease.
No
The device is a physical bandage made from chitosan, designed for wound care and bleeding control. The description focuses on the material and its physical properties, not software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the external temporary control of bleeding wounds. This is a direct therapeutic application to the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description focuses on the physical properties of the bandage and how it interacts with the wound to control bleeding and act as an antibacterial barrier. It doesn't describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The device is a wound dressing with hemostatic and antibacterial properties, which falls under the category of a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
HemCon® Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis.
The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The HemCon® Bandage is manufactured from chitosan. When applied directly to the wound, the HemCon® Bandage controls bleeding. The HemCon® Bandage is a sterile chitosan based dressing intended for use for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HernCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
The original HemCon® Bandage and HemCon® Bandage OTC were cleared via 510(k) K043050 on 03 June 2005 to include the description that the bandage provides an antibacterial barrier as demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the America Association of Textile Chemists and Colorists) in laboratory testing for two microorganisms. This submission expands this antibacterial claim to a total of twenty-four micro-organisms.
The HemCon® Bandage is similar to the original HemCon® Bandage and another antibacterial wound dressing, Maersk Medical's Arglaes-AB Antimicrobial (K990810, cleared 17 September 1999), the HemCon® Bandage was challenged with microbial strains in vitro to support the claim of antibacterial barrier activity and extend the list of microorganisms used in the challenge test.
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)
The HemCon® Bandage demonstrated through in vitro laboratory testing log 4 reductions of multiple organisms. Additionally, testing was conducted demonstrating the bandage is a barrier to microbial penetration against log 6 inoculum. Only single strains of most species mentioned have been studied. Testing challenged for log reduction and barrier abilities against the following microbial strains:
Staphylococcus aureus (MRSA) ATCC 33591
Klebsiella pneumoniae ATCC 4352
Escherichia coli ATCC 8739
Streptococcus pyogenes ATCC 19615
Staphylococcus epidermidis ATCC 12228
Salmonella choleraesuis ATCC 10708
Pseudomonas aeruginosa ATCC 9027
Acinetobacter baumanii ATCC 15308
Enterococcus faecalis (VRE) ATCC 51299
Enterococcus faecalis ATCC 700802
Serratia marcescens ATCC 13880
Stenotrophomonas maltophilia ATCC 12714
Streptococcus mutans ATCC 25175
Streptococcus pneumoniae ATCC 10015
Shigella species ATCC 11126
Enterobacter aerogenes ATCC 13048
Proteus mirabilis ATCC 4630
Proteus vulgaris ATCC 12454
Citrobacter freundii ATCC 8090
Enterobacter cloacae ATCC 13047
Micrococcus luteus ATCC 49732
Vibrio cholerae ATCC 11558
Moraxella catarrhalis ATCC 8193
Clostridium difficile ATCC 9689
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
log 4 reductions of multiple organisms
barrier to microbial penetration against log 6 inoculum
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.
Not Found
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.
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 & Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
July 28, 2023
Re: K072486
Trade/Device Name: HemCon® Bandage and HemCon® Bandage OTC 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 August 6, 2008. 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 U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2008
Hemcon Medical Technologies, Inc. % Mr. Kevin Hawkins Director, Quality & Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97233
Re: K072486
Trade/Device Name: HemCon® Bandagesh, HemCon® Bandage OTC Regulatory Class: Unclassified Product Code: FRO Dated: July 14, 2008 Received: July 15, 2008
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.
2
Page 2 - Mr. Kevin Hawkins
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 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 M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
HemCon Medical Technologies, Special 510(k) for the HemCon Bandage
August 23, 2007
- INDICATIONS FOR USE STATEMENT
Applicant: HemCon, Inc. 510(k) Number (if known): Not Yet Assigned Device Name: HemCon® Bandage
Indications for Use:
HemCon® Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis.
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Mark A. Millican
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Page of
(Posted November 13, 2003)
4
HemCon Medical Technologies, Special 510(k) for the HemCon Bandage
August 23, 2007
Indications for Use Statement
Applicant: HemCon, Inc. 510(k) Number (if known): Not Yet Assigned Device Name: HemCon® Bandage OTC
Indications for Use:
The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Mark A. Milken
Page of
(Posted November 13, 2003)
5
510(K) Summary
AUG - 6 2008
HemCon® Bandage 510(k) K072486
Name and Address of Sponsor:
Device Name:
HemCon Medical Technologies, Inc. 10575 SW Cascade Avenue, Suite 103 Portland, OR 97223
Proprietary Names: HemCon® Bandage; ChitoFlex Hemostatic Dressing; HemCon® Bandage OTC Common Name: Wound Dressing Classification Name: Dressing Product Code: FRO
Establishment Registration Number:
3004050854
Contact Person and Phone Number:
Kevin Hawkins Director - Quality & Regulatory Phone (503)245.0459 x114 Fax (503)245.1326
Device Description:
The HemCon® Bandage is manufactured from chitosan. When applied directly to the wound, the HemCon® Bandage controls bleeding. The HemCon® Bandage is a sterile chitosan based dressing intended for use for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HernCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
The original HemCon® Bandage and HemCon® Bandage OTC were cleared via 510(k) K043050 on 03 June 2005 to include the description that the bandage provides an antibacterial barrier as demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the America Association of Textile Chemists and Colorists) in laboratory testing for two microorganisms. This submission expands this antibacterial claim to a total of twenty-four micro-organisms.
The HemCon® Bandage is similar to the original HemCon® Bandage and another antibacterial wound dressing, Maersk Medical's Arglaes-AB Antimicrobial (K990810, cleared 17 September 1999), the HemCon® Bandage was challenged with microbial strains in vitro to support the claim of antibacterial barrier activity and extend the list of microorganisms used in the challenge test.
Indication for Use Rx:
HemCon® Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis.
510(k) Summarv HemCon Medical Technologies, Inc.
K072486 Page 1 of 2
6
K072486
page 2 of 2
Indications for Use OTC:
The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
Technical Characteristics:
The HemCon® Bandage demonstrated through in vitro laboratory testing log 4 reductions of multiple organisms. Additionally, testing was conducted demonstrating the bandage is a barrier to microbial penetration against log 6 inoculum. Only single strains of most species mentioned have been studied. Testing challenged for log reduction and barrier abilities against the following microbial strains:
| Staphylococcus aureus (MRSA) ATCC 33591 |
|---|
| Klebsiella pneumoniae ATCC 4352 |
| Escherichia coli ATCC 8739 |
| Streptococcus pyogenes ATCC 19615 |
| Staphylococcus epidermidis ATCC 12228 |
| Salmonella choleraesuis ATCC 10708 |
| Pseudomonas aeruginosa ATCC 9027 |
| Acinetobacter baumanii ATCC 15308 |
| Enterococcus faecalis (VRE) ATCC 51299 |
| Enterococcus faecalis ATCC 700802 |
| Serratia marcescens ATCC 13880 |
| Stenotrophomonas maltophilia ATCC 12714 |
| Streptococcus mutans ATCC 25175 |
| Streptococcus pneumoniae ATCC 10015 |
| Shigella species ATCC 11126 |
| Enterobacter aerogenes ATCC 13048 |
| Proteus mirabilis ATCC 4630 |
| Proteus vulgaris ATCC 12454 |
| Citrobacter freundii ATCC 8090 |
| Enterobacter cloacae ATCC 13047 |
| Micrococcus luteus ATCC 49732 |
| Vibrio cholerae ATCC 11558 |
| Moraxella catarrhalis ATCC 8193 |
| Clostridium difficile ATCC 9689 |