(218 days)
Not Found
No
The device description and intended use focus on the material properties and physical mechanism of action for hemostasis and antibacterial barrier. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making.
Yes
The device is indicated for the local management of bleeding wounds and for the promotion of rapid control (hemostasis) of bleeding in patients, which are therapeutic interventions.
No
The device description indicates that the HemCon Bandage family of products are dressings designed to control bleeding and provide an antibacterial barrier at the site of injury, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a physical dressing made of chitosan, a non-mammalian polymer, designed to be applied directly to wounds. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The HemCon Bandage family of products are dressings applied directly to wounds on the body to control bleeding and provide an antibacterial barrier. They are not used to analyze samples taken from the body.
- Intended Use: The intended use clearly describes the application of the dressing to wounds for local management of bleeding and bacterial barrier, not for diagnostic testing of bodily fluids or tissues.
- Device Description: The description details the physical composition and mechanism of action of the dressing when applied to a wound, not a method for analyzing a sample.
Therefore, the HemCon Bandage family of products falls under the category of a medical device used for wound management and hemostasis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HemCon Bandage OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
The Hem Con Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.
Hem Con ChitoFlex PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.
The HemCon Patch PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.
The HemCon Strip First Aid PRO is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Strip First Aid PRO also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
The HemCon Strip PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.
Product codes (comma separated list FDA assigned to the subject device)
QSY, LYA, FRO
Device Description
The HemCon® Bandage family of products are lyophilized (freeze dried) chitosan based dressings designed to optimize the muco adhesive surface density and structural integrity of chitosan at the site of injury. The bandages are soft, pliable, off-white, non-woven, lamellar dressings composed of a non-mammalian biocompatible, hydrophilic cellulose polymer, poly-N-acetylglucosamine (NAG), isolated from arctic shrimp "Pandalus Borealis' chitosan.
When applied directly to a wound the dressing controls bleeding. The chitosan dressings offer an antibacterial barrier against a wide range of gram positive and gram negative organisms including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
The HemCon Bandage Family of products may be manufactured to any size and are currently available in sizes: 1.5" x 1.5", 1" x 4", 2" x 2", 2"x 4", 4"x 4",3" x 9″ and 3" x 28".
The HemCon Bandage family products are safe, durable, highly effective, and do not contain human proteins or clotting factors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (minor cuts, minor lacerations, minor abrasions), nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites, sites involving percutaneous catheters, tubes and pins.
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:
The biocompatibility evaluation of The HemCon Bandage family of products was conducted in accordance with International Standards ISO-10993 -10. ISO 10993-5, ISO 10993-11, and USP : 2007: Section 88 Biological Reactivity Tests, In Vivo Implantation. The battery of tests included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
The HemCon Bandage family of products are considered dressings for prolonged contact. (24 hours to 30 days) with breached or compromised tissue surfaces. The HemCon Bandages dressings are recommended to be removed within 48 hours.
Antibacterial Barrier:
Antibacterial testing on the HemCon® Bandage family for end of shelf life efficacy was conducted using a modified version of the AATCC Test Method 100-2004 "Antibacterial Finishes on Textiles – Assessment of". The results show a log reduction of 4.0 or greater achieved on all of the organisms tested supporting the antibacterial barrier claim. Only single strains of most species listed below have been studied.
Organisms Included in Antibacterial Testing:
- Acinetobacter baumannii ATCC 15308
- Enterococcus faecalis (VRE) - ATCC 700802
- Enterococcus faecalis (VRE) - ATCC 51299
- Moraxella catarrhalis – ATCC 8193
- Shigella species ATCC 11126
- Staphylococcus aureus MRSA ATCC 33591
- Staphylococcus aureus MRSA - ATCC BAA-1556
- Staphylococcus epidermis – ATCC 12228
- Streptococcus pneumoniae – ATCC 10015
- Streptococcus pyogenes ATCC 19615
Animal Studies:
Study type: Prospective randomized open label study
Sample size: 9 heparinized sheep
Key results: Hemostasis time in the HemCon group was significantly less than the control. This animal study demonstrated the HemCon Bandage's ability to control bleeding in an anticoagulated model.
Clinical Performance Data:
Study 1:
Study type: Interventional, open label prospective investigation
Sample size: Twenty subjects on anticoagulant therapy for complicated epistaxis.
Key results: HemCon® Bandage nasal packaging was performed with 19 out of 20 subjects achieving immediate hemostasis (time to hemostasis was defined as the time interval between insertion of the nasal pack and complete cessation of bleeding). The dressings were removed at 48 hours without rebleeding or evidence of any adverse events such as adhesions, scarring, or infection.
Study 2:
Study type: Interventional, randomized open label study
Sample size: Seventy subjects treated with HemCon and sixty six treated with control (standard pad).
Key results: Time to hemostasis with HemCon Bandage was lower (p
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2023
HemCon Medical Technologies, Inc. Ms. Jody Oyama Vice President Clinical and Regulatory Market Strategy United States 720 SW Washington Street, Suite 200 Portland, Oregon 97225
Re: K150916
Trade/Device Name: HemCon® Bandage PRO, HemCon® Patch PRO, HemCon® Strip PRO, HemCon® Strip First Aid PRO, HemCon® ChitoFlex PRO Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Ms. Jody Oyama:
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 10, 2015. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.
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,
Image /page/0/Picture/9 description: The image shows the name "Julie A. Morabito" in a large, bold font. The text is black and appears to be centered on a white background. The name is likely associated with a person, possibly for identification or branding purposes.
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 & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2015
HemCon Medical Technologies Incorporated Ms. Jody Oyama Vice President Clinical and Regulatory Market Strategy United States 720 Southwest Washington Street, Suite 200 Portland, Oregon 97205
Re: K150916
Trade/Device Name: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO Regulatory Class: Unclassified Product Code: FRO Dated: October 12, 2015 Received: October 14, 2015
Dear Ms. Oyama:
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
2
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) K150916
Device Name HemCon Bandage PRO (OTC)
Indications for Use (Describe)
The HemCon Bandage OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known) K150916
Device Name HemCon Bandage PRO
Indications for Use (Describe)
The Hem Con Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K150916
Device Name HemCon ChitoFlex PRO
Indications for Use (Describe)
Hem Con ChitoFlex PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| V Proporintian Hoo (Dart 21 CED 001 Cubnart D) | Over The Countar Uno 124 CED 001 Cubn |
||X| Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(k) Number (if known) K150916
Device Name HemCon Patch PRO
Indications for Use (Describe)
The HemCon Patch PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use (Part 9 of SBC 2015) | Care Type Occupancy (Part 3 of SBC 2015) |
|---|---|
| ---------------------------------------------------- | -------------------------------------------------------- |
| > Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
510(k) Number (if known) K150916
Device Name HemCon Strip First Aid PRO
Indications for Use (Describe)
The HemCon Strip First Aid PRO is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Strip First Aid PRO also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
510(k) Number (if known) K150916
Device Name HemCon Strip PRO
Indications for Use (Describe)
The HemCon Strip PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.
Type of Use (Select one or both, as applicable)
| Depository Use (Part 21 CFR 201, Subpart D) |
|---|
| On-Site Control Use (21 CFR 601.31) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
9
TEL: +1.503.245.0459 FAX: +1.503.245.1326 WEB: www.hemcon.com
510(k) Summary - K150916
HemCon 510(k) Notification
- l. Submitter:
Company Name: HemCon Medical Technologies, Inc. Company Address: 720 SW Washington Street, Suite 200 Portland, OR 97205-3504 Contact Person: Máire Ní Beilliú PhD VP Regulatory & Quality Contact Phone: (971) 327.5729 Contact Fax: (503) 245.1326 Date of Preparation: 6th November 2015 II. Device HemCon® Bandage PRO, HemCon® Bandage Trade Name: PRO OTC, HemCon® Patch PRO, HemCon® Strip PRO, HemCon® Strip First Aid PRO, HemCon® ChitoFlex PRO
Common Name: Classification Name: Product Code: Regulatory Class:
Wound Dressing Dressing FRO Unclassified
III. Predicate Device(s):
Predicate Devices:
HemCon Bandage (K080818, K072486, K071519, K043050, K030946, K023298)
Clo-Sur Pad (Plus) P.A.D. Scion Cardio-Vascular, Inc (K112961, K092552, K032986)
The predicate devices have not been subject to a design related recall.
10
IV. Description of the Device:
The HemCon® Bandage family of products are lyophilized (freeze dried) chitosan based dressings designed to optimize the muco adhesive surface density and structural integrity of chitosan at the site of injury. The bandages are soft, pliable, off-white, non-woven, lamellar dressings composed of a non-mammalian biocompatible, hydrophilic cellulose polymer, poly-N-acetylglucosamine (NAG), isolated from arctic shrimp "Pandalus Borealis' chitosan.
When applied directly to a wound the dressing controls bleeding. The chitosan dressings offer an antibacterial barrier against a wide range of gram positive and gram negative organisms including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
The HemCon Bandage Family of products may be manufactured to any size and are currently available in sizes: 1.5" x 1.5", 1" x 4", 2" x 2", 2"x 4", 4"x 4",3" x 9″ and 3" x 28".
The HemCon Bandage family products are safe, durable, highly effective, and do not contain human proteins or clotting factors.
V. Indications for Use:
Prescription Use:
HemCon® Bandage PRO:
The HemCon® Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins
HemCon Patch® PRO:
The HemCon® Patch PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins
HemCon® Strip PRO:
The HemCon® Strip PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds:
11
lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins
HemCon® ChitoFlex® PRO:
HemCon® ChitoFlex® PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins
Over-The-Counter-Use
HemCon® Bandage PRO OTC:
The HemCon® Bandage OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms
HemCon® Strip First Aid PRO:
The HemCon® Strip First Aid PRO is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
VI. Comparison of Technological Characteristics with the Predicate Device:
The HemCon® Bandage PRO, HemCon® Bandage PRO OTC, HemCon® Patch PRO, HemCon® Strip PRO. HemCon® Strip First Aid PRO. and HemCon® ChitoFlex® PRO are technologically similar to the predicate device. At a high level, the subject and predicate devices are based on the following same technological elements:
- External dressing
- Single use .
- poly-ß-(1-4)-N-acetyl-D-glucosamine polysaccharide (chitosan) composition
- Polysaccharide solid matrix freeze phase-separated and freeze-dried dressings ●
- Hemostatic indication for use
- . Effective for bleeding control in anti-coaqulated patients
- Provides an antibacterial barrier
- Sterile Gamma-irradiated ●
- . Prolong contact (temporary)
- Non-implantable ●
- Biocompatible
12
VII. Performance Data:
Biocompatibility
The biocompatibility evaluation of The HemCon Bandage family of products was conducted in accordance with International Standards ISO-10993 -10. ISO 10993-5, ISO 10993-11, and USP : 2007: Section 88 Biological Reactivity Tests, In Vivo Implantation. The battery of tests included the following tests:
- Cytotoxicity
- . Sensitization
- Irritation
- . Systemic toxicity
The HemCon Bandage family of products are considered dressings for prolonged contact. (24 hours to 30 days) with breached or compromised tissue surfaces. The HemCon Bandages dressings are recommended to be removed within 48 hours.
Antibacterial Barrier
Antibacterial testing on the HemCon® Bandage family for end of shelf life efficacy was conducted using a modified version of the AATCC Test Method 100-2004 "Antibacterial Finishes on Textiles – Assessment of". The results show a log reduction of 4.0 or greater achieved on all of the organisms tested supporting the antibacterial barrier claim. Only single strains of most species listed below have been studied.
Organisms Included in Antibacterial Testing
- Acinetobacter baumannii ATCC 15308 ●
- Enterococcus faecalis (VRE) - ATCC 700802
- . Enterococcus faecalis (VRE) - ATCC 51299
- . Moraxella catarrhalis – ATCC 8193
- Shigella species ATCC 11126 ●
- Staphylococcus aureus MRSA ATCC 33591 ●
- . Staphylococcus aureus MRSA - ATCC BAA-1556
- Staphylococcus epidermis – ATCC 12228
- . Streptococcus pneumoniae – ATCC 10015
- Streptococcus pyogenes ATCC 19615 ●
Animal Studies
To evaluate the efficacy of HemCon® Bandages in anticoagulated populations a prospective randomized open label study in 9 heparinized sheep was conducted. Both superficial femoral arteries were catheterized with 8F sheaths for 5 minutes before application of a HemCon® Bandage 2" x 2" dressing or standard manual compression. Angiography was used to confirm hemostasis at the artery. Time to hemostasis were recorded for both groups.
Hemostasis time in the HemCon group was significantly less than the control. This animal study demonstrated the HemCon Bandage's ability to control bleeding in an anticoagulated model.
13
Clinical Performance Data
To further evaluate the efficacy of HemCon® Bandages in anticoagulation populations two clinical studies were conducted.
An interventional, open label prospective investigation of the efficacy of HemCon® ChitoFlex® dressing in control of complicated epistaxis in twenty subjects on anticoagulant therapy was conducted. The control was a polyvinyl acetal (PVA) nasal sponge. The study included eleven patients on antiplatelet Aspirin: four subjects on antiplatelet Clopidogrel; seven subjects on anticoagulant Warfarin; three subjects on antiplatelet Aspirin + Clopidogrel; two subjects on Warfarin + Clopidogrel + Aspirin, four subjects were on no anticoaqulants or anti-platelets. Subjects discontinued anticoagulation and antiplatelet treatments after chitosan dressing application. Success was defined as achieving active control of bleeding before subject leaves the physician's office and absence of rebleeding after dressing removal at 48 hrs.
HemCon® Bandage nasal packaging was performed with 19 out of 20 subjects achieving immediate hemostasis (time to hemostasis was defined as the time interval between insertion of the nasal pack and complete cessation of bleeding). The dressings were removed at 48 hours without rebleeding or evidence of any adverse events such as adhesions, scarring, or infection.
The second clinical study was an interventional, randomized open label study with a primary endpoint of time to hemostasis with HemCon® Bandage vs. control (standard pad). Seventy subjects were treated with HemCon and sixty six were treated with control. Catheterization was with a 6 Fr sheath and subjects were anticoagulated with 2500 u of heparin. Forty-one of seventy HemCon treated subjects were on antiplatelet Aspirin while forty of sixty six control subjects were on Aspirin. Fifteen of seventy HemCon treated subjects used the anti-platelet Clopidogrel while eight of the sixty six control subjects were on Clopidogrel. Secondary endpoints included vascular complication rate and patient satisfaction.
Time to hemostasis with HemCon Bandage was lower (p