(32 days)
Not Found
No
The device description and performance studies focus on the material properties and physical application of a hemostatic bandage, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section states that the device is for "external temporary control of severely bleeding wounds" and "controls bleeding in patients following hemodialysis," which are therapeutic actions.
No
Explanation: The provided text describes the HemCon™ Bandage as a hemostatic dressing for controlling bleeding, which is a therapeutic function, not a diagnostic one. It does not mention any capabilities for imaging, analyzing, or identifying medical conditions.
No
The device description clearly indicates it is a physical bandage made from a material (chitosan) and applied to a wound, which is a hardware component.
Based on the provided information, the HemCon™ Bandage is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "external temporary control of severely bleeding wounds" and "controls bleeding in patients following hemodialysis." This describes a device that is applied directly to the body to treat a physical condition.
- Device Description: The description details a "hemostatic dressing" made from a material applied to a wound. This is a topical, physical treatment.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. IVDs are designed for testing samples in vitro (in glass or in a lab setting).
Therefore, the HemCon™ Bandage is a medical device used for wound care and hemostasis, not an in vitro diagnostic device.
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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The HemCon™ Bandage is intended as an external temporary wound treatment for the control of severely bleeding wounds for emergency use. In addition, the HemCon™ Bandage also controls bleeding in patients following hemodialysis.
The HemCon™ Bandage is applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site.
The HemCon™ Bandage is manufactured from ChitoClear™ chitosan ,a material consisting of cellulosic polymer, poly-N-acetylglucosamine. This formulation has been self-affirmed by the manufacturer as a GRAS (Generally Recognized as Safe) food ingredient in accordance with 21 CFR § 170.30. Several biomedical applications of chitosan have already been reported. The GRAS Report provided by the supplier refers to safety studies in human beings and several species of animals. The studies cited represent research on the safety and use of chitosan, which have been published over a period of decades by scientists from around the world. This large body of scientific literature satisfies the requirement in 21 CFR § 170.30 (a), that a general recognition of safety requires common knowledge about the substance throughout the scientific community.
Chitosan has many advantages due to its nontoxicity and biodegradability without damaging the environment. It is a biocompatible material that breaks down slowly in to a harmless product, glucosamine, that is absorbed completely by the body. Please see the reference list provided.
This device is packaged in a foil package and is provided sterile. It is sterilized by gamma irradiation at 15 kGy ensuring a SAL of 10°. The validation study conducted according to ISO 11137, Method I is on file at Hemcon. Labeling has been provided in this application.
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 has been tested in several settings utilizing accepted and approved animal models of hemorrhage and compared to existing hemostatic control products. The HemCon™ Bandage out-performed the gauze control in all criteria. There was no statistical difference in the pre-injury animal characteristics. The HemCon™ Bandage exhibited a lower rate of post treatment blood loss, a reduction in thuid use, and a higher rate of survival and hemostasis.
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.
RDH Bandage, Marine Polymer Technologies 510(k) # #K002550, SyvekPatch®, Marine Polymer Technologies 510(k) # K972914
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 two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
June 11, 2023
Hemcon, Inc. James F. Hensel President 10575 SW Cascade Avenue, Suite 130 Tigard, Oregon 97223
Re: K023298 Trade/Device Name: HemCon™ Bandage Regulatory Class: Unclassified Product Code: QSY
Dear James F. Hensel:
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 4, 2002. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code OSY.
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 consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the eagle figure in the center.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 4 2002
Hemcon, Inc. James F. Hensel President 10575 SW Cascade Avenue, Suite 130 Tigard, Oregon 97223
Re: K023298
Trade/Device Name: HemCon™ Bandage Regulation Name: Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 2, 2002 Received: October 3, 2002
Dear Mr. Hensel:
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. James F. Hensel
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
ん Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Hemcon (
SECTION T - STATEMENT OF INDICATIONS FOR USE
INDICATIONS FOR USE
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.
(PLEASE DO NOT WRITE BELOW THIS LINE- -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number_KO23298 Prescription Use OR ﺎ ﮨ Over-The-Counter Use (Per 21 C.F.R. 801.109) (Optional Format 1-2-9
4
NOV 4 2002
Hem('on™ Bandage 510(k) application
10-01-02
Hemcon
SECTION P - 510(K) SUMMARY
| Trade Name: | HemCon™ Bandage |
|---|---|
| Device Class: | Class 1 |
| Classification Panel: | 878 - General and Plastic Surgery |
| Common Name: | Traumatic Wound Dressing |
| Classification Name: | Bandage, Liquid |
| Predicate Devices: | RDH Bandage, Marine Polymer Technologies |
| 510(k) # #K002550 | |
| SyvekPatch®, Marine Polymer Technologies | |
| 510(k) # K972914 | |
| Submitted by: | James F. Hensel, President |
| Company Name: | Hemcon, Inc. |
| Company Address: | 10575 SW Cascade Ave., Suite 130 |
| Tigard, OR 97223 | |
| Company Telephone: | 503-245-0459 |
| Company Fax: | 503-245-1326 |
| Prepared On: | October 1, 2002 |
The HemCon™ Bandage is intended as an external temporary wound treatment for the control of severely bleeding wounds for emergency use. In addition, the HemCon™ Bandage also controls bleeding in patients following hemodialysis.
The HemCon™ Bandage is applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site.
The HemCon™ Bandage is manufactured from ChitoClear™ chitosan ,a material consisting of cellulosic polymer, poly-N-acetylglucosamine. This formulation has been self-affirmed by the manufacturer as a GRAS (Generally Recognized as Safe) food ingredient in accordance with 21 CFR § 170.30. Several biomedical applications of chitosan have already been reported. The GRAS Report provided by the supplier refers to safety studies in human beings and several species of animals. The studies cited represent research on the safety and use of chitosan, which have been published over a period of decades by scientists from around the world. This large body of scientific literature satisfies the requirement in 21 CFR § 170.30 (a), that a general recognition of safety requires common knowledge about the substance throughout the scientific community.
Chitosan has many advantages due to its nontoxicity and biodegradability without damaging the environment. It is a biocompatible material that breaks down slowly in to a harmless product, glucosamine, that is absorbed completely by the body. Please see the reference list provided.
This device is packaged in a foil package and is provided sterile. It is sterilized by gamma irradiation at 15 kGy ensuring a SAL of 10°. The validation study conducted
5
K023298 page 2/2
HemCon™ Bandage 510(k) application 10-01-02 Hemcon according to ISO 11137, Method I is on file at Hemcon. Labeling has been provided in
this application.
The HemCon™ Bandage has been tested in several settings utilizing accepted and approved animal models of hemorrhage and compared to existing hemostatic control products. The HemCon™ Bandage out-performed the gauze control in all criteria. There was no statistical difference in the pre-injury animal characteristics. The HemCon™ Bandage exhibited a lower rate of post treatment blood loss, a reduction in thuid use, and a higher rate of survival and hemostasis.
The HemCon™ Bandage is similar to Marine Polymer Technologies' RDH Bandage™ and SyvekPatch® in intended use, indications, material, performance, sterilization method, and method of application. In summary, the HemCon™ Bandage is expected to achieve the same safety and effectiveness as the predicate devices mentioned above. Predicate device comparison tables are included in this submission.