(32 days)
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 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 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°.
This document is a 510(k) summary for the HemCon™ Bandage, which means it describes the device's substantial equivalence to existing legally marketed devices rather than providing detailed clinical study results and acceptance criteria as would be found in a Premarket Approval (PMA) application. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics is not explicitly detailed in the provided text.
However, based on the information available in the 510(k) summary, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating that the HemCon™ Bandage "out-performed the gauze control in all criteria" and showed "no statistical difference in the pre-injury animal characteristics" compared to predicate devices in animal models. The reported performance is qualitative and comparative rather than against predefined numerical thresholds.
| Acceptance Criteria (Inferred from Comparative Statement) | Reported Device Performance (Comparative) |
|---|---|
| Superior to gauze control | Out-performed the gauze control in all criteria |
| Comparable to predicate devices (RDH Bandage, SyvekPatch®) | Expected to achieve the same safety and effectiveness as the predicate devices mentioned above. (Implies performance is at least equivalent to these.) |
| Reduced post-treatment blood loss | Exhibited a lower rate of post-treatment blood loss (compared to gauze control) |
| Reduced fluid use | Exhibited a reduction in fluid use (compared to gauze control) |
| Higher survival rate | Exhibited a higher rate of survival (compared to gauze control) |
| Higher hemostasis rate | Exhibited a higher rate of hemostasis (compared to gauze control) |
| No statistical difference in pre-injury characteristics | No statistical difference in the pre-injury animal characteristics (between HemCon™ Bandage and control groups) |
2. Sample size used for the test set and the data provenance
The document states, "The HemCon™ Bandage has been tested in several settings utilizing accepted and approved animal models of hemorrhage..." However, it does not provide any specific sample sizes for these animal studies.
The data provenance is stated as "accepted and approved animal models of hemorrhage," implying animal studies rather than human clinical trials. The country of origin of the data is not specified. It is likely a retrospective analysis of animal study data submitted for 510(k) purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary, as the studies mentioned are animal models, not human clinical trials requiring expert ground truth for interpretation of human data.
4. Adjudication method for the test set
This information is not provided and is generally not applicable to the type of animal studies described in a 510(k) for substantial equivalence.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not relevant to this device. The HemCon™ Bandage is a hemostatic dressing, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the HemCon™ Bandage, as it is a physical medical device (hemostatic dressing), not an algorithm or AI system.
7. The type of ground truth used
For the animal studies, the "ground truth" would be the direct physiological outcomes measured in the animal models, such as actual blood loss, survival rates, and observed hemostasis. This is a form of outcomes data directly observed and measured in the study subjects (animals).
8. The sample size for the training set
This information is not provided. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not applicable to the HemCon™ Bandage. The reported "studies" are likely preclinical animal studies rather than data sets used to train a model.
9. How the ground truth for the training set was established
As the concept of a training set is not applicable, this information is not provided.
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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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
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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 Technologies510(k) # #K002550SyvekPatch®, Marine Polymer Technologies510(k) # K972914 |
| Submitted by: | James F. Hensel, President |
| Company Name: | Hemcon, Inc. |
| Company Address: | 10575 SW Cascade Ave., Suite 130Tigard, 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
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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.
N/A