(85 days)
Not Found
No
The device description and intended use focus on the material properties of the bandage for bleeding control, with no mention of AI or ML.
No
The device is indicated for local management of bleeding, which is a supportive rather than therapeutic function.
No
A diagnostic device is used to identify or detect a disease or condition. The provided text indicates that the HemCon™ Bandage OTC is for "the local management of bleeding," which is a treatment or management function, not a diagnostic one.
No
The device description clearly states it is a physical bandage made from chitosan, a material consisting of cellulosic polymer, poly-N-acetylglucosamine. It is packaged in a foil package and provided sterile, indicating a physical, non-software device.
Based on the provided information, the HemCon™ Bandage OTC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "local management of bleeding such as laceration and minor bleeding." This describes a direct therapeutic action on the body (stopping bleeding), not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a bandage made from chitosan, applied externally to a wound. This is consistent with a wound dressing or hemostatic device, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The HemCon™ Bandage OTC does not fit this description.
N/A
Intended Use / Indications for Use
The HemCon™ Bandage OTC Is indicated for the local management of bleading such as laceration and minor bleeding.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The HemCon™ Bandage OTC is manufactured from chilosan, a material consisting of callulosic polymer, poly-N-acetylgiucosamine. The HemCon™ Bandage OTC device is packaged in a foll package and are provided sterile. Performance data for the HemCon™ Bandage OTC has been previously submitted in the referenced device submission.
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
Over-The-Counter Use
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)
Performance data for the HemCon™ Bandage OTC has been previously submitted in the referenced device submission.
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.
HemCon™ Bandage, K023298, ProDeln™ Patch/ SyvekPatch®, K984177
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 shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized caduceus. The FDA logo is on the right and features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 11, 2023
HemCon, Inc. James F. Hensel President 10575 SW Cascade Avenue, Suite 130 Tigard, Oregon 97223
Re: K030946 Trade/Device Name: HemCon™ Bandage OTC 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 June 19, 2003. 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.
Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is the Assistant Director at DHT4B: Division of Infection Control and Plastic Surgery Devices. She also works at OHT4: Office of Surgical and Infection Control Devices. Her office is the Office of Product Evaluation and Quality, Center for Devices and Radiological Health. The signature block starts with "Sincerely,", followed by her name and title.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines curving upwards, resembling a stylized caduceus or a representation of human figures.
JUN 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James F. Hensel President HemCon, Inc. 10575 SW Cascade Avenue, Suite 130 Tigard, Oregon 97223
Re: K030946
Trade/Device Name: The HemCon™ Bandage OTC Regulatory Class: Unclassified Product Code: FRO Dated: March 25, 2003 Received: March 26, 2003
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), 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" (21CFR Part 807.97) you may obtain. 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
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
$\phi 3\phi 946
March 25, 2003
HemCon™ Bandage OTC 510(k) application HemCon™ Confidential
SECTION T - STATEMENT OF INDICATIONS FOR USE
INDICATIONS FOR USE
Applicant: HemCon, Inc.
510(K) Number (If known): Not Yot Assigned
Device Name: The HemCon™ Bandage OTC
The HemCon™ Bandage OTC is Intended to be available Over the Counter for the following Indication
Indications for Use:
The HemCon™ Bandage OTC Is indicated for the local management of bleading such as laceration and minor bleeding.
(PLEASE DO NOT WRITE BELOW THIS LINE- -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K630946
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Page 22 of 24 10575 SW Cascade Ave . #130 . Tigard, OR . 97223 . 503-245-0459
4
KΦ3Φ946
March 25, 2003
HemCon™ Bandage OTC 510(k) application HemCon™ Confidential
SECTION P - 510(K) SUMMARY
JUN 1 9 2003
| Trade Name: | HemCon™ Bandage OTC |
|---|---|
| Device Class: | Class 1 |
| Classification Panel: | 878 - General and Plastic Surgery |
| Common Name: | Traumatic Wound Dressing |
| Classification Name: | Bandage, Liquid |
| Predicate Devices: | HemCon™ Bandage, HemCon, Inc |
| 510(K) # K023298 (by reference) | |
| ProDeln™ Patch/ SyvekPatch®, Marine Polymer Technologies | |
| 510(k) # K984177 | |
| 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: | March 25, 2003 |
The HemCon™ Bandage OTC is intended for the local management of bleeding such as laceration and minor bleeding. The HemCon™ Bandage OTC is manufactured from chilosan, a material consisting of callulosic polymer, poly-N-acetylgiucosamine. The HemCon™ Bandage OTC device is packaged in a foll package and are provided sterile. Performance data for the HemCon™ Bandage OTC has been previously submitted in the referenced device submission.
The HemCon™ Bandage OTC is similar to Marine Polymer Technologies' ProDein™ Patch in Intended use, Indications, material, performance, sterilization method of application. In summary, the HemCon™ Bandage OTC is expected to achieve the same safety and effectiveness as the predicate devices mentioned above. Predicate device companson tables are included in this submission.
10575 SW Cascade Ave = #130 = Tigard, OR . 97223 . 503-245-0459 Page 19 of 24