(211 days)
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 OTC is intended for the local management of bleeding such as laceration and minor bleeding.
The HemCon® Bandage and the HemCon® Bandage OTC are each 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 and the HemCon® Bandage OTC are manufactured from chitosan, a material consisting of cellulosic polymer, poly[ß(1->4)-2-amino-2-deoxy-D-dlucopyranose]. These devices are packaged in a foil package and provided sterile. They are sterilized by gamma irradiation at a dose adequate to ensure a SAL of 10 %.
This document is a 510(k) summary for the HemCon® Bandage and HemCon® Bandage OTC. It refers to previous submissions for performance data and states that the current devices are identical to predicate devices in intended use, material, performance, sterilization method, and method of application. This means a new study specifically for this 510(k) submission was not required as equivalence was based on prior data and minor modifications.
Therefore, many of the requested details about a new study (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new study) are not applicable to this specific 510(k) submission.
However, I can extract information regarding acceptance criteria and reported performance from the provided text, as well as details about the previous studies that established equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance (from predicate device data) |
|---|---|---|
| Hemostasis | Achieve hemostasis for severely bleeding wounds (emergency use). | HemCon® Bandage: Controls severely bleeding wounds. Controls bleeding in patients following hemodialysis. |
| Hemostasis | Achieve hemostasis for local management of laceration and minor bleeding. | HemCon® Bandage OTC: Controls bleeding in laceration and minor bleeding. |
| Antibacterial | Demonstrate antibacterial properties. | HemCon® Bandage & OTC: Demonstrated antibacterial barriers by AATCC Test Method 100-2004 with Staphylococcus aureus and Klebsiella pneumonia. |
| Biocompatibility | Be biocompatible. | HemCon® Bandage & OTC: Complete biocompatibility data presented in referenced predicate device submissions. |
| Sterility | Achieve sterility with a SAL of 10^-6. | HemCon® Bandage & OTC: Sterilized by gamma irradiation at a dose adequate to ensure a SAL of 10^-6. Validation study conducted according to ISO 11137, Method IIB. |
| Safety & Effectiveness | Equivalent to predicate devices. | HemCon® Bandage & OTC: Expected to achieve the same safety and effectiveness as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This 510(k) submission states, "Performance data for the HemCon® Bandage and the HemCon® Bandage OTC have been previously submitted in the referenced predicate device submissions."
Therefore, for this specific submission K043050, a new test set was not used. The data provenance and sample sizes would be found in the predicate submissions (K023298 for HemCon® Bandage and K030946 for HemCon® Bandage OTC), which are not provided in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this 510(k) submission, as it relies on previously submitted data.
4. Adjudication Method for the Test Set
Not applicable for this 510(k) submission, as it relies on previously submitted data.
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
Not applicable. This device is a hemostatic bandage, not an AI-powered diagnostic device involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Based on the description of the device (hemostatic bandage), the ground truth for performance in the predicate device studies would likely involve:
- Clinical outcomes data: Direct observation of hemostasis (cessation of bleeding) in human or animal subjects for the hemostatic claims.
- Laboratory test results: For antibacterial properties (AATCC Test Method 100-2004) and biocompatibility.
- Sterilization validation data: For sterility claims (ISO 11137).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
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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. John W. Morgan President and CEO 10575 SW Cascade Avenue, Suite 130 Tigard, Oregon 97223-4363
Re: K043050 Trade/Device Name: HemCon® Bandage and HemCon® Bandage OTC Regulatory Class: Unclassified Product Code: QSY
Dear John W. Morgan:
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 13, 2005. 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 end of a formal letter. The letter is signed by Julie A. Morabito, Ph.D., who is the Assistant Director at DHT4B: Division of Infection Control and Plastic Surgery Devices. The letter also mentions OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.
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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
F w d and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2005
Mr. John W. Morgan President and CEO HemCon Incorporated 10575 SW Cascade Avenue, Suite 130 Tigard, Oregon 97223-4363
Re: K043050
Trade/Device Name: HemCon® Bandage and HemCon® Bandage OTC Regulatory Class: Unclassified Product Code: FRO Dated: April 8, 2005 Received: April 11, 2005
Dear Mr. Morgan:
This letter corrects our June 3,2005 substantially equivalent letter.
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. John W. Morgan
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 (240) 276-0115 . 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 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/industry/support/index.html.
Sincerely yours,
0 Miriam C. Provost, Ph.D. Acting Director /0 Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE Applicant: HemCon, Inc. 510(K) Number (if known): K043050 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 bleeding 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)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Num: / K043056
Prescription Use (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use ×
(Optional Format 1-2-96)
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INDICATIONS FOR USE Applicant: HemCon, Inc. 510(K) Number (if known): K043050 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)
Erika Munoz
Revision Sign-Off
ivision Sign-Off) Civision of General, Restorative and Neurological Devices
Number K047050
Prescription Use X
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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JUN 3 - 2005
510(k) SUMMARY
Ko4 3050
| Trade Name: | HemCon® BandageHemCon® Bandage OTC |
|---|---|
| Device Class: | Class 1 |
| Classification Panel: | 878 - General and Plastic Surgery |
| Common Name: | Traumatic Wound Dressing |
| Classification Name: | Dressing |
| Predicate Devices: | HemCon® Bandage510(k) # K023298HemCon® Bandage OTC510(k) # K030946 |
| Submitted by: | John W. Morgan, President & CEO |
| Company Name: | HemCon, Inc. |
| Company Address: | 10575 SW Cascade Ave., Suite 130Tigard, OR 97223 |
| Company Telephone: | 503-245-0459 |
| Company Fax: | 503-245-1326 |
| Approval Date: | 01 October 2004 (Updated 11 May 2005) |
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 OTC is intended for the local management of bleeding such as laceration and minor bleeding. Performance data for the HemCon® Bandage and the HemCon® Bandage OTC have been previously submitted in the referenced predicate device submissions. The HemCon® Bandage and the HemCon® Bandage OTC are antibacterial barriers as demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the American Association of Textile Chemist and Colorists) in laboratory testing with Staphylococcus aureus and Klebsiella pneumonia.
The HemCon® Bandage and the HemCon® Bandage OTC are each applied to the wound and held in place until it adheres to the wound and hemostasis is
HemCon, Inc. K043050 510(k) Summary Page 1 of 2
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K043050
page 2 of 2
achieved. Then, an outer bandage is applied to secure the dressing on the wound site.
The HemCon® Bandage and the HemCon® Bandage OTC are manufactured from chitosan, a material consisting of cellulosic polymer, poly[ß(1->4)-2-amino-2-deoxy-D-dlucopyranose]. Several biomedical applications of chitosan have already been reported. Chitosan has many advantages due to its absence of toxicity and biodegradability without damaging the environment. It is a biocompatible material that breaks down slowly into a harmless product, alucosamine, which is absorbed completely by the body. Complete biocompatibility data is presented in the referenced predicate devices submissions.
These devices are packaged in a foil package and provided sterile. They are sterilized by gamma irradiation at a dose adequate to ensure a SAL of 10 %. The validation study conducted according to ISO 11137, Method IIB is on file at HemCon.
The HemCon® Bandage and HemCon Bandage OTC are identical to the HemCon® Bandage and HemCon® Bandage OTC in intended use, material, performance, sterilization method, and method of application and are expected to achieve the same safety and effectiveness as the predicate devices mentioned above while providing additional antibacterial barrier properties.
HemCon. Inc. K043050 510(k) Summary Page 2 of 2
N/A