(52 days)
No
The description focuses on the material properties and intended use of a hemostatic dressing, with no mention of AI or ML.
Yes
The device is a hemostatic dressing intended for the control of bleeding from wounds and percutaneous sites, which is a therapeutic intervention.
No
The device description and intended use clearly state that it is a hemostatic dressing for controlling bleeding, not for diagnosing conditions.
No
The device description clearly states it is a "hemostatic chitosan dressing," which is a physical material, not software. The entire summary focuses on the physical properties and performance of a bandage.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The HemCon Bandage and ChitoFlex Surgical are described as hemostatic dressings applied externally to control bleeding from wounds on the skin. They are physical barriers and agents that promote clotting at the site of injury.
- Intended Use: The intended use is for the external, temporary control of bleeding from wounds and access sites. This is a direct application to the body's surface, not a test performed on a sample taken from the body.
Therefore, the function and intended use of these devices clearly fall outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- HemCon ChitoFlex™ Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries. The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
- The 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 dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
Product codes
QSY, FRO
Device Description
The HemCon dressings are a hemostatic chitosan dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the dressing also controls bleeding in patients following hemodialysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, femoral artery (implicitly, from catheter puncture sites)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Emergency use, surgical use, hemodialysis setting
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)
In vivo testing evaluated the efficacy of the Hemcon Bandage versus control to provide hemostasis in femoral artery catheter puncture sites. This data supports the effectiveness of the Hemcon Bandage in achieving hemostasis at percutaneous catheter sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HemCon Bandage (K043050), HemCon ChitoFlex-Surgical (K071519), ExcelArrest (K072900), Chito-Seal (K021062), Clo-Sur (plus) P.A.D. (K032986), Hemadern containging MPH (Microporous Polysaccharide Hemospheres) (K033666)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
HemCon Medical Technologies, Inc. c/o Kevin Hawkins Director, Quality and Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
Re: K080818
Trade/Device Name: HemCon Bandage; HemCon Bandage OTC; ChitoFlex-Surgical Regulatory Class: Unclassified Product Code: QSY
Dear Kevin Hawkins:
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 May 15, 2008. 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.
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
July 28, 2023
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 an emblem. The emblem is a stylized depiction of an eagle, with its wings forming three distinct, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 15 2008
HemCon Medical Technologies, Inc. % Mr. Kevin Hawkins Director, Quality and Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
Re: K080818 Trade/Device Name: HemCon Bandage ChitoFlex-Surgical Regulatory Class: Unclassified Product Code: FRO
Dated: April 28, 2008 Received: May 2, 2008
Dear Mr. Hawkins:
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. Kevin Hawkins
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 2. of 2
28 April 2008
Applicant: HemCon Medical Technologies, Inc.
510(k) Number (if known): Not Yet Assigned K080818
Device Name: ChitoFlex-Surgical
Indications for Use:
HemCon ChitoFlex™ Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries.
The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RPgh for
Division File 083 aka
Division of General. Restorative. and Neurological Devic
510(k) Number K090818
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Page 1 of 2
28 April 2008
1. SECTION 4- INDICATIONS FOR USE STATEMENT
Applicant: HemCon Medical Technologies, Inc. 510(k) Number (if known): Not Yet Assigned |