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.
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 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.
The provided text is a 510(k) Substantial Equivalence Determination letter and associated documents for the HemCon Bandage, HemCon Bandage OTC, and ChitoFlex-Surgical devices. It does not include information about acceptance criteria or a specific study proving the device meets those criteria, as it's primarily focused on demonstrating substantial equivalence to predicate devices for expanded indications for use.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from this document.
However, I can extract information related to the device's indications for use and the basis for its substantial equivalence. The document states:
"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."
This indicates that some in vivo testing was performed to support the effectiveness of the device for a specific new indication. However, it does not provide details on:
- Specific acceptance criteria used in that test.
- The exact study design (e.g., sample size, methodology, statistical analysis, full results).
- Details about the ground truth methods, experts, or training data for any AI component (as this is a medical device, not an AI/ML device in this context).
- Any multi-reader multi-case (MRMC) or standalone comparative effectiveness studies.
The document focuses on establishing substantial equivalence based on similar intended use, indications, and the fact that the majority of predicate devices are chitosan-based dressings. It lists several predicate devices, implying that their performance and safety data would have been considered during the initial clearance of those devices and serve as a basis for comparison.
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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
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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.
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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 |< 0808 | 8 Device Name: HemCon Bandage
Indications for Use:
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 bronding 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.
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)
Nil Re Q.L. for mson
Division Sign Off
Division of General, Restorative. and Neurological Devices
510(k) Number K080818
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K080818 Page 1 of
28 April 2008
HemCon 510(k) Notification
2. SECTION 5 - 510(K) SUMMARY
Name and Address of Sponsor:
Device Name:
HemCon Medical Technologies, Inc. 10575 SW Cascade Avenue, Suite 103 Portland, OR 97223
Proprietary Name: Hemcon Bandage: HemCon Bandage OTC; ChitoFlex-Surgical
Common Name: Wound Dressing Classification Name: Dressing Product Code: FRO
Establishment Registration Number:
9053189
General Description:
The HemCon Bandage and HemCon Bandage OTC were cleared in K043050 on June 3, 2005. Additionally, the Hemcon ChitoFlex-Surgical dressing was cleared in K071519 on August 6, 2007 for temporary surgical use. With this 510(k), the bandage remains unchanged; this application solely expands the indications for use.
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.
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. In addition, the Hemcon dressings are substantially equivalent to other legally marketed chitosan-based bandages with the same indications. With this 510(k) Hemcon is proposing to add the following indications to the Hemcon Bandage and ChitoFlex-Surgical dressing:
"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 predicate devices are indicated for use in control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. The HemCon Bandage is substantially equivalent to these predicate devices in that it has similar intended use and indications as well as the majority are chitosan-based dressings. The predicated devices include: HemCon Bandage (K043050, cleared June 3, 2005), HemCon ChitoFlex-Surgical (K071519, cleared August 6, 2007) Hemostas, LLC Corporation's ExcelArrest (K072900, cleared Oct. 26, 2007), Perclose/Abbott Labs' Chito-Seal (K021062, cleared Aug 23, 2002), Scion Cardio-Vascular, Inc's (Medtronic) Clo-Sur (plus) P.A.D. (K032986, cleared Mar 1, 2004) and Medafor, Inc.'s Hemadern containging MPH (Microporous Polysaccharide Hemospheres) (K033666, cleared Dec. 17, 2003).
MAY 1 5 2008
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ROSOSIS Page 2 of 2
28 April 2008
Indications for Use:
Indication Rx Hemcon Bandage: 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.
Indications Rx ChitoFlex-Surgical:
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.
Contact Person(s) and Phone Number:
Kevin Hawkins Director - Quality & Regulatory Phone (503)245.0459 x114 Fax (503)245.1326
N/A