(63 days)
No
The 510(k) summary describes a topical dressing for wound management and does not mention any AI or ML components.
No.
The device is a topical dressing for managing bleeding wounds, which is a supportive function rather than a therapeutic one (i.e., it does not aim to cure or treat the underlying condition beyond managing symptoms).
No
The device is described as a topical dressing for managing bleeding wounds, indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "sterile chitosan based dressing," which is a physical, hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states it's a "topical dressing for local management of bleeding wounds." This describes a device applied externally to the body to control bleeding, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description reinforces that it's a "sterile chitosan based dressing intended for use as a topical dressing." Again, this points to an external application for wound management.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, the HemCon ChitoFilex™ Surgical is a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HemCon ChitoFilex™ Surgical is intended for use as a topical 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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The HemCon ChitoFlex™-Surgical Dressing is a sterile chitosan based dressing intended for use as a topical 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, donor sites, dermatalogical, etc.) and traumatic injuries.
The HemCon ChitoFlex™ Surgical Dressing is nearly identical to the legally marketed HemCon® Bandage (K043050, cleared June 3, 2005) in composition, design and processing; the chly major difference is the size and the modification of the intended use for temporary treatment of severely bleeding wounds such as surgical wounds. In this respect, the indications for use are identical to the Bloxx Rapid Clotting Agent (K061722, cleared August 2, 2006).
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
Not Found
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)
Not Found
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
HemCon, Medical Technologies, Inc. c/o Kevin Hawkins Director, Quality & Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
June 11, 2023
Re: K071519 Trade/Device Name: HemCon ChitoFlex™ -Surgical Dressing 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 August 6, 2007. 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. It also lists OHT4: Office of Surgical and Infection Control Devices. The signature block concludes with Office of Product Evaluation and Quality Center for Devices and Radiological Health.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three overlapping profiles, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HemCon Medical Technologies, Inc. % Mr. Kevin Hawkins Director, Quality & Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
AUG - 6 2007
Re: K071519
Trade/Device Name: HemCon ChitoFlex™ -Surgical Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 31, 2007 Received: June 5, 2007
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.
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
2
Page 2 - Mr. Kevin Hawkins
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
4. SECTION 4- INDICATIONS FOR USE STATEMENT
Applicant: HemCon, Inc.
510(k) Number (if known): Not Yet Assigned Device Name: HemCon ChitoFlex™-Surgical Dressing
Indications for Use:
HemCon ChitoFilex™ Surgical is intended for use as a topical 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.
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)
Mark N. Melkman
and Neurologi
510(k) Number K
Page of
(Posted November 13, 2003)
4
HemCon Medical Technologies, Inc. ChitoFlex™ Surgical™ 510(k)
Mav 31, 2007
AUG -6 2007
HemCon ChitoFlex™ -Surgical 510(k) Notification
5. 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 ChitoFlexTM-Surgical Dressing
Common Name: Traumatic Wound Dressing Classification Name: Dressing Product Code: FRO
Establishment Registration Number:
9053189
General Description:
The HemCon ChitoFlex™-Surgical Dressing is a sterile chitosan based dressing intended for use as a topical 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, donor sites, dermatalogical, etc.) and traumatic injuries.
The HemCon ChitoFlex™ Surgical Dressing is nearly identical to the legally marketed HemCon® Bandage (K043050, cleared June 3, 2005) in composition, design and processing; the chly major difference is the size and the modification of the intended use for temporary treatment of severely bleeding wounds such as surgical wounds. In this respect, the indications for use are identical to the Bloxx Rapid Clotting Agent (K061722, cleared August 2, 2006).
Indication for Use:
HemCon ChiteFlex™ Surgical is intended for use as a topical 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, donor sites, dermatalogical, etc.) and traumatic injuries.
Contact Person(s) and Phone Number: Kevin Hawkins Director - Quality & Regulatory Phone (503)245.0459 x114 Fax (503)245.1326