(307 days)
K-090100, K-0309046
Not Found
No
The device description focuses on the material composition and physical properties of a topical pad for wound management. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is indicated for use in the management of minor topical bleeding wounds, which describes a therapeutic action.
No
The device description and intended use indicate it is a topical pad for managing minor bleeding, not for diagnosing conditions.
No
The device description clearly states it is a sterile topical pad composed of physical materials (chitosan fibers and polypropylene backing), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations." This describes a direct application to the body for a therapeutic purpose (stopping bleeding).
- Device Description: The device is a "sterile topical pad" applied externally.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are designed to perform tests in vitro (outside the body).
This device is a topical hemostatic dressing, which is a type of medical device used to control bleeding.
N/A
Intended Use / Indications for Use
SoftSeal-C is indicated for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations.
Product codes
OSY, FRO
Device Description
SoftSeal-C pad is a sterile topical pad, packed in a foil pouch, and sterilized with gamma irradiation to a 10-6 SAL. The SoftSeal-C pad is a non-woven pad composed of chitosan fibers attached to a thin polypropylene backing material. The SoftSeal-C is formed as a 1" by 1" square pad 0.4" thick. The soft, fleece-like pad consists of fine (5 to 20 micrometer) chitosan fibers spun from high molecular weight chitosan. The chitosan fleece is attached to a thin polypropylene backing, which provides dimensional support for fabricating and handling the soft fibers.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Chitogen SoftSeal-STF K-090100, HemCon Bandage-OTC K-0309046
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logos are displayed against a white background.
April 21, 2023
Chitogen, Incorporated James Drake 7255 Ohms Lane Minneapolis, Minnesota 55439
Re: K112864 Trade/Device Name: SoftSeal-C Regulatory Class: Unclassified Product Code: OSY
Dear James Drake:
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 2, 2012. 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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2 2012 AUG
Chitogen. Incorporated % Mr. James Drake 7255 Ohms Lane Minneapolis, Minnesota 55439
Re: K112864
Trade/Device Name: SoftSeal-C Regulatory Class: Unclassified Product Code: FRO Dated: June 14, 2012 Received: June 21, 2012
Dear Mr. Drake:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
2
Page 2 - Mr. James Drake
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours, 0 Mark N. Melkers
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K112864 Device Name: SoftSeal-C
Indications for Use:
SoftSeal-C is indicated for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use X_
AND/OR
(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)
Daniel Knaeper WM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112864
4
510K Summary
Submitted by:
Chitogen Inc 7255 Ohms Lane Minneapolis, MN 55439 Phone: (952) 835-5707 Fax: (952) 835-5040
Contact Person:
James F. Drake
SoftSeal-C
Unclassified
FRO
September 28, 2011
Topical Hemostasis Pad
Topical Wound Dressing Pad
Date Prepared:
Proprietary Name:
Common Name:
Classification:
Classification Name:
Product Code:
Predicate Devices:
Device Description:
SoftSeal-C pad is a sterile topical pad, packed in a foil pouch, and sterilized with gamma irradiation to a 10-6 SAL. The SoftSeal-C pad is a non-woven pad composed of chitosan fibers attached to a thin polypropylene backing material. The SoftSeal-C is formed as a 1" by 1" square pad 0.4" thick. The soft, fleece-like pad consists of fine (5 to 20 micrometer) chitosan fibers spun from high molecular weight chitosan. The chitosan fleece is attached to a thin polypropylene backing, which provides dimensional support for fabricating and handling the soft fibers.
Chitogen SoftSeal-STF K-090100, (by reference)
HemCon Bandage-OTC K-0309046
Intended Use:
The SoftSeal-C pad made by Chitogen Inc. is intended for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations.
5
K112864 Page 2/2
Technological Characteristics: The Chitogen Inc. SoftSeal-C pad is a non-woven pad made of a proprietary formulation of chitosan (poly-D-glucosamine and poly-N-acetylglucosamine). Several biomedical applications of chitosan have been reported. These studies represent research on the safety and use of these materials, published over a period of decades by scientists from around the world. This large body of scientific literature satisfies the requirement that a general recognition of safety is commonly accepted throughout the scientific community. For recent review articles, see for instance; "Hemostatic Agents Derived from Chitin and Chitosan," Hudson, et al, Journal of Macromolecular Science, Part C, Polymer Reviews 45:309-323, 2005, "Chitin and Chitosan: Functional Biopolymers from Marine Crustaceans" Kurita, K., Marine Biotechnology 5:203-226, 2006, "Chitins and Chitosans as Immunoadjuvants and Non-Allergenic Drug Carriers," Muzzarelli, R.A., Marine Drugs 8:292-312, 2010.
This formulation has many advantageous properties in applications as a wound dressing, such as biocompatibility and hemostatic activity.
The technological characteristics of the SoftSeal-C pad are the same as the predicate device (SoftSeal-STF and HemCon Bandage OTC). The Chitogen SoftSeal-C pad works in the same manner as the approved predicate device.