(55 days)
K-032986
Not Found
No
The summary describes a sterile topical pad for bleeding management and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the management of bleeding wounds and promotes the rapid control of bleeding, which constitutes a therapeutic action.
No
The device is described as a topical pad used for managing bleeding wounds, promoting rapid control of bleeding. Its function is therapeutic (to stop bleeding), not diagnostic (to identify or determine the nature of a disease or condition).
No
The device description clearly states it is a "sterile topical pad," indicating a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of bleeding wounds on the skin surface. This is a topical application for hemostasis, not for diagnosing a condition or analyzing a sample taken from the body.
- Device Description: It's described as a "sterile topical pad." This further reinforces its external application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. SoftSeal-STF does not fit this description.
N/A
Intended Use / Indications for Use
SoftSeal-STF is indicated for use in the management of bleeding wounds such as skin lacerations, vascular access sites, or percutaneous catheter or tube sites. SoftSeal promotes the rapid control of bleeding for patients on hemodialysis and patients on anticoagulation therapy.
The SoftSeal-STF pad made by Chitogen Inc. is intended for the local management of topical bleeding wounds, the rapid control of bleeding in patients following hemo-dialysis, or in patients on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, and the skin surface puncture sites resulting from vascular access procedures, percutaneous catheters or tubes.
Product codes (comma separated list FDA assigned to the subject device)
QSY, LYA, FRO
Device Description
SoftSeal-STF is a sterile topical pad, packaged in a foil pouch, and sterilized with gamma irradiation to a SAL of 10-6.
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.
K-032986
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 shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Chitogen, Inc. c/o Janna Bereuter Director, Clinical & Regulatory Affairs 7255 Ohms Lane Minneapolis, Minnesota 55439
July 28, 2023
Re: K090100 Trade/Device Name: SoftSeal-STF Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Janna Bereuter:
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 March 11, 2009. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. In the center of the seal is an image of an eagle.
MAR 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chitogen, Inc. % Ms. Janna Bereuter Director, Clinical and Regulatory Affairs 7255 Ohms Lane Minneapolis, Minnesota 55439
Re: K090100 Trade/Device Name: SoftSeal-STF Regulatory Class: Unclassified Product Code: FRO Dated: January 12, 2009 Received: January 29, 2009
Dear Ms. Bereuter:
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 - Ms. Janna Bereuter
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.
L.A. Ahmed. for.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K090100 510(k) Number (if known):
Device Name: SoftSeal-STF
Indications for Use:
SoftSeal-STF is indicated for use in the management of bleeding wounds such as skin lacerations, vascular access sites, or percutaneous catheter or tube sites. SoftSeal promotes the rapid control of bleeding for patients on hemodialysis and patients on anticoagulation therapy.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kraune for MXWM 3/10/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page _ of _
§510(k) Number K090100
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510(k) Summary
page 1/2
MAR 1 1 2009
| Submitted by: | Chitogen Inc.
7255 Ohms Lane
Minneapolis, MN 55439
Phone: (952) 229-8899
Fax: (952) 229-8898 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Janna Bereuter |
| Date Prepared: | 15 December 2008 |
| Proprietary Name: | Chitogen Inc. SoftSeal-STF |
| Common Name: | Topical Hemostasis Pad |
| Classification: | Unclassified |
| Classification Name: | Topical Wound Dressing Pad |
| Product Code: | FRO |
| Predicate Device: | Scion Cardio-Vascular Clo-Sur P.A.D K-032986 |
| Device Description: | SoftSeal-STF is a sterile topical pad, packaged in a foil pouch, and sterilized with gamma irradiation to a SAL of 10-6. |
| Intended Use: | The SoftSeal-STF pad made by Chitogen Inc. is intended for the local management of topical bleeding wounds, the rapid control of bleeding in patients following hemo-dialysis, or in patients on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, and the skin surface puncture sites resulting from vascular access procedures, percutaneous catheters or tubes. |
5
510(k) Summary
Technological Characteristics:
The Chitogen Inc., SoftSeal-STF pad is a non-woven pad made of a proprietary formulation of poly-D-glucosamine and poly-N- acety|glucosamine derived from chitosan. The natural biological property of this material gives the SoftSeal pad an advantage as an effective bacterial barrier while providing for an optimal wound-healing environment. Several biomedical applications of poly-D-glucosamine and poly-Nacetylglucosamine have been reported. The 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 requires common knowledge about the substance throughout the scientific community. This formulation has many useful and advantageous properties in their application as a wound dressing, namely biocompatibility, biodegradability, hemostatic activity, anti-infectional activity. The technological characteristics of the SoftSeal-STF pad are the same as the predicate device (Scion Cardio-Vascular, Inc., Clo-Sur PAD ). The Chitogen SoftSeal-STF pad works in the same manner as the approved predicate device.
KO90100