(22 days)
Not Found
Not Found
No
The device description focuses on the physical and chemical properties of the bandage and its components to achieve hemostasis. There is no mention of AI, ML, or any computational processing of data.
Yes
The device is intended for the local management and control of bleeding, which is a therapeutic action. It actively contributes to hemostasis by creating a physical barrier and enhancing natural blood clotting.
No
The device description states its intended action is hemostasis (stopping bleeding) by creating a physical barrier and aiding clot formation, not diagnosing a condition.
No
The device description clearly outlines physical components (lyophilized pad, adhesive bandage) and their physical mechanisms of action (physical barrier, compression, enzymatic cleavage). There is no mention of software as a component or its role in the device's function.
Based on the provided information, the Vascular Solutions D-Stat 2 Dry Hemostatic Bandage is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local management and control of bleeding from vascular access sites and percutaneous catheters and tubes." This is a direct therapeutic application on the patient's body to stop bleeding.
- Mechanism of Action: The device works by creating a physical barrier and enhancing the natural clotting process at the site of bleeding. It does not involve testing or analyzing samples of blood or other bodily fluids outside the body to diagnose a condition or provide information about a patient's health status.
- Device Description: The components and their function are described in terms of their role in forming a physical barrier and promoting clotting in situ.
- Lack of IVD Characteristics: The description does not mention any analysis of samples, diagnostic purposes, or any of the typical characteristics of an IVD device (e.g., reagents for testing, instruments for analysis of samples).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The D-Stat 2 Dry Hemostatic Bandage is a topical hemostatic device used directly on the patient's body to control bleeding.
N/A
Intended Use / Indications for Use
The Vascular Solutions D-Stat 2 Dry Hemostatic Bandage is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.
Product codes
QSX, FRO
Device Description
The D-Stat 2 Dry hemostatic bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and . calcium chloride
- Adhesive bandage .
The D-Stat 2 Dry hemostatic bandage achieves their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the adhesive bandage. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment, in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access sites and percutaneous catheters and tubes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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
No additional non-clinical testing of this product for this use was conducted.
No clinical evaluations of this product for this use have been conducted.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 10, 2023
Vascular Solutions, Inc. Gregory W. Sachs Director of Regulatory Affairs 2495 Xenium Lane North Minneapolis, Minnesota 55441-3625
Re: K033709
Trade/Device Name: Vascular Solutions D-Stat 2 Dry™ Hemostatic Bandage Regulatory Class: Unclassified Product Code: QSX
Dear Gregory W. Sachs:
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 December 18, 2003. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSX.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wavy lines representing its body and wings.
Public Health Service
DEC 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gregory W. Sachs Director of Regulatory Affairs Vascular Solutions, Inc. 2495 Xenium Lane North Minneapolis, Minnesota 55441
Re: K033709
Trade/Device Name: Vascular Solutions D-Stat 2 Dry™ Hemostatic Bandage Regulatory Class: Unclassified Product Code: FRO Dated: November 25, 2003 Received: November 28, 2003
Dear Mr. Sachs:
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 10 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. Gregory W. Sachs
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 Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K033709 510(k) Number (if known): _
Device Name: Vascular Solutions D-Stat 2 Dry™ Hemostatic Bandage
Indications For Use:
The Vascular Solutions D-Stat 2 Dry Hemostatic Bandage is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Page 1 of of _________________________________________________________________________________________________________________________________________________________________
510(k) Number K033709
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K03 37 09
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Common/Usual Name: | Topical Hemostat |
|---|---|
| Product Trade Name: | D-Stat 2 Dry™ Hemostatic Bandage |
| Classification Name: | Unclassified |
| Product Code FRO | |
| Manufacturer: | Vascular Solutions, Inc. |
| 2495 Xenium Lane North | |
| Minneapolis, Minnesota 55441 | |
| Establishment Registration: | 2134812 |
| Contact: | Gregory W. Sachs |
| Director of Regulatory Affairs | |
| Performance Standards: | No performance standards have been developed |
| under section 514 for this device. |
Device Description:
The D-Stat 2 Dry hemostatic bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and . calcium chloride
- Adhesive bandage .
The D-Stat 2 Dry hemostatic bandage achieves their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the adhesive bandage. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment, in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
Intended Use:
The Vascular Solutions D-Stat 2 Dry Hemostatic Bandage is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.
Summary of Non-Clinical Testing:
No additional non-clinical testing of this product for this use was conducted.
5
Summary of Clinical Testing:
No clinical evaluations of this product for this use have been conducted.
Predicate Devices:
The intended use of the D-Stat 2 Dry Hemostatic Bandage is a subset of the intended use of the:
- · Vascular Solutions Inc., D-Stat Dry Hemostatic Bandage
Conclusions:
The D-Stat Dry 2 Hemostatic Bandage is substantially equivalent to Vascular Solutions Inc. D-Stat Dry Hemostatic Bandage.