(19 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the hemostatic pad and its ability to promote blood clotting, with no mention of AI or ML.
No
The device is described as a hemostatic pad and trauma dressing for temporary control of bleeding, which is a wound care treatment rather than a therapeutic intervention for a disease or condition. Its primary function is to aid in stopping bleeding.
No
The device is described as a hemostatic pad intended to control bleeding, not to diagnose a condition or disease.
No
The device description clearly states it is a lyophilized pad consisting of physical components (thrombin, sodium carboxymethylcellulose, and calcium chloride) and is applied topically. This indicates a physical medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary control of bleeding from wounds and vascular access sites. This is a therapeutic and topical application, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a topical pad containing components that facilitate blood clotting. It works by creating a physical barrier and enhancing the natural clotting process at the site of bleeding.
- Lack of IVD Characteristics: There is no mention of analyzing a sample (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor a treatment, or screen for a disease.
IVD devices are used to perform tests on samples to provide information about a person's health status. This device is applied directly to the body to control bleeding.
N/A
Intended Use / Indications for Use
The D-Stat Dry 3X3 is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
The Vascular Solutions D-Stat Dry 3x3 Hcmostatic Pad is intended to be a topical compression bandage for use under the direction of a healthcare professional and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Product codes
FRO, QSX
Device Description
The D-Stat Dry 3x3 Hemostatic Pad consists of a: Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride
The D-Stat Dry 3x3 Hemostatic Pad achieves its principal intended action (hemostasis) in the same manner as the other devices in the D-Stat Dry Product Family; it is applied directly over the source of bleeding therefore creating a physical barrier to blood flow through the application of adjunctive manual compression. 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
Not Found
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 clinical evaluations of this product for this use have been conducted.
Testing conducted included assessments of the physical properties of the lyophilized pad and packaging and the ability of the lyophilized components to achieve its intended use (clot blood). The results of this battery of tests confirmed the suitability of the D-Stat Dry 3x3 Hemostatic Pad for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Vascular Solutions Inc., D-Stat Dry Hemostatic Bandage, On Site Gas Systems, Inc., QuikClot, Marine Polymer Technologies, Inc. RDH Bandage
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). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is commonly used to indicate that a product or establishment is regulated by the FDA.
February 10, 2023
Vascular Solutions, Inc. Gregory Sachs Director of Regulatory Affairs 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K040510
Trade/Device Name: Vascular Solutions D-Stat - Dry™ 3x3 Hemostatic Pad Regulatory Class: Unclassified Product Code: QSX
Dear Gregory 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 March 17, 2004. 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Mr. Gregory W. Sachs Director of Regulatory Affairs Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K040510
Trade/Device Name: Vascular Solutions D-Stat -- Dry™ 3x3 Hemostatic pad Regulatory Class: Unclassified Product Code: FRO Dated: February 26, 2004 Received: February 27, 2004
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 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 (scc 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 equivalcnce 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,
Miriàm 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
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Indications for Use Statement
510(k) Number:
Device Name: Vascular Solutions I)-Stat-Dry™ 3x3 Hemostatic Pad
240510
Indications for Use:
The D-Stat Dry 3X3 is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page 1 of
February 26, 2004
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Common/Usual Name: | Topical Hemostat |
|---|---|
| Product Trade Name: | D-Stat Dry 3x3 Hemostatic Pad |
| Classification Namc: | Unclassified |
| Product Code FRO | |
| Manufacturer: | Vascular Solutions, Inc. |
| 6464 Sycamore Court | |
| Minneapolis, MN 55369 | |
| 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 Dry 3x3 Hemostatic Pad consists of a: Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride
The D-Stat Dry 3x3 Hemostatic Pad achieves its principal intended action (hemostasis) in the same manner as the other devices in the D-Stat Dry Product Family; it is applied directly over the source of bleeding therefore creating a physical barrier to blood flow through the application of adjunctive manual compression. 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 Dry 3x3 Hcmostatic Pad is intended to be a topical compression bandage for use under the direction of a healthcare professional and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Summary of Non-Clinical Testing:
Testing conducted included assessments of the physical properties of the lyophilized pad and packaging and the ability of the lyophilized components to achieve its intended use
5
(clot blood). The results of this battery of tests confirmed the suitability of the D-Stat Dry 3x3 Hemostatic Pad for its intended use.
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 Dry 3x3 Hemostatic Pad is a combination of the intended use of the:
- Vascular Solutions Inc., D-Stat Dry Hemostatic Bandage .
- On Site Gas Systems, Inc., QuikClot, .
- Marine Polymer Technologies, Inc. RDH Bandage .
Conclusions:
The D-Stat Dry 3x3 Hemostatic Pad is substantially equivalent to Vascular Solutions Inc., D-Stat Dry Hemostatic Bandage, the On Site Gas Systems QuikClot and the Marine Polymer Technologics, Inc. RDH Bandage. The testing performed confirms that the D-Stat Dry 3x3 Hemostatic Pad will perform as intended.