(158 days)
Not Found
No
The device description focuses on the physical and chemical properties of the bandage and its components to achieve hemostasis, with no mention of AI or ML.
Yes.
The device is used to control surface bleeding and reduce time-to-hemostasis, which are therapeutic actions.
No
The device is indicated for controlling surface bleeding and reducing time-to-hemostasis, not for diagnosing any condition.
No
The device description clearly outlines physical components (lyophilized pad, adhesive bandage) and a mechanism of action based on physical and biochemical interactions, not software processing.
Based on the provided information, the D-Stat Dry is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes, and reducing time-to-hemostasis. This is a therapeutic or hemostatic function, applied directly to the patient's body.
- Device Description: The device is a bandage with a pad containing components that interact with blood in situ (on the patient's body) to promote clotting.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes.
The D-Stat Dry is a topical hemostatic device applied to the patient's body to control bleeding, not a device used to analyze samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The D-Stat Dry is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths.
Product codes (comma separated list FDA assigned to the subject device)
QSX, DXC, FRO
Device Description
The D-Stat Dry Hemostatic Bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose (CMC) and calcium chloride
- · Adhesive bandage
The D-Stat Dry Hemostatic Bandage achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the 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
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)
A prospective, randomized, non-significant risk clinical investigation was conducted and provided r clinical evidence that use of the D-Stat Dry Hemostatic Bandage in the intended study population was safe and reduced the time-to-hemostasis following diagnostic catheterization procedures.
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 shows 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 a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
February 10, 2023
Vascular Solutions, Inc. c/o Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K061219
Trade/Device Name: D-Stat Dry Hemostatic Bandage Regulatory Class: Unclassified Product Code: QSX, DXC
Dear Julie Tapper:
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 October 6, 2006. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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, which is a symbol featuring a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 6 2006
Vascular Solutions, Inc. c/o Ms. Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K061219
Trade Name: D-Stat Dry Hemostatic Bandage accessory Regulation Number: 21 CFR 870.4450 and unclassified Regulation Name: Vascular Clamp, Topical Hemostat Regulatory Class: Class II Product Code: DXC. FRO Dated: September 28, 2006 Received: October 3, 2006
Dear Ms. Tapper:
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 Foond, Or vo 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, l'isting 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, EDA over publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Julie Tapper
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 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) 276-0120. Also, please note (24 creation over), pro-"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain 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) 633-2011 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bfimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement-D-Stat Dry™ Hemostatic Bandage
510(k) Number:
Device Name:
Vascular Solutions D-Stat Dry™ Hemostatic Bandage
Indications for Use:
The D-Stat Dry is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths.
Prescription Use x 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) Page 1 of 1
Bhumma
sion Sign-Off) scular Devices Division of Cardlova 510(k) Number_
4
K061219
Page 1 of 2
D-Stat Dry Hemostatic Bandage 510(k) Summary
| Common/Usual Name: | Topical Hemostat | |
|---|---|---|
| Product Trade Name: | D-Stat Dry™ Hemostatic Bandage | |
| Classification Name: | Unclassified | |
| Product Code: | DXC | OCT - 6 2000 |
| Manufacturer: | Vascular Solutions, Inc. | |
| 6464 Sycamore Court | ||
| Minneapolis, Minnesota 55369 | ||
| USA | ||
| Establishment Registration: | 2134812 | |
| Contact: | Linda Busklein | |
| Regulatory Affairs Manager | ||
| (763) 656-4217 phone | ||
| (763) 656-4250 fax |
Performance Standards:
No performance standards have been developed under section 514 for this device. Device Description:
The D-Stat Dry Hemostatic Bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose (CMC) and calcium chloride
- · Adhesive bandage
The D-Stat Dry Hemostatic Bandage achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the 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 D-Stat Dry is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths.
5
Summary of Non-Clinical Testing:
No non-clinical testing was conducted.
Summary of Clinical Testing:
A prospective, randomized, non-significant risk clinical investigation was conducted and provided r clinical evidence that use of the D-Stat Dry Hemostatic Bandage in the intended study population was safe and reduced the time-to-hemostasis following diagnostic catheterization procedures.
Predicate Devices:
D-Stat Dry™ Dry Hemostatic - K030836
Syvek excel Vascular Access Hemostasis System - K053300
Conclusions:
The D-Stat Dry™ Hemostatic Bandage is substantially equivalent to the D-Stat Dry™ Hemostatic Bandage, based on comparisons between the intended use, construction materials, and device dimensions.