D-STAT DRY HEMOSTATIC BANDAGE

K061219 · Vascular Solutions, Inc. · QSX · Oct 6, 2006 · SU

Device Facts

• Record ID: K061219
• Device Name: D-STAT DRY HEMOSTATIC BANDAGE
• Applicant: Vascular Solutions, Inc.
• Product Code: QSX · SU
• Decision Date: Oct 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

D-Stat Dry Hemostatic Bandage is a topical hemostat used as an adjunct to manual compression. It consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose (CMC), and calcium chloride, integrated with an adhesive bandage. Applied by clinicians at vascular access sites following diagnostic endovascular procedures. Thrombin facilitates hemostasis via enzymatic conversion of fibrinogen to fibrin; CMC and calcium chloride support clot formation. The bandage provides a physical barrier to blood flow. Benefits include reduced time-to-hemostasis for patients.

Clinical Evidence

Prospective, randomized, non-significant risk clinical investigation conducted. Results demonstrated the device was safe and reduced time-to-hemostasis following diagnostic catheterization procedures in the intended patient population.

Technological Characteristics

Lyophilized pad containing thrombin, sodium carboxymethylcellulose (CMC), and calcium chloride; adhesive bandage. Mechanical hemostasis via physical barrier and enzymatic clotting cascade enhancement.

Indications for Use

Indicated for patients undergoing diagnostic endovascular procedures using 4-6 Fr. introducer sheaths to control surface bleeding from vascular access sites and percutaneous catheters/tubes and to reduce time-to-hemostasis.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• D-Stat Dry™ Dry Hemostatic (K030836)
• Syvek excel Vascular Access Hemostasis System (K053300)

Submission Summary (Full Text)

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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, [e-mail].

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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.

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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 [phone]. 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 [phone] or [phone] 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

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## Indications for Use Statement-D-Stat Dry™ Hemostatic Bandage

510(k) Number:

K061219

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

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Bhumma

sion Sign-Off) scular Devices Division of Cardlova 510(k) Number_

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K061219
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## 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.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369<br>USA | |
| Establishment Registration: | 2134812 | |
| Contact: | Linda Busklein<br>Regulatory Affairs Manager<br>[phone] phone<br>[phone] 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.

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## 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.