VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE

K033709 · Vascular Solutions, Inc. · QSX · Dec 18, 2003 · SU

Device Facts

• Record ID: K033709
• Device Name: VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
• Applicant: Vascular Solutions, Inc.
• Product Code: QSX · SU
• Decision Date: Dec 18, 2003
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

D-Stat 2 Dry Hemostatic Bandage is a topical hemostat consisting of a lyophilized pad (thrombin, sodium carboxymethylcellulose, calcium chloride) and an adhesive bandage. Used in clinical settings by healthcare professionals to manage bleeding at vascular access sites. Device functions by providing physical compression via the adhesive bandage while the lyophilized components create an environment for natural clot formation; thrombin enzymatically converts fibrinogen to fibrin to accelerate the clotting cascade. The device acts as a physical barrier to blood flow.

Clinical Evidence

No clinical evaluations of this product for this use have been conducted.

Technological Characteristics

Topical hemostatic bandage. Components: lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride; adhesive bandage. Mechanism: physical compression and enzymatic clotting cascade activation. No performance standards developed under section 514.

Indications for Use

Indicated for local management and control of bleeding from vascular access sites and percutaneous catheters and tubes in patients requiring hemostasis under the direction of a healthcare professional.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Vascular Solutions Inc., D-Stat Dry Hemostatic Bandage

Submission Summary (Full Text)

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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, [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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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.

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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 [phone]. 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 [phone] or [phone] 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

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#### 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<br>Product Code FRO |
| Manufacturer: | Vascular Solutions, Inc.<br>2495 Xenium Lane North<br>Minneapolis, Minnesota 55441 |
| Establishment Registration: | 2134812 |
| Contact: | Gregory W. Sachs<br>Director of Regulatory Affairs |
| Performance Standards: | No performance standards have been developed<br>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.

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# 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.