D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE

K030836 · Vascular Solutions, Inc. · QSX · Sep 17, 2003 · SU

Device Facts

• Record ID: K030836
• Device Name: D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE
• Applicant: Vascular Solutions, Inc.
• Product Code: QSX · SU
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band 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 Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band are topical hemostats; used for local management/control of bleeding at vascular access sites, percutaneous catheters, and tubes. Devices consist of lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. D-Stat Dry uses adhesive bandage; D-Stat Radial uses adjustable retention strap/collar. Principle of operation: physical barrier to blood flow via compression; lyophilized components create environment for natural clot formation. Thrombin enhances clotting cascade via enzymatic conversion of fibrinogen to fibrin. Used in clinical settings under direction of healthcare professional. Benefits include accelerated hemostasis at access sites.

Clinical Evidence

No clinical evaluations conducted. Evidence based on non-clinical bench testing, including physical property assessments, clotting efficacy of lyophilized components, and biocompatibility testing.

Technological Characteristics

Components: Lyophilized pad (thrombin, sodium carboxymethylcellulose, calcium chloride). D-Stat Dry: adhesive bandage. D-Stat Radial: adjustable retention strap, collar, non-woven gauze. Principle: Mechanical compression combined with chemical hemostatic agents. Non-electronic, non-implantable.

Indications for Use

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

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Vascular Solutions Inc., D-Stat Flowable Hemostat (K012293)
• TZ Medical Inc., EZ Band
• Gambro Healthcare, Hospal Tipstop (K982818)

Submission Summary (Full Text)

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February 10, 2023

Vascular Solutions, Inc. Deborah Jensen Vice President, Clinical and Quality Systems 907 South Lakewood AvenueBaltimore, Maryland 21224

Re: K030836

Trade/Device Name: Vascular Solutions D-Stat - Dry™ Hemostatic Bandage, D-Stat Radial™ Hemostatic Band Regulatory Class: Unclassified Product Code: QSX

Dear Deborah Jensen:

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 September 17, 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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ood and Drug Administras 200 Corporate Boulevard Rockville MD 20050

SEP 1 7 2003

Ms. Deborah Jensen Vice President, Clinical and Quality Systems Vascular Solutions. Inc. 6464 Sycamore Court Minneapolis. Minnesota 55369

Re: K030836

Trade/Device Name: Vascular Solutions D-Stat -- Dry™ Hemostatic Bandage and D-Stat Radial™ Hemostatic Band Regulatory Class: Unclassified Product Code: FRO Dated: June 20, 2003 Received: June 23, 2003

Dear Ms. Jensen:

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 (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 - Ms. Deborah Jensen

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,

Marle N. Millenn

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

K030836

Vascular Solutions D-Stat-Dry™ Hemostatic Bandage and D-Device Name: Stat Radial™ Hemostatic band

Indications for Use:

The Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band 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.

Mark N. Milkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030836

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# SEP 1 7 2003

K030836
Page 1/2

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Common/Usual Name: | Topical Hemostat |
|-----------------------------|------------------------------------------------------------------------------------|
| Product Trade Name: | D-Stat Dry™ Hemostatic Bandage<br>D-Stat Radial™ Hemostatic Band |
| Classification Name: | Unclassified<br>Product Code MHW |
| Manufacturer: | Vascular Solutions, Inc.<br>2495 Xenium Lane North<br>Minneapolis, Minnesota 55441 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah Jensen<br>VP Regulatory, Clinical and Quality Systems |
| Performance Standards: | No performance standards have been developed<br>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 and . calcium chloride
- Adhesive bandage ●

The D-Stat Radial hemostatic band consists of the following components:

- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and . calcium chloride in a non-woven gauze
- Application device consisting of an adjustable retention strap, collar and attached ● gauze pad

The D-Stat Dry hemostatic bandage and D-Stat Radial hemostatic band achieves their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by either the adhesive bandage or the retention band. The Iyophilized 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 Hemostatic Bandage and D-Stat Radial Hemostatic Band 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.

Confidential

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K030836
Page 2/2

#### Summary of Non-Clinical Testing:

Testing conducted included assessments of the physical properties of the lyobhilized pad, the ability of the lyophilized components to achieve its intended use (clot blood) and biocompatibility assessments. The results of this battery of tests confirmed the suitability of the D-Stat Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band 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 Hemostatic Bandage and D-Stat Radial Hemostatic Band is a subset of the intended use of the

- Vascular Solutions Inc., D-Stat Flowable Hemostat, K012293; product code ● MHW, unclassified.
- . TZ Medical Inc., EZ Band; product code MHW class I
- Gambro Healthcare, Hospal Tipstop, K982818 (cleared for market distribution on . October 21, 1998); product code KMF, Unclassified

#### Conclusions:

The D-Stat Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band is substantially equivalent to Vascular Solutions Inc., D-Stat Flowable Hemostat, TZ Medical Inc., EZ Band, and the Gambro Healthcare Hospal Tipstop. The testing performed confirms that the D-Stat Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band will perform as intended.