VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC

K040118 · Vascular Solutions, Inc. · QSX · Feb 12, 2004 · SU

Device Facts

• Record ID: K040118
• Device Name: VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC
• Applicant: Vascular Solutions, Inc.
• Product Code: QSX · SU
• Decision Date: Feb 12, 2004
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Vascular Solutions 1)-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and the 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 Dry Hemostatic Bandage family consists of lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride, integrated with adhesive bandage. Device applied by healthcare professional to vascular access sites or percutaneous catheter/tube sites. Hemostasis achieved via physical compression and chemical promotion of clotting cascade; thrombin enzymatically converts fibrinogen to fibrin to form physical barrier. Intended to manage bleeding post-procedure. Benefits include accelerated clot formation and localized bleeding control.

Clinical Evidence

No clinical data. No clinical evaluations were conducted for this submission.

Technological Characteristics

Lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride; adhesive bandage. Mechanical compression combined with chemical hemostatic agents. 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

• D-Stat Dry Hemostatic Bandage (K040118)
• D-Stat Radial Hemostatic Band (K030836)
• D-Stat 2 Dry Hemostatic Bandage (K033709)

Submission Summary (Full Text)

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February 10, 2023

Vascular Solutions, Inc. Gregory Sachs Director of Regulatory Affairs 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K040118

Trade/Device Name: Vascular Solutions D-Stat Dry Hemostatic Bandage, D-Stat Radial Hemostatic Band, D-Stat 2 Dry Hemostatic Bandage 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 February 12, 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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

FEB 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gregory W. Sachs Director of Regulatory Affairs Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K040118

Trade/Device Name: Vascular Solutions D-Stat Dry Hemostatic Bandage, D-Stat Radial Hemostatic Band, D-Stat 2 Dry Hemostatic Bandage

Regulatory Class: Unclassified Product Code: FRO Dated: January 16, 2004 Received: January 20, 2004

Dear Mr. Sachs:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications forchered address and he sure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to conninered pror to this 20, 1978, ac excerdance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic 710 (710) that the device, subject to the general controls provisions of the Act. The r on may, merore, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back as a same 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 docs 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 or any I 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 (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) I mis letter will anow you to begin finding of substantial equivalence of your device to a legally prematicated predicate device 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 If you desire 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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PAGE 3

#### Indications for Use

510(k) Number (if known): K040116

Device Name: Vascular Solutions D-Stat Dry™ Product Family [the D-Stat Dry Hemostatic Bandage, D-Stat Radial Hemostatic Band (K030836) and the D-Stat 2 Dry Hemostatic Bandage (K033709)] ......

Indications For Use:

.... 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.

AND/OR Prescription Use × (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)

Myriam C. Provost

Division of General, Restorative, and Neurological Devices

Page 1 of

**510(k) Number** K040118

January 16, 2004

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K040118 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<br>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 under section<br>514 for this device. |

### Device Description:

The D-Stat Dry Family Products consists of the following components:

- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride .
- Adhesive bandage .

These Products achieve their principal intended action (hemostasis) by creating a physical barrier to blood flow with 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 1)-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and the 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.

CONFIDENTIAL January 16, 2004

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K040118 Page 2/2

Special 510(k) Notification D-Stat Dry Product Family

# Summary of Clinical Testing:

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

## Predicate Devices:

Prodicate devices are the Vascular Solutions D-Stat Dry Product Family: D-Stat Dry Hemostatic Bandage, the ID-Stat Radial Hemostatic Band and the D-Stat 2 Dry Hemostatic Bandage.

#### Conclusions:

The D-Stat Dry Family Products, as noted above, 12-month testing results are acceptable, within product specification and substantiate an extension in product shelf life to 12 months.