VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP

K040730 · Vascular Solutions, Inc. · DXC · Jun 18, 2004 · Cardiovascular

Device Facts

• Record ID: K040730
• Device Name: VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
• Applicant: Vascular Solutions, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jun 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System (Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Pressure Products) compression devices or as a standalone device to assist in the control of bleeding following catheterization or cannulation procedures.

Device Story

D-Stat Clamp Accessory consists of lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride, secured to compressible foam pad and plastic base. Device functions as vascular clamp to achieve hemostasis via physical compression and enzymatic conversion of fibrinogen to fibrin. Designed for attachment to existing femoral access compression devices or for standalone use. Used in clinical settings following catheterization or cannulation procedures to assist in bleeding control. Benefits patient by facilitating faster hemostasis at access site.

Clinical Evidence

No clinical evaluations conducted. Bench testing only.

Technological Characteristics

Lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride; compressible foam pad; plastic base. Mechanical compression principle combined with chemical hemostatic agent. Standalone or accessory to femoral compression systems.

Indications for Use

Indicated for patients requiring control of bleeding following catheterization or cannulation procedures. Used in conjunction with compatible femoral artery compression devices or as a standalone device.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• D-Stat Dry Hemostatic Bandage (K030836)
• CompressAR (K002767)
• Femoral Artery Vascular Clamp (K964662)
• Femoral Artery Vascular Clamp (K973216)
• Femostop Compression System (K024107)

Submission Summary (Full Text)

{0}------------------------------------------------

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS K040730

| Common/Usual Name: | Topical Hemostat/Vascular Clamp |
|-----------------------------|------------------------------------------------------------------------------------|
| Product Trade Name: | D-Stat Clamp™ Accessory |
| Classification Name: | Vascular Clamp (21 CFR 870.4450) |
| Manufacturer: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah L. Neymark<br>Vice President, Regulatory Affairs |
| Performance Standards: | No performance standards have been developed under<br>section 514 for this device. |

#### Device Description:

The D-Stat Clamp Accessory consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose and calcium chloride secured to a compressible foam pad and plastic base. The device is designed for attachment to several commercially available femoral access compression devices or as a standalone device.

D-Stat Clamp achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow and facilitating wound compression. The thrombin contained in the lyophilized pad further facilitates hemostasis through enzymatic cleavage and conversion of fibrinogen to fibrin.

#### Intended Use:

The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System (Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Pressure Products) compression devices or as a standalone device to assist in the control of bleeding following catheterization or cannulation procedures.

#### Summary of Non-Clinical Testing:

No additional non-clinical testing of this product for this use was conducted as it represents a slight modification of an existing product.

#### Summary of Clinical Testing:

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

{1}------------------------------------------------

# KO40730 A2022

510(k) Summary of Safety and Effectiveness K040730 Page 2

#### Predicate Devices:

D-Stat Dry Hemostatic Bandage (K030836) CompressAR (K002767) Femoral Artery Vascular Clamp (K964662 and K973216) Femostop Compression System (K024107)

#### Conclusions:

The D-Stat Clamp is similar in design and function to the currently marketed D-Stat Dry Hemostatic Bandage, performs the same function as the disposable clamp components used richtostude Narrage, possed Artery Vascular Clamp devices, and incorporates a hemostatic material like the Femostop Compression System. It may therefore be considered as substantially equivalent to the identified predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a circular seal with text around the perimeter and a stylized eagle-like symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be a stylized representation of an eagle or bird in flight, with three curved lines forming the body and wings.

Public Health Service

JUN 1 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Ms. Deborah L. Neymark C/O MS. Deborair Driver Clinical Research and Quality Systems 6464 Sycamore Court Minneapolis, MN 55369

Re: K040730

D-Stat Clamp™ Accessory Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: May 4, 2004 Received: May 5, 2004

Dear Ms. Neymark:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaon 910(x) premier is substantially equivalent (for the indications ferenced above and nave acterimes ally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce provision of May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have occh recultion in asses approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen of controls provisions of the Act. The You may, increfore, market the as not include requirements for annual registration, listing of general controls provisions of the tice, 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 is classifical (soc above) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation PD may be subject to such additional connounce 27th 21, Parts 800 to 898. In addition, FDA may be found in the Oouveements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 -- Ms. Deborah L. Neymark

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that FDA s issualled of a basice complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that FDA has made a decemmation administered by other Federal agencies. You must of any Federal statutes and regulations danialities, but not limited to: registration and listing (21 comply with an the Act 3 requirements) necessor and acturing practice requirements as set CFK Part 807), fabeling (21 CFR Part 820); and If applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declems be r over device as described in your Section 510(k) I his letter will anow you to begin maxeming your and equivalence of your device to a legally premarket nothleadon. The PDA miding of casomically of 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 specific at no not your your 301) 594-4646. Additionally, for questions on the comact the Office of Comphanes and ice, please contact the Office of Compliance at promotion and advertising of your ass not the regulation entitled, "Misbranding by reference to ( 2017) 394-4039. Also, picase note me rogation. Other general information on your premarket notification - (21 OF IC and obtained from the Division of Small Manufacturers, Itsponsional and Consumer Assistance at its toll-free number [phone] or [phone] nternet and

Sincerely yours,

Duana R. Vochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): K040730

Device Name: Vascular Solutions D-Stat™ Clamp Accessory

Indications For Use:

The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System The D-Stat Claimp Accessory is multies Februar Clamp (Pressure Products)
(Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Alastiga following following (Advanced Vascular Dythanies) and the Penesa Price) = the control of bleeding following catheterization or cannulation procedures.

X Prescription Use (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)

Duna R- bochnes

Division
Division Vascular Device

510(k) number: K040730