AUTO-FILL SYRINGE KIT, MODEL 7600

K063851 · Vascular Solutions, Inc. · FMF · Jan 26, 2007 · General Hospital

Device Facts

• Record ID: K063851
• Device Name: AUTO-FILL SYRINGE KIT, MODEL 7600
• Applicant: Vascular Solutions, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Auto-Fill® Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.

Device Story

Auto-Fill Syringe Kit is a disposable kit for delivering dilute lidocaine solutions into subcutaneous tissues for tumescent local anesthesia. The kit includes a 12cc control syringe, IV tubing with a spike, a dual check valve, a roller clamp, and an extension line (6" to 48"). The device functions by providing an extension tubing mechanism that allows the clinician to refill the 12cc syringe directly from an IV bag, eliminating the need for multiple reconnections to the solution container. It is intended for use by healthcare professionals in clinical settings.

Clinical Evidence

No clinical evaluations of this product have been performed. Bench testing was conducted to verify static and dynamic pressure capabilities of the extension tubing, and biocompatibility was demonstrated through testing performed by the original component manufacturers.

Technological Characteristics

Kit includes 12cc control syringe, IV tubing with spike, dual check valve, roller clamp, and extension line (6"-48"). Materials are biocompatible. Device is a manual fluid delivery system; no energy source or software.

Indications for Use

Indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for tumescent local anesthesia.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Auto-Fill™ Syringe Kit (K033721)
• IV Administration Set (DeRoyal/Codan USA)
• Angiographic Control Syringe (K920135)
• L.O.N. Pressure Monitoring Lines, CPC Lines, Administration (K853099)
• Multi-Ad Fluid Dispensing System (K792227)

Submission Summary (Full Text)

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463851(P.i 0.2)

JAN 26 2007

# 510(k) Summary

Vascular Solutions, Inc.

Minneapolis, MN 55369

6464 Sycamore Court

510(k) Number:_

Date Prepared December 27, 2006

# Submitter Information

Submitter's Name/ Address:

Establishment Registration 2134812

Contact Person:

Patrice Stromberg Sr. Regulatory Affairs Associate [phone] telephone [phone] fax [e-mail]

## Device Information

Trade Name: Classification Name: Product Codes: Regulations:

Auto-Fill® Syringe Kit Piston Syringe; Intravascular Administration Set FMF, FPA Class II, 880.5860, 880.5440

## Performance Standards

No performance standards applicable to this product have been developed under Section 514 of the Act.

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#### Predicate Device(s)

- Auto-Fill™ Syringe Kit marketed by Vascular Solutions, Inc. (K033721) �
- . IV Administration Set marketed by DeRoyal® (Codan USA) (pre-amendment device)
- Angiographic Control Syringe, marketed by DeRoyal, Inc. (CDI) (K920135) ◆
- L.O.N. Pressure Monitoring Lines, CPC Lines, Administration, marketed by . DeRoyal (CDI) (K853099)
- Multi-Ad Fluid Dispensing System, marketed by B. Braun Medical, K792227 .

#### Device Description

The Auto-Fill Syringe Kit contains disposable components that may be used to deliver dilute lidocaine solutions into subcutaneous tissues for the purposes of local anesthesia. The kit provides an extension tubing mechanism to conveniently refill a 12cc syringe from an IV bag eliminating the need for multiple reconnections to the solution container.

The kit contains the following items:

- 12cc Control Syringe .
- IV tubing with spike, dual check valve, and roller clamp .
- Extension line (various lengths ranging from 6" to 48") .

#### Intended Use/Indications for Use

The AutoFill® Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.

#### Summary of Non-Clinical Testing

Performance Testing: The static and dynamic pressure capabilities of the extension tubing for the Auto-Fill Syringe Kit were tested. The extension tubing met the specified design and performance requirements.

Biocompatibility Testing: The material in the components used to create the Auto-Fill Syringe Kit has been demonstrated to be biocompatible through biocompatibility testing performed by the original manufacturers.

#### Summary of Clinical Testing

No clinical evaluations of this product have been performed.

#### Statement of Equivalence

Through the data and information presented, Vascular Solutions considers the Auto-Fill® Syringe Kit to be substantially equivalent to the identified predicate devices based on a comparison of the indications for use and the technological characteristics of the supplied components.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patrice Stromberg Senior Regulatory Affairs Associate Vascular Solutions, Incorporated 6464 Sycamore Court North Minneapolis, Minnesota 55369

JAN 26 2007

Re: K063851

Trade/Device Name: Auto-Fill Syringe Kit, Model 7600 Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FPA Dated: December 27, 2006 Received: December 28, 2006

Dear Ms. Stromberg:

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, Or u 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 revire 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 Pegister.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean

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#### Page 2 - Ms. Stromberg

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 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/industry/support/index.html.

Sincerely yours.

Clues
Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known):

Device Name: Auto-Fill® Syringe Kit

Indications for Use:

The Auto-Fill® Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aina Bima

(Division Sign-Off) provision Olgh-Clif)
Division of Anesthesiology, General Hospital, and Cloin of Anesthesiology, Generiniestion Control, Dental Devices

510(k) Number:_ K463857