VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT

K033721 · Vascular Solutions, Inc. · FMF · Feb 13, 2004 · General Hospital

Device Facts

• Record ID: K033721
• Device Name: VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
• Applicant: Vascular Solutions, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Feb 13, 2004
• 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 subcutancous tissues for the purposes of tumescent local anesthesia.

Device Story

The Auto-Fill Syringe Kit is a fluid administration set used to deliver dilute lidocaine for tumescent local anesthesia. The device consists of a control syringe and a fluid administration set equipped with a check valve. It is intended for use by clinicians in a surgical or clinical setting. The check valve facilitates the repetitive injection process required for tumescent anesthesia. The device functions as a manual delivery system; it does not involve automated processing or electronic components. The clinician manually operates the syringe to introduce the anesthetic solution into the patient's subcutaneous tissues.

Clinical Evidence

Bench testing only. Testing was conducted to verify the integrity and strength of the bond used to attach the check valve to the tubing.

Technological Characteristics

The device consists of a control syringe and a fluid administration set with a check valve. It is a manual, non-powered fluid delivery system. No performance standards were developed under section 514.

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

• Disposable Coronary Control Syringe (Merit Medical Systems, Inc.)
• Merit Administration Set (Merit Medical Systems, Inc.)
• KMI Repetitive Injection kit (KMI Kolster Methods, Inc.)
• Fluid administration set (Merit Medical Systems, Inc.)

Submission Summary (Full Text)

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## K033721

:

| FEB 1 3 2004 | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(K) SUMMARY |
| Common/Usual Name: | Fluid Administration Set |
| Product Trade Name: | Auto Fill Syringe Kit |
| Classification Name: | Fluid Administration kit for use in General and Plastic<br>Surgery and in Dermatology<br>21 CFR 880.5440 (Product Code FPA) |
| Manufacturer: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, MN 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Sara L. Coon<br>Senior Regulatory Affairs Associate<br>[phone] phone<br>[phone] fax |
| Performance Standards: | No performance standards have been developed under<br>section 514 for this device. |
| Device Description: | The Auto Fill Syringe Kit consists of a control syringe and<br>fluid administration set with check valve. |
| Intended Use: | The Auto-Fill™ Syringe Kit is indicated for the<br>introduction of dilute lidocaine solutions into subcutancous<br>tissues for the purposes of tumescent local anesthesia. |
| Summary of Non-Clinical Testing: | Testing has been conducted to verify the integrity and<br>strength of the bond used to attach the check valve to the<br>tubing. |
| Predicate Devices: | The Disposable Coronary Control Syringe marketed by<br>Merit Medical Systems, Inc .; the Merit Administration Set<br>marketed by Merit Medical Systems, Inc.; the KMI<br>Repetitive Injection kit marketed by KMI Kolster Methods,<br>Inc .; fluid administration set, marketed by Merit Medical<br>Systems, Inc |
| Conclusions: | The Auto-Fill Syringe Kit is substantially equivalent to the<br>identified predicate devices based on a comparison of the<br>indications for use and the components supplied and the<br>technological characteristics of the supplied components. |

- Station Company of Children

.

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Public Health Service

FEB 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sara L. Coon Senior Regulatory Affairs Specialist Vascular Solutions 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K033721

Trade/Device Name: Vascular Solutions Auto-Fili™ Syringe Kit Regulation Number: 880.5860, 880.5440 Regulation Name: Piston Syringe Intravascular Administration Set Regulatory Class: II Product Code: FMF, FPA Dated: November 25, 2003 Received: November 26, 2003

Dear Ms. Coon:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, and 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 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.

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Page 2 - Ms. Coon

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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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

Simon Runner

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

510(k) Number (if known):

Device Name: Vascular Solutions 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 _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _

(21 CFR 807 Subpart C)

(IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Rumm

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control Dental Devices

510(k) Number: K033721

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