SWABSITE SWABBABLE VALVE, MODEL 245000

K002689 · Quest Medical, Inc. · FPA · Mar 6, 2001 · General Hospital

Device Facts

• Record ID: K002689
• Device Name: SWABSITE SWABBABLE VALVE, MODEL 245000
• Applicant: Quest Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The intended use for the Swabsite Swabbable Valve is to allow access to IV administration sets, medication vials. blood types, and solution bags with one convenient device without the use of needles or blunt cannulas.

Device Story

Swabsite Swabbable Valve is a needle-free valve for IV administration sets; enables medication addition to IV sets, medication vials, blood tubes, and solution bags without needles or blunt cannulas. Device features a silicone stem; closed position provides flat, smooth surface for cleaning; insertion of male luer connector (syringe or secondary line) pushes stem to open fluid path; removal of connector allows valve body to force stem shut, maintaining sealed fluid path. No cap required for sterility. Used in clinical settings by healthcare providers to manage IV access; benefits include needle-free safety and simplified fluid transfer.

Clinical Evidence

Bench testing only. Evidence includes performance testing, biocompatibility testing, and a microbial barrier challenge to demonstrate substantial equivalence.

Technological Characteristics

Needle-free valve; silicone stem mechanism; flat, smooth surface for cleaning; provides sealed fluid path when disconnected. No external cap required. Materials and design are similar to predicate K970485.

Indications for Use

Indicated for use as an IV administration set accessory to facilitate needleless luer connections to luer access devices such as syringes.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Smartsite Access Pin (K970485)

Submission Summary (Full Text)

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

K002689

## SWABSITE SWABBABLE VALVE 510(K) PREMARKET NOTIFICATION SUMMARY

1. SUMBITTER'S NAME:

Quest Medical, Inc. One Allentown Parkway Allen. Texas 75002 [phone] [phone] FAX

Proprietary Name: Swabsite

Intravascular Administration Set

Intravascular Administration Set

August 28, 2000

Swabbable Valve

Swabbable Valve

Doug Bryan QA Manager

DATE PREPARED:

CONTACT PERSON:

2. DEVICE NAME:

Common Names:

Classification Names:

3. PREDICATE DEVICE:

4. DEVICE DESCRIPTION:

INTENDED USE: 5.

I.V. Fluid Transfer Set Smartsite Access Pin, K970485 The Swabsite Swabbable Valve is a needle free valve that allows the user to add medication into IV sets without the use of a needle. When the valve is in the closed position it has a flat, smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve, the silicone

stem opens in the middle creating a fluid path. When the male connector is removed from the valve, the body of the valve forces the stem shut and maintains a sealed fluid path. A cap is not required to seal the valve or to maintain sterility.

The intended use for the Swabsite Swabbable Valve is to allow access to IV administration sets, medication vials. blood types, and solution bags with one

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

TECHNOLOGICAL 6. CHARACTERISTICS: convenient device without the use of needles or blunt cannulas.

The Swabsite Swabbable Valve allows needleless access to IV administration sets, medication vials, blood tubes, and solution bags. The technological characteristics of the device are similar to the Smartsite Access Pin (K970485) and raises no new questions of safety and effectiveness. Quest concludes that the SwabSite Swabbable Valve is substantially equivalent to current marketed devices.

## 7. NON-CLINICAL DATA:

The Swabsite Swabbable Valve has been shown to be substantially equivalent to the predicate device by non-clinical performance testing data. The testing involved performance testing, biocompatibility testing, and a microbial barrier challenge of the valves.

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

Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread.

MAR - 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Doug Bryan Mr. Doug Bryan
Plant Quality Assurance & Regulatory Affairs Manager Quest Medical, Incorporated One Allentown 75002 Allen, Texas

Re : K002689 Swabsite Swabbable Valve Trade Name: Regulatory Class: II Product Code: FPA February 7, 20001 Dated: February 8, 2001 Received:

Dear Mr. Bryan:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beceies. beve and we have determined the market the device referenced above the indications for device is substancially cquivalene ally marketed predicate use stated in the encrobare, or onmerce prior to May 28, 1976, devices marketed in theorbed al Device American or to the enactment date of the nassified in accordance with the devices that have been recrabblians of Cosmetic Act (Act) .
provisions of the Federal Food, Drug, and Cosm to the general provisions of the rederal rood, avay, subject to the general The general controls controls provisions of the Act. controls provibloms of include requirements for annual provisions of the Act incraac requirementiacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II If your device is crabbirled (boodsmarket Approval), it may Existing major be subject to such additional controls. be subject to sach addrois device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal kegularioner rrors termination assumes compliance with substantly equivalenceuring Practice requirements, as set the Current Sood handsusseem Regulation (QS) for Medical Forth In the Quarrey Byson (21 CFR Part 820) and that, beview. School QS inspections, the Food and Drug Chrough periodic go inspecify such assumptions. Failure to Adminiberation (GMP regulation may result in regulatory In addition, FDA may publish further announcements action. accron. I wour device in the Federal Register. Please note: concerning your device in and ification submission does

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

Page 2 - Mr. Bryan

not affect any obligation you might have under sections 531 not arrest any obs of for devices under the Electronic chrough 342 or on control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your in your device of your device to a legally marketed predicate device results in a classification for your markees problems, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use Statement

K002689

510(k) Number (if known)

Device Name

Quest Medical, Inc. Swabsite Swabbable Valve

Indications for Use

The SWABSITE injection port is an IV administration set accessory that allows needleless luer connections to luer access devices (syringes, etc.)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

Patino Cucente

(Division Sign-Off) Tivision of Dental, Infection Control, General Hospital Devices 1 100k) Number ---