TERUMO VENOJECT,LUER ADAPTER

K983490 · Terumo Corp. · JKA · Nov 30, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983490
• Device Name: TERUMO VENOJECT,LUER ADAPTER
• Applicant: Terumo Corp.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

Device Story

Device acts as sterile conduit for blood specimen collection; connects hypodermic needles, catheters, or luer-fitted collection systems to collection containers. Consists of cannula joined to female hub with luer taper; cannula covered by synthetic isoprene rubber tip. Operation: manual; collection container pushed over cannula to retract rubber tip, allowing blood flow; removal of container allows rubber tip to reseal cannula, stopping flow. Used in clinical settings for phlebotomy; operated by healthcare professionals. No direct patient contact. Benefits include facilitating blood sample collection via single venipuncture.

Clinical Evidence

Bench testing only. Performance evaluated via cannula elasticity, cannula/barrel adherence, bending strength, visual inspection, dimensional analysis, and extraction testing. Sterility validated per ISO 11137 to SAL 10^-6.

Technological Characteristics

Sterile, single-use, non-invasive. Materials: stainless steel needle, polypropylene hub/cap, synthetic isoprene rubber tip, polypropylene/polyethylene case. Manual operation. Sterilization: Gamma radiation per ISO 11137.

Indications for Use

Indicated for use as a conduit for blood specimen collection from hypodermic needles, blood vessel catheters, or luer-fitted blood collection systems during venipuncture.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• B-D Vacutainer Luer Adapter (K931367)

Submission Summary (Full Text)

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NOV 30 1998

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

TERUMO® VENOJECT® Luer Adapter or similar Proprietary Device Name: proprietary name Classification Name: Blood Specimen Collection Device

#### INTENDED USE

The Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

## DESCRIPTION/SPECIFICATIONS

The Terumo Venoject Luer Adapter is a sterile, single use device consisting of a cannula joined to a female connector (hub) which is connected to a luer taper. The cannula is covered with a synthetic isoprene rubber tip for stopping blood flow. When blood is collected, the collection container is placed over the cannula, pushing the rubber tip back, allowing blood flow. When the collection container is removed, the rubber tip extends back over the cannula, stopping blood flow. The luer adapter has no direct patient contact.

## SUBSTANTIAL EQUIVALENCE

The Terumo Venoject Luer Adapter submitted in this 510k is substantially equivalent in intended use, design, principle of operation, and materials to the cleared B-D® Vacutainer® Luer Adapter which is the subject of K931367.

#### PRINCIPLE OF OPERATION/TECHNOLOGY

The Terumo Venoject Luer Adapter and the B-D Vacutainer Luer Adapter are both operated manually.

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## MATERIALS

| MATERIALS | PROPOSED | PREDICATE |
|------------|-----------------------------------|---------------------|
| Needle | Stainless Steel | Stainless Steel |
| Hub | Polypropylene | Polystyrene |
| Rubber Tip | Synthetic Isoprene Rubber | Dipped Latex Rubber |
| Cap | Polypropylene | Polypropylene |
| Case | Polypropylene and<br>polyethylene | Polyethylene |

## PERFORMANCE

The performance of the TERUMO® VENOJECT® Luer Adapter has been evaluated and the device performs according to specification.

The following tests were performed to evaluate the performance of the Terumo Venoject Luer Adapter submitted in this 510k:

- . Cannula elasticity
- Cannula/barrel adherence ●
- Bending strength .
- Visual .
- Dimensional .
- Extraction .

## ADDITIONAL SAFETY INFORMATION

The sterility of the product is assured using a sterilization method validated and qualified in accordance with the ISO 11137- "Sterilization of Healthcare Products Requirements for Validation and Routine Control - Radiation Sterilization" to a sterility assurance level (SAL) of 10-6.

Additionally each lot is monitored with calibrated Radics plastic dosimeters to determine the Gamma radiation dose delivered. Critical parameters, such as exposure time and dose delivery interruption are confirmed to comply with procedure.

Because this device does not come in direct contact with the patient, biocompatibility screening tests were performed. The results of these screening tests gave no indication that additional biocompatibility testing was necessary.

The expiration dating for the TERUMO® VENOJECT® Luer Adapter has been established to be 30 months.

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SECTION II: Summary of Safety and Effectiveness

# CONCLUSION

」、

The Terumo Venoject Luer Adapter submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation, and materials to the cleared B-D® Vacutainer® Luer Adapter which is the subject of K931367. Differences between the devices cited in this section are not significant and do not raise any new issues of safety or effectiveness.

| Date Prepared | September 30, 1998 |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Prepared by | Kristine Wagner<br>Regulatory Affairs Specialist |
| Prepared for | Terumo Medical Corporation<br>125 Blue Ball Road<br>Elkton, MD 21921<br>Phone [phone] or [phone]<br>Fax [phone] |

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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement and upward direction.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 30 1998

Kristine Wagner Regulatory Affairs Specialist TERUMO MEDICAL CORPORATION 125 Blue Ball Road Elkton, MD 21921

Re: K983490 Trade Name: TERUMO® VENOJECT® Luer Adapter Requlatory Class: II Product Code: 75 JKA September 30, 1998 Dated: Received: October 05, 1998

Dear Ms. Wagner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Drug, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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"(21 CFR 807.97). Other qeneral 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,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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R 983490 510(k) Number (if known):

TERUMO® VENOJECT® Luer Adapter Device Name:

## Indications For Use:

The Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
6983490

510(k) Number

Prescription Use J (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)