TERUMO LAUER LOCK ADAPTER

K093992 · Terumo Cardiovascular Systems Corporation · DTL · May 19, 2010 · Cardiovascular

Device Facts

• Record ID: K093992
• Device Name: TERUMO LAUER LOCK ADAPTER
• Applicant: Terumo Cardiovascular Systems Corporation
• Product Code: DTL · Cardiovascular
• Decision Date: May 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The adapters are single use, disposable components, intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. The devices may be used in procedures lasting up to 6 hours in duration.

Device Story

Single-use, disposable luer lock adapters; used to interconnect tubing and devices within cardiopulmonary bypass circuits. Features male or female luer lock connections on one end; barbed or internal slip-fit tubing connection points on the other. Tubing secured via bonding (cyclohexaprope) or tie-bands. Operated by clinicians during bypass procedures; provides leak-proof, disconnectable/reconnectable interface between circuit components. Benefits include secure, flexible circuit configuration during surgery.

Clinical Evidence

Bench testing only. Testing included dimensional stability, pre-connection, connection strength, circulation test, and pressure test. Biocompatibility evaluated per ISO 10993 for external communicating devices, circulating blood, limited exposure (≤ 24 hours).

Technological Characteristics

Single-use, disposable luer lock adapters. Materials: blood-contacting materials biocompatible per ISO 10993. Connection types: male/female luer lock, barbed, or internal slip-fit. Sterilization: Ethylene oxide (SAL 10^-6).

Indications for Use

Indicated for use in patients undergoing cardiopulmonary bypass procedures requiring interconnection of tubing and devices for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Luer Lock Adapters (K992906)

Submission Summary (Full Text)

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K093992

# () TERUMO

# Section 5 510(k) Summary

:

| | | Page |
|------------------------------------|-------------|------|
| Submitter Information | MAY 19 2010 | 22 |
| Device Names / Classification | : | 22 |
| Identification of Predicate Device | | 22 |
| Device Indications/Intended Uses | | · 22 |
| Device Description | | 23 |
| Performance Testing | | 23 |
| Additional Safety Information | | 23 |
| Conclusion for 510(k) Summary | | 24 |

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# TERUMO

## Submitter Information:

This submission was prepared in December 2009 by:

Eileen Dorsey Regulatory Affairs Specialist Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: [phone], Ext. 7406 Fax: [phone]

This submission was prepared for: Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Registration #1124841

## Device Names/Classifications:

Proprietary Name Terumo Luer Lock Adapters Classification Name Adapter, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Common Name Adapters

### Predicate Device(s):

The Terumo Luer Lock Adapters are substantially equivalent to following predicate Luer Lock Adapters (510(k): K992906) with respect to intended use, design,

| Corresponding New Terumo | Terumo Luer Lock | Predicate Description |
|--------------------------|------------------|------------------------------|
| Luer Lock Adapter Part # | Predicate Part # | |
| 0001-11302 | 0001-11301 | 1/8" Female Luer Adapter |
| 0001-12302 | 0001-12301 | 1/8" Male Luer Adapter |
| 0001-21302 | 0001-21301 | 3/16" Female Luer Adapter |
| 0001-22302 | 0001-22301 | 3/16" Male Luer Adapter |
| 0001-31302 | 0001-31012 | Threaded Female Luer Adapter |
| 0001-32302 | 0001-22301 | 3/16" Male Luer Adapter |
| 0001-71303 | 0001-71302 | Female Luer Lock Adapter |
| 0001-72303 | 0001-72302 | Male Luer Lock Adapter |

technology/principles of operation, materials and performance:

The differences between the devices do not raise any new issues of safety or effectiveness.

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# T TERUMO

## Device Indications/Intended Uses:

The adapters are single use, disposable components, intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. The devices may be used in procedures lasting up to 6 hours in duration.

### Device Description:

The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. For use up to six hours.

One end of the luer lock adapter has a male or female luer lock connection which may be connected to any opposite luer fitting within the tubing pack. w The opposite side of the luer lock adapter has a tubing connection point which is barbed for the 1/8", 3/16" and 1/4" male and female adapters. The Pressure line luer adapters have an internal slip fit connection point for tubing.

The tubing connection points are generally bonded to tubing with the appropriate inner diameter (1/8", 3/16", %") or pressure line tubing using cyclohexaprope. In some cases, a tie-band is attached to the outside of the tubing connection to the luer lock adapter.

The luer fitting may be pre-connected to an opposite luer fitting within the cardiopulmonary bypass circuit by Terumo Cardiovascular Systems. The luer fitting may be connected by the end-user to either another opposite " 110 160 within the cardiopulmonary bypass circuit or to an external luer fitting.

The luer lock adapters provide a leak proof connection point between components and various lines within the circuit, with the ability for a user to easily disconnect and re-connect the adapters as needed to any other opposite standard luer fitting, The luer lock adapters can be disconnected and re-connected by hand.

#### Performance Testing:

The following tests were conducted in order to demonstrate the Terumo Luer Lock Adapters are substantially equivalent to the predicate devices.

- Dimensional Stability �
- Pre-connection ●
- . Connection Strength
- Circulation Test
- . Pressure Test

#### Additional Safety Information:

Sterilization conditions for the Terumo Luer Lock Adapters are validated to provide a Sterility Assurance Level (SAL) of 10 . Terumo further asserts that the ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution.

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Terumo maintains biocompatibility studies as recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contract Duration]. The blood contacting materials were found to be biocompatible.

### Conclusion:

Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the Terumo Luer Lock Adapters are substantially equivalent to the predicate Luer Lock Adapters. It is further concluded that any recognized differences noted during the assessments do not raise any new issues of patient/user safety or product effectiveness.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around a central emblem. The emblem depicts a stylized human figure with three faces in profile, suggesting a sense of community and care.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUL -8 2010

Terumo Cardiovascular Systems Corporation c/o Ms. Eileen Dorsey Regulatory Affairs Specialist 125 Blue Ball Rd. Elkton, MD 21921

K093992 Re: Terumo Luer Lock Adapter Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II (two) Product Code: DTL Dated: April 2, 2010 Received: April 5, 2010

Dear Ms. Dorsey:

This letter corrects our substantially equivalent letter of May 19, 2010.

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. Drug, 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 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. Eileen Dorsey

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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## · Section 4 Indications for Use

Unknown-at-time-of-submission-> K. 0 93992 510(k) Number (if known):

Device Name: Terumo Luer Lock Adapters

Indications for Use:

The Terumo Luer Lock Adapters are single use, disposable components, intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. The devices may be used in procedures lasting up to 6 hours in duration.

Prescription Use XX (Part 21 CFR 801 Subpart D)

OROver-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

~~~~~~~~~ R. ~~~~~~~~

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K093992