DUAL LUER LOCK CAP

K981318 · Baxter Healthcare Corp · FPA · Apr 22, 1998 · General Hospital

Device Facts

• Record ID: K981318
• Device Name: DUAL LUER LOCK CAP
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Apr 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.

Device Story

Dual Luer Lock Cap; sterile replacement cap for male or female luer ports on medical devices (manifolds, stopcocks, sets). Integrated design with male luer lock on one end and female luer lock on other. Used in clinical settings to cover open luer ports after access. Device provides physical barrier to maintain sterility of port. No active components; manual operation by clinician.

Clinical Evidence

Bench testing only. Functional performance data provided to demonstrate that the cap meets or exceeds all functional requirements.

Technological Characteristics

Sterile, dual-ended luer lock cap (male/female). Materials identical to existing Baxter MultiPort Manifold port protectors. Mechanical design; no energy source; no software.

Indications for Use

Indicated for use as a protective cap for male or female luer ports on medical devices, including manifolds, stopcocks, and sets, to cover ports after access.

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

• Medex Male/Female Luer Lock Plug
• B. Braun Blue Cap Dual Function Lock Lock Plug
• Abbott Male/Female Sterile Cap

Reference Devices

• Baxter MultiPort Manifold

Submission Summary (Full Text)

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# K981318

## 510(k) SUMMARY

Dual Luer Lock Cap

#### Submitted by:

Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073

#### Date Prepared:

April 9, 1998

Proposed Device: Dual Luer Lock Cap

#### Predicate Device:

Medex Male/Female Luer Lock Plug B. Braun Blue Cap Dual Function Lock Lock Plug Abbott Male/Female Sterile Cap

## Proposed Device Description:

The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing port cap on a number of currently marketed Baxter devices such as sets, stopcocks and manifolds. It will also be sold individually as a replacement cap to cover an open luer port after it has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male luer lock connection on one end and a female luer lock connection on the other end.

#### Statement of Intended Use:

The Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.

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# Summary of Technological Characteristics of New Device to Predicate Devices

The proposed Dual Luer Lock Cap is similar in design characteristics to several other marketed sterile replacement caps which feature a dual male/female luer connection. These include the Medex Male/Female Luer Lock Plug, the B. Braun Blue Cap Dual Function Lock Lock Plug and the Abbott Male/Female Sterile Cap. It is also similar to the existing port cap on Baxter's MultiPort Manifold.

There are no new materials involved in the proposed device. It is comprised of the same material used to fabricate the current port protector on Baxter's marketed MultiPort Manifold.

## Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature

Data regarding the functional performance of the proposed Dual Luer Lock Cap have been generated. A description of the functional testing along with test results has been provided. The data indicate that the proposed cap meets or exceed all functional requirements and support its suitability for use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 22 1998

Ms. Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road 60073 Round Lake, Illinois

K981318 Re : Dual Luer Lock Cap Trade Name: Requlatory Class: II Product Code: FPA Dated: April 9, 1998 Received: April 10, 1998

Dear Ms. Snyder:

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 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 The general controls provisions of the Act 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. ਖੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Snyder

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as The FDA described in your 510 (k) premarket notification. 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 and additionally 809.10 for in vitro 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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### 510(k) Premarket Notification Dual Luer Lock Cap

Not Available 510(k) Number:

Dual Luer Lock Cap Device Name:

Indication for Use:

Baxter's Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.

Patricia Cuccenti
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Infection of

510(k) Number K981318

Prescription Use (Per 21 CFR 801.109)

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