LUER ACCESS INJECTION SITE

K984060 · Baxter Healthcare Corp · FPA · Jul 26, 1999 · General Hospital

Device Facts

• Record ID: K984060
• Device Name: LUER ACCESS INJECTION SITE
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters e.g., syringes or sets, to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.

Device Story

Luer access injection site; stand-alone device or integrated into solution sets. Input: male luer adapters (syringes/sets). Operation: pre-slit synthetic polyisoprene septum opens upon insertion of male luer; reseals automatically upon removal. Output: needleless access to vascular path for fluid administration or blood sampling. Used in clinical settings; operated by healthcare professionals. Benefit: reduces needle-stick injuries and transmission of blood-borne pathogens.

Clinical Evidence

Bench testing only. Microbiological evaluations and functional performance testing conducted. Data indicate device meets or exceeds all functional and microbiological requirements.

Technological Characteristics

Materials: synthetic polyisoprene septum, polyester housing. Sensing/Actuation: mechanical, activated by male luer insertion. Form factor: injection port/site. Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for use with vascular access devices for fluid administration and blood sampling in patients requiring needleless access to the vascular path to reduce needle-stick injuries and blood-borne pathogen transmission.

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

• ICU Medical Inc. Clave™ Needleless Connector (K970855, K915571)

Submission Summary (Full Text)

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510(k) Premarket Notification Luer Access Injection Site

JUL 26 1999

510(k) Summary

K984060

. ...

## Luer Access Injection Site

### Submitted by:

Mary Ellen Snyder Senior Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rt. 120 and Wilson Road Round Lake, IL 60073

### Date Prepared:

November 12, 1998

### Proposed Device:

Luer Access Injection Site

#### Predicate Device:

ICU Medical Inc. Clave™ Needleless Connector

## Proposed Device Description:

The subject of this submission is a luer access injection site which will be marketed as a stand-alone device for use as a heparin lock and will also be incorporated into currently marketed solution sets. The proposed injection site consists of a pre-slit synthetic polyisoprene septum and a polyester housing.

#### Statement of Intended Use

The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters e.g., syringes or sets, to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.

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### Summary of Technological Characteristics of New Device to Predicate Devices

The proposed luer access injection site is similar to the currently marketed ICU Medical Inc. Clave" Needleless Connector, cleared under K970855 and K915571. Both devices are injection ports activated by male luer connectors to allow needleless access to the fluid or vascular path. One key difference between the proposed luer access injection site and the Clave" Connector is the method of operation. The proposed injection site contains a preslit septum which is opened with insertion of a male luer adapter. The septum reseals when the male luer is removed. The Clave™ Connector contains a silicone seal which is depressed, with insertion of the male luer, below the openings of an internal plastic conduit, permitting fluid flow. With disconnection of the silicone seal springs back above the conduit, resealing it and stopping fluid flow. There are no new materials involved in the proposed device. All solution contact materials to be used in the proposed device are identical to materials used in legally marketed devices under comparable conditions of use.

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

Performance testing of the proposed luer access injection site has been conducted including microbiological evaluations. A description of the testing along with test results has been provided. All data indicate that the proposed device meets or exceeds all functional and microbiological requirements and thus support its suitability for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 1999

Ms. Mary Ellen Snyder Senior Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073-0490

Re: K984060 Luer Access Injection Site Trade Name: Requlatory Class: II Product Code: FPA Dated: June 23, 1999 Received: June 24, 1999

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 against 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Snyder

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 regulations.

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 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 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 ene 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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# Indication for Use

510(k) Number: Not Available

Device Name: Luer Access Injection Site

Indication for Use: The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters, (e.g., syringes or sets) to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.

Verl Huband for Pat Cincinti

Prescription Use.
(Per 21 CFR 801. 109)

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