STERILE SALINE FOR CATHETER CARE

K974397 · Baxter Healthcare Corp · JOL · Feb 10, 1998 · General Hospital

Device Facts

• Record ID: K974397
• Device Name: STERILE SALINE FOR CATHETER CARE
• Applicant: Baxter Healthcare Corp
• Product Code: JOL · General Hospital
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Baxter Sterile Saline for Catheter Care is indicated for flushing or cleaning urinary drainage and suction catheters.

Device Story

Sterile Saline for Catheter Care consists of normal saline solution provided in 250 mL containers. The device is used by healthcare professionals to flush or clean urinary drainage and suction catheters. It functions as a sterile irrigation solution to maintain catheter patency and hygiene. The device is identical in formulation and container-closure system to previously cleared Baxter Respiratory Therapy Solutions, with the submission representing a change in intended use/labeling.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Normal saline solution in 250 mL container-closure system. Identical to predicate Baxter Respiratory Therapy Solutions.

Indications for Use

Indicated for flushing or cleaning urinary drainage and suction catheters in patients requiring catheter maintenance.

Regulatory Classification

Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

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 § 880.9.

Predicate Devices

• Current Baxter Respiratory Therapy Solutions

Submission Summary (Full Text)

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K974397

510(k) Premarket Notification
Sterile Saline for Catheter Care

# 510(k) SUMMARY

FEB 10 1998

## Submitted by:

Marcia Marconi
Baxter Healthcare Corporation
I.V. Systems Division
Route 120 and Wilson Road
Round Lake, IL 60073

## Date Prepared:

November 17, 1997

## Proposed Device:

Sterile Saline for Catheter Care

## Predicate Device:

Current Baxter Respiratory Therapy Solutions

## Proposed Device Description:

Baxter Healthcare Corporation intends to manufacture and market Sterile Saline for Catheter Care in 250 mL containers.

## Indication for Use:

Sterile Saline for Catheter Care is intended for use in flushing urinary drainage and suction catheters.

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

The proposed Sterile Saline for Catheter Care is the same as existing Baxter Respiratory Therapy Solutions, except for the labeling. The solution of normal saline and the container-closure system are the same as those used in the existing Baxter Respiratory Therapy Solutions.

## Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

The subject of this submission is a change in the indication for a previously cleared medical device. There are no new issues of safety or effectiveness.

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NOV 17 1997

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 10 1998

Ms. Marcia Marconi
Vice President, Regulatory Affairs
Baxter Healthcare Corporation
I.V. Systems Division
Route 120 and Wilson Road
Round Lake, Illinois 60073-0490

Re: K974397
Trade Name: Sterile Saline for Catheter Care
Regulatory Class: II
Product Code: JOL
Dated: November 17, 1997
Received: November 21, 1997

Dear Ms. Marconi:

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 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 (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 requirement, as set forth in the Quality System Regulation (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 regulatory action. In addition, FDA may publish further 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

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Page 2 - Ms. Marconi

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 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
Sterile Saline for Catheter Care

510(k) Number: Not Available k974397

Device Name: Baxter Sterile Saline for Catheter Care

Indication For Use:

Baxter Sterile Saline for Catheter Care is indicated for flushing or cleaning urinary drainage and suction catheters.

*Tobacco Cigarette*
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number k974397

Prescription use ☑
(Per 21 CFR 801.139)

NOV 17 1997
44
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