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

Device Description

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

AI/ML Overview

This 510(k) premarket notification for "Sterile Saline for Catheter Care" from Baxter Healthcare Corporation is a re-classification of an existing device (Sterile Saline for Respiratory Therapy Solutions) with a new indication for use. As such, the submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data for device performance against specific acceptance criteria.

Therefore, the requested information components related to device performance studies (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) are not explicitly described or provided in the given document.

Here's how we can address the request based on the provided text, highlighting the absence of typical clinical study details:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified. This submission is for a re-purposed device, and performance criteria for the new indication are not explicitly defined or measured in a study within this document. The argument for safety and effectiveness relies on the device being identical to a previously cleared product for a different, but similar, use.
Reported Device Performance: Not reported. There are no performance metrics provided for the "Sterile Saline for Catheter Care" for its new indication because no new performance study was deemed necessary.

Performance Metric	Acceptance Criteria	Reported Device Performance
Not Applicable	Not Applicable	Not Applicable

2. Sample sized used for the test set and the data provenance

Sample Size: Not applicable. No new test set or clinical data for the "Sterile Saline for Catheter Care" is discussed.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. No ground truth for a test set was established as no new clinical study was conducted.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No test set was adjudicated.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This is a medical device (saline solution), not an AI algorithm.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance Study: No. This is not an algorithm; it's a physical medical device (saline solution).

7. The type of ground truth used

Type of Ground Truth: Not applicable. No new clinical ground truth was established for this submission. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set

Sample Size: Not applicable. This is not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Ground Truth Establishment: Not applicable.

Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets acceptance criteria, in this context, is the demonstration of substantial equivalence to a previously cleared predicate device.

Study Design: This was essentially a comparative analysis of the proposed device against a predicate device, focusing on technological characteristics and intended use. It is not a clinical performance study.
Key Argument: The core argument provided by Baxter Healthcare Corporation is:
- "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."
- "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."
Conclusion: The FDA agreed with this assessment, stating, "We have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." This determination implies that the safety and effectiveness for the new indication are considered equivalent to the predicate device, given the identical composition and container system. The "acceptance criteria" were therefore met by demonstrating this substantial equivalence rather than through new performance data.

Summary

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K974397

510(k) Premarket Notification Sterile Saline for Catheter Care

510(k) SUMMARY

FEB 1 0 1998

Submitted by:

Marcia Marconi Baxter Health care 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 Baxt :r Respiratory Therapy Solutions

Proposed Device Description:

Baxter Healthcare Corporation intends to manufacture and market Sterile Saline for Catheter Cares 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 "herapy Solutions, except for the labeling. The solution of normal saline and the conti iner-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 «f 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 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

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

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 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. 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Marconi

through 542 of the Act for devices under the Electronic chrough Jr. Or the not on other Federal laws or requlations.

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 diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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¥974397 510(k) Number: Not Available

Baxter Sterile Saline for Catheter Care Device Name:

Indication For Use:

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

Labrica Cascenite
(Division Sign Off)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 14 510(k) Number _

Prescription use ✓
(Per 21 CFR 801.139

NOV 17 1997 44

s:\510k\saline\cvshttloc.doc

Regulation Number and Section

§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a)
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).(b)
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.