(81 days)
Not Found
Not Found
No
The device is a sterile saline solution for flushing catheters, and the summary contains no mention of AI, ML, or any related technologies.
No
The device is described as "Sterile Saline for Catheter Care," intended for flushing and cleaning catheters, which are medical devices, not for directly treating a disease or condition in a patient.
No
Explanation: The device is described as "Sterile Saline for Catheter Care" intended for flushing and cleaning catheters. This is a maintenance or care product, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical product (Sterile Saline in 250 mL containers) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "flushing urinary drainage and suction catheters." This is a procedure performed in vivo (within the body) or on a medical device connected to the body, not on a sample taken from the body for diagnostic purposes.
- Device Description: The device is "Sterile Saline for Catheter Care." This is a solution used for flushing, not a reagent or instrument used to analyze a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health status
The device is a medical device used for the maintenance and care of catheters, which are medical devices themselves.
N/A
Intended Use / Indications for Use
Baxter Sterile Saline for Catheter Care is indicated for flushing or cleaning urinary drainage and suction catheters.
Product codes
JOL
Device Description
Baxter Healthcare Corporation intends to manufacture and market Sterile Saline for Catheter Cares in 250 mL containers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary drainage and suction catheters (flushing/cleaning)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Current Baxt :r Respiratory Therapy Solutions
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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
3
¥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