(78 days)
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Not Found
No
The description focuses on a material change in tubing and functional performance testing, with no mention of AI or ML.
No
This device is an irrigation set designed for delivering solutions to an irrigation site, which is a supportive function during medical procedures rather than directly providing a therapeutic effect itself.
No
Explanation: The device is an irrigation set designed for delivering irrigating solutions during medical procedures. It does not perform any diagnostic functions like detecting, monitoring, or identifying diseases or conditions.
No
The device description clearly outlines a physical medical device (irrigation sets with tubing) and a material change to a physical component (tubing segment). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of irrigating solutions to a specific site in the body (bladder, knee joint) during medical procedures. This is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description focuses on the physical components and function of the irrigation set for delivering fluid. It mentions a material change for safety reasons, which is related to the device's physical properties and patient interaction, not its ability to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for diagnosing a disease or condition. IVDs are specifically designed for in vitro examination of specimens derived from the human body.
Therefore, this device falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Baxter's line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transureurethral resection (TUR) and arthroscopic procedures.
Product codes
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Device Description
The subject of this submission is a material change in the distal tubing segment of the irrigation set from natural rubber latex to styrene ethylene butadiene styrene (SEBS). This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee joint. The change from latex to SEBS is being made to improve user safety by eliminating the potential for sensitivity reactions associated with natural rubber proteins.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bladder, knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The biological and chemical reactivity of the new SEBS material has been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.
Data regarding the functional performance of irrigation sets with the proposed SEBS tubing segment have been generated. Studies included kink testing, pull testing and pressure testing. Performance testing indicate that the proposed irrigation set meets or exceeds all functional requirements and support its suitability for use.
Key Metrics
Not Found
Predicate Device(s)
Current Baxter Irrigation Sets
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
960787
510(k) Premarket Notification Irrigation Sets
510(k) SUMMARY Irrigation Sets
MAY 1 4 1996
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
February 23, 1996
Proposed Device: Irrigation Sets with Modified Tubing Segment
Predicate Devices: Current Baxter Irrigation Sets
Proposed Device Description:
Baxter's line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures. The subject of this submission is a material change in the distal tubing segment of the irrigation set from natural rubber latex to styrene ethylene butadiene styrene (SEBS). This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee joint. The change from latex to SEBS is being made to improve user safety by eliminating the potential for sensitivity reactions associated with natural rubber proteins.
Summary of Technological Characteristics of New Device to Predicate Devices
The proposed irrigation sets are identical to current Baxter irrigation sets except for the material change from latex to SEBS in the tubing segment. The design and dimensions of the latex tubing segment will remain unchanged. Also, all other materials of the irrigation sets, as well as overall product design and intended use will remain unchanged.
50
1
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
The biological and chemical reactivity of the new SEBS material has been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.
Data regarding the functional performance of irrigation sets with the proposed SEBS tubing segment have been generated. Studies included kink testing, pull testing and pressure testing. Performance testing indicate that the proposed irrigation set meets or exceeds all functional requirements and support its suitability for use.
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