(82 days)
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No
The summary describes a standard urological catheter with a hydrogel coating for lubrication, with no mention of AI or ML technology.
No
A urological catheter, though used in the urinary tract, primarily functions for fluid management (passing fluids) and not directly for therapy or treatment of a disease. Its coating is for ease of insertion, not therapeutic action.
No
The device is described as a urological catheter used to pass fluids to or from the urinary tract, and its description focuses on its physical properties for insertion. There is no mention of it being used to detect, diagnose, treat, or prevent disease.
No
The device description clearly states it is a physical catheter, a tubular device inserted into the body, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to pass fluids to or from the urinary tract via insertion through the urethra. This is a direct interaction with the body for therapeutic or diagnostic purposes related to the urinary system, not for examining specimens in vitro (outside the body).
- Device Description: The description details a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (like urine, blood, etc.) in vitro, using reagents, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This catheter does not fit that description.
N/A
Intended Use / Indications for Use
This device is a urological catheter, which is a tubular device that is inserted through the urethra and is used to pass fluids to or from the urinary tract.
Product codes
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Device Description
The Rüsch SympaCath Hydrogel Coated Foley Catheter is a standard foley catheter, which has been coated with a coating known as hydrogel. The purpose of the coating is to make the catheter slippery on insertion, post activation with water.
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
urinary tract
Indicated Patient Age Range
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
Image /page/0/Picture/0 description: The image shows the logo for Rusch International. The logo is in black and white and features the word "Rusch" in a stylized font. Below the word "Rusch" is the word "INTERNATIONAL" in a smaller, sans-serif font. Below that, it says "A Subsidiary of Teleflex Incorporated (USA)".
P1022
510(k) Summary
Tall Pines Park ey, NH 03452 532-7706 FAX (603) 532-8211
1. Submitter Name, Address, and Date of Submission:
Miss Karenann J. Brozowski Group Requiatory Affairs Director Rüsch International Tall Pines Park Jaffrey, NH 03452
FEB - 4 1997
Telephone: (603)532-7706
Contact: Same as above.
2. Names of the Device, Common, Proprietary(if Known), and Classification.
Classification Name: Urological Catheter, Retention Type, Balloon
Proprietary Name: Rüsch SympaCath™ Hydrogel Coated Foley Catheter
Common Name: Foley Catheter
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Rusch International Hydrogel Coated Foley Catheter is equivalent to the Bard Biocath and Lubricath or the Curity Kendall Ultramer coated catheters.
4. Description of the Device:
The Rüsch SympaCath Hydrogel Coated Foley Catheter is a standard foley catheter, which has been coated with a coating known as hydrogel. The purpose of the coating is to make the catheter slippery on insertion, post activation with water.
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K9644575
P2072
5. Intended Use of the Device:
This device is a urological catheter, which is a tubular device that is inserted through the urethra and is used to pass fluids to or from the urinary tract.
6. Summary of Technological Characteristics:
The following technological characteristics are the same or equivalent as predicate devices:
The coating is added to a standard foley catheter.
The coating is activated with contact with water, making the catheter slippery to ease insertion.
The design, material construction and principals of operation for the SimpaCath Hydrogel Foley Catheters are the same as the competitors.
sumhcl