(35 days)
Rüsch SupraFoley Suprapubic Introducer and Foley Catheter, Rüsch Simplastic Suprapubic Catheter, Microvasive Percutaneous Suprapubic Balloon Catheter Set, Cook Stamey Percutaneous Catheter Set, Rüsch Suprapubic Catheters
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No
The summary describes a purely mechanical device (catheter and introducer) with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is used for drainage, which is a therapeutic intervention to remove fluids from the body or urinary tract.
No
The device is a kit for percutaneous bladder drainage, which is a therapeutic procedure involving fluid drainage, not diagnosis. Its components (catheter, introducer, etc.) are used for direct intervention, not for gathering diagnostic information from the body.
No
The device description explicitly lists physical components like a silicone catheter, plastic introducer assembly, attachment tape, and an optional scalpel, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the device is used for "percutaneous bladder drainage and to drain fluids to and from the urinary tract." This is a procedure performed on the patient's body to manage fluids, not to analyze samples for diagnostic purposes.
- Components: The components (catheter, introducer, tape, scalpel) are all tools for a medical procedure, not for performing laboratory tests.
This device is a surgical or procedural device used for drainage, not an IVD.
N/A
Intended Use / Indications for Use
The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract.
Product codes
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Device Description
The kit consists of two major components: silicone catheter and plastic introducer assembly, along with attachment tape to fix the catheter to the skin, if required, and an optional scalpel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
bladder, urinary tract
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Rüsch SupraFoley Suprapubic Introducer and Foley Catheter, Rüsch Simplastic Suprapubic Catheter, Microvasive Percutaneous Suprapubic Balloon Catheter Set, Cook Stamey Percutaneous Catheter Set, Rüsch Suprapubic Catheters
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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.
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Image /page/0/Picture/0 description: The image shows the logo for Rusch International. The logo is black and white and features the word "Rusch" in a bold, stylized font. Below the word "Rusch" is the word "INTERNATIONAL" in a smaller font. Below that is the text "A Subsidiary of Teleflex Incorporated (USA)".
1970021
Pin 2
510(k) Summary
Tall Pines Park
FEB - 7 1997
- Submitter Name, Address, and Date of Submission:
Miss Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, NH 03452
Telephone: (603)532-7706
Contact: Same as above.
2. Names of the Device, Common, Proprietary(if Known), and Classification.
Classification Name: Suprapubic Catheter and Accessories
Common Name: Suprapubic Catheter Kit
Proprietary Name: Rusch Suprapubic Tray
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Rusch Suprapubic Tray is substantially equivalent in design and function to the Rüsch SupraFoley Suprapubic Introducer and Foley Catheter, Rüsch Simplastic Suprapubic Catheter, Microvasive Percutaneous Suprapubic Balloon Catheter Set, and the Cook Stamey Percutaneous Catheter Set and the Rüsch Suprapubic Catheters.
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Page 2
P2072
4. Description of the Device:
The kit consists of two major components: silicone catheter and plastic introducer assembly, along with attachment tape to fix the catheter to the skin, if required, and an optional scalpel. The kit is used for percutaneous bladder drainage. There are two types of silicone catheters. The first comes equip with one pair of drainage eyes. The second type of silicone catheter comes with six drainage eves arranged in a pigtail shape.
5. Intended Use of the Device:
The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract.
The usage of this product is identical to previous devices, which have the same technological characteristics.
6. Summary of Technological Characteristics:
The following technological characteristics are the same or equivalent as predicate devices:
The kit consists of introducer system for the catheter, which provides the pathway for percutaneous insertion. One introduced the introducer system is removed, the catheter remaining provides the conduit for fluid passage to and from the urinary tract.
sumsup