(35 days)
The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract.
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.
This document is a 510(k) Summary for a medical device (Rusch Suprapubic Tray). It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices.
This document does not contain information regarding acceptance criteria, device performance, study details (like sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text. The document focuses on regulatory submission for substantial equivalence rather than a detailed performance study.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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
§ 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.