(37 days)
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No
The device description and performance studies focus on the mechanical and material properties of a suprapubic catheter, with no mention of AI or ML.
No
The device is used for drainage and irrigation, which are functional purposes rather than therapeutic in nature. The term "therapeutic device" usually implies a device that treats a disease or condition, which is not the primary function described for this catheter.
No
The device is described as a suprapubic catheter intended for urinary bladder drainage or irrigation, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it consists of physical components like catheters and accessories, and performance studies include biocompatibility and functional/mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a procedure performed directly on the patient's body for therapeutic purposes (drainage and irrigation).
- Device Description: The device is a catheter designed for insertion into the body.
- Lack of In Vitro Testing: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not perform any such testing on specimens.
The device is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Kendall CURITY Suprapubic Catheter Trays and kits are intended to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a useful method of controlling urinary bladder drainage postoperatively.
Product codes
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Device Description
The Kendall Suprapubic Catheter Trays and Kits are sterile, single use devices which are designed to provide suprapubic access to the bladder for bladder irrigation and urine drainage. The proposed device consists of 100% silicone suprapubic catheters in 10, 12 and 14 French sizes packaged with various accessories.
The catheters are two-way balloon catheters having a drainage and inflation lumen.
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
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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
Biocompatibility testing was performed on the catheter following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.
Functional/Mechanical testing was performed to determine flow rates, balloon burst volume, valve retention, funnel/shaft bond strength, static load, dynamic load, water loss and non-deflator test. Testing showed equivalence between the proposed catheter and commercially available suprapubic catheters.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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APR 23 1997
Exhibit 6
510(k) Summary
Kendall CURITY Suprapubic Catheter Trays and Kits
In accordance with section 513(I) of the SMDA and as described in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Kendali Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 Date: February 6, 1997
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- Contact Person
David A. Olson, Regulatory Affairs Telephone: (508) 261-8530
- Contact Person
-
- Name of the Device
Classification Name: Suprapubic Urological Catheter and Accessories
- Name of the Device
Common or Usual Name: Suprapubic Catheter
Proprietary Name: Kendall CURITY Suprapubic Catheter Travs and Kits
3. Statement of Substantial Equivalence
The Kendall CURITY Suprapubic Catheter Trays and Kits are substantially equivalent in intended use, design and function to the Kendall CURITY Suprapubic Drainage System, 510(k) No. K842899.
4. Description of Device
The Kendall Suprapubic Catheter Trays and Kits are sterile, single use devices which are designed to provide suprapubic access to the bladder for bladder irrigation and urine drainage. The proposed device consists of 100% silicone suprapubic catheters in 10, 12 and 14 French sizes packaged with various accessories.
The catheters are two-way balloon catheters having a drainage and inflation lumen.
1
K970969
2012
ട്. Device Intended Use
The Kendall CURITY Suprapubic Catheter Trays and kits are intended to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a useful method of controlling urinary bladder drainage postoperatively.
6. Product Comparison
The Kendall CURITY Suprapubic Catheter Trays and Kits is equivalent to the referenced predicate device in that they are fabricated from similar materials, have the same function, equivalent indications for use, and similar designs.
7. Nonclinical Testing
Biocompatibility testing was performed on the catheter following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.
Functional/Mechanical testing was performed to determine flow rates, balloon burst volume, valve retention, funnel/shaft bond strength, static load, dynamic load, water loss and non-deflator test. Testing showed equivalence between the proposed catheter and commercially available suprapubic catheters.