(72 days)
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Not Found
No
The summary describes a physical medical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Explanation: The device is used for ureteral dilation, which is a therapeutic procedure to treat a medical condition (ureteral stricture or to facilitate stone manipulation/ureteroscopy).
No
The device description states its use is for "ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter," which are therapeutic procedures, not diagnostic.
No
The device description clearly describes a physical catheter with a balloon, made of materials like urethane and polyethylene, and specifies physical dimensions (diameter, length, balloon size). This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (ureteral dilation) performed in vivo (within the body).
- Device Description: The device is a physical catheter with a balloon, designed for mechanical action within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to perform procedures within the body.
N/A
Intended Use / Indications for Use
The Ascend™ Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter.
Product codes
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Device Description
The Ascend™ Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon are urethane and polyethylene. The Ascend™ Balloon Dilation Catheter will be offered in a 7 FR diameter and 40cm to 65cm long catheter with a 5mm to 10mm x 4cm to 12cm balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
ureteral, intramural ureter
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
Balloon Catheters manufactured by Bard, High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
0
K9700041
MAR 1 9 1997
9
5100k) Premarket Notification Ascend™ Balloon Dilation Catheter Cook Urological
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS L
Submitted By:
Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 January 3, 1997
Device
Trade Name: Proposed Classification Name: Ascend™ Balloon Dilation Catheter Dilator, Catheter, Ureteral
Predicate Devices:
The Ascend™ Balloon Dilation Catheter is substantially equivalent to predicate devices in terms of indications for use and design. Predicate devices include Balloon Catheters manufactured by Bard and High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive.
Device Description:
The Ascend™ Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon are urethane and polyethylene. The Ascend™ Balloon Dilation Catheter will be offered in a 7 FR diameter and 40cm to 65cm long catheter with a 5mm to 10mm x 4cm to 12cm balloon.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate device meets the requirements for section 510(k) substantial equivalence.