(155 days)
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No
The summary describes a physical medical device (dilators) with a hydrophilic coating to reduce friction. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes.
The device is intended to dilate anatomical lumens (fascial tract, urethra, ureters) to treat or alleviate a medical condition.
No
Explanation: The device is described as a dilator, intended to mechanically expand tracts and lumens, which is a therapeutic rather than diagnostic function.
No
The device description clearly states the device is constructed of physical materials (polyethylcuse and vinyl) and has a hydrophilic coating, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to dilate anatomical tracts (suprapubic and/or nepluostomy fascial tract, urethra and ureters). This is a physical intervention on the body.
- Device Description: The device is a physical dilator made of polyethylcuse and vinyl with a hydrophilic coating. It is designed to mechanically expand tissue.
- 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 samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose (dilation).
N/A
Intended Use / Indications for Use
The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters. The constructions of the materials are polyethylcuse and vinyl. The lydrophilic coating will allow the catheters to become lubricious which will reduce friction.
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
suprapubic and/or nepluostomy fascial tract, urethra and ureters
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.5520 Urethral dilator.
(a)
Identification. A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.(b)
Classification. (1) Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. 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/1 description: The image shows a handwritten string of characters. The characters appear to be 'K61904'. The writing is bold and dark, making it easily readable against the white background. The style of writing is casual and appears to be done quickly.
510(k) Premarket Notification AQ Lydrophilic Dilators Couk Urulogical
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 May 15, 1996
Device
Trade Name:
AQ Hydrophilic Dilators
Proposed Classification Name:
Dilator, Catheter, Urcleral Dilator, Urchra!
Predicate Devices:
The AQ Hydrophilic Dilators are substantially equivalent to prodicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Ureteral Dilators with Hydro Plus™ manufactured by Microvasive and uncoated dilators manufactured by Cook Urological.
Device Description:
The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters. The constructions of the materials are polyethylcuse and vinyl. The lydrophilic coating will allow the catheters to become lubricious which will reduce friction.
Substantial Equivalence:
These devices will be manufactured according to specificd 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 devices, these devices meet the requirements for section 510(k) substantial equivalence.