(15 days)
The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications
The catheter consists of a single lumen catheter with two or four drainage eyes on the proximal tip. The catheter is available in a combination of French sizes and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths range from 6.4 to 15.65 inches and French sizes from 6 to 26 French.
The provided text is a 510(k) summary for a medical device (Rochester Medical Corporation Personal Catheter™). It describes the device, its intended use, and comparisons to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML powered device.
The "Testing and Test Results" section refers to:
- Flow rates meeting ASTM 623-89 Standard for Foley Catheters.
- Biocompatibility testing (Cytotoxicity, Sensitization, Reactivity, Genotoxicity, Systemic Toxicity, Muscle Implant, and Bladder Irritation).
These are standard performance and safety tests for a physical medical catheter, not an AI/ML algorithm.
Therefore, I cannot provide the requested information as it is not present in the given input.
To answer your request, the input document would need to describe a study evaluating an AI/ML device, including details such as:
- Acceptance Criteria: Specific quantitative thresholds for metrics like accuracy, sensitivity, specificity, AUC, F1-score, etc.
- Reported Device Performance: The actual measured values of these metrics.
- Sample Size & Data Provenance: Details about the datasets used for testing and training.
- Ground Truth Establishment: How the true labels (e.g., presence/absence of disease) were determined.
- Adjudication Method: If human experts were used for ground truth, how disagreements were resolved.
- MRMC Study: If the AI was evaluated in a human-in-the-loop setting.
- Standalone Performance: If the AI's performance without human intervention was measured.
- Training Set Details: Information about the data used to train the AI model.
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Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K970704". The characters are written in a cursive style, with varying stroke thicknesses. The background is plain white.
MAR | 3 1997
Image /page/0/Picture/2 description: The image shows the logo for Rochester Medical. The logo consists of a stylized mountain range above the word "Rochester" in a bold, italicized font. Below "Rochester" is the word "MEDICAL" in a smaller, non-italicized font. To the left of the mountain range is a circle.
14.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter and Contact Person Mary M. Wilen
Name of the Device
Rochester Medical Corporation Classification Name: Urological catheter Common/Usual Name: Urethral or Intermittent catheter Proprietary Name: Rochester Medical Corporation Personal Catheter™
Predicate Device
The predicate device for purposes of substantial equivalence is the Rochester Medical All Silicone Intermittent Catheter which received marketing approval under K943851 and Bard Urology Inc. Urethral Catheters.
Intended Use of the Device
The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications
Device Description
The catheter consists of a single lumen catheter with two or four drainage eyes on the proximal tip. The catheter is available in a combination of French sizes and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths range from 6.4 to 15.65 inches and French sizes from 6 to 26 French.
Technological Characteristics
The catheter described in the 510(k) has similar technological and performance characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer. The predicate devices are manufactured from silicone elastomer, plastic, latex or red rubber. The catheter is supplied with either two or four drainage eyes. The predicate devices are available with 1, 2 or 3 drainage eves. The device is supplied in French sizes from 6 to 26. The predicate devices are available in French sizes from 6 to 26. The device is supplied in male and female lengths. The predicate devices are supplied in male and female lengths. All of the devices are supplied sterile for single use.
Testing and Test Results
Test results indicated that flow rates of the Personal Catheter meet or exceed the requirements of ASTM 623-89 Standard Specification for Foley Catheters.
Samples of Personal Catheters were required to pass MEM Cytotoxicity, Sensitization Study in the Guinea Pig (Maximization Method), Acute Intracutaneous Reactivity, Genotoxicity ( Ames Mutagenicity), USP Systemic Toxicity, Muscle Implant Study (2 week), and Urinary Bladder Irritation Study testing.
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§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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.