(15 days)
Not Found
No
The summary describes a standard intermittent catheter and does not mention any AI or ML capabilities.
No
The device, a catheter for urethral or intermittent catheterization, is used for diagnostic or supportive purposes rather than directly treating a medical condition or disease.
No
The provided text states the device is intended for urethral or intermittent catheterization, which is a therapeutic or interventional procedure, not a diagnostic one. There is no mention of it being used to diagnose a condition.
No
The device description clearly describes a physical catheter with specific dimensions and materials, indicating it is a hardware 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 for "urethral or intermittent catheterization." This is a procedure performed on the body to drain urine, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into the urethra. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnosing, monitoring, or screening for diseases or conditions based on the analysis of such samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a medical device used for a therapeutic or procedural purpose (draining urine).
N/A
Intended Use / Indications for Use
The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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