(78 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a standard urinary catheter, with no mention of AI or ML.
No
The device, a catheter, is used to pass fluids (urine) from the bladder. While it aids in a bodily function, it does not treat a disease or condition; it merely facilitates drainage. Therefore, it is not considered a therapeutic device.
No
Explanation: The device is a urinary catheter used for continuous drainage of urine from the bladder, not for diagnosing medical conditions. Its function is to facilitate fluid passage, not to identify or monitor diseases.
No
The device description clearly describes a physical, tubular catheter made of silicone, requiring an introducer for insertion, and intended for continuous drainage of urine. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The OPTICON™ Direct Male Urinary Catheter is a device that is inserted into the body to drain urine. It is a physical tool for managing a bodily function, not for analyzing a sample to diagnose or monitor a condition.
- Intended Use: The intended use is to "pass fluids from the urinary bladder," which is a mechanical function, not a diagnostic test.
- Device Description: The description details a physical catheter for insertion and drainage, not a system for analyzing biological samples.
Therefore, based on the provided information, the OPTICON™ Direct Male Urinary Catheter is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags.
Product codes
Not Found
Device Description
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular catheter that is inserted through the urethra to pass urine from the urinary bladder, when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone. The male catheter requires an introducer for insertion. OPTICON™ Medical currently recommends the use of a commonly available introducer, (such as the Bard 0420 Wire Stylet) to aid in insertion. This introducer is not sold by OPTICON™ Medical, nor is the introducer included in the packaging for the OPTICON™ Direct Male Urinary Catheter for Continuous Drainage Catheter. The catheter is to be used only with standard urinary drainage tubes, drainage tube adaptors, tubes and bags.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage has been tested to the ASTM Standard F623-89, "Standard Performance Specification for Foley Catheter" and was found to meet all performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
MAY 16 1997
510(k) Summary
SUBMITTER: OPTICON™ Medical Inc.
Address: Telephone:
Greg Sachs
14505 21st Avenue North, Suite 216 Plymouth, MN 55447 612-404-0113
CONTACT PERSON:
612-404-0113
February 26, 1997 DATE SUMMARY PREPARED:
OPTICON™ Direct Male Urinary Catheter for Continuous TRADE NAME: Drainage COMMON NAME: Foley Catheter Urological Catheter CLASSIFICATION NAME:
SUBSTANTIALLY EQUIVALENT TO:
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is substantially equivalent to the OPTICON™ Direct Female Urinary Catheter for Continuous Drainage (K961697).
DESCRIPTION of the DEVICE:
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular catheter that is inserted through the urethra to pass urine from the urinary bladder, when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone. The male catheter requires an introducer for insertion. OPTICON™ Medical currently recommends the use of a commonly available introducer, (such as the Bard 0420 Wire Stylet) to aid in insertion. This introducer is not sold by OPTICON™ Medical, nor is the introducer included in the packaging for the OPTICON™ Direct Male Urinary Catheter for Continuous Drainage Catheter. The catheter is to be used only with standard urinary drainage tubes, drainage tube adaptors, tubes and bags.
INDICATIONS for USE:
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags.
CLINICAL INFORMATION and SAFETY and EFFECTIVENESS:
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage has been tested to the ASTM Standard F623-89, "Standard Performance Specification for Foley Catheter" and was found to meet all performance requirements.