(120 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and standard performance of a urinary catheter, with no mention of AI or ML capabilities.
No
A therapeutic device is one that treats a disease or condition. This device is a catheter used for continuous urinary drainage, which is a supportive function rather than a treatment of a disease itself.
No
The device is described as a catheter used to pass fluids from the urinary bladder, which is a therapeutic or drainage function, not a diagnostic one.
No
The device description clearly states it is a physical, tubular device made of silicone, which is inserted into the body. This indicates it is a hardware 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 "pass fluids from the urinary bladder" and "pass urine from the urinary tract". This is a direct interaction with the body for drainage, not for analyzing a sample of the body.
- Device Description: The description details a physical device inserted into the body for drainage. It does not mention any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (urine, blood, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is a medical device used for drainage, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The OPTICONT Female Uninary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage rube adaptors, tubes and bags.
Product codes
Urological Catheter
Device Description
The OPTICON™ Female Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular device that is inserted through the urethra and is used to pass urine from the uningry tract when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone and comes in only one size (18 French) and leagth, 10.8 cm (4.3 inches). When inserted, all that is visible ouside of the body is a microvalve for balloon inflation and retainer ring. The device is to be used only with standard urinary 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
The OPTICONTA Female 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
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
AUG 30 1996
510(k) Summary
SUBMITTER: Medical Device International, Inc.
| Address: | 5116 Birch Road
Minnetonka, MN 55345 |
|------------|-----------------------------------------|
| Telephone: | 612-938-4125 |
CONTACT PERSON: Greg Sachs 612-938-4125
DATE SUMMARY PREPARED: April 30, 1996
OPTICON™ Female Urinary Catheter for Continuous Drainage TRADE NAME: COMMON NAME: Foley Catheter CLASSIFICATION NAME: Urological Catheter
SUBSTANTIALLY EQUIVALENT TO:
The OPTICONT Female Urinary Cather for Continuous Drainage is substantially equivalent to the Bardex Silicone Foley Catheter (K760093) and the Rochester Medical Female Uretheral Catheter (K941692).
The OPTICON™ Female Urinary Catheter for Continuous DESCRIPTION of the DEVICE: Drainage is a sterile, single use/disposable, flexible, tubular device that is inserted through the urethra and is used to pass urine from the uningry tract when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone and comes in only one size (18 French) and leagth, 10.8 cm (4.3 inches). When inserted, all that is visible ouside of the body is a microvalve for balloon inflation and retainer ring. The device is to be used only with standard urinary drainage tube adaptors, tubes and bags.
INDICATIONS for USE: The OPTICON™ Female Uninary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage rube adaptors, tubes and bags.
CLINICAL INFORMATION and SAFETY and EFFECTIVENESS:
The OPTICONTA Female 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.
5)cam86.doc