(119 days)
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No
The device description and performance studies focus on mechanical and electrical components and their function, with no mention of AI or ML.
Yes
The device is intended to allow individuals to empty their urine collection leg bag, which is a therapeutic function related to managing bodily waste.
No
The Liberty Valve is an assistive device that helps individuals in a wheelchair empty their urine collection leg bag. It facilitates a physical action (draining fluid) rather than diagnosing a condition or providing information about a patient's health state.
No
The device description explicitly lists hardware components such as a switch box, solenoid valve, fuse, battery leads, wiring, tubing, clamps, and wire ties.
Based on the provided information, the Liberty Valve is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to allow individuals in a wheelchair to empty their urine collection leg bag. This is a functional device for managing urine collection, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a mechanical and electrical system for controlling the flow of urine. It does not involve reagents, test strips, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any aspects related to in vitro testing, such as sample analysis, diagnostic markers, or laboratory procedures.
The Liberty Valve is a medical device, but it falls under a different classification than IVD devices. It is a device designed to assist with the management of a medical condition (urinary incontinence/retention requiring catheterization) through a functional mechanism.
N/A
Intended Use / Indications for Use
The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements. Previously such a task required external assistance or unwanted difficulty, thus limiting the individual's independence.
Product codes
IRN
Device Description
The Liberty Valve consists of a switch box, a solenoid valve with electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.
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
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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)
The Liberty Valve was tested in worst case scenario for possible current leaks. Placed in a supersaturated salt water solution for 2.5 hours, with continuous flushing of same solution through the valve, no part on the valve exhibited a potential, (relative to the negative terminal), and there was no current leaks. This is true for readings taken both in the solution, and from the surface of the valve. With both the internal components of the valve tested simultaneously, the absence of electrical activity in the solution confirmed the electrical stability of the Liberty Valve. (This result is achieved through the use of the septum and o-ring at the interface of the valve and connector.)
Tests were conducted at 0 °C, 23 °C and 70 °C to determine the range of operation for the Liberty Valve. At all three temperatures, the Valve required less than two minutes to drain 500 mL from a urine collection bag held ten inches above the valve itself.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, 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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Cleveland Medical Devices Inc."
MAR 2 1 1997
1000 CEDAR AVENUE · SUITE 439 · CLEVELAND, OHIO · PHONE: (216) 791-8720 · FAX: (216) 791-6744
510(K) SUMMARY
| A) Submitter's Name: | Cleveland Medical Devices Inc. |
|---|---|
| B) Address: | 11000 Cedar Ave. Suite 439 |
| Cleveland, Ohio 44106 | |
| C) Phone and Fax numbers: | Phone: (216) 791-6720 |
| Fax: (216) 791-6744 | |
| D) Contact Person: | Robert N. Schmidt |
| E) Preparation Date: | November 21, 1996 |
| F) Classification Name: | Urine Collector and Accessories |
| Common / Usual Name: | Urine Drainage Valve |
| Proprietary Name: | Liberty Valve™ |
Classification: Class II The classification number for this device is 89 IRN and is reviewed by the Physical Medicine Panel.
Regulation: 876.5250
a) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are: (1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag: and (2) a urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device and the paste-on device for incontinence.
Class II for a urine collector and accessories intended to be connected to an b) 1) indwelling catheter.
1
Cleveland Medical Devices Inc.
તુનું ર્વિંગ્
The design concept of the Liberty Valve is substantially G) Substantial Equivalence: equivalent in design to:
EZMT Valve Co. E-Z Pull Urinary Drainage Valve;
R.D. Equipment Electric Leg Bag Emptier.
1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Liberty Valve consists of a switch box, a solenoid valve with H) Description: electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.
- I) Intended Use: The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements. Previously such a task required external assistance or unwanted difficulty, thus limiting the individual's independence.
J) Summary of Safety and Effectiveness of Liberty Valve:
The Summary of Safety and Effectiveness on Liberty Valve reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
The Liberty Valve was tested in worst case scenario for possible current leaks. Placed in a supersaturated salt water solution for 2.5 hours, with continuous flushing of same solution through the valve, no part on the valve exhibited a potential, (relative to the negative terminal), and there was no current leaks. This is true for readings taken both in the solution, and from the surface of the valve. With both the internal components of the valve tested simultaneously, the absence of electrical activity in the solution confirmed the electrical stability of the Liberty Valve. (This result is achieved through the use of the septum and o-ring at the interface of the valve and connector.)
| time(min) | A, in solution | V, in solution | A, on surface | V, on surface |
|---|---|---|---|---|
| 3 | 0 | 0 | 0 | 0 |
| 13 | 0 | 0 | 0 | 0 |
| 30 | 0 | 0 | 0 | 0 |
| 150 | 0 | 0 | 0 | 0 |
2
12964690
Cleveland Medical Devices Inc.
The Liberty Valve is similar in operation and function to the E-Z Pull Urinary Drainage Valve of the EZMT Valve Co.
1 . . . . .
| | Liberty Valve | R.D. Equipment
Electric Leg Bag
Emptier | E-Z Pull Urinary
Drainage Valve |
|--------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| 1 Valve Operation | Normally closed
Opens when activated
Automatically closes | Normally closed
Opens when activated
Automatically closes | Normally closed
Opens when activated
Automatically closes |
| 2 Valve type | Solenoid | Solenoid | Stretch |
| 3 Switch Operation | Push Button
On/off Toggle | Toggle | Pull Tab |
K) Bench Testing: Tests were conducted at 0 °C, 23 °C and 70 °C to determine the range of operation for the Liberty Valve. At all three temperatures, the Valve required less than two minutes to drain 500 mL from a urine collection bag held ten inches above the valve itself. It is advised that the Liberty Valve be used at temperatures between 0° C and 70 °C.
| Liberty Valve Test Results at Selected Temperatures | |||
|---|---|---|---|
| Temperature (°C) | 0 | 23 | 70 |
| Time (min) | 1:53 | 1:49 | 1:45 |
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