(36 days)
The LuMax Cystometry Tube Set is intended to be used in the exact same manner as the previous tube sets manufactured by NASP and cleared by FDA under K911865/B. The intended use of these tube sets is to provide a conduit from a liquid resevoir to the infusion lumen of a bladder pressure catheter.
The LuMax Cystometry Tube Set is to be used to provide a conduit from a liguid reservoir to the infusion lumen of a bladder catheter whenever filling a bladder is required in conjunction with performing a Urodynamic Cystometry test.
The LuMax Cystometry Tube Set consists of a vented spike with a drip chamber for connection to the liquid reservoir, usually a one to three liter saline or DI water bag, a roller clamp for regulating fluid flow rates, and a male luer lock connector for connecting to the filling lumen of the bladder catheter. It is assembled with polyurethane tubing giving it an overall length of 72 inches.
The LuMax Cystometry Tube Set is a Class II medical device intended to provide a conduit from a liquid reservoir to the infusion lumen of a bladder pressure catheter. The device was found to be substantially equivalent to an existing administration tube set from North American Sterilization and Packaging Company (NASP) (K911865/B).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Required Specifications) | Reported Device Performance |
|---|---|---|
| Physical Bench Testing | ||
| Visual Examination | Visual inspection for workmanship. | All samples met required specifications. |
| Tensile Strength Testing | Refer to Attachment H for specific specifications. | All samples met required specifications. |
| Pressure Withstand Testing | Refer to Attachment H for specific specifications. | All samples met required specifications. |
| Sterilization | Sterility Assurance Level (SAL) of better than 10⁻⁶. | Complete kill of Bacillus var niger spores, proving SAL > 10⁻⁶. |
| Packaging | Packaging identical to predicate device's standards. | Identical to MedAmicus Urodynamic Fiberoptic Pressure Catheter products (sealed Tyvek Pouch, carton for shipping). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Physical Bench Testing: "Sample devices" were subjected to physical bench testing. The exact number of samples is not explicitly stated in the provided text, but it is implied that a sufficient number was tested to make a general statement about all samples meeting specifications.
- Sterilization Validation: "Sample product" was used for sterilization validation. The exact number of samples is not explicitly stated.
- Data Provenance: The data is retrospective, generated from in-house bench testing and sterilization validation performed by MedAmicus, Inc. The country of origin for the data is implicitly the United States, given the company's address and communication with the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
No external experts were explicitly mentioned as being used to establish a ground truth for the device's performance in the provided text. The "ground truth" for the physical and sterilization tests was based on established engineering specifications and validation methods (e.g., AAMI method for sterilization).
4. Adjudication Method for the Test Set
Not applicable. The tests performed were objective physical and sterilization validation tests against predefined specifications, not subjective assessments requiring adjudication by multiple readers or experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was conducted or reported. This device is a passive conduit tube set, and its performance is not evaluated in terms of human reader improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone study was performed. The device performance (physical bench testing, sterilization, and packaging) was evaluated in an "algorithm-only" or "device-only" manner without human interaction influencing the core performance metrics being tested. The device itself was the subject of the performance tests.
7. Type of Ground Truth Used
- Physical Bench Testing: Engineering specifications and material science standards (e.g., for tensile strength, pressure withstand) were used as the ground truth.
- Sterilization: The AAMI method's criteria for a Sterility Assurance Level (SAL) of better than 10⁻⁶, demonstrated by a complete kill of 1 million spores of Bacillus var niger after a half-cycle, served as the ground truth.
8. Sample Size for the Training Set
Not applicable. This device is a passive medical device, not an AI/ML algorithm requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a passive medical device, not an AI/ML algorithm requiring a "training set."
§ 876.1620 Urodynamics measurement system.
(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.