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510(k) Data Aggregation
(108 days)
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
MTG fustant Cath™, MTG firstant Cath™ 'title (f VF or BZK), MTG finstant Cath 'M Detuxe and MTG Tinstant Cath™ Deluxe kit (PVP or BZK) are intended to be used to drain urine from the patient's bladder.
The MTG Instant Cath™ is a sterile, closed system, single use, disposable, pre-lubricated PVC or Red Rubber (based on user preference for softness both are offered) catheter self-contained in a collection bag. It is used to drain urine from the bladder. When it is not practical or feasible for the patient to drain the bladder into a commode or bedpan, the urine may be drained into the collection bag. The MTG Instant Cath™ is designed with a collection bag and introducer tip for inserting the catheter without having to directly touch the catheter. reducing the possibility of contamination. The MTG Instant Cath 100 Deluxe is the same as the MTG Instant Cath", and includes an easy advancer that will make it less likely for the catheter to slip back into the bag during insertion. The purpose of this easy advancer, which does not come in contact with the patient, is solely to make the device casier for the patient or caregiver to advance the catheter and will in no way affect safety or effectiveness of the device. The MTG Instant Cath™ kit and MTG Instant Cath™ Deluxe kit include the intermittent catheter, with either PVP swabs and/or BZK prep pad/swab, gloves, gauze and an underpad. These roducts will be available in various sizes to accommodate a wide range of male, female and pediatric users.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MTG Instant Cath™:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Flow Rate | Matched predicate within +/- 10% and exceeded specification criteria. |
| Lubricity | Exceeded minimum gel quantity for both predicate and specification criteria. |
| Catheter Tensile Strength | All devices tested passed when evaluated according to EN1616:1997 +A1:1999 Annex A. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each performance test (Flow Rate, Lubricity, Catheter Tensile Strength). It uses phrases like "all MTG devices" and "all samples of MTG Instant Cath™ and MTG Instant Cath™ Deluxe tested," suggesting that a representative number of devices were tested, but precise figures are not given.
The provenance of the data is not specified. It is likely a combination of laboratory testing conducted by the manufacturer. Whether the data is retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance testing appears to be objective, laboratory-based physical measurements rather than assessments requiring human expert interpretation against a ground truth.
4. Adjudication Method for the Test Set
No adjudication method is mentioned or appears applicable, as the tests are objective physical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a medical catheter for draining urine, and the performance tests described are focused on physical and functional characteristics, not diagnostic accuracy requiring human-in-the-loop assessment.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical medical catheter, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth for the performance tests appears to be:
- Predicate device's performance: For Flow Rate and Lubricity, the performance of the predicate device (Apogee Closed System Catheter K032710) served as a benchmark.
- Established specification criteria: Both Flow Rate and Lubricity exceeded independent specification criteria, though the specifics of these criteria are not detailed.
- International standard: For Catheter Tensile Strength, the ground truth was adherence to the method and passing criteria outlined in EN1616:1997 +A1:1999 "Sterile Urethral Catheters for Single Use" annex A.
8. Sample Size for the Training Set
This is not applicable as the device is a physical medical catheter, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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