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510(k) Data Aggregation
(29 days)
MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.
MIC-KEY* SF Over-the-Wire Stoma Measuring Device is designed for measuring the length of a stoma prior to placement of a low profile feeding tube. The Stoma Measuring Device comprises a tubular shaft 10 Fr with graduated scale, an inflation valve and retaining balloon. The MIC-KEY* SF Over the Wire Stoma Measuring Device is made of polyurethane tubing, EtO sterilized and for single use. Like the predicate device, it is intended to be use in hospital environment.
This document describes the non-clinical tests performed on the MIC-KEY* SF Over-the-Wire Stoma Measuring Device to demonstrate its performance and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion | Result |
|---|---|---|
| Tensile Strength, Head/Tube | ≥ 15 N per EN 1615:2000 | Pass |
| Balloon Concentricity | < 2:1 per ASTM F 2528-06 | Pass |
| Deflated Balloon OD | Pass through 4 Fr size larger ring gauge per ASTM F 2528-06 (without lubricant) | Pass |
| Deflated Balloon OD | Pass through 2 Fr size larger ring gauge per ASTM F 2528-06 (with lubricant) | Pass |
| Tube Outer Diameter | Pass through 1 Fr size larger ring gauge per ASTM F 2528-06 | Pass |
| Balloon Valve Luer Tip Comp. | Able to inflate balloon with a Luer tip syringe | Pass |
| Printed Ink Durability | Printing remains legible following cleaning | Pass |
| Device Removal Force | ≤ 0.48 lbf | Pass |
| Balloon System Leak Test | No leakage when the balloon is inflated for five minutes | Pass |
| Collar Movement | The collar can slide along the tubing for the entire length of the printed ruler | Pass |
| System Leak Test, Cap/Head | No leakage when pressurized to 0.5 psi | Pass |
| Guidewire Insertion | Device can slide along a 0.038" diameter guidewire | Pass |
| Device Radiopacity | ASTM F640-7 | Pass |
| Sterile Barrier | No bubbles per ASTM F 2096-11 | Pass |
Biocompatibility tests were also conducted and all met acceptance criteria:
- ISO 10993-1
- AAMI ANSI ISO 10993-5
- ISO 10993-10
- ISO 10993-11
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample size for each test. However, it indicates "Performance testing on the device under submission was conducted to demonstrate the modified device continued to meet performance specification." The data provenance is not specified, but these are non-clinical verification tests, likely conducted in a laboratory setting by the manufacturer, Halyard Health, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This study focuses on physical and material performance of a medical device, not on expert interpretation of data. The "ground truth" for these tests are the defined engineering and material standards (e.g., N, Fr size, lbf, psi).
4. Adjudication method for the test set:
Not applicable. These are objective engineering and material tests with pass/fail criteria based on established standards. There is no mention of human adjudication for these non-clinical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical instrument for measuring stoma length, not an AI or diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for the non-clinical tests are established engineering standards, material specifications, and quality control metrics (e.g., EN 1615:2000, ASTM F 2528-06, ISO 14971:2012, ISO 10993 series).
8. The sample size for the training set:
Not applicable. This is a non-clinical performance study of a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device performance study.
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