Search Results
Found 1 results
510(k) Data Aggregation
(87 days)
MDT CORP., INC.
The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are intended to be used for the monitoring of sterilization processes in health care facilities. A biological indicator is a calibrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.
A biological indicator is a calibrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.
This document describes the 510(k) Safety and Effectiveness Summary for MDT Biologic Company's UNISPORE® and SPOR-TEST® Biological Indicators.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or percentage format typically seen for diagnostic devices. Instead, the study aims to demonstrate substantial equivalence to existing devices and justify expanded storage conditions and sterilization claims. The "performance" is demonstrated by the stability of the biological indicators under different storage conditions and their continued effectiveness in monitoring sterilization processes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain population viability and resistance: Biological indicators should retain their calibrated population of bacterial spores and their resistance characteristics (steam and chemical vapor) over their shelf life under proposed storage conditions. | The study conducted "Population analysis" and tested "steam resistance, and chemical vapor resistance" for all lots at each sampling interval under freezer (0°C), refrigerator (2°C - 8°C), and controlled room temperature (15° - 30°C) conditions. "Limited endpoint bracket testing" was also conducted. The conclusion drawn is that the labeling can be revised for: |
- Refrigerator storage instead of freezer storage.
- Cool, dry place or refrigeration for indicators used with MDT's Culturing Service.
- Unispore® can be used with chemical vapor sterilization. This implies the performance remained acceptable under these conditions. |
| Substantial Equivalence: Device performs comparably to predicate devices. | The document states, "We believe this product to be substantially equivalent to the Unispore® and Spor-Test® biological indicators currently having market clearance in accordance with K792649 & K801152 and K800482, & K801980 respectively." While the specific data proving this equivalence is not detailed in terms of a head-to-head comparison with the predicate, the stability study supports the continued effectiveness of the new storage conditions/claims, thereby supporting substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "different lots each of Unispore® dual-species paper strip biological indicators and Spor-Test® paper strip biological indicators." It also states "Each lot was sampled at intervals according to test protocol." However, the exact number of lots or individual units tested (sample size for the test set) is not specified.
- Data Provenance: The study was conducted by MDT Biologic Company between December 1992 and March 1995. This indicates the data is prospective as it involves active testing over time. The country of origin is not explicitly stated for the data itself, but MDT Biologic Company is located in Rochester, New York, USA, implying the study was conducted in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this document. The "ground truth" for biological indicators is the measurable presence or absence of spore viability/resistance, not a subjective interpretation by experts. The performance is assessed through laboratory testing (population analysis, resistance testing).
4. Adjudication method
Not applicable. See point 3.
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 document describes biological indicators used for monitoring sterilization, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes biological indicators, not an algorithm or AI system.
7. The type of ground truth used
The ground truth for this study is based on objective laboratory measurements of:
- Bacterial spore population viability
- Resistance to steam sterilization
- Resistance to chemical vapor sterilization
- Formaldehyde content (for Vapo-Steril® used in testing)
8. The sample size for the training set
Not applicable. This study does not involve machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
Ask a specific question about this device
Page 1 of 1