(284 days)
The MyoSure™ Instrument Tray is intended to enclose, protect, and organize the MyoSure Rod Lens Hysteroscope, MyoSure Removable Outflow Channel, and associated components during sterilization and storage. The MyoSure Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycle, and may be stored for up to 30 days in accordance with the wrap manufacturer's instructions.
The MyoSure™ Instrument Tray has been validated for the following sterilization cycles:
| Prevacuum Steam | Gravity Steam | STERRAD 100S |
|---|---|---|
| 132°C (270°F) | 132 °C (270 °F) | 59% H2O2 |
| 4 minutes exposure | 15 minutes exposure | Normal Cycle Setting |
| 30 minutes dry time | 30 minutes dry time | 30 minutes dry time |
| Contents - 1 MyoSure Rod Lens | Contents - 1 MyoSure Rod Lens | Contents - 1 MyoSure Rod Lens |
| Hysteroscope, 1 Removable | Hysteroscope, 1 Removable | Hysteroscope, 1 Removable |
| Outflow Channel, 2 Seal Caps, 2 | Outflow Channel, 2 Seal Caps, 2 | Outflow Channel, 2 Seal Caps, 2 |
| Light Guides | Light Guides | Light Guides |
The MyoSure Instrument Tray consists of an approximate 13.45 inch x 8.41 inch x 2.0 inch plastic, perforated base and lid with posts and cradles to position the devices to be sterilized. Each tray and lid has an evenly distributed hole pattern that allows sterilant penetration and air removal.
Here's an analysis of the acceptance criteria and study details for the MyoSure Instrument Tray, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Sterilization Type) | Specific Parameters | Required Performance | Reported Device Performance |
|---|---|---|---|
| Prevacuum Steam Sterilization | Temperature: 132°C (270°F) | 6 log reduction of all spore strips and inoculated devices; Excellent sterilant penetration | Achieved 6 log reduction; Excellent sterilant penetration demonstrated by thermocouple data |
| Exposure time: 4 minutes | |||
| Dry time: 30 minutes | |||
| Contents: 1 MyoSure Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides | |||
| Gravity Steam Sterilization | Temperature: 132°C (270°F) | 6 log reduction of all spore strips and inoculated devices; Excellent sterilant penetration | Achieved 6 log reduction; Excellent sterilant penetration demonstrated by thermocouple data |
| Exposure time: 15 minutes | |||
| Dry time: 30 minutes | |||
| Contents: 1 MyoSure Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides | |||
| STERRAD 100S Sterilization | Sterilant: 59% H2O2 | 6 log reduction of all spore strips and inoculated devices; Excellent sterilant penetration | Achieved 6 log reduction; Excellent sterilant penetration demonstrated by chemical indicator data |
| Cycle Setting: Normal | |||
| Dry time: 30 minutes (implied, mentioned once for other cycles) | |||
| Contents: 1 MyoSure Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides | |||
| Materials Compatibility | Post-processing | Not explicitly stated but implied successful results for use with sterilization process | Indicated successful results |
| Biocompatibility | Intracutaneous irritation | Not explicitly stated but implied successful results | Indicated successful results |
| Hemolysis | Not explicitly stated but implied successful results | Indicated successful results |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set in terms of the number of individual devices or sterilization cycles performed beyond "all spores strips and inoculated devices." However, it refers to "half cycle testing" for STERRAD.
The data provenance is a validation study performed by the manufacturer, Hologic, Inc., to demonstrate the effectiveness of the MyoSure Instrument Tray with specific sterilization methods. It is an internal prospective study conducted for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For sterilization validation, ground truth is typically established through quantitative microbial inactivation assays (e.g., spore strip testing) and physical measurements (e.g., thermocouple data, chemical indicators), rather than expert consensus on subjective interpretations. The expertise would lie in microbiology and sterilization science to design and interpret these tests, but specific "experts" for ground truth establishment are not mentioned for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable/provided for this type of device validation. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., reading medical images) where there can be disagreement among experts. For sterilization validation, the results are generally objective and quantifiable (e.g., counting colony-forming units from spore strips, temperature readings).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is compared. The MyoSure Instrument Tray is a sterilization tray, which does not involve human interpretation or AI assistance in its primary function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This device does not involve an algorithm. The "performance" being evaluated is the ability of the tray to facilitate sterilization, which is assessed through direct physical and microbiological tests, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this validation study is primarily microbiological validation (6 log reduction of spore strips and inoculated devices) combined with physical measurements (thermocouple data for steam sterilization, chemical indicator data for STERRAD). This is standard for sterilization efficacy testing.
8. The Sample Size for the Training Set
This information is not applicable/provided. The MyoSure Instrument Tray is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no training set for this type of device.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).