(91 days)
The MTS300 System is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterlization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the MTS300 Transfer Cart, MTS300 filters and integrity locks.
The MTS300 System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The MTS300 System was tested and validated with rigid instruments containing lumens with an inner diameter of 3.8mm and an overall length of 370mm. Do not use with instruments containing lumens with an inner diameter smaller than 3.8mm and an overall length longer than 370mm.
Use only uncovered, perforated or wire mesh general delivery trays within the MTS300 System.
The MTS300 Multiple Tray Sterilization System (also referred to as the MTS300 System) includes the stainless steel sterilization cabinet and adjustable transfer cart. Single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. An optional STEAMPlus TM tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. The MTS System is intended to sterilize a maximum weight of 300 pounds of devices and instruments for a single patient surgery. The loaded cabinet is deployed from the adjustable transfer cart and processed in a pre-vacuum steam sterilizer and then dried for 30 minutes. Sterility is maintained for up to 30 days.
Here's a breakdown of the acceptance criteria and study information for the MTS300 Multiple Tray Sterilization System, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it often references studies done to meet existing standards or guidance documents rather than detailing a single, comprehensive study testing a device against specific, novel acceptance criteria. The information below reflects what is extractable from this type of document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claimed | Reported Device Performance (from studies/validation) |
|---|---|
| Sterilization Efficacy | Demonstrated through verification studies in accordance with ANSI/AAMI ST77:2013 and FDA Draft Guidance (2002). |
| Sterility Maintenance Duration | Up to 30 days |
| Compatibility with Prevacuum Steam Sterilizers | Prevacuum cycle of 270°F, 4 minutes exposure time |
| Maximum Tray Load per Shelf | No more than 3 trays per shelf |
| Maximum Weight per Tray | 25 lbs. per tray |
| Lumen Instrument Compatibility | Rigid instruments with inner diameter ≥ 3.8mm and overall length ≤ 370mm |
| Tray Type Compatibility | Uncovered, perforated, or wire mesh general delivery trays |
| System Stability (Cabinet on Transfer Cart) | Stable during deployment and use. |
| User Needs/Intended Use (Usability) | Meets user needs and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" of items tested for the sterilization efficacy studies (e.g., number of sterilization cycles, number of biological indicators). It refers to "sterilization efficacy verification studies" performed.
- Data Provenance: The studies were performed in accordance with ANSI/AAMI ST77:2013 and the recommendations of the Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Healthcare Facilities, Draft Guidance for Industry and FDA, March 7, 2002. This implies that the testing methodologies would follow standard industry practices and regulatory guidance, likely conducted in a controlled laboratory or healthcare setting. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's for a 510(k) submission, it would typically involve prospective testing conducted by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish ground truth. For sterilization efficacy, ground truth is typically established by laboratory methods (e.g., culturing biological indicators to confirm sterility), not usually by expert consensus in the typical sense of reading medical images.
4. Adjudication Method for the Test Set
Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are typically used for interpreting results from human readers (e.g., radiologists) in diagnostic studies, not for the technical performance testing of a sterilization system. The verification studies follow established protocols where results (e.g., growth/no growth of biological indicators) are objective.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging devices where human readers interpret results, comparing their performance with and without AI assistance. The MTS300 is a sterilization system, not an imaging or diagnostic device involving human interpretation in that manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "sterilization efficacy verification studies" and "engineering analysis" are standalone performance evaluations of the device itself (the "algorithm" in this context refers to the device's functional performance). There isn't an "AI algorithm" involved in the way typically discussed in diagnostic imaging. The device is intended to perform its function without constant human intervention during the sterilization cycle. The "usability study" involves human interaction but evaluates the system's ease of use and ability to meet human needs, not human diagnostic performance.
7. The Type of Ground Truth Used
For sterilization efficacy, the ground truth is primarily based on microbiological testing (e.g., culturing biological indicators to confirm the absence of viable microorganisms after the sterilization process). For stability and usability, the ground truth would be based on engineering analysis (meeting design specifications) and potentially user feedback/observation in the usability study demonstrating successful and safe operation.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI in a way that requires a "training set." Its performance is based on physical and chemical principles and validated through engineered design and testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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).