(195 days)
The Midmark Smart M9® and Smart M11® Sterilizers can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.
The Midmark Smart M9® and Smart M11® Sterilizers utilize steam flush pressure pulse (SFPP) technology to achieve sterilization on heat and moisture stable items (including dental handbieces) that are compatible with steam sterilization.
The Midmark Smart M9® and Smart M11® Sterilizers are compact, self-contained portable units. They can be placed on any level support surface where an electrical outlet is available with no other installation required. The M9 sterilizer models are the smaller of the models with a 9 in (22.9 cm) diameter x 15 in (38.1 cm) deep stainless-steel chamber. The M 1 sterilizer models have an 11" (27.9 cm) diameter x 18" (45.7 cm) deep stainless-steel chamber.
The Midmark Smart M9® and Smart M11® Sterilizers use saturated steam at high pressure and temperature as the sterilizing agent to kill infectious bio-organisms on items placed in the chamber for processing. They use the dynamic Steam Flush Pressure Pulse (SFPP) cycle type for the pre-set cycles that include a 4-minute 270°F and a 3-minute 275°F cycle for wrapped or pouched instruments (including dental handpieces) and cassettes, a 30-minute 250°F cvcle for textiles and instrument packs requiring a lower temperature. and a 3-minute 270°F cycle for unwrapped instruments. The 3-minute 275°F is added to align with Table B.2 in AAMI TIR12:2020. In the SFPP type cycle, residual air is removed from the chamber and its contents by a series of controlled pressure pulses and steam flushes.
The Midmark Smart M9® and Smart M11® Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject models extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. On the subject units there are options for the user to enter load type and indicator information. Once the cycle is selected and the operator presses "Start," there is an option to capture the identification of the operator. The sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying, Audible signals indicate cycle initiation, completion, and/or interruption, and the user interface provides visual communication of device status, operator instructions, and troubleshooting information. The LED light bar also provides an estimate of the cycle progression. At the conclusion of the cycle there is another option to capture the identification of the operator that unloads and approves or rejects the results of the sterilization cycle.
All sterilizer cycle and user maintenance (Routine Care) records are stored internally on an SD card. Midmark has developed a Digital Ecosystem Connectivity Module that is incorporated into the Midmark Smart M9® and Smart M11® Sterilizers which adds the ability to transfer electronic sterilization records to the Midmark cloud and to remotely view the current status of, or cycle history for multiple sterilizers. Optional features and settings that may be distributed to multiple sterilizers from the cloud include distribution of software updates to the connectivity module, compliance settings, and entering the results of biological indicator tests. Connectivity is not needed to perform the sterlizer's intended use, and connecting a sterilizer does not change the intended use.
The provided document is a 510(k) summary for the Midmark Smart M9® and Smart M11® Sterilizers. It details the device's characteristics and its non-clinical performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on its ability to perform sterilization effectively and safely according to established standards. The reported device performance is indicated by its compliance with these standards.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Used) | Reported Device Performance (Results) |
|---|---|
| Performance: ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers (FDA Recognition Number 14-518) | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| Safety: ANSI/UL 61010-1 Third Edition 5/12/2012 / Revised 7/19/2019, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements (FDA Recognition Number 19-41) | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| Safety: IEC 61010-2-040:2020 Edition 3.0 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| EMC (Electromagnetic Compatibility): IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (FDA Recognition Number 19-36) | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| Pressure Vessel: American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code, Section VIII, Division 1: 2023 Edition | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
Study Details:
The document states that non-clinical evaluations were performed for the Midmark Smart M9® and Smart M11® Sterilizer. The purpose of these evaluations was to demonstrate compliance with recognized standards for safety and performance, thereby proving substantial equivalence to a legally marketed predicate device.
-
Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the test set (e.g., number of sterilization cycles tested, number of units tested).
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it concerns a medical device seeking FDA clearance, it's implied that the testing was conducted under controlled conditions to regulatory standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and study. The ground truth for a sterilizer is established through physical and biological indicators demonstrating the elimination of microorganisms, not through expert consensus on image interpretation or diagnosis. The "experts" implicit in this context are the testing laboratories and their personnel following the specified scientific and engineering standards.
-
Adjudication method for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For device performance testing against engineering standards, the results are objective measurements (e.g., temperature, pressure, biological indicator kill) that either pass or fail the predefined criteria.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging AI/CAD systems that assist human readers. The Midmark Smart M9® and Smart M11® Sterilizers are steam sterilizers, and their performance is evaluated directly against physical, chemical, and biological sterilization parameters, not through human interpretation of cases.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the conventional sense of AI/algorithm performance. The device is a physical sterilizer with automated cycles. Its "performance" is inherently "standalone" in that it performs its function without human intervention during the sterilization cycle once initiated. The evaluations listed are standalone device performance tests.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for a sterilizer's performance is objectively defined by the complete kill of specific biological indicators (e.g., bacterial spores known to be highly resistant to sterilization processes) under specified conditions (temperature, pressure, time). It also includes measured physical parameters (e.g., temperature and pressure profiles over time) matching the standards, and the successful completion of cycles without errors. This is a scientific and engineering ground truth, not based on human consensus or pathology from patient outcomes.
-
The sample size for the training set:
- The document does not mention a "training set" in the context of machine learning or AI. This device is a traditional medical device (steam sterilizer), not a deep learning or AI-based diagnostic tool that requires a training set. The design and validation of the sterilizer are based on established engineering principles and extensive physical and biological testing.
-
How the ground truth for the training set was established:
- This question is not applicable as there is no mention of a training set for an AI/ML algorithm.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).