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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 4, 2024

Midmark Corporation Adam Clutter Quality Systems and Regulatory Affairs Manager 60 Vista Drive Versailles, Ohio 45380

Re: K233026

Trade/Device Name: Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: March 7, 2024 Received: March 8, 2024

Dear Adam Clutter:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical

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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233026

Device Name Midmark Smart M9® Sterilizer Midmark Smart M11® Sterilizer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	X Over-The-Counter Use (21 CFR 801 Subpart C)

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Standard Cycle Parameters

Cycle Type	Cycle ParametersTemperature Minimum	Time	Pressure 1 Reference	Drying Time 2	Items to be Sterilized(Always follow the item manufacturer's recommendations for sterilization.)	M9 Maximum Capacity 4	M11 Maximum Capacity 4
Image: Wrapped Cycle Type	132°C (270°F)	4 min.	186 kPa(27.1 psi)	30 min.	• Pouched or wrapped items manufacturers recommend for exposure at 132°C (270°F) for 4 minutes.• Wrapped cassettes.• Dental Handpieces (wrapped or unwrapped)	3,629 grams (8.0 lb) or 8 handpieces (2 per tray) with other instruments 3,629 grams (8.0 lb) total	4,082 grams (9.0 lb) or 8 handpieces (2 per tray) with other instruments 4,082 grams (9.0 lb) total
Image: Wrapped Cycle Type	135°C (275°F)	3 min.	214 kPa(31 psi)	30 min.	• Pouched or wrapped items manufacturers recommend for exposure at 135°C (275°F) for 3 minutes.• Wrapped cassettes.• Dental Handpieces (wrapped or unwrapped)	3,629 grams (8.0 lb) or 8 handpieces (2 per tray) with other instruments 3,629 grams (8.0 lb) total	4,082 grams (9.0 lb) or 8 handpieces (2 per tray) with other instruments 4,082 grams (9.0 lb) total
Image: Delicate Cycle Type	121°C (250°F)	30 min.	104 kPa(15 psi)	30 min.	• Textiles and surgical packs wrapped for sterilization.3• Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes.	3,629 grams (8.0 lb) or 590 grams (1.3 lb) textile load	4,082 grams (9.0 lb) or 2 packs each @ 590 grams (1.3 lb) textile load
Image: Unwrapped Cycle Type	132°C (270°F)	3 min.	186 kPa(27.1 psi)	30 min.	• Instruments loose on a tray.• Open glass or metal canisters.• Tubing not used in surgical procedures. (Max. length - 40 in and Min. inside diameter - .187 in)• Loose items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes.Note: The sterility of unwrapped items is compromised on exposure to a non-sterile environment.	3,629 grams (8.0 lb)	4,082 grams (9.0 lb)
1 The pressure is absolute. The pressure inside the chamber is the sum of the atmospheric pressure and the pressure shown in this table. The values are included for reference and may not be exact.

The pressures shown in this table are at sea level and a resure of saturated steam at the sterilization temperature The pressures on the sterilizer display may be higher.

Dry time can be changed from 5 to 60 minne can be changed from 1 to 5 minutes.) Refer to Standard Cycle Operation.
Allow a minimum of 6.4 mm (1/4 in) space between each pack and from the chamber wall.
The default dry time may need increased due to variation, wrapping materials and the environment to completely dry the chamber contents at these capacities.

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Image /page/5/Picture/1 description: The image shows the word "midmark" in a sans-serif font. Above the word is a logo consisting of two overlapping shapes. The shape on the left is blue, and the shape on the right is pink. The two shapes together form an "M" shape.

Designing better care."™

Midmark Corporation 60 Vista Drive Versailles, Ohio 45380 1-800-MIDMARK midmark.com

As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR §807.92, a 510(k) summary is provided below with the required information.

Table 1. Administrative Information Date Summary March 28, 2024 Prepared 510(k) Sponsor Midmark Corporation Address 60 Vista Drive Versailles, Ohio 45380 Contact Person Adam Clutter Quality Systems and Regulatory Affairs Manager Email: aclutter@midmark.com Phone: 937-526-8474 Fax: 937-526-8482 Midmark Smart M9® Sterilizer, Trade Name Midmark Smart M11® Sterilizer Common Name Table Top Steam Sterilizer Classification Name 21 CFR §880.6880 Steam sterilizer (Product Code FLE) Device Classification Class II Review Panel General Hospital

1. Administrative Information

2. Equivalent Predicate Comparators

Table 2. Predicate Device
Manufacturer Name	Trade Name	510(k) No.	Decision Date

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Table 2. Predicate Device
Midmark Corporation	Midmark and Ritter M9 and M11UltraClave® Automatic Sterilizers andRitter M9D AutoClave® AutomaticSterilizers	K163337	August 31, 2017

3. Indications for Use

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 reusable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

Standard Cycle Parameters

Cycle Type	TemperatureMinimum	Time	Pressure 1Reference	DryingTime 2	Items to be Sterilized(Always follow the item manufacturer'srecommendationsfor sterilization.)	M9MaximumCapacity 4	M11MaximumCapacity 4
Wrapped	132°C (270°F)	4 min.	186 kPa(27.1 psi)	30 min.	• Pouched or wrapped items manufacturersrecommend for exposure at 132°C (270°F)for 4 minutes.• Wrapped cassettes.• Dental Handpieces (wrapped or unwrapped)	3,629 grams (8.0 lb)or 8 handpieces(2 per tray)with otherinstruments 3,629grams (8.0 lb) total	4,082 grams (9.0 lb)or 8 handpieces(2 per tray)with otherinstruments 4,082grams (9.0 lb) total
Wrapped	135°C (275°F)	3 min.	214 kPa(31 psi)	30 min.	• Pouched or wrapped items manufacturersrecommend for exposure at 135°C (275°F)for 3 minutes.• Wrapped cassettes.• Dental Handpieces (wrapped or unwrapped)	3,629 grams (8.0 lb)or 8 handpieces(2 per tray)with otherinstruments 3,629grams (8.0 lb) total	4,082 grams (9.0 lb)or 8 handpieces(2 per tray)with otherinstruments 4,082grams (9.0 lb) total
Delicate	121°C (250°F)	30 min.	104 kPa(15 psi)	30 min.	• Textiles and surgical packs wrapped forsterilization.3• Items, except liquids, manufacturersrecommend for exposure at 121°C (250°F)for 30 minutes.	3,629 grams (8.0 lb)or590 grams (1.3 lb)textile load	4,082 grams (9.0 lb)or2 packs each @590 grams (1.3 lb)textile load
Unwrapped	132°C (270°F)	3 min.	186 kPa(27.1 psi)	30 min.	• Instruments loose on a tray.• Open glass or metal canisters.• Tubing not used in surgical procedures.(Max. length - 40 in and Min. insidediameter - .187 in)• Loose items manufacturers recommend forexposure at 132°C (270°F) for 3 minutes.Note: The sterility of unwrapped items iscompromised on exposure to a non-sterileenvironment.	3,629 grams (8.0 lb)	4,082 grams (9.0 lb)
1. The pressures shown in this table are at sea level and are for reference only. These are the ideal pressure of saturated steam at the sterilization temperature.The pressures on the sterilizer display may be higher.2. Dry time can be changed from 5 to 60 minutes. (IUSS dry time can be changed from 1 to 5 minutes.) Refer to Standard Cycle Operation.3. Allow a minimum of 6.4 mm (1/4 in) space between each pack and from the chamber wall.4. The default dry time may need increased due to variations in load configuration, wrapping materials and the environment to completely dry the chamber

4. Models

Table 3. Models

Model Name	Model Number	Input Voltage
Midmark Smart M9® Sterilizer	M9-050	115V
Midmark Smart M9® Sterilizer	M9-052	115V
Midmark Smart M11® Sterilizer	M11-050	115V

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Midmark® Smart Sterilizers 510(k) Summary

Table 3. Models
Model Name	Model Number	Input Voltage
	M11-051	230V
	M11-052	115V

5. Device Description

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Midmark® Smart Sterilizers 510(k) Summary

Table 4. Specifications
Specification	Smart M9® Sterilizer	Smart M11® Sterilizer
Physical dimensions:
Overall Length with Plug	20.5 in (52.0 cm)	23.5 in (59.7 cm)
Overall Width	15.8 in (40.1 cm)	17.8 in (45.2 cm)
Overall Height	16.6 in (42.2 cm)	18.6 in (47.2 cm)
Required Support Surface	19.8 in x 23.5 in(50.3 cm x 59.7 cm)	21.8 in x 26.5 in(55.4 cm x 67.3 cm)
Chamber Size	9 in diameter x 15 in deep(22.9 cm x 38.1 cm)	11 in diameter x 18 in deep(27.9 cm x 45.7 cm)
Trays, Large	7-5/16 in x 12 in x 7/8 in(18.6 cm x 30.5 cm x 2.2 cm)	9-1/8 in x 15-1/4 in x 7/8 in(23 cm x 38.7 cm x 2.2 cm)
Trays, Small	5-5/8 in x 12 in x 7/8 in(14.3 cm x 30.5 cm x 2.2 cm)	6-3/4 in x 15-1/4 in x 7/8 in(17 cm x 38.7 cm x 2.2 cm)
Weights:
Weight with Empty Reservoir	82 lb. (37.2 kg)	99 lb. (44.9 kg)
Weight with Shipping Carton	92 lb. (41.7 kg)	131 lb. (59.4 kg)
Water Reservoir Capacity	1.1 gallons (4.1 liters) full,0.6 gallons (2.3 liters) usable	1.4 gallons (5.3 liters) full,0.8 gallons (3.0 liters) usable
Electrical Ratings:
Note: A separate (dedicated) circuit is required for these sterilizers. Sterilizer should not beconnected into an electrical circuit with other appliances or equipment unless circuit is rated forthe additional load.
115 Volt Models	115 VAC, 12 Amp, 50/60 Hz	115 VAC, 12 Amp, 50/60 Hz
230 Volt Models	Not Applicable	230 VAC, 6.4 Amp, 50/60 Hz
Table 4. Specifications
Specification		Smart M9® Sterilizer	Smart M11® Sterilizer
115 VAC	F1	15 Amp, 250 V, Fast Acting,0.250 in Dia. x 1.250 in L(6.35 mm x 31.75 mm)	15 Amp, 250 V, Fast Acting,0.250 in Dia. x 1.250 in L(6.35 mm x 31.75 mm)
	F2	15 Amp, 250 V, Fast Acting,0.250 in Dia. x 1.250 in L(6.35 mm x 31.75 mm)	15 Amp, 250 V, Fast Acting,0.250 in Dia. x 1.250 in L(6.35 mm x 31.75 mm)
	F3	2.5 Amp, 250 V, TimeDelay/Slow-Blow,5.20 mm Dia. x 20.00 mm L(0.205 in x 0.787 in)	2.5 Amp, 250 V, TimeDelay/Slow-Blow,5.20 mm Dia. x 20.00 mm L(0.205 in x 0.787 in)
230 VAC	F1	Not Applicable	8 Amp, 250 V, Fast Acting,5.20 mm Dia. x 20.00 mm L(0.205 in x 0.787 in)
	F2	Not Applicable	8 Amp, 250 V, Fast Acting,5.20 mm Dia. x 20.00 mm L(0.205 in x 0.787 in)
	F3	Not Applicable	2.5 Amp, 250 V, TimeDelay/Slow-Blow,0.250 in Dia. x 1.250 in L(6.35 mm x 31.75 mm)
Safety Valve Setting		43 psi (296 kPa)	43 psi (296 kPa)
Heat Emission		5000 BTU / hr. duringoperation	5000 BTU / hr. duringoperation
Operating Environment:
Ambient Temperature Range		68°F to 104°F (+20°C to +40°C)	68°F to 104°F (+20°C to +40°C)
Relative Humidity		< 80% (non-condensing)
Operating Altitude		< 9842 ft (3000 m) above sea level

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6. Technological Characteristics

Refer to Table 5 for a comparison of Midmark Smart M9® and Smart M11® Sterilizer technological characteristics with those of its predicate. Changes made to the Midmark Smart M9® and Smart M11® Sterilizers do not raise new issues of safety or effectiveness in terms of Indications for Use, design, material, chemical composition, principle of operation, energy source, and performance.

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Characteristic	Subject Device: MidmarkSmart M9® and Smart M11®Sterilizers	Predicate Device:Midmark and Ritter M9 andM11 UltraClave® AutomaticSterilizers	Comparison
510(k)Clearance	K233026	K163337	NotApplicable
RegulationNumber	21 CFR §880.6880 Steamsterilizer	21 CFR §880.6880 Steamsterilizer	Same
Product Code	FLE	FLE	Same
Intended Use	The Midmark Smart M9® andSmart M11® Sterilizers can beused in medical and dentaloffices, hospitals, clinics,nursing homes, laboratories,and other facilities to sterilizeheat and moisture stablereusable items (includingdental handpieces) that arecompatible with steamsterilization. Refer to StandardCycle Parameters for detailedinformation.	The Midmark and Ritter M9,M9D and M11 Steam Sterilizerscan be used in medical anddental offices, hospitals,clinics, nursing homes,laboratories, and otherfacilities to sterilize heat andmoisture stable reusable items(including dentalhandpieces) that arecompatible with steamsterilization. Refer toGuidelines for loading andStandard Cycle Parametersfor detailed information.	Same
Standard CycleParameters	Wrapped 1 Cycle4 min./ 132°C (270°F) / 30 min.	Pouches Cycle4 min./ 132°C (270°F) / 30 min.Handpiece Cycle4 min./ 132°C (270°F) / 30 min.	Same
	Wrapped 2 Cycle3 min./ 135°C (275°F) / 30 min.	Not Available	Different
	Delicate Cycle30 min./ 121°C (250°F) / 30min.	Packs Cycle30 min./ 121°C (250°F) / 30min.	Same
Unwrapped Cycle3 min./ 132°C (270°F) / 30 min.	Unwrapped Cycle3 min./ 132°C (270°F) / 30 min.	Same
Dry Time	5 to 60 minutes.(Immediate Use SteamSterilization dry time can bechanged from 1 to 5 minutes.)	0 to 60 minutes.	Same
Table 5. Predicate Comparison
Characteristic	Subject Device: MidmarkSmart M9® and Smart M11®Sterilizers	Predicate Device:Midmark and Ritter M9 andM11 UltraClave® AutomaticSterilizers	Comparison
Wrapped 1Cycle	3,629 grams (8.0 lb.)or 8 handpieces(2 per tray) with otherinstruments 3,629 grams (8.0lb.) total	8 handpieces with otherinstruments3629 grams (8.0 lb.)	Same
Wrapped 2Cycle	3,629 grams (8.0 lb.)or 8 handpieces (2 per tray)with other instruments 3,629grams (8.0 lb.) total	Not available	Different
Delicate Cycle	3,629 grams (8.0 lb.)or590 grams (1.3 lb.)textile load	4752 cm3(290 in3)	Similar
UnwrappedCycle	3,629 grams (8.0 lb.)	3,629 grams (8.0 lb.)	Same
M11 Maximum Capacity
Wrapped 1Cycle	4,082 grams (9.0 lb.)or 8 handpieces(2 per tray)with otherinstruments 4,082grams (9.0 lb.) total	8 handpieces with otherinstruments4,082 grams (9.0 lb.)	Same
Wrapped 2Cycle	4,082 grams (9.0 lb.)or 8 handpieces(2 per tray)with otherinstruments 4,082grams (9.0 lb.) total	Not Available	Different
Delicate Cycle	4,082 grams (9.0 lb.)or2 packs each @590 grams (1.3 lb.)textile load	505 in3(8275 cm3)	Similar
Table 5. Predicate Comparison
Characteristic	Subject Device: MidmarkSmart M9® and Smart M11®Sterilizers	Predicate Device:Midmark and Ritter M9 andM11 UltraClave® AutomaticSterilizers	Comparison
UnwrappedCycle	4,082 grams (9.0 lb.)	4,082 grams (9.0 lb.)	Same
Controls, Features, and Data Records
Sterilizer Control	Microcontroller basedembedded control	Microcontroller basedembedded control	Same
User Interface	LCD Touch Screen, 5-inch, 800x 480 color displayGlass cover	Membrane switch with LCDdisplay (2 row x 20 character)Polyester overlay	Different
	Operator Alerts	Audible signalsVisual signals via touch screendisplay and a full-width LEDlight bar	Audible signalsVisual signals via LCD display
Data Records		Built-in communicationmodule with wireless andethernet available networkconnections; optional USBthumb drive accessory	Optional add-on Data Loggerwith USB thumb drive;optional thermal printer
Water Fill System	Gravity fill with ChamberWater Level Sensor	Gravity fill with ChamberWater Level Sensor	Same
	Optional autofill solenoid kit	Not available	Different
Reservoir WaterLevel Detection	Visual Indicator	Visual indicator	Same
	PCBA Mounted PressureTransducer	Not included	Different
ChamberPressure Sensor	PCBA Mounted GaugePressure Transducer	PCBA Mounted GaugePressure Transducer	Same
OverpressureProtection	ASME pressure relief valve (43psi)	ASME pressure relief valve (40psi)	Same
OverheatProtection	Dual Auto-Reset Thermostats450°F (232°C)	Dual Auto-Reset Thermostats450°F (232°C)	Same
Door Interlock	Safety rated switch	Safety rated switch	Same
	Pneumatic interlock	Not included	Different
ChamberTemperatureSensor	Platinum RTD	Platinum RTD	Same
Table 5. Predicate Comparison
Characteristic	Subject Device: MidmarkSmart M9® and Smart M11®Sterilizers	Predicate Device:Midmark and Ritter M9 andM11 UltraClave® AutomaticSterilizers	Comparison
Cooling System	Three DC fans	Single AC fan	Different
Other Sensors	PCBA circuitry to monitorvoltage/current, altimeterwith microcontrollerembedded control	Not Included	Different
Dry Cycle	Door Automatically OpensPartially (Motor Driven) whileheater cycled on/off	Door Automatically OpensPartially (Motor Driven) whileheater cycled on/off	Same
Design and Materials
Chamber	Stainless SteelM9 – 9 in. dia. X 15 in. deepM11 - 11 in. dia. x 18 in. deep	Stainless SteelM9 - 9 in. dia. X 15 in. deepM11 - 11 in. dia. x 18 in. deep	Same
Chamber Door	Double HingePainted carbon steel withstainless steel liner	Double HingePainted carbon steel withstainless steel liner	Same
Door Latch	Double bolt latch withAutomatic opening andclosingZinc alloy, stainless steel, andheat-treated carbon steel	Double bolt latch withAutomatic opening andManual closingStainless steel and heat-treated carbon steel	Different
Door Gaskets	High Temperature SiliconRubber	High Temperature SiliconRubber	Same
Door Motor	Low voltage DC poweredgearmotorheat-treated steel geartraindie-cast metal housing	High voltage AC poweredgearmotorheat-treated steel geartraindie-cast metal housing	Different
Standard TrayRack	Formed wire stainless steel	Formed sheet metal stainlesssteel	Similar
Trays	2 small and 2 large wire meshstainless steel trays	2 small and 2 large formedperforated stainless-steel trays	Similar
Water Reservoir	Copolyester plasticM9 - 1.1 gal.M11 - 1.4 gal.	Polyethylene PlasticM9 - 1.1 gal.M11 - 1.4 gal.	Similar
Table 5. Predicate Comparison
Characteristic	Subject Device: MidmarkSmart M9® and Smart M11®Sterilizers	Predicate Device:Midmark and Ritter M9 andM11 UltraClave® AutomaticSterilizers	Comparison
Water Fill Valve	Electronic SolenoidBrass body, stainless steelpiston, Viton seals	Electronic SolenoidBrass body, stainless steelpiston, Viton seals	Same
Heater	Immersion Heater(1360 W nominal, 115V and230V models)Incoloy 800 sheath withstainless steel bulkhead fittings	Immersion Heater(1425 W maximum, 115Vmodels)(1500 W maximum, 230Vmodels)Incoloy 800 sheath withstainless steel bulkhead fittings	Same
Air RemovalValve	Electronic SolenoidBrass body, stainless steelpiston, Viton seals	Electronic SolenoidBrass body, stainless steelpiston, Viton seals	Same
Vent Valve	Electronic SolenoidBrass body, stainless steelpiston, Viton seals	Electronic SolenoidBrass body, stainless steelpiston, Viton seals	Same
Enclosure	Painted carbon steel side andback panels, stainless steelbase, copolyester plastic topand door cover	Painted carbon steel side andback panels, stainless steelbase, polycarbonate plastictop and door cover	Similar

Table 5 Predicate Comparison

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Table 5. Predicate Comparison

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Table 5 Predicate Comparison

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7. Non-clinical Performance Data

Non-clinical evaluations were performed for the Midmark Smart M9® and Smart M 1® Sterilizer. A summary of evaluations and results are shown in the table below. Based on these results of studies performed, the Midmark Smart M9® and Smart M11® Sterilizers do not raise new issues of safety or effectiveness.

Table 6. Non-Clinical Performance Data
Evaluation	Standards Used	Results
Performance	ANSI/AAMI ST55:2016 Table-Top Steam SterilizersFDA Recognition Number 14-518	Passed; the results of theevaluation demonstratecompliance of the deviceto the standards.

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Midmark® Smart Sterilizers 510(k) Summary

Evaluation	Standards Used	Results
Safety	ANSI/UL 61010-1 Third Edition 5/12/2012 / Revised7/19/2019 , Safety Requirements for ElectricalEquipment for Measurement, Control, andLaboratory Use; Part 1: General RequirementsFDA Recognition Number 19-41IEC 61010-2-040:2020 Edition 3.0 SafetyRequirements for Electrical Equipment forMeasurement, Control and Laboratory Use - Part2-040: Particular Requirements for Sterilizers andWasher-Disinfectors Used to Treat MedicalMaterials	Passed; the results of theevaluation demonstratecompliance of the deviceto the standards.
EMC	IEC 60601-1-2 Edition 4.1 2020-09 ConsolidatedVersion Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral Standard:Electromagnetic disturbances - Requirementsand testsFDA Recognition Number 19-36	Passed; the results of theevaluation demonstratecompliance of the deviceto the standards.
Pressure Vessel	American Society of Mechanical Engineers(ASME) Boiler and Pressure Vessel Code, SectionVIII, Division 1: 2023 Edition	Passed; the results of theevaluation demonstratecompliance of the deviceto the standards.

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8. Clinical Performance Data

Clinical data was not required.

9. Conclusion

The results from the nonclinical testing demonstrate that the subject device in submission K233026, the Midmark Smart M9® and Smart M11® Sterilizers are as safe, effective, and perform as well or better than the legally marketed predicate devices Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers (K163337).

Regulation Number and Section

§ 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).