The Midmark M3 UltraFast™ Automatic Sterilizer can be used in medical, dental, and veterinary 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, in Table-1, on the following page, for detailed information:

Device Description

The M3 UltraFast™ Automatic Sterilizer is a small table-top steam sterilizer that uses saturated steam at high temperature and pressure to kill infectious bio-organisms.

The device is composed of a water reservoir, an oscillatory pump, a small electric boiler, an ASME certified pressure vessel, surface heaters for drying, a removable door/tray assembly, an electric gear motor for opening and closing the door/tray, and a solenoid valve for venting. The action of all of these components is coordinated by an integral proprietary design electronic control system, which includes a PC board, an LCD display, and a user interface membrane switch. The entire device is enclosed by a plastic and steel case. External to this device is a condensation tank, which is connected to the back of the unit, via a plastic tube.

Three different fully automatic pre-programmed sterilization cycles with parameters specific to the different load characteristics provide fast and easy use for efficient instrument processing. This sterilizer provides both audible and visual notification upon cycle completion and will dry the load in accordance with the CDC guidelines. A programmable dry cycle allows the user to customize the dry times from 20-60 minutes. This sterilizer has integrated technology to let the operator know if they have low water in the reservoir, or a full external condensing tank eliminating the need to continually monitor water levels.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Midmark M3 UltraFast™ Automatic Sterilizer are a Sterility Assurance Level (SAL) of 10⁻⁶ for all three sterilization cycles. The reported device performance demonstrates that the device successfully meets this criterion for each cycle.

Acceptance Criteria (Sterility Assurance Level - SAL)	Reported Device Performance
Unwrapped Cycle: 10⁻⁶	Validated to a SAL of 10⁻⁶ for the Unwrapped Cycle
Pouches Cycle: 10⁻⁶	Validated to a SAL of 10⁻⁶ for the Pouches Cycle
Low Temp Cycle: 10⁻⁶	Validated to a SAL of 10⁻⁶ for the Low Temp Cycle
Thermal Conditions	Achieves and maintains steady state thermal conditions
Total Kill Endpoint Time	Established as a starting point for cycle development

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific "sample size" in terms of number of sterilization runs for the test set. However, it mentions "Repetitive testing" for the validation of each cycle, implying multiple runs were conducted.

The data provenance indicates that the studies were conducted by a "third party, SPSmedical Supply Corporation," on behalf of Midmark Corp. This suggests an independent laboratory performed the testing. The country of origin of the data is not specified, but given the submission to the FDA, it is highly likely to be the United States. The studies are prospective in nature, as they involve actively testing the device's performance to establish its efficacy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The ground truth for sterilization efficacy (total kill endpoint and sterility assurance level) is established through standardized microbiological testing using biological indicators (Geobacillus stearothermophilus spores) rather than human expert opinion. Therefore, the concept of "experts" in the traditional sense of medical image interpretation (e.g., radiologists) is not applicable here. The experts involved would be microbiologists and validation scientists from SPSmedical Supply Corporation, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set:

Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of data where consensus is needed (e.g., image reading). This is not relevant for the type of testing performed for a sterilizer. The "adjudication" is based on objective scientific criteria: the complete kill of a specified number of bacterial spores, as measured by microbiological techniques, to achieve a defined Sterility Assurance Level (SAL).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate the diagnostic performance of human readers, typically in medical imaging, and are not applicable to the performance evaluation of a sterilizer. The device's effectiveness is measured against objective microbiological and thermal criteria, not against human interpretation performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies conducted were standalone performance evaluations of the Midmark M3 UltraFast™ Automatic Sterilizer. The tests focused solely on the device's ability to achieve sterilization without human intervention during the sterilization cycle itself. The device is an automatic sterilizer, performing its function independently once initiated.

7. The Type of Ground Truth Used:

The ground truth used for the sterilizer's performance evaluation is microbiologically established sterility, specifically a 10⁻⁶ Sterility Assurance Level (SAL), based on the complete inactivation of Geobacillus stearothermophilus spores.

This includes:

Biological Indicators: The use of Geobacillus stearothermophilus spores as a challenge organism. The "total kill endpoint study" directly measures the time required to inactivate these spores.
Thermal Profiles: Measurement of temperature throughout the chamber to ensure consistent thermal conditions.
Validation of Sterilization Cycles: Confirmation that specific cycles (Unwrapped, Pouches, Low Temp) consistently achieve the desired SAL under defined load conditions.

8. The Sample Size for the Training Set:

This information is not applicable to this type of device and study. "Training set" refers to data used to train a machine learning algorithm. The Midmark M3 UltraFast™ Automatic Sterilizer is a physical device, not an AI or software algorithm. Its performance is validated through defined testing protocols, not through a training/testing split of a dataset.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no "training set" for a physical sterilizer device. The device's operational parameters (e.g., temperature, pressure, time for each cycle) are designed and engineered by Midmark based on scientific principles of steam sterilization and validated through the performance studies described in the document.

Summary

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JUL - 7 2009

Midmark M3 UltraFast™ Automatic Sterilizer

Midmark Corporation M3 UltraFast™ Automatic Sterilizer FDA 510(k) Submittal 510(k) Summarv

Image /page/0/Picture/3 description: The image is a logo for Midmark. The logo is white text on a black background. The text says "MIDMARK" with a registered trademark symbol next to it. There is a white swoosh above the text.

The information required by 21 CFR § 807.92 is listed below:

Submitter:

Midmark Corporation 60 Vista Drive PO Box 286 Versailles, OH 45380-0286

Contact Persons:

Gary Benning R & D Engineer, Dental New Product Development Phone: (937) 526-8357 Fax: (937) 526-8316 Email: gbenning@midmark.com

Gene Harshbarger Regulatory and Quality Systems Manager Phone: (937) 526-8297 Fax: (937) 526-8316 Email: gharshbarger@midmark.com

Date Submitted:

Device Names:

Ch. 1 Introduction

Claimed Equivalence:

Claimed equivalence w/ respect to performance w/ similar cycle parameters:

Company: Product: 510(k):

10Mar2009

Proprietary: Common:

Company:

Product:

510(k):

SciCan, Inc. STATIM 7000 K072466

Steam Sterilizer

Classification: FLE: Sterilizer, Steam

SciCan, Inc.

K915054

STATIM 2000

Device Description:

The M3 UltraFast™ Automatic Sterilizer is a small table-top steam sterilizer that uses saturated steam at high temperature and pressure to kill infectious bio-organisms.

Midmark Corporation M3 UltraFast™ Automatic Sterilizer FDA 510(k) Submittal

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action of all of these components is coordinated by an integral proprietary design electronic control system, which includes a PC board, an LCD display, and a user interface membrane switch. The entire device is enclosed by a plastic and steel case. External to this device is a condensation tank, which is connected to the back of the unit, via a plastic tube,

Intended Use:

Differences in Intended Use from Predicate Devices:

The Midmark M3 UltraFast™ Automatic Sterilizer has three standard sterilization cycles, and all three of these cycles are capable of sterilizing dental handpieces (validated by third party efficacy testing). This differs from the predicate devices, the SciCan STATIM 2000 and STATIM 7000, which only have two of their three standard cycles approved for use with dental handpieces.

This difference in intended use does not affect the safety or effectiveness of the Midmark M3 UltraFast™ when used as labeled.

Technological Comparisons:

The design of the Midmark M3 UltraFast™ differs from the predicate device, the SciCan STATIM 2000, in two key areas: The pressure vessel, and the method of drying.

1. Pressure Vessel: (This difference also applies to the STATIM 7000 also)
- The predicate device, the STATIM 2000, pressure vessel has an integral bulkhead for containing the forces generated by the steam. However, the liner of the pressure vessel responsible for containing the fluids (in their words, the "cassette") is removable. The operator, when loading and unloading the "cassette" full of instruments is actually inserting and removing the liner of the pressure vessel. Furthermore, this "cassette" is like a small metallic briefcase that the operator manually inserts into, and removes from, the unit.

Like the SciCan STATIM 2000, the Midmark M3 UltraFast™'s pressure vessel is rectangular. However, unlike the STATIM 2000, five of the six walls of the pressure

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vessel are integral to the M3 UltraFast™, with the door, or sixth wall, being removable. A light tray constructed of formed sheet metal is attached to this door. The operator loads the tray with items to be sterilized, and slides this door/tray assembly into the pressure vessel. Once a cycle is initiated, the unit automatically closes the door, via set of claws that are attached to the bulkhead and that engage the door/tray assembly. This fixes the door tightly to the pressure vessel. Once sterilization has ended, the unit automatically opens the door, again by action of the claws attached to the bulkhead.

It should be noted here that the Midmark M3 UltraFast™'s pressure vessel meets the requirements of the current ASME Boiler and Pressure Vessel Code Section VIII, Division 1 and is stamped as such. The SciCan STATIM 2000 pressure vess clic, not currently certified to the ASME Boiler and Pressure Vessel Code.

2. Method of Drying:

At the end of a sterilization cycle, when the steam has been vented from the chamber, the predicate device, the SciCan STATIM 2000, begins drying its sterilized contents via an air pump arrangement which intakes air through a filter, pushes it through a boiler for warmth, then into the "cassette", and out through the tube that leads to the external condensation tank.

By contrast, the Midmark M3 UltraFast™ has thin surface heaters attached to the outside of the integral pressure vessel which can warm the inside of the pressure vessel. Because the removable door of the M3 UltraFast™ is automatically opened and closed at the end of sterilization, the chamber can be opened to the outside atmosphere. This combination of warming the chamber with a clear path for moisture to escape is a very effective method for drying the sterile load.

Because of these design differences – that the M3 UltraFast™ has an automatic door opening mechanism, as opposed to a removable liner; that the M3 UltraFast™ uses surface heaters to dry the load, as opposed to forced air - the safeguards, physical design, and control systems see necessarily different from one another. However, the general performance of the two devices (the STATIM 2000 and the M3 UltraFast™) once the chamber is closed, and through sterilization is nearly identical to one another.

Non-Clinical Performance Data Summaries:

There are many similarities between the Midmark M3 UltraFast™ steam sterilizer, and its predicate devices, the SciCan STATIM 2000 and STATIM 7000, including its effectiveness at neutralizing micro-organisms.

In support of this claim, five studies were conducted on behalf of Midmark Corp. by a third party, SPSmedical Supply Corporation. These were:

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1. A thermal profile of the chamber during normal operation
A total kill endpoint study using a micro-organism 2.
Validation of the Unwrapped Cycle (Efficacy Test) 3.
Validation of the Pouches Cycle (Efficacy Test) র্ব .
Validation of the Low Temp Cycle (Efficacy Test) 5.

The data for these tests are included in the 510(k) materials, proper. However, a brief summary of the results are submitted for your inspection:

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1. Thermal Profile Study (SPS Document # 0604-46):

Test Objective: To demonstrate that steady state thermal conditions are maintained when using the Midmark M3 UltraFast™ Sterilizer

The results of thermal profile testing demonstrate that the Midmark M3 UltraFast™ Sterilizer can achieve and maintain steady state thermal conditions throughout all three preset cycles.

Total Kill Endpoint Testing (SPS Document # 0604-45): 2.

Test Objective: To demonstrate the total kill endpoint time of Geobacillus stearothermophilus spores when exposed to the Midmark M3 UltraFast™ Sterilizer. This data will be used for the development of the Unwrapped, Pouches, and Low Temp cycles.

The results of this test were meant to serve as a starting point for development of the validation of the three preset cycles. Based on the results of this study, validation testing for the unwrapped cycle started with the following parameters:

Temperature: Half-Cycle Time: Configuration: Maximum Load:

132°C (270°F) 1.75 minutes Unwrapped 2.4 lbs. (1.09 kg)

3. Unwrapped Cycle Validation (SPS Document # 0604-47):

Test Objective: To validate the Midmark M3 UltraFast™ Sterilizer Unwrapped Cycle for a 106 Sterility Assurance Level (SAL),

Based on the results of this study, the Midmark M3 UltraFast™ Sterilizer is validated to a sterility assurance level (SAL) of 106 for the Unwrapped Cycle. Repetitive testing has shown the following full cycle parameters to be safe and effective when sterilizing loads of no more than 2.4 lbs., including handpieces;

Cycle Description:	Unwrapped
Temperature:	132°C (270°F)
Sterilization Time:	3.5 minutes

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4. Pouches Cycle Validation (SPS Document # 0604-48):

Test Objective: To validate the Midmark M3 UltraFast™ Sterilizer Pouches Cycle for a 10-6 Sterility Assurance Level (SAL).

Based on the results of this study, the Midmark M3 UltraFast™ Sterilizer is validated to a sterility assurance level (SAL) of 106 for the Pouches Cycle. Repetitive testing has shown the following full cycle parameters to be safe and effective when sterilizing loads of no more than 2.4 lbs., including handpieces wrapped in a cassette:

Cycle Description:	Pouches
Temperature:	132°C (270°F)
Sterilization Time:	5.5 minutes

1. Low Temp Cycle Validation (SPS Document # 0604-49):
  Test Objective: To validate the Midmark M3 UltraFast™ Sterilizer Low Temp Cycle for a 10th Sterility Assurance Level (SAL).

Based on the results of this study, the Midmark M3 UltraFast™ Sterilizer is validated to a sterility assurance level (SAL) of 106 for the Low Temp Cycle. Repetitive testing has shown the following full cycle parameters to be safe and effective when sterilizing loads of no more than 2.4 Ibs., including handpieces wrapped in a cassette:

Cycle Description: Low Temp Temperature: 121°C (250°F) Sterilization Time: 20 minutes

Performance Data Conclusions:

The Midmark M3 UltraFast™ Automatic Sterilizer has been independently proven to be capable of sterilizing a mixed load, no greater than 2.4 lbs., including handpieces, when used according to its labeling, and intended use statement.

The differences between the Midmark M3 UltraFast™, and its predicate devices, the SciCan STATIM 2000 and STATIM 7000 represent product improvements. The M3 UltraFast™ is as safe and effective, and performs as well or better than the SciCan STATIM 2000 and STATIM 7000.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3002009

Midmark Corporation C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K090670

Trade/Device Name: Midmark M3 UltraFast™ Automatic Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: June 26, 2009 Received: July 1, 2009

Dear Mr. Kogoma:

This letter corrects our substantially equivalent letter of July 7, 2009.

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 (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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.

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Page 2- Mr. Kogoma

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Antara C. nutta

Susan Runner, DDS, MA Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ¥096670

Device Name: _ Midmark M3 UltraFast™ Automatic Sterilizer

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A Murphy

(Division Sign-Off) Tivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K090670

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	Sterilization	Dry
Cycle	Parameters	Time	Items to be Sterilized
Image: Unwrapped	Temperature:270°F(132°C)Pressure:27.1 PSI(186 kPa)Time:3:30 minutes	Time:40:00 minutes	● Dental instruments / handpieces loose on a trayor in an unwrapped cassette.● Other items manufacturers recommend forexposure at 270°F (132°C), loose on tray or in anunwrapped cassette.
Image: Pouches	Temperature:270°F(132°C)Pressure:27.1 PSI(186 kPa)Time:5:30 minutes	Time:40:00 minutes	● Dental instruments / handpieces in pouches,wrapped, or in a wrapped cassette.● Items manufacturers recommend for exposure at270°F (132°C), in pouches, wrapped, or in awrapped cassette.
Image: Low Temp	Temperature:250°F(121°C)Pressure:15.0 PSI(104 kPa)Time:20:00 minutes	Time:60:00 min.	● Rubber or plastic dental devices, dentalinstruments / handpieces loose on tray, inpouch, wrapped, or in a wrapped or unwrappedcassette.● Items manufacturers recommend for exposure at250°F (121° C), loose on tray, in pouches,wrapped, or in a wrapped or unwrapped cassette.

Table-1: M3's Intended Use: Cycles and Load Types

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).