The M9 UltraClave™ is intended to 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 on the following page for detailed information.

Device Description

The Midmark M9 UltraClave™ Steam Sterilizer uses saturated steam at high pressures and temperatures to kill infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature, and pressure parameters.

Items to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle, and presses the appropriate switch. The sterilizer automatically admits a controlled volume of water to the chamber, heats the water into steam, sterilizes the items, and automatically vents the steam and dries the items after sterilization is complete.

AI/ML Overview

The provided documentation describes the Midmark M9 UltraClave™ Steam Sterilizer. This device is a sterilizer, not an AI/ML powered diagnostic device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable.

The "acceptance criteria" for this device are its "Standard Cycle Parameters" which define the time and temperature minimums for various types of sterilization programs. The "study that proves the device meets the acceptance criteria" is implicitly the general validation and testing undertaken by Midmark Corporation to demonstrate its sterilizing capabilities, as inferred by its 510(k) clearance by the FDA. The document states that "the M9 UltraClave™ meets performance standards that the predicate device does not," implying that internal testing was conducted.

However, detailed information on how performance was measured, including specific sample sizes, a detailed test protocol, or explicit statistical results is not present in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

Program	Acceptance Criteria (Minimums)	Reported Device Performance (Implied by design and 510(k) clearance)
Unwrapped	Temperature: 270° F (132° C), Time: 3 minutes	Meets or exceeds these parameters to achieve sterilization.
Pouches	Temperature: 270° F (132° C), Time: 6 minutes	Meets or exceeds these parameters to achieve sterilization.
Packs	Temperature: 250° F (121° C), Time: 30 minutes	Meets or exceeds these parameters to achieve sterilization.
Handpieces	Temperature: 270° F (132° C), Time: 6 minutes	Meets or exceeds these parameters to achieve sterilization.
Programmable 1 & 2	User defined: Temp 230°-275° F (110°-135° C), Time 3-90 min	Operates within user-defined parameters, ensuring proper coordination of time and temperature for effective sterilization (within 250°-275°F range for sterilization).

2. Sample size used for the test set and the data provenance: Not applicable for this type of device (sterilizer). The "test set" would be various sterilization loads and cycles, but detailed data on the size or provenance of these internal tests is not provided in the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer is based on the inactivation of microorganisms, which is evaluated through established microbiological testing protocols rather than expert human interpretation.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone device in the sense that it performs sterilization cycles automatically, but it is not an algorithm-only device. Its performance is measured directly (e.g., against biological indicators, temperature/pressure sensors) rather than through comparison to human interpretation.

7. The type of ground truth used: The ground truth for sterilizers is based on the inactivation of resistant microorganisms (e.g., bacterial spores) under defined conditions. This is typically assessed using biological indicators (e.g., Geobacillus stearothermophilus spores) during validation studies, along with chemical indicators and physical monitoring of temperature, pressure, and time.

8. The sample size for the training set: Not applicable. This device does not use a training set in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable.

Summary

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Ko23348

MAR 0 3 2003

Image /page/0/Picture/2 description: The image shows the word "MIDMARK" in all capital letters. The letters are bold and black. There is a registered trademark symbol to the right of the letter "K".

510(k) SUMMARY

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

Submitter:	Midmark Corporation60 Vista DriveVersailles, OH 45380(800) 633-0508
Contact Person:	Gene HarshbargerRegulatory & Quality Systems Administrator(937) 526-8297Fax: (937) 526-8316
Date Submitted:	10/2/02	M9-20X
Device Names:	Proprietary:	Midmark M9 UltraClave™ Steam Sterilizer
	Common:	Steam Sterilizer
	Classification:	80FLE: Sterilizer, Steam

Device to which the Midmark M9 UltraClave™ Steam Sterilizer claims equivalence: Midmark M-11 UltraClave Steam Sterilizer with dental handpiece indications for use, cleared for marketing 4/19/99 on K990189

Device Description:

Intended Use:

Pg.12 of 16

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PROGRAM	TEMP.(minimums)	TIME(minimums)	ITEMS TO BE STERILIZED(Always consult the item manufacturer'srecommendations for sterilization.)
Unwrapped	270° F (132° C)	3 minutes	• Instruments loose on a tray.• Open glass or metal canisters.• Tubing not used in surgical procedures.• Loose items manufacturers recommendfor exposure at 270°F (132°C).
Pouches	270° F (132° C)	6 minutes	• Pouched or loosely wrapped instruments.• Multiple layers of instruments separated byfabric.• Wrapped trays of loose instruments.• Tubing not used in surgical procedures.• Wrapped items manufacturers recommendfor exposure at 270°F (132°C).
Packs	250°F (121° C)	30 minutes	• Textiles and surgical packs wrapped forsterilization.• Items, except liquids, manufacturersrecommend for exposure at 250°F (121°C)for 30 minutes.
Handpieces	270° F (132° C)	6 minutes	• Dental handpieces• Other complex lumened devices,manufacturers recommend for exposureat 270° F (132° C)
Programmable1&Programmable2	User defined230° F to 275° F(110° C to 135° C)	User defined3 min. to 90 min.	• Items appropriate for the user definedparametersCAUTION: All material run in these cyclesmust be validated by the user. Theseprogrammable functions allow you to setdifferent time and temperature parameters.It is important to properly coordinatesterilization temperature with cycle time.Permitted temperature range for propersterilization is 250°-275°F (121°-135°C).Temperatures below 250°F (121°C) should

Standard Cycle Parameters

Technological Characteristics Comparison:

The intended use, principles of operation, safeguards, energy sources, target population, and performance are the same for the proposed device and its predicate.

The physical design, control system, materials of construction, and method of manufacture differ slightly from the predicate device. The most significant difference is the use of an electronic air valve on the M9 UltraClave™ in place of the mechanical steam trap used on the predicate device to remove air from the chamber. This change allows for enhanced removal of air from the chamber. The electronic air valve is controlled via the embedded control system in response to the actual chamber conditions sensed by the temperature and pressure inputs. Thus, the air valve can be operated during the warm-up cycle as needed to remove air escaping from the sterilizer load late in the warm-up cycle to create a more ideal saturated steam environment. Both devices are designed to the appropriate industrial standards, and the M9 UltraClave™ meets performance standards that the predicate device does not.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract human figure, represented by three curved lines, with the head facing to the right.

Public Health Service

MAR 0 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gene Harshbarger Regulatory & Ouality Systems Administrator Midmark Corporation 60 Vista Drive Versailles, Ohio 45380

Re: K023348

Trade/Device Name: Midmark M9 UltraClave™ Steam Sterilizer (M9-02X) Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: January 6, 2003 Received: January 7, 2003

Dear Mr. Harshbarger:

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 application (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 such 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. Harshbarger

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runser

Susan Runner, DDS, MA Interim 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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STATEMENT OF INDICATIONS FOR USE

510(k) Number: K023348

Device Name: Midmark M9 UltraClave™ Steam Sterilizer

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Quim S. Lin

Infection Control, &
510(k) Number: K023348

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PROGRAM	TEMP.(minimums)	TIME(minimums)	ITEMS TO BE STERILIZED(Always consult the item manufacturer'srecommendations for sterilization.)
Unwrapped	270° F (132° C)	3 minutes	· Instruments loose on a tray.· Open glass or metal canisters.· Tubing not used in surgical procedures.· Loose items manufacturers recommendfor exposure at 270°F (132°C).
Pouches	270° F (132° C)	6 minutes	· Pouched or loosely wrapped instruments.· Multiple layers of instruments separated byfabric.· Wrapped trays of loose instruments.· Tubing not used in surgical procedures.· Wrapped items manufacturers recommendfor exposure at 270°F (132°C).
Packs	250° F (121° C)	30 minutes	· Textiles and surgical packs wrapped forsterilization.· Items, except liquids, manufacturersrecommend for exposure at 250°F (121°C)for 30 minutes.
Handpieces	270° F (132° C)	6 minutes	· Dental handpieces· Other complex lumened devices,manufacturers recommend for exposureat 270° F (132° C)
Programmable1	User defined230° F to 275° F(110° C to 135° C)	User defined3 min. to 90 min.	· Items appropriate for the user definedparametersCAUTION: All material run in these cyclesmust be validated by the user. Theseprogrammable functions allow you to setdifferent time and temperature parameters.It is important to properly coordinatesterilization temperature with cycle time.Permitted temperature range for propersterilization is 250°-275° F (121°-135° C).Temperatures below 250°F (121°C) shouldonly be used for disinfection.
Programmable2	User defined230° F to 275° F(110° C to 135° C)	User defined3 min. to 90 min.	· Items appropriate for the user definedparametersCAUTION: All material run in these cyclesmust be validated by the user. Theseprogrammable functions allow you to setdifferent time and temperature parameters.It is important to properly coordinatesterilization temperature with cycle time.Permitted temperature range for propersterilization is 250°-275° F (121°-135° C).Temperatures below 250°F (121°C) shouldonly be used for disinfection.

Standard Cycle Parameters

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).