The M-11 UltraClave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat- and moisturestable, reusable equipment. Dental handpieces can be sterilized in the M-11 in the Pouches cycle. This device is not recommended for sterilization of liquids intended for direct patient contact. Refer to Standard Cycle Parameters below for detailed information.

Device Description

The Midmark M-11 Ultraclave Steam Sterilizer uses saturated steam at high pressures and temperatures and 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, summarized below.

AI/ML Overview

The provided text describes a steam sterilizer, not an AI/ML powered device, so many of the requested fields are not applicable. However, I can extract the relevant information regarding the device's acceptance criteria and the study performed to meet those criteria.

Acceptance Criteria and Reported Device Performance

The device is a steam sterilizer, and its core function is to sterilize items according to established time, temperature, and pressure parameters. The key acceptance criterion is the ability to sterilize items to an acceptable Sterility Assurance Level (SAL).

The relevant "performance" here is defined by meeting these parameters for various cycles, and crucially, for the newly added indication for dental handpieces.

Cycle	Temperature	Pressure	Time	Items to be Sterilized
Unwrapped	132°C (270°F)	186 kPa (27 psi)	3 Minutes	Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment.
Pouches	132°C (270°F)	186 kPa (27 psi)	15 Minutes	Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 15 minutes.
Liquids	121°C (250°F)	104 kPa (15 psi)	30 Minutes	Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions. Not recommended for sterilization of liquids intended for direct patient contact.
Packs	121°C (250°F)	104 kPa (15 psi)	30 Minutes	Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes.

Study Proving Device Meets Acceptance Criteria

Midmark developed a new test protocol specifically to validate sterility claims for dental handpieces.

Sample size used for the test set and the data provenance: The document states that the protocol was designed to evaluate the M-11's ability to sterilize commercially available dental handpieces, "when presented as a worst-case challenge." It does not specify the exact number of handpieces or test runs, nor does it explicitly state the country of origin. The test was conducted by Midmark, implying internal, prospective testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. This is a sterilizer, so "ground truth" would be established through microbiological testing (e.g., spore-kill assays), not expert review of images. The document does not specify the experts involved in the testing, but it would typically be microbiologists or sterilization validation specialists.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations (like medical image diagnosis), not for objective sterility testing.
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-powered device, nor does it involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "study" described is a standalone performance validation of the sterilizer itself (algorithm only in the sense of the sterilizer's pre-programmed cycles).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for sterility is the absence of viable microorganisms to a scientifically accepted Sterility Assurance Level (SAL), typically 10^-6. This is established through microbiological testing using biological indicators (spore strips) placed in the most challenging locations and subsequent culture. The document states "The resulting testing showed that, when used in accordance with Midmark's directions for use, the M-11 can sterilize dental handpieces to an acceptable SAL."
The sample size for the training set: Not applicable. There is no training set for a mechanical sterilizer; it operates based on pre-programmed physical parameters.
How the ground truth for the training set was established: Not applicable.

Summary

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K 998189

h) 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:	James Rile, Regulatory Coordinator(937) 526-8797
Date Submitted:	January 15, 1999
Device Names:	Proprietary:Midmark M-11 Ultraclave Steam SterilizerCommon:Steam SterilizerClassification:80FLE: Sterilizer, Steam	Proprietary:	Midmark M-11 Ultraclave Steam Sterilizer	Common:	Steam Sterilizer	Classification:	80FLE: Sterilizer, Steam
Proprietary:	Midmark M-11 Ultraclave Steam Sterilizer
Common:	Steam Sterilizer
Classification:	80FLE: Sterilizer, Steam

Device to which the Midmark M-11 Ultraclave Steam Sterilizer with dental handpiece indications for use claims equivalence:

Midmark M-11 Ultraclave Steam Sterilizer, cleared for marketing 11/30/94 on K936181

Device Description:

CYCLE	TEMPERATURE	PRESSURE	TIME
Unwrapped	132° C (270° F)	186 kPa (27 psi)	3 Minutes
Pouches	132° C (270° F)	186 kPa (27 psi)	15 Minutes
Liquids	121° C (250° F)	104 kPa (15 psi)	30 Minutes
Packs	121° C (250° F)	104 kPa (15 psi)	30 Minutes

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

Intended Use:

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direct patient contact. Refer to Standard Cycle Parameters below for detailed information.

Indications for Use:

Standard Cycle Parameters

Cycle	Temp/Press/Time(minimums)	Items to be Sterilized(Always consult the item manufacturer's recommendations forsterilization.)
Unwrapped	132°C (270°F)/186 kPa (27 psi)3 minutes	Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment.
Pouches	132°C (270°F)/186 kPa (27 psi)15 minutes	Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 15 minutes.
Liquids	121°C (250°F)/104 kPa (15 psi)30 minutes	Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions. Not recommended for sterilization of liquids intended for direct patient contact.
Packs	121°C (250°F)/104 kPa (15 psi)30 minutes	Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes.

To validate sterility claims for dental handpieces, which were not included in the predicate devices indications for use when it was cleared by the FDA, Midmark developed a new test protocol for the M-11. This protocol was designed to evaluate the M-11's ability to sterilize commercially available dental handpieces, when presented as a worst-case challenge. The resulting testing showed that, when used in accordance with Midmark's directions for use, the M-11 can sterilize dental handpieces to an acceptable SAL.

Technological Characteristics that differ between the Midmark M-11 Ultraclave Steam Sterilizer and its predicate device:

None. The intended use, principles of operation, physical design, control system, safeguards, energy sources, target population, materials of construction, method of manufacture, and performance are the same for the proposed device and its predicate.

(Division Sign-off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number

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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 consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 1999

Mr. James Rile Regulatory Coordinator Midmark Corporation 60 Vista Drive Versailles, Ohio 45380

Re : K990189 Modification Of: Midmark M-11 Ultraclave Trade Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: January 15, 1999 January 20, 1999 Received:

Dear Mr. Rile:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Rile

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours, liferan

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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i) STATEMENT OF INDICATIONS FOR USE: KGG C 189

Midmark Corporation Applicant:

Midmark M-11 Ultraclave Steam Sterilizer Device Name:

Indications for Use:

Cycle	Temp/Press/Time (minimums)	Items to be Sterilized (Always consult the item manufacturer's recommendations for sterilization.)
Unwrapped	132°C (270°F)/186 kPa (27 psi)3 minutes	Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment.
Pouches	132°C (270°F)/186 kPa (27 psi)15 minutes	Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 15 minutes.
Liquids	121°C (250°F)/104 kPa (15 psi)30 minutes	Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions. Not recommended for sterilization of liquids intended for direct patient contact.
Packs	121°C (250°F)/104 kPa (15 psi)30 minutes	Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes.

Standard Cycle Parameters

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chine S. Lin

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

Optional Format 1-2-96)

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).