MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER

K990189 · Midmark Corp. · FLE · Apr 19, 1999 · General Hospital

Device Facts

• Record ID: K990189
• Device Name: MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
• Applicant: Midmark Corp.
• Product Code: FLE · General Hospital
• Decision Date: Apr 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Indications for Use

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 Story

Steam sterilizer using saturated steam at high pressure/temperature to kill infectious bio-organisms. Electric heating element generates steam within chamber. Electronic control system manages pre-programmed cycles (Unwrapped, Pouches, Liquids, Packs) based on time, temperature, and pressure. Operator selects cycle and initiates via switch; device automatically fills, heats, sterilizes, vents, and cools. Used in clinical/laboratory settings by healthcare staff. Output is sterilized equipment; ensures instrument sterility for patient safety. Dental handpiece sterilization validated via specific test protocol.

Clinical Evidence

Bench testing only. Validation protocol performed to evaluate the M-11's ability to sterilize commercially available dental handpieces as a worst-case challenge, confirming acceptable sterility assurance levels (SAL).

Technological Characteristics

Steam sterilizer; electric heating element; electronic control system. Operates via saturated steam at 121°C-132°C and 104-186 kPa. Cycles: Unwrapped, Pouches, Liquids, Packs. No differences from predicate device.

Indications for Use

Indicated for sterilization of heat- and moisture-stable, reusable equipment in medical/dental offices, hospitals, clinics, nursing homes, and laboratories. Includes dental handpieces. Not for liquids intended for direct patient contact.

Regulatory Classification

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.

Predicate Devices

• Midmark M-11 Ultraclave Steam Sterilizer (K936181)

Submission Summary (Full Text)

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K 998189

h) 510(k) SUMMARY ・ The information required by 21 CFR § 807.92 is listed below.

| Submitter: | Midmark Corporation<br>60 Vista Drive<br>Versailles, OH 45380<br>[phone] | | | | | | |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------|---------|------------------|-----------------|--------------------------|
| Contact Person: | James Rile, Regulatory Coordinator<br>[phone] | | | | | | |
| Date Submitted: | January 15, 1999 | | | | | | |
| Device Names: | <table><tr><td>Proprietary:</td><td>Midmark M-11 Ultraclave Steam Sterilizer</td></tr><tr><td>Common:</td><td>Steam Sterilizer</td></tr><tr><td>Classification:</td><td>80FLE: Sterilizer, Steam</td></tr></table> | 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:

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.

| 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:

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

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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<br>(minimums) | Items to be Sterilized<br>(Always consult the item manufacturer's recommendations for<br>sterilization.) |
|-----------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unwrapped | 132°C (270°F)/<br>186 kPa (27 psi)<br>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)/<br>186 kPa (27 psi)<br>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)/<br>104 kPa (15 psi)<br>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)/<br>104 kPa (15 psi)<br>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

10

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

| Cycle | Temp/Press/Time (minimums) | Items to be Sterilized (Always consult the item manufacturer's recommendations for sterilization.) |
|-----------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unwrapped | 132°C (270°F)/<br>186 kPa (27 psi)<br>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)/<br>186 kPa (27 psi)<br>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)/<br>104 kPa (15 psi)<br>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)/<br>104 kPa (15 psi)<br>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

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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)