MIDMARK M9 ULTRACLAVE STEAM STERILIZER

K023348 · Midmark Corp. · FLE · Mar 3, 2003 · General Hospital

Device Facts

• Record ID: K023348
• Device Name: MIDMARK M9 ULTRACLAVE STEAM STERILIZER
• Applicant: Midmark Corp.
• Product Code: FLE · General Hospital
• Decision Date: Mar 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

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 Story

Steam sterilizer for medical/dental offices; uses electric heating element to generate saturated steam in chamber. Operator selects cycle; device automatically admits water, heats to steam, sterilizes, vents, and dries. Features electronic air valve controlled by embedded system using temperature/pressure inputs to optimize air removal during warm-up. Output is sterilized instruments/devices. Benefits patient by ensuring reusable items are free of infectious bio-organisms.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Steam sterilizer; electric heating element; electronic control system; electronic air valve for air removal; temperature and pressure sensors; sterilization chamber; dimensions/form factor not specified; standalone operation; steam sterilization method.

Indications for Use

Indicated for sterilization of heat and moisture stable reusable items, including dental handpieces and complex lumened devices, in medical, dental, and laboratory settings. Contraindicated for items not compatible with steam sterilization or liquids.

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 (K990189)

Submission Summary (Full Text)

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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 Corporation<br>60 Vista Drive<br>Versailles, OH 45380<br>[phone] | |
|-----------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Contact Person: | Gene Harshbarger<br>Regulatory & Quality Systems Administrator<br>[phone]<br>Fax: [phone] | |
| 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:

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.

### Intended Use:

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.

Pg.12 of 16

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| PROGRAM | TEMP.<br>(minimums) | TIME<br>(minimums) | ITEMS TO BE STERILIZED<br>(Always consult the item manufacturer's<br>recommendations for sterilization.) |
|---------------------------------------------|--------------------------------------------------------|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unwrapped | 270° F (132° C) | 3 minutes | • Instruments loose on a tray.<br>• Open glass or metal canisters.<br>• Tubing not used in surgical procedures.<br>• Loose items manufacturers recommend<br>for exposure at 270°F (132°C). |
| Pouches | 270° F (132° C) | 6 minutes | • Pouched or loosely wrapped instruments.<br>• Multiple layers of instruments separated by<br>fabric.<br>• Wrapped trays of loose instruments.<br>• Tubing not used in surgical procedures.<br>• Wrapped items manufacturers recommend<br>for exposure at 270°F (132°C). |
| Packs | 250°F (121° C) | 30 minutes | • Textiles and surgical packs wrapped for<br>sterilization.<br>• Items, except liquids, manufacturers<br>recommend for exposure at 250°F (121°C)<br>for 30 minutes. |
| Handpieces | 270° F (132° C) | 6 minutes | • Dental handpieces<br>• Other complex lumened devices,<br>manufacturers recommend for exposure<br>at 270° F (132° C) |
| Programmable<br>1<br>&<br>Programmable<br>2 | User defined<br>230° F to 275° F<br>(110° C to 135° C) | User defined<br>3 min. to 90 min. | • Items appropriate for the user defined<br>parameters<br>CAUTION: All material run in these cycles<br>must be validated by the user. These<br>programmable functions allow you to set<br>different time and temperature parameters.<br>It is important to properly coordinate<br>sterilization temperature with cycle time.<br>Permitted temperature range for proper<br>sterilization is 250°-275°F (121°-135°C).<br>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 [phone]. 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 [phone] or [phone] 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:

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.

## (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.<br>(minimums) | TIME<br>(minimums) | ITEMS TO BE STERILIZED<br>(Always consult the item manufacturer's<br>recommendations for sterilization.) |
|-------------------|--------------------------------------------------------|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unwrapped | 270° F (132° C) | 3 minutes | · Instruments loose on a tray.<br>· Open glass or metal canisters.<br>· Tubing not used in surgical procedures.<br>· Loose items manufacturers recommend<br>for exposure at 270°F (132°C). |
| Pouches | 270° F (132° C) | 6 minutes | · Pouched or loosely wrapped instruments.<br>· Multiple layers of instruments separated by<br>fabric.<br>· Wrapped trays of loose instruments.<br>· Tubing not used in surgical procedures.<br>· Wrapped items manufacturers recommend<br>for exposure at 270°F (132°C). |
| Packs | 250° F (121° C) | 30 minutes | · Textiles and surgical packs wrapped for<br>sterilization.<br>· Items, except liquids, manufacturers<br>recommend for exposure at 250°F (121°C)<br>for 30 minutes. |
| Handpieces | 270° F (132° C) | 6 minutes | · Dental handpieces<br>· Other complex lumened devices,<br>manufacturers recommend for exposure<br>at 270° F (132° C) |
| Programmable<br>1 | User defined<br>230° F to 275° F<br>(110° C to 135° C) | User defined<br>3 min. to 90 min. | · Items appropriate for the user defined<br>parameters<br>CAUTION: All material run in these cycles<br>must be validated by the user. These<br>programmable functions allow you to set<br>different time and temperature parameters.<br>It is important to properly coordinate<br>sterilization temperature with cycle time.<br>Permitted temperature range for proper<br>sterilization is 250°-275° F (121°-135° C).<br>Temperatures below 250°F (121°C) should<br>only be used for disinfection. |
| Programmable<br>2 | User defined<br>230° F to 275° F<br>(110° C to 135° C) | User defined<br>3 min. to 90 min. | · Items appropriate for the user defined<br>parameters<br>CAUTION: All material run in these cycles<br>must be validated by the user. These<br>programmable functions allow you to set<br>different time and temperature parameters.<br>It is important to properly coordinate<br>sterilization temperature with cycle time.<br>Permitted temperature range for proper<br>sterilization is 250°-275° F (121°-135° C).<br>Temperatures below 250°F (121°C) should<br>only be used for disinfection. |

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# Standard Cycle Parameters