IMAX 9.5 STERILIZERS

K052532 · Dental X Srl · FLE · Sep 5, 2006 · General Hospital

Device Facts

• Record ID: K052532
• Device Name: IMAX 9.5 STERILIZERS
• Applicant: Dental X Srl
• Product Code: FLE · General Hospital
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities. Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below). * Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.) **Dental handpieces can be processed in the Wrapped instruments cycle only The sterilizer is not intended to sterilize patient-contacting liquids.

Device Story

Gravity table-top steam sterilizer for healthcare facilities. Uses heating elements for steam generation; diaphragm compressor and HEPA filter circulate filtered air during drying phase. Operates via microprocessor-controlled cycles (Unwrapped, Wrapped, Packs). User selects cycle based on instrument type; device manages pressure, temperature, and exposure time. Provides sterilization for heat/moisture resistant instruments, including complex lumened dental handpieces. Benefits patient by ensuring effective sterilization of reusable medical/dental equipment.

Clinical Evidence

Bench testing only. Performance verified through electrical safety, electromagnetic compatibility, and physical testing. Sterilization efficacy validated via biological testing of preprogrammed cycles. Additional testing performed using laboratory-inoculated and clinically contaminated dental handpieces to confirm efficacy for complex lumened devices.

Technological Characteristics

Gravity-fed table-top steam sterilizer. Features: sterilization chamber, water storage/transport system, heating elements, valve system for air/steam exhaust, diaphragm compressor, and HEPA filter. Microprocessor-controlled. Connectivity: standalone. Sterilization: steam-based.

Indications for Use

Indicated for sterilization of heat and moisture resistant medical and dental instruments and cloth packs in healthcare facilities. Includes complex lumened devices (e.g., dental handpieces). Contraindicated for patient-contacting liquids and complex instruments (lumens, hinges, mated surfaces) in the Unwrapped cycle.

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

• Delta Steam Sterilizer (K945117)
• Midmark M9 UltraClave (K023348)

Submission Summary (Full Text)

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# 510(k) Summary for iMax 9.5 DS Sterilizer

SEP - 5 2006

#### SPONSOR 1.

----

Dental X srl Via Marzotto 11 36031 Dueville Vicenza ITALY

Dr. Marco Nesti Contact Person: 0039-0444-367411 Telephone:

August 17, 2006 Date Prepared:

#### 2. DEVICE NAME

| Proprietary Name: | iMax 9.5 DS Sterilizer |
|----------------------|------------------------|
| Common/Usual Name: | Steam sterilizer |
| Classification Name: | Steam sterilizer |

#### 3. PREDICATE DEVICES

- Delta Steam Sterilizer (K945117) .
- Midmark M9 UltraClave (K023348) .

## DEVICE DESCRIPTION 4.

The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer. The iMax 9.5 DS Sterilizer is provided with a diaphragm compressor and HEPA filter that circulates filtered air in the sterilization chamber during the drying phase.

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#### INTENDED USE న.

The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities.

Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below).

| Cycle | Temperature<br>(°C) | Pressure<br>(bar) | Exposure Time<br>(min.) | Drying<br>Time (min.) | Maximum Load<br>(kg) |
|---------------------------|---------------------|-------------------|-------------------------|-----------------------|----------------------|
| Unwrapped<br>instruments* | 134 | 2.14 - 2.21 | 4 | 6 | 4.0 |
| Wrapped<br>instruments ** | 134 | 2.14 - 2.21 | 20 | 20 | 4.0 |
| Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 |

* Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.)

**Dental handpieces can be processed in the Wrapped instruments cycle only

The sterilizer is not intended to sterilize patient-contacting liquids.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Both the proposed and predicate devices are gravity-fed microprocessorcontrolled table top steam sterilizers consisting of a sterilization chamber with a water storage and transport system, heating elements for steam generation, and a valve system for exhausting air and steam for the chamber. Differences in the technical features between the proposed and predicate devices are limited to minor differences in chamber volume, dimensions, etc.

## PERFORMANCE TESTING 7.

Software and performance testing was conducted to determine the safety and effectiveness of the proposed iMax 9.5 DS Sterilizer for its' intended use. The testing included electrical safety testing, electromagnetic compatibility testing and physical testing to ensure that all design requirements were fulfilled. Biological testing was conducted to verify the sterilization efficacy of the preprogrammed process parameters. Additional testing was conducted using both laboratoryinoculated and clinically contaminated dental handpieces to confirm that the iMax 9.5 Sterilizers could be used for the sterilization of complex lumened devices. The

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results confirm that the iMax 9.5 DS Sterilizer is safe and effective for the sterilization of steam-compatible medical and dental instruments, including dental handpieces.

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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dental X SRL C/O Cynthia J.M. Nolte Medical Device Consultant, Incorporated 49 Plain Street North Attleboro. Massachusetts 02760

SEP - 5 2006

Re: K052532

Trade/Device Name: iMAX DS 9.5 Sterilizers Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 17, 2006 Received: August 17, 2006

Dear Ms. Nolte:

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 -- Ms. Nolte

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 vour 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 lttp://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clue

Chiu Lin, Ph.D. 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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510(k) Number (if known): K052532

Device Name: iMax 9.5 DS Sterilizer

Indications for Use:

ﺎ

The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities.

Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below).

| Cycle | Temperature<br>(°C) | Pressure<br>(bar) | Exposure<br>Time (min.) | Drying Time<br>(min.) | Maximum<br>Load (kg) |
|---------------------------|---------------------|-------------------|-------------------------|-----------------------|----------------------|
| Unwrapped<br>instruments* | 134 | 2.14 – 2.21 | 4 | 6 | 4.0 |
| Wrapped<br>instruments** | 134 | 2.14 – 2.21 | 20 | 20 | 4.0 |
| Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 |

* Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.)

** Dental handpieces can be processed in the Wrapped instruments cycle only

The sterilizer is not intended to sterilize patient-contacting liquids.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-the-Counter Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shuley F. Murphy D 9/1/04

f Anesthesiology, General Hospita ontrol, Dental Device

Number: A052532

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