STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101

K072466 · Scican , Ltd. · FLE · Dec 19, 2007 · General Hospital

Device Facts

• Record ID: K072466
• Device Name: STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
• Applicant: Scican , Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) within a hospital or clinical setting such as medical and/or dental surgeries. The instruments processed within the STATIM 7000 Cassette Autoclave must be suitable for steam sterilization at 134°C (273°F) or 121°C (250°F).

Device Story

Pressure pulse steam autoclave; processes medical/dental instruments via saturated steam at high pressure. User places instruments in cassette; inserts cassette into armature; selects cycle parameters; initiates cycle. Device operates automatically to achieve sterilization. Used in hospitals, clinics, and dental surgeries by clinical staff. Output is sterilized instruments; facilitates infection control by killing bio-organisms. Benefits patient by ensuring sterile equipment for procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Pressure pulse steam autoclave; utilizes saturated steam. Operates at 134°C or 121°C. Features automated cycle control for unwrapped, wrapped, and rubber/plastic instrument sterilization. Form factor is a cassette-based system.

Indications for Use

Indicated for sterilization of heat and moisture stable medical and dental instruments (including dental handpieces) in clinical settings, hospitals, and offices. Contraindicated for liquids, cloths, textiles, biomedical waste, and specific rubber/plastic materials defined in the Operator's Manual.

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

• STATIM 5000 Cassette Autoclave (K962179)

Submission Summary (Full Text)

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K072466

## Summary of Safety & Effectiveness Information

| 510(k) Summary: | | |
|----------------------|--------------------------------------------------------------------------|--------------|
| Submitted by: | SciCan Ltd.<br>1440 Don Mills Road<br>Toronto, Ontario Canada<br>M3B 3P9 | DEC 1 9 2007 |
| Contact Person: | Teresa Boyce - Senior Regulatory Affairs Specialist<br>[phone] | |
| Date of Preparation: | August 31, 2007 | |
| Name of Device: | STATIM 7000 Cassette Autoclave | |
| Predicate Device: | STATIM 5000 Cassette Autoclave<br>510(k) K962179 | |

### Description of Device:

The STAT/M 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization. The unit utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. Instruments are placed within the provided cassette, the cassette is placed within the armature, the cycle parameters are selected and the start button depressed. The unit is then fully automatic for the complete sterilizing cycle.

### Intended use:

The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) within a hospital or clinical setting such as medical and/or dental surgeries. The instruments processed within the STATIM 7000 Cassette Autoclave must be suitable for steam sterilization at 134°C (273°F) or 121°C (250°F).

The sterilization cycles as to established times, temperatures and indicated uses for the STAT/M 7000 Cassette Autoclave are as follows:

| CYCLE | TEMPERATURE | TIME | INTENDED USE |
|----------------------|---------------|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| UNWRAPPED | 134°C (273°F) | 3.5 min. | Solid instruments, hinged instruments, dental<br>handpieces, with heated drying |
| WRAPPED | 134°C (273°F) | 3.5 min. | Solid, hollow (including dental handpieces) &<br>hinged instruments wrapped in paper/paper or<br>paper/plastic pouches or paper sterilization<br>wrap, with improved drying performance |
| RUBBER &<br>PLASTICS | 121°C (250°F) | 30 min. | Instruments of rubber & plastic construction<br>(exceptions are listed in the Operator's<br>Manual) with heated drying |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing left and is surrounded by a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the border of the circle.

Public Health Service

DEC 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Teresa Boyce Senior Regulatory Affairs Specilist SciCan Limited 1440 Don Mills Road Toronto, Ontario CANADA M3B 3P9

Re: K072466

Trade/Device Name: STATIM 7000 Cassette Autoclave Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: November 28, 2007 Received: November 30, 2007

Dear Ms. Boyce:

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. Boyce

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/industry/support/index.html.

Sincerely yours,

C. Lin, Ph.D.

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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# INDICATIONS FOR USE

510(k) Number:

#### Device Name: STATIM 7000 Cassette Autoclave

Indications for Use: The STATIM 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection.

> The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) that are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 134℃ (273%) or 121 °C (250°F). The STATIM 7000 Cassette Autoclave is not intended nor recommended for the sterilization of liquids, cloths, text les, biomedical waste and certain rubber and plastic materials specified in the Operator's Manual.

The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 7000 Cassette Autoclave are as follows:

| CYCLE | TEMPERATURE | NO. OF PURGES | STERILIZATION TIME | INTENDED USE |
|-------------------|----------------|---------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| UNWRAPPED | 134°C (273°F) | 3 | 3.5 min. | Solid instruments, hinged<br>instruments, dental handpieces, with<br>drying |
| WRAPPED | 134°C (273°F) | 6 | 3.5 min. | Solid, hollow (including dental<br>handpieces) & hinged instruments<br>wrapped in paper/paper or<br>paper/plastic pouches or paper<br>sterilization wrap, with improved<br>drying performance |
| RUBBER & PLASTICS | 121°C (250°F). | 3 | 30 min. | Instruments of rubber & plastic<br>construction (exceptions are listed in<br>the Operator's Manual) with drying |

Sheila K. Murphy, 52
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K02444

SCICAN STATIM 7000 510(k) 1-5