STATIM 2000 G4 CASSETTE

K112872 · Scican , Ltd. · FLE · Jul 10, 2012 · General Hospital

Device Facts

• Record ID: K112872
• Device Name: STATIM 2000 G4 CASSETTE
• Applicant: Scican , Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Jul 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms. The units are intended to sterilize heat and moisture stable medical instruments (including handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.

Device Story

STATIM 2000/5000 G4 are steam flush pressure pulse dynamic air removal autoclaves; process reusable medical/dental instruments. Device uses saturated steam at high pressure (121°C or 134°C/135°C) to achieve sterilization. Operated by clinical staff in medical/dental offices or hospitals. Input: heat/moisture stable instruments (solid, hollow, hinged, handpieces, endoscopes). Output: sterilized instruments. System provides cycle status and documentation. Benefits: effective kill of infectious bio-organisms; rapid reprocessing of instruments for immediate use.

Clinical Evidence

No clinical data. Bench testing only. Validation performed to demonstrate sterilization efficacy for specified loads (solid, hollow, hinged instruments, handpieces, endoscopes) across defined cycles, temperatures, and exposure times.

Technological Characteristics

Steam flush pressure pulse dynamic air removal autoclave. Operates at 121°C or 134°C/135°C. Cassette-based form factor. Includes G4 interface for cycle monitoring. Standalone unit. Sterilization via saturated steam.

Indications for Use

Indicated for sterilization of heat and moisture stable medical instruments, including solid, hollow, and hinged metal instruments, dental and phaco handpieces, rigid endoscopes, and rubber/plastic items in clinical settings. Contraindicated for non-heat stable instruments.

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.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

JUL 10 2012

Re: K112872

Trade/Device Name: STATIM 2000/5000 G4 Cassette Autoclave Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: June 7, 2012 Received: June 11, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. 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: K112872

STATIM 2000/5000 G4 Cassette Autoclave Device Name:

### Indications for Use:

The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms.

The units are intended to sterilize heat and moisture stable medical instruments (including handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other frecillies. nancheco) which are vehilization at 134°C (275°F) or 121 °C (250°F). The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrently of BRANA frice of Device Evaluation (ODE Division of Anesthesiology, General Hospital

SciCan Ltd. K112872

2000 / 5000 G4 510/k)

Infection Control, Dental Devices

510(k) Nugherm

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## INDICATIONS FOR USE - Page 2 of 3

### 510(k) Number: K112872

The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 2000 G4 Cassette Autoclave are as follows:

| CYCLE | TEMPERATURE | STERILIZATION /<br>DRYING TIME | MAX<br>LOAD | INTENDED USE |
|-------------------------------------|----------------|--------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| UNWRAPPED<br>(for Immediate<br>Use) | 135°C (275°F) | 3.5 min. /<br>60 min. | 1.0 kg<br>(2.2 lbs) | Solid metal instruments, hinged<br>metal instruments, dental¹ and<br>phaco² handpieces, with drying. |
| WRAPPED | 135°C (275°F) | 10 min. /<br>60 min. | 1.0 kg<br>(2.2 lbs) | Solid, hollow (including dental¹ and<br>phaco² handpieces) & hinged metal<br>instruments wrapped in paper/paper<br>or paper/plastic pouches that are<br>cleared by FDA for the claimed<br>cycles, with drying. |
| RUBBER &<br>PLASTICS | 121°C (250°F). | 15 min. /<br>60 min. | 0.4 kg<br>(0.9 lbs) | Instruments of rubber & plastic<br>construction (exceptions are listed in<br>the Operator's Manual) with drying |

The lumen specifications are as follows:

1Dental Handpieces: 7 handpieces within a 1 kg load

2 handpieces, 2 lumens per handpiece, where the lumens have a minimum inner 2Phaco Handpieces: diameter of 1.5 mm (0.06") and a maximum length of 150 mm (6") or a minimum inner diameter of 2 mm (0.08") and maximum length of 190 mm (7.5")

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
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| | <span style="text-decoration: overline;">El L. H. Adams -NW</span> |
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Concur(**Division Sign Off**) Office of Device Evaluation (ODE)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | SciCan Ltd. K112872 |
|----------------|---------------------|
|----------------|---------------------|

STATIM 2000 / 5000 G4 510(k)

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### INDICATIONS FOR USE - Page 3 of 3

### 510(k) Number: K112872

The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 5000 G4 Cassette Autoclave are as follows:

| CYCLE | TEMPERATURE | STERILIZATION /<br>DRYING TIME | MAX<br>LOAD | INTENDED USE |
|---------------------------------------------------|---------------|--------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| UNWRAPPED<br>(for Immediate<br>Use) | 132°C (270°F) | 3.5 min. /<br>60 min. | 0.5 kg<br>(1.1 lbs) | Solid metal instruments, hinged metal<br>instruments with drying. |
| WRAPPED | 132°C (270°F) | 6 min. /<br>60 min. | 1.5 kg<br>(3.3 lbs) | Solid, hollow (including dental¹ and<br>phaco² handpieces) & hinged metal<br>instruments wrapped in paper/paper or<br>paper/plastic pouches that are cleared by<br>FDA for the claimed cycles, with drying. |
| RUBBER &<br>PLASTICS | 121°C (250°F) | 35 min. /<br>60 min. | 0.4 kg<br>(0.9 lbs) | Instruments of rubber & plastic<br>construction (exceptions are listed in the<br>Operator's Manual) with drying. |
| HEAVY DUTY<br>UNWRAPPED<br>(for Immediate<br>Use) | 132°C (270°F) | 6 min. /<br>60 min. | 1.5 kg<br>(3.3 lbs) | Solid metal instruments, hinged metal<br>instruments and dental¹ and phaco²<br>handpieces with drying. The extended<br>cassette must be used for the processing<br>of longer instruments such as<br>autoclavable rigid endoscopes³ in this<br>cycle. |

The lumen specifications are as follows:

8 handpieces within a 1.5 kg load 1Dental Handpieces:

5 handpieces, 2 lumens per handpiece, where the lumens have a minimum inner 2Phaco Handpieces: diameter of 1.5 mm (0.06") and a maximum length of 150 mm (6") or a minimum inner diameter of 2 mm (0.08") and maximum length of 190 mm (7.5")

3 scopes, 1 lumen per scope, where the lumens have a minimum inner diameter of 1 3Rigid Endoscopes: mm (0.04") and a maximum length of 490 mm (19")

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Elillatt Allع

Concurrence of CDRH, Office of Device Evaluation (ODF)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

SciCan Ltd.
STATIM 2000 / 5000 G4 510(k)
510(k) Number: K112872