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, hingedinstruments, dental handpieces, withdrying
WRAPPED	134°C (273°F)	6	3.5 min.	Solid, hollow (including dentalhandpieces) & hinged instrumentswrapped in paper/paper orpaper/plastic pouches or papersterilization wrap, with improveddrying performance
RUBBER & PLASTICS	121°C (250°F).	3	30 min.	Instruments of rubber & plasticconstruction (exceptions are listed inthe Operator's Manual) with drying

Device Description

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.

AI/ML Overview

The provided document, K072466, is a 510(k) Summary for the STATIM 7000 Cassette Autoclave. This document outlines the device's intended use and general characteristics, but it is not a study report proving the device meets specific acceptance criteria based on performance studies.

A 510(k) submission generally relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive performance studies with detailed acceptance criteria and statistical analysis as might be found for a novel AI/software device. For a sterilizer, performance is typically confirmed through validation studies (e.g., biological indicator tests, temperature distribution studies) conducted internally by the manufacturer against recognized standards. These summaries rarely include the detailed data asked for in your prompt.

Therefore, many of the requested fields cannot be filled from the provided text because the document is not a performance study report in the way your prompt describes for a device involving AI or software analysis of data.

Here's an attempt to answer based on the available information, noting where data is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines the intended use and operational parameters (temperature, time) for different sterilization cycles. For a sterilizer, the ultimate acceptance criterion is achieving sterilization (i.e., effective kill of infectious bio-organisms). The "reported device performance" in this context refers to the specified cycle parameters that are intended to achieve sterilization. The document does not provide quantitative performance metrics (e.g., sterilization assurance level, spore log reduction) and a direct comparison to
acceptance criteria for those metrics.

Acceptance Criterion (Implicit)	Reported Device Performance (Operational Parameters)
UNWRAPPED Cycle: Sterilization of solid instruments, hinged instruments, and dental handpieces at 134°C (273°F) with heated drying.	UNWRAPPED Cycle: 134°C (273°F) and 3.5 minutes sterilization time (3 purges).
WRAPPED Cycle: Sterilization of solid, hollow (including dental handpieces) & hinged instruments wrapped in paper/paper, paper/plastic pouches, or paper sterilization wrap at 134°C (273°F) with improved drying performance.	WRAPPED Cycle: 134°C (273°F) and 3.5 minutes sterilization time (6 purges).
RUBBER & PLASTICS Cycle: Sterilization of instruments of rubber & plastic construction (with exceptions) at 121°C (250°F) with heated drying.	RUBBER & PLASTICS Cycle: 121°C (250°F) and 30 minutes sterilization time (3 purges).
Overall functionality: Operate as a pressure pulse steam autoclave to achieve successful sterilization.	Device is described as a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided. This document is a 510(k) summary, not a detailed study report. Sterilizer performance is typically established through validation studies. The specific sample sizes (e.g., number of cycles, number of biological indicators) for such validation would not typically be in a 510(k) summary. Data provenance would likely be from the manufacturer's internal testing facilities (SciCan Ltd. in Canada).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. For a sterilizer, "ground truth" for basic performance validation is established by objective measurements (temperature probes, pressure sensors) and the results of biological indicators (e.g., sterility achieved or not). It does not involve expert interpretation in the way an AI diagnostic device would.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods are relevant for subjective interpretations by multiple experts, which is not the case for sterilizer validation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a sterilizer, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical/electrical sterilizer, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For sterilizers, the ground truth for effectiveness is typically established through:
- Biological Indicator (BI) tests: Using highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to ensure sterilization. Failure to recover viable spores after a cycle indicates sterilization.
- Physical Monitoring: Calibrated sensors to verify temperature, pressure, and time parameters are met throughout the sterilization chamber.
- Chemical Indicators (CI): Strips or labels that change color when exposed to specific sterilization conditions.
The document itself does not explicitly state which of these methods were used for validation, but these are standard for sterilizer testing.

8. The sample size for the training set

Not applicable/Not provided. This device is a sterilizer. It does not use "training data" in the sense of machine learning. Its design and performance are based on engineering principles (thermodynamics, microbiology) and validation studies, not on learning from a dataset.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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K072466

Summary of Safety & Effectiveness Information

510(k) Summary:
Submitted by:	SciCan Ltd.1440 Don Mills RoadToronto, Ontario CanadaM3B 3P9	DEC 1 9 2007
Contact Person:	Teresa Boyce - Senior Regulatory Affairs Specialist(416) 446-2783
Date of Preparation:	August 31, 2007
Name of Device:	STATIM 7000 Cassette Autoclave
Predicate Device:	STATIM 5000 Cassette Autoclave510(k) K962179

Description of Device:

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, dentalhandpieces, with heated drying
WRAPPED	134°C (273°F)	3.5 min.	Solid, hollow (including dental handpieces) &hinged instruments wrapped in paper/paper orpaper/plastic pouches or paper sterilizationwrap, with improved drying performance
RUBBER &PLASTICS	121°C (250°F)	30 min.	Instruments of rubber & plastic construction(exceptions are listed in the Operator'sManual) 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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, hingedinstruments, dental handpieces, withdrying
WRAPPED	134°C (273°F)	6	3.5 min.	Solid, hollow (including dentalhandpieces) & hinged instrumentswrapped in paper/paper orpaper/plastic pouches or papersterilization wrap, with improveddrying performance
RUBBER & PLASTICS	121°C (250°F).	3	30 min.	Instruments of rubber & plasticconstruction (exceptions are listed inthe 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

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
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.(b)
Classification. Class II (performance standards).