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(°C)	Pressure(bar)	ExposureTime (min.)	Drying Time(min.)	MaximumLoad (kg)
Unwrappedinstruments*	134	2.14 – 2.21	4	6	4.0
Wrappedinstruments**	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.

Device Description

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.

AI/ML Overview

The iMax 9.5 DS Sterilizer is not an AI/ML device, therefore, the requested information elements such as sample size for the test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details are not applicable as these pertain to performance studies for AI/ML devices.

However, based on the provided text, the acceptance criteria and the study that proves the device meets the acceptance criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iMax 9.5 DS Sterilizer are based on its ability to effectively sterilize heat and moisture-resistant medical and dental instruments and cloth packs according to predefined cycles. The "reported device performance" is essentially the successful demonstration of sterilization efficacy for these cycles.

Cycle	Temperature (°C)	Pressure (bar)	Exposure Time (min.)	Drying Time (min.)	Maximum Load (kg)	Acceptance Criteria (Sterilization Efficacy)	Reported Device Performance
Unwrapped instruments*	134	2.14 - 2.21	4	6	4.0	Effective sterilization of instruments	Verified (Biological testing)
Wrapped instruments**	134	2.14 - 2.21	20	20	4.0	Effective sterilization of instruments	Verified (Biological testing)
Packs	121	1.10 - 1.17	30	20	1.5	Effective sterilization of cloth packs	Verified (Biological testing)
Dental Handpieces	134	2.14 - 2.21	20	20	4.0	Effective sterilization of complex lumened dental handpieces	Verified (Biological testing)

*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

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for this type of device. The "test set" in this context refers to items subjected to sterilization. The document mentions "clinically contaminated dental handpieces" but does not specify locations or if these were specifically from different countries. The general nature of the testing implies a retrospective use of samples for verification, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable for this type of device. Sterilization efficacy is determined through biological indicators and laboratory methods, not expert consensus on image interpretation or similar.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Sterilization testing is objective, based on growth or no growth of microbial indicators.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

Not applicable. The iMax 9.5 DS Sterilizer is a medical device, not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The iMax 9.5 DS Sterilizer is a standalone medical device, but not an algorithm. Its performance is evaluated on its own ability to sterilize.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets the acceptance criteria is sterility, typically confirmed through biological indicator (BI) testing. This involves challenging the sterilizer with highly resistant bacterial spores. A successful sterilization cycle renders the biological indicators sterile (i.e., no microbial growth after incubation), indicating effective killing of microorganisms. The document explicitly states "Biological testing was conducted to verify the sterilization efficacy of the preprogrammed process parameters."

8. The Sample Size for the Training Set

Not applicable for this type of device. This device does not use a "training set" in the AI/ML sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable for this type of device.

Summary

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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.

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INTENDED USE న.

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

Cycle	Temperature(°C)	Pressure(bar)	Exposure Time(min.)	DryingTime (min.)	Maximum Load(kg)
Unwrappedinstruments*	134	2.14 - 2.21	4	6	4.0
Wrappedinstruments **	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 (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 (240) 276-3150 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

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

Cycle	Temperature(°C)	Pressure(bar)	ExposureTime (min.)	Drying Time(min.)	MaximumLoad (kg)
Unwrappedinstruments*	134	2.14 – 2.21	4	6	4.0
Wrappedinstruments**	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

Page 1 of 1

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).