Rinse, flush, lubricate and steam sterilize dental handpieces, air-motors, and . attachments which are suitable for steam sterilization
Rinse and steam sterilize dental instruments which are suitable for steam ● sterilization
Steam sterilization at 134℃ and 3.1 bar absolute for ten minutes .
Maximum load is six (6) dental handpieces (highspeed handpieces, . air-motors, and/or attachments) or five (5) dental instruments
Sterility of devices is compromised on exposure to a non-sterile environment .

Device Description

The CLS-2000 UNIT is an integrated unit for rinsing, flushing, lubricating, and steam sterilizing dental handpieces, air-motors, and attachments, and for rinsing and steam sterilizing static instruments which are suitable for steam sterilization.

Dental handpieces and instruments are placed in the CLS-2000 UNIT. The CLS-2000 UNIT utilizes water and pulsed steam to rinse and flush the articles. The CLS-2000 UNIT then utilizes saturated steam at elevated pressures in order to attain an effective kill of infectious bio-organisms and prevent crosscontamination. The CLS-2000 UNIT is also equipped with a lubrication feature for the delivery of service oil to dental handpieces, air-motors, and attachments.

AI/ML Overview

The provided text describes the Dentsply CLS-2000 UNIT, a steam sterilizer for dental instruments, and its 510(k) submission. It details its function, intended use, technological characteristics, and testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Sterilization Efficacy	End-point criteria of no positive biological indicators with Geobacillus Stearothermophilus spores.
Temperature Profile	AAMI ST55 section 5.4.2 criteria for temperature profiling.

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

Sample Size: Not explicitly stated as a numerical count of instruments or loads. The testing included:
- "half-cycle testing, replicates, with and without lubricant"
- "full-cycle simulated use testing"
- "in-use testing"
  These phrases indicate multiple tests were performed, but the specific number of test cycles or articles per test is not provided.
Data Provenance: Not explicitly stated. Given it's a 510(k) submission to the FDA, it is expected that the testing was conducted per recognized standards (AAMI ST55) and would likely be prospective testing carried out by the manufacturer or a contracted lab. There is no indication of retrospective data or data originating from specific countries other than the manufacturer's location (York, PA, USA).

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

This information is not applicable to this type of device and study. The "ground truth" for a sterilizer's performance is objective (e.g., presence/absence of microbial growth, temperature readings, pressure readings). It does not rely on expert consensus or interpretation in the same way a diagnostic imaging device might. The "experts" involved would be microbiologists and engineers validating the testing protocols and results, but their number and specific qualifications are not detailed as they would be for an AI-based diagnostic device.

4. Adjudication Method for the Test Set:

This is not applicable. The outcome of sterilization (sterility or non-sterility) is determined by objective biological and physical measurements, primarily the absence of Geobacillus Stearothermophilus growth for the biological testing. There is no human interpretation or "adjudication" of findings in the traditional sense for these types of tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. An MRMC comparative effectiveness study is designed to assess how human readers' performance changes with or without AI assistance, typically in diagnostic imaging. This is a sterilizer, not a diagnostic device, and therefore such a study is irrelevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence. The entire testing regimen described for the CLS-2000 UNIT (physical and biological testing) represents the standalone performance of the device without human intervention influencing the sterilization outcome. The device, once started, operates automatically to achieve its intended function.

7. The Type of Ground Truth Used:

The ground truth used is a combination of:

Biological End-point: Absence of microbial growth (specifically, Geobacillus Stearothermophilus spores) after sterilization. This is a direct measure of efficacy.
Physical Parameters: Temperature profiling meeting the specified standard (AAMI ST55). This verifies the physical conditions required for sterilization are met.

8. The Sample Size for the Training Set:

This is not applicable. The CLS-2000 UNIT is a physical device, not an AI/ML algorithm that requires a training set. Its design and operational parameters are engineered, not learned from data.

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

This is not applicable for the reason stated in point 8.

Summary

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510(k) SUMMARY

NAME & ADDRESS:

Dentsply International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 P. J. Lehn Telefax (717) 849-4343

CONTACT: DATE PREPARED: TRADE OR PROPRIETARY NAME: CLASSIFICATION NAME: PREDICATE DEVICES:

P. Jeffery Lehn September 10, 2003 CLS-2000 UNIT Steam sterilizer (880.6880) EasyClave™ Steam Sterilizer K992744

DEVICE DESCRIPTION

INTENDED USE

Rinse, flush, lubricate, and steam sterilize dental handpieces, and attachments which are suitable for steam sterilization.

Rinse and steam sterilize dental instruments which are suitable for steam sterilization.

Steam sterilization at 134°C and 3.1 bar absolute for ten minutes.

Maximum load is six (0) dental handpieces (highspeed handpieces, air-motors, and/or attachments) or five (5) dental instruments.

Sterility of devices is compromised on exposure to a non-sterile environment.

TECHNOLOGICAL CHARACTERISTICS

Operating Principle and Energy Type:

The CLS-2000 UNIT uses electrical energy to heat water into steam that is passed into the sterilization chamber. (Substantially equivalent to the EasyClave.)

The CLS-2000 UNIT uses compressed air to drive water and lubricant through lumens of the articles being processed.

Sources of Energy:

The CLS-200 UNIT requires 115 VAC, 60 Hz, and also requires compressed air. (Substantially equivalent to the EasyClave.)

Software or Firmware:

The CLS-2000 UNIT is operated by firmware. (Substantially equivalent to the EasyClave.)

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Materials of Construction:

Stainless steel sterilization chamber; electronic circuit boards; electric heat element; plastic and metal support structures and external housing. (Substantially equivalent to the EasyClave.)

Valves and internal plumbing of various conventional materials. (Substantially equivalent to the EasyClave.)

Testing

The CLS-2000 UNIT was tested according to the FDA's Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities.

Physical testing included temperature profiling per section 5.4.2 of AAMI ST55.

Biological testing with Geobacillus Stearothermophilus spores included the following, and all biological testing met the end-point criteria of no positives.

half-cycle testing, replicates, with and without lubricant
. full-cycle simulated use testing
in-use testing

Other Characteristics

There are no known materials in this device which would create a biocompatibility hazard. The device itself does not contact the patient. Dental handpieces and instruments placed in the device contact only stainless steel and elastomeric o-rings.

The fluids (steam, air, water, and lubricating oil) which flow through the device and into the dental handpieces touch only standard engineering materials (stainless steel, PTFE, plated brass) with no known biocompatibility hazard.

The Unit does not use any cleaning agents, detergents, or other chemicals. The sole washing agent is distilled or de-ionized water provided by the user.

The lubricant used will be at the discretion of the user, since the CLS-2000 lubricant reservoir will accept any liquid lubricant.

We conclude that the CLS-2000 UNIT is substantially equivalent to the EasyClave, and that the data provided herein and previously support the safety and effectiveness of the CLS-2000 UNIT for the intended uses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three horizontal bars that curve and taper, resembling a bird in flight or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2003

Ms. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York. Pennsylvania 17405-0872

Re: K024133

Trade/Device Name: CLS-2000 Unit Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 11, 2003 Received: August 12, 2003

Dear Mr. Lehn:

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 vour 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 - Mr. Lehn

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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runoe

Susan Runner, DDS, MA Interim 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 STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): K024133

Device Name:

CLS-2000 UNIT

Indications for Use:

Rinse, flush, lubricate and steam sterilize dental handpieces, air-motors, and . attachments which are suitable for steam sterilization
Rinse and steam sterilize dental instruments which are suitable for steam ● sterilization
Steam sterilization at 134℃ and 3.1 bar absolute for ten minutes .
Maximum load is six (6) dental handpieces (highspeed handpieces, . air-motors, and/or attachments) or five (5) dental instruments
Sterility of devices is compromised on exposure to a non-sterile environment .

Clain S. Lin

(Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K024133

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

000185

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).