The DDS 7000 is a countertop convective dry heat sterilizer designed for use in Healthcare facilities for the sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216°C (420° F). There is a single software-controlled cycle that includes a warm-up and cool down phase in addition to the 3-minute sterilization (exposure) phase. Sterilize (exposure) starts when the RTD/control temperature reaches the operating temperature set point of 190°C (374° F). Complete cycle times average 34-44 minutes and are load dependent. The DDS 7000 achieves optimum results by uniform load distribution utilizing a dedicated rack and tray system as detailed below.

Maximum recommended loads validated for the DDS 7000-115 sterilizer: -
a) Maximum load for a four (4)-rack configuration is four (4) plier racks each holding nine (9) orthodontic pliers each for a total of thirty-six (36) pliers. Other maximum load configuration options are: 32 pliers on eight mini vertical racks; or 20 pliers and hand instruments on four Combo Racks -(OR)-
b) Maximum load for a full tray configuration is one (1) Horizontal Tray each holding up to six (6) orthodontic pliers or up to (12) single-handle hand instruments. Other maximum load combinations include: (5) orthodontic pliers with up to (2) single-handle hand instruments; or (4) orthodontic pliers with up to (4) single-handle hand instruments; or (3) orthodontic pliers with up to (6) single-handle hand instruments, or (2) Orthodontic pliers with up to (8) single-handle hand instruments; or (1) Orthodontic pliers with up to (10) single-handle hand instruments. - (OR)-
c) Maximum load for the one (1) half tray and two (2) racks is one (1) Half Tray holding three (3) Orthodontic pliers or six (6) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks. Other maximum load combinations include: (2) orthodontic pliers with up to (2) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks; or (1) orthodontic pliers with up to (4) singlehandle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks.

Device Description

The DDS 7000, like the DDS 5000 is a convective dry heat batch sterilizer capable of sterilizing un-bagged dental instruments and cooling them for immediate use. It is designed for use with a dedicated rack system that provides for uniform loading to achieve optimum load distribution.
The DDS 7000 is equipped with a replaceable HEPA filter to comply with ANSI/AAMI ST50: 2004 cooling requirements. The HEPA filter has a filtration efficiency of 99.7% for 0.3-micron particles.
The DDS 7000 is a software-controlled device that allows for the user to preprogram options such as display units (Celsius or Fahrenheit), audible alarm enabled/disabled and safety interlock enabled/disabled The DDS 7000 monitors the entire cycle and will provide diagnostic error codes in the event of any failure or disruption to the sterilization cycle. A printable log is available for the most recently performed cycle that includes pass/fail notification and error codes if applicable

AI/ML Overview

The Dentronix "DDS 7000" Rapid Dry Heat Sterilizer Sterilization System is designed for the dry heat sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216℃ (420° F).

Here's an analysis of its acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Achieve Sterility Assurance Level (SAL) of 10^-6	Half cycle kills result in an overall 12-log reduction of spores, thereby producing a 10^-6 SAL.
Sterilize un-bagged dental instruments	Demonstrated to sterilize un-bagged dental instruments.
Withstand exposure temperatures up to 216°C (420°F)	Instruments capable of withstanding these temperatures are intended for use. The sterilizer operates at 190°C (374°F).
Complete sterilization cycle (warm-up, 3-minute exposure, cool down)	Complete cycle times average 34-44 minutes, load dependent, including warm-up, 3-minute sterilization at 190°C (374°F), and cool down.
Uniform load distribution	Achieved through a dedicated rack and tray system.
Effective across various validated load configurations	Tested and validated with specified maximum load configurations for pliers and hand instruments.
Temperature monitoring and error detection	Yes (LED Display, software monitors cycle parameters, provides diagnostic error codes and audible alarm).

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

Sample Size for Test Set: The document mentions "Performance testing of the DDS 7000 was performed using Bacillus atrophaeus spore strips and inoculated tools." While the specific number of spore strips or inoculated tools used is not quantified, it implies a sufficient sample was used to demonstrate a 12-log reduction of spores. Full, partial, and empty chambers were also included in temperature studies.
Data Provenance: The study was conducted by Coltene/Whaledent Incorporated for the purpose of a 510(k) premarket notification to the FDA. The data provenance is internal testing performed by the manufacturer in the USA (Cuyahoga Falls, Ohio). It is a prospective study as it involves specific performance testing of the device.

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

This type of device (sterilizer) relies on established microbiological and engineering principles rather than clinical expert consensus for its "ground truth."

Experts: Not applicable in the sense of medical image interpretation or diagnosis. The "ground truth" for sterilization efficacy is typically defined by microbiologists who assess the viability of biological indicators (spore strips) after exposure to the sterilization cycle.
Qualifications: While not explicitly stated, it is assumed that personnel with expertise in microbiology, sterilization science, and engineering were involved in designing, executing, and analyzing the performance tests.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads where multiple experts evaluate cases and discrepancies are resolved). For sterilizer performance, the assessment is objective, based on laboratory results (e.g., no growth of Bacillus atrophaeus spores).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where the performance of human readers, with and without AI assistance, is compared. The DDS 7000 is a sterilization device, not a diagnostic imaging device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Yes, a standalone performance study was done. The performance testing described (using Bacillus atrophaeus spore strips and inoculated tools) is a direct evaluation of the device's ability to sterilize, independent of human interaction during the sterilization cycle itself (though human operation is required to initiate the cycle). The study directly assesses the sterilizer's efficacy.

7. Type of Ground Truth Used:

The ground truth used is microbiological evidence. Specifically, the absence or reduction of viable microorganisms (spores of Bacillus atrophaeus) on biological indicators and inoculated tools after the sterilization cycle. This is an objective measure of sterilization efficacy.

8. Sample Size for the Training Set:

Not applicable. The DDS 7000 is a hardware device (dry heat sterilizer) with software controls, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software validation" mentioned refers to ensuring the software correctly controls the device and functions as intended, not to training a predictive model.

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

Not applicable, as there is no "training set" for an AI or machine learning model in this context. The "software" validation principles refer to ensuring appropriate design, development, and testing of the control software to meet functional and safety requirements, as per FDA guidance documents.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three abstract human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2006

Ms. Loretta Mooney Compliance Engineer Coltene/Whaledent Incorporated 235 Ascot Parkway Cuyahoga Falls, Ohio 44223-3701

Re: K051660

Trade/Device Name: Dentronix "DDS 7000" Rapid Dry Heat Sterilizer Sterilization Regulation Number: 21 CFR 880.6870 Regulation Name: Dry Heat Sterilizer Regulatory Class: II Product Code: KMH Dated: June 21, 2005 Received: June 23, 2005

Dear Ms. Mooney:

This letter corrects our substantially equivalent letter of August 4, 2005.

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 (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 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 - Ms. Mooney

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 continue 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/dsma/dsmamain.html

Sincerely vours.

Senita Y. Mckiernan M.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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Image /page/2/Picture/1 description: The image shows the logos for Coltene and Whaledent. The text "K 05/660" is at the top right of the image. The Coltene logo is above the Whaledent logo. The Coltene logo has three black bars to the right of the word.

Premarket Notification [510(k)] Summary

Owner andContact	Device Sponsor and Manufacturer:Coltene/Whaledent, Inc.235 Ascot ParkwayCuyahoga Falls, Ohio 44223-3701Contact Person:Loretta Moonеу235 Ascot ParkwayCuyahoga Falls, Ohio 44223330-916-8800Summary prepared on June 15, 2005
Device	Trade name - Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization System referred to as the"DDS 7000" for the remainder of this documentCommon name - Dry Heat Table Top SterilizerClassification name - Sterilizer, Dry Heat
PredicateDevice	The Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization System is substantially equivalent tothe Dentronix DDS 5000 Dry Heat Sterilization System, referred to as the "DDS 5000" for theremainder of this document, legally marketed per 510(k) K880322. The DDS 7000 utilizes the sameaccessories used by the predicate device.
GeneralDescription	The DDS 7000, like the DDS 5000 is a convective dry heat batch sterilizer capable of sterilizing un-bagged dental instruments and cooling them for immediate use. It is designed for use with a dedicatedrack system that provides for uniform loading to achieve optimum load distribution.The DDS 7000 is equipped with a replaceable HEPA filter to comply with ANSI/AAMI ST50: 2004cooling requirements. The HEPA filter has a filtration efficiency of 99.7% for 0.3-micron particles.The DDS 7000 is a software-controlled device that allows for the user to preprogram options such asdisplay units (Celsius or Fahrenheit), audible alarm enabled/disabled and safety interlockenabled/disabled The DDS 7000 monitors the entire cycle and will provide diagnostic error codes inthe event of any failure or disruption to the sterilization cycle. A printable log is available for the mostrecently performed cycle that includes pass/fail notification and error codes if applicable
Intended Use	The DDS 7000 is a countertop convective dry heat sterilizer designed for use in Healthcarefacilities for the sterilization of un-bagged dental instruments that can withstand exposuretemperatures up to 216°C (420° F). There is a single software-controlled cycle that includesa warm-up and cool down phase in addition to the 3-minute sterilization (exposure) phase.Sterilize (exposure) starts when the RTD/control temperature reaches the operatingtemperature set point of 190°C (374° F). Complete cycle times average 34-44 minutes andare load dependent. The DDS 7000 achieves optimum results by uniform load distributionutilizing a dedicated rack and tray system as detailed below.
	1) Maximum recommended loads for the DDS 7000-115 sterilizer:
	a) Maximum load for a four (4)-rack configuration is four (4) plier racks each holdingnine (9) orthodontic pliers each for a total of thirty-six (36) pliers. Other maximumload configuration options are: 32 pliers on eight mini vertical racks; or 20 pliers andhand instruments on four Combo Racks -(OR)-
	b) Maximum load for a full tray configuration is one (1) Horizontal Tray each holdingup to six (6) orthodontic pliers or up to (12) single-handle hand instruments. Othermaximum load combinations include: (5) orthodontic pliers with up to (2) single-handle hand instruments; or (4) orthodontic pliers with up to (4) single-handle handinstruments; or (3) orthodontic pliers with up to (6) single-handle hand instruments;or (2) Orthodontic pliers with up to (8) single-handle hand instruments; or (1)Orthodontic pliers with up to (10) single-handle hand instruments. -(OR)-
	c) Maximum load for the one (1) half tray and two (2) racks is one (1) Half Trayholding three (3) Orthodontic pliers or six (6) single-handle hand instruments incombination with two (2) plier racks capable of holding nine (9) pliers each for atotal of eighteen (18) pliers on plier racks. Other maximum load combinationsinclude: (2) orthodontic pliers with up to (2) single-handle hand instruments incombination with two (2) plier racks capable of holding nine (9) pliers each for atotal of eighteen (18) pliers on plier racks; or (1) orthodontic pliers with up to (4)single-handle hand instruments in combination with two (2) plier racks capable ofholding nine (9) pliers each for a total of eighteen (18) pliers on plier racks.

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Characteristic	DDS 5000 / K880322	DDS 7000
Method of organismDestruction	Dry heat (Forced air)	Dry heat (Forced air)
Method of heating	Electric element,mechanical convection	Electric element, mechanical convection
Sterilizing Temperature	375° F	190° C (374° F)
Sterilizing cycle time	6 minute plus warm-up andcool down	3 minute plus warm-up and cool down
Forced Air Cool Down	Yes - time monitored	Yes - temperature monitored
Controlled instrument	Yes. dedicated rack and	Same

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	loading	tray system
	Safety Door Interlock	On 230 V Unit only	Standard on 115 V and 230 V Unit
	Printer/PC COM Port	No	Yes, Allows Cycle log print out of lastcycle
	HEPA Filter Air DuringCool Down	No	Yes
	Temperature Monitoring	Yes, LCD display	Yes, LED Display
	Process Error Detection	No	Yes, Software monitors all cycleparameters and provides diagnostic errorcodes and audible alarm
	User Option(s) Interface	No	Yes, options such as units of measure, doorlock and use of the audible alarm can be setby the user
	The chamber sizes are similar in size. The DDS 7000 is slightly taller due to the added HEPA filtrationsystem
PerformanceTesting	Temperature studies were performed on full, partial and empty chambers. Performance testing of theDDS 7000 was performed using Bacillus atrophaeus spore strips and inoculated tools using the sameorganism. Half cycle kills result in an overall 12-log reduction of spores and thus produces a 106sterility assurance level (SAL). This testing showed that the DDS 7000 is as safe and effective andperforms as well if not better than the predicate device (DDS 5000).
SoftwareValidation	The software was designed and validated to assure that the device is as safe and effective or better thanthe predicate device (DDS 5000). "General Principles of Software Validation; Final Guidance forIndustry" and "FDA Staff and Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices; Final" were used in the development and validation of the devicesoftware.

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coltène
whaledent

Indications for Use

510(k) Number (if known): Unknown

Device Name: Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization System

Indications for Use:

The DDS 7000 is a countertop convective dry heat sterilizer designed for use in Healthcare facilities for the sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216℃ (420° F). There is a single software-controlled cycle that includes a warm-up and cool down phase in addition to the 3-minute sterilization (exposure) phase. Sterilize (exposure) starts when the RTD/control temperature reaches the operating temperature set point of 190°C (374° F). Complete cycle times average 34-44 minutes and are load dependent. The DDS 7000 achieves optimum results by uniform load distribution utilizing a dedicated rack and tray system as detailed below.

1) Maximum recommended loads validated for the DDS 7000-115 sterilizer: -

a) Maximum load for a four (4)-rack configuration is four (4) plier racks each holding nine (9) orthodontic pliers each for a total of thirty-six (36) pliers. Other maximum load configuration options are: 32 pliers on eight mini vertical racks; or 20 pliers and hand instruments on four Combo Racks -(OR)-
b) Maximum load for a full tray configuration is one (1) Horizontal Tray each holding up to six (6) orthodontic pliers or up to (12) single-handle hand instruments. Other maximum load combinations include: (5) orthodontic pliers with up to (2) single-handle hand instruments; or (4) orthodontic pliers with up to (4) single-handle hand instruments; or (3) orthodontic pliers with up to (6) single-handle hand instruments, or (2) Orthodontic pliers with up to (8) single-handle hand instruments; or (1) Orthodontic pliers with up to (10) single-handle hand instruments. - (OR)-
c) Maximum load for the one (1) half tray and two (2) racks is one (1) Half Tray holding three (3) Orthodontic pliers or six (6) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks. Other maximum load combinations include: (2) orthodontic pliers with up to (2) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks; or (1) orthodontic pliers with up to (4) singlehandle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks.

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)	x

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sharly H. Murphy, A3/5

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

510(k) Number:__

Regulation Number and Section

§ 880.6870 Dry-heat sterilizer.

(a)
Identification. A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.(b)
Classification. Class II (performance standards).