DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

K172918 · Kavo Dental Technologies, LLC · MUH · Dec 18, 2017 · Dental

Device Facts

• Record ID: K172918
• Device Name: DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
• Applicant: Kavo Dental Technologies, LLC
• Product Code: MUH · Dental
• Decision Date: Dec 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The DEXIS / KaVo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

Device Story

DEXIS Titanium and KaVo IXS HD are digital intraoral sensors using CMOS-based light detection imagers coupled to a scintillating material (Cesium Iodide). Device captures incident x-rays, converts them to visible light, and generates digital images. Operated by dental professionals in clinical settings; requires connection to a PC via USB 2.0 and dedicated imaging software (e.g., DEXIS Imaging Suite) for image reconstruction, display, and management. Sensors feature automatic x-ray detection and motion sensing. Output is a digital radiograph used by clinicians for diagnostic purposes. Benefits include efficient acquisition of dental images compared to traditional film.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993), and software validation (IEC 62304).

Technological Characteristics

Indirect converting x-ray detector; Cesium Iodide (CsI) scintillator; CMOS light detection imager. USB 2.0 connectivity. Dimensions vary by model (Size 1, 1.5, 2). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-65, ISO 10993, ISO 14971, IEC 62304, IEC 62366. Software class: Moderate level of concern.

Indications for Use

Indicated for healthcare professionals to acquire dental intraoral radiographic images in patients requiring dental x-rays.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• DEXIS Sensor (K090458)

Submission Summary (Full Text)

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December 18, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features an abstract image of people. On the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a blue square.

KaVo Dental Technologies, LLC % Mr. Frank Ray Regulatory Affairs Manager 11727 Fruehauf Drive CHARLOTTE NC 28273

Re: K172918

Trade/Device Name: DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: September 15, 2017 Received: November 16, 2017

Dear Mr. Ray:

We have reviewed vour 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.

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 of medical device-related adverse events) (21 CFR 803); 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

# K172918

Device Name DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

Indications for Use (Describe)

The DEXIS / KaVo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / Ka Vo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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KAVO-Kerr

Section V - 510(k) Summary for

# Digital Intraoral Sensor DEXIS Titanium, Kavo IXS HD (Size 1, Size 2)

1. Submitter Information:

KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte, NC 28273

Contact Person: Frank Ray - Telephone Number: [phone] [phone] Fax Number:

Date Prepared: November 15, 2017

# 2. Device Name:

- Proprietary Name: DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) .
- . Common Name: System, x-ray, extraoral source, digital
- Classification Name: Extraoral source x-ray system .

II

- CFR Number: 872.1800 .
- Device Class: .
- Product Code: . MUH

# 3. Predicate Device:

.

- Proprietary Name: DEXIS Sensor - (K090458) .
- Common Name: System, x-ray, extraoral source, digital ●
- Classification Name: Extraoral source x-ray system
- . CFR Number: 872.1800
- Device Class: II ●
- Product Code: мин ●

# 4. Device Description:

The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors supports USB2.0 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.

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Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, KaVo Dental Technologies, LLC is bundling the 3 sensor models listed below in Table 5.1. These 3 models of digital intraoral sensor only differ in branding, size and external industrial design (e.g. chamfered corners, angled USB cable exit), the main components are identical, though the layering is slightly adjusted due to the size of the housing and are cosmetic in nature. The device description and intended use are identical for all 3 proposed models listed below.

| Table | 5.1 |
|-------|-----|
|-------|-----|

| Brand | Model Name | Size<br>Differentiation | Housing Design Differentiation |
|-------|----------------------|-------------------------|------------------------------------------|
| DEXIS | DEXIS Titanium | Size 1.5 | Chamfered corners, angled USB cable exit |
| KaVo | KaVo IXS HD - Size 1 | Size 1 | Rounded Corners, parallel USB cable exit |
| KaVo | KaVo IXS HD - Size 2 | Size 2 | Rounded Corners, parallel USB cable exit |

# Accessories:

The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors have optional accessories/devices as listed in table 5.2 below. The barrier/sheaths have already been cleared by the FDA and contain their own labeling indicating they are disposable devices and the six Holders are Class I Exempt devices. Performance Bench Testing has been performed on all Device / Accessories. Also, KaVo Dental Technologies, LLC has quality system processes implemented for risk assessment for devices manufactured in compliance with ISO 14971:2007. This includes the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors with the Devices / Accessories listed below in Table 5.2. The Risk Management File was reviewed by our test house Intertek as part of obtaining 60601-1 certification. All Devices/Accessories in table 5.2 are non-electrical.

# TABLE 5.2

| Device /<br>Accessory | Device Description | Manufacturer | Product<br>Code | 510(k)<br>Clearance |
|---------------------------------------|-----------------------------------------|----------------------------------|-----------------|---------------------|
| Sheath, Positioning<br>System Barrier | Dental barriers and<br>sleeves | Pac-Dent International | PEM | K151123 |
| Sheath, Universal<br>Sensor Barrier | Dental barriers and<br>sleeves | Pac-Dent International | PEM | K151123 |
| Anterior Holder | Dental X-ray film<br>holder | KaVo Dental Technologies,<br>LLC | EGZ | 510(k)<br>Exempt |
| Posterior Holder | Dental X-ray film<br>holder | KaVo Dental Technologies,<br>LLC | EGZ | 510(k)<br>Exempt |
| Horizontal Bitewing<br>Holder | Dental X-ray film<br>holder | KaVo Dental Technologies,<br>LLC | EGZ | 510(k)<br>Exempt |
| Vertical Bitewing<br>Holder | Dental X-ray film<br>holder | KaVo Dental Technologies,<br>LLC | EGZ | 510(k)<br>Exempt |
| Hand-Held Holder | Dental X-ray film<br>holder | KaVo Dental Technologies,<br>LLC | EGZ | 510(k)<br>Exempt |
| Endo Holder | Dental X-ray film<br>holder | KaVo Dental Technologies,<br>LLC | EGZ | 510(k)<br>Exempt |
| DEXIS Imaging<br>Suite | System, Imaging<br>Acquisition Software | DEXIS, LLC | LLZ | K090431 |

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# Principle of Operation:

The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are a digital intraoral sensor that utilizes scintillating material to convert incident x-rays into visible light coupled optically to a light detection imager based on CMOS technology. X-ray images are acquired when x-ray photons generated by an external x-ray source penetrate a patient's facial structure and impinae on the sensor which is then transferred via USB to a computer running an imaging software program. The digital x-ray sensor serves the same basic function as traditional x-ray film. The firmware controls the on-board function of the FPGA, and the software drivers provides image reconstruction, data transmission through USB, and interface with a dental imaging software for basic sensor management functionality.

The basic sensor management SW functionality contains the following:

- USB plug-n-play event handling for connected sensor(s) to PC .
- Monitor sensor status .
- . Activate sensor for x-ray detection
- . Monitor sensor for x-ray detection
- Transfer image from sensor to PC ●
- Basic Image Correction .

:

The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral require Dental Imaging Acquisition Software such as DEXIS Imaging Suite (K090431) to be operational. The Dental Imaging Acquisition Software is the Graphic User Interface (GUI) used by healthcare professionals to collect images and perform clinical diagnosis.

#### Indications for Use: 5.

The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

#### Description of Substantial Equivalence: 6. Technological Characteristics:

The device comparison table below (Table 5.3) compares the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors to one (1) other legally marketed Class II device DEXIS Sensor (K090458) which was granted marketing clearance by the FDA.

The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors has the same intended use and technological characteristics as compared to the predicate device DEXIS Sensor (K090458). The changes raise no new questions of substantial equivalence.

There are 3 models of digital intraoral sensor described in this 510(k) submission and the only differences between the models are the sizes and external industrial design (e.q. chamfered corners, angled USB cable exit), the main components are identical, though the layout is slightly adjusted due to the size of the housing.

The proposed DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors has been determined to be substantially equivalent to the predicate device, the DEXIS Sensor (K090458) and shares the same intended use and fundamental technology as the predicate. The

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differences do not render the device NSE because the performance tests demonstrate that the differences in technological characteristics do not raise different questions regarding substantial equivalence to the predicate device. Hence, the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are substantial equivalent to the DEXIS Sensor (K090458).

| Descriptive | Proposed Device | | | Predicate Device<br>DEXIS Sensor - K090458 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Information | DEXIS<br>Titanium | KaVo IXS HD<br>Size 1 | KaVo IXS HD<br>Size 2 | |
| Regulation No. | | 21 CFR 872.1800 | | 21 CFR 872.1800 |
| Classification Name<br>Regulation Class | Extraoral source x-ray system<br>II | | Extraoral source x-ray system<br>II | |
| Product Code | | MUH | | MUH |
| Trade Name | DEXIS | KaVo | | DEXIS Sensor |
| Common Name | | Digital Intraoral X-ray Sensor | | Digital Intraoral X-ray Sensor |
| Indications for Use | The DEXIS / KaVo sensor is a USB-driven<br>digital sensor which is intended to acquire<br>dental intra-oral radiographic images. The<br>DEXIS / KaVo sensor shall be operated by<br>healthcare professionals, who are educated and<br>competent to perform the acquisition of dental<br>intra-oral radiographs. The DEXIS / KaVo<br>sensor can be used either in combination with<br>special positioning devices to facilitate<br>positioning and alignment with the x-ray beam<br>or it may also be positioned by hand with the<br>assistance of the patient. | | | The DEXIS Sensor is a USB-<br>driven digital sensor which is<br>intended to acquire dental intra-<br>oral radiography images. The<br>DEXIS Sensor shall be<br>operated by healthcare<br>professionals, who are educated<br>and competent to perform the<br>acquisition of dental intra-oral<br>radiographs. The DEXIS<br>Sensor can be used either in<br>combination with special<br>positioning devices to facilitate<br>positioning and alignment with<br>the x-ray beam or it may also<br>be positioned by hand with the<br>assistance of the patient. |
| Device Description | The DEXIS Titanium / KaVo IXS HD Intraoral<br>Sensors are an indirect converting x-ray<br>detector, e.g. incident x-rays are converted by a<br>scintillating material into (visible) light, this<br>light is coupled optically to a light detection<br>imager based on CMOS technology. The design<br>of the sensor assembly supports the automatic<br>detection of the incident x-rays to generate<br>digital images for dental intra oral applications.<br>The DEXIS Titanium / KaVo IXS HD Intraoral<br>Sensors supports USB2.0 connectivity to<br>personal computers using a dedicated electronic<br>assembly and a sensor software driver. | | | The DEXIS sensor is an<br>indirect converting x-ray<br>detector, e.g. incident x-rays<br>are converted by a scintillating<br>material into (visible) light, this<br>light is coupled optically to a<br>light detection imager based on<br>CMOS technology.<br>The design of the sensor<br>assembly supports the<br>automatic detection of the<br>incident x-rays to generate<br>digital images for dental intra<br>oral applications.<br>The DEXIS sensor supports<br>USB2.0 and USB 1.1<br>connectivity to personal<br>computers using a dedicated<br>electronic assembly and a<br>sensor software driver. |
| Fundemental<br>Technology | | CMOS | | CMOS |
| Sensor Exterior | 39.9mm x | 37.0mm x | 42.3mm x | |
| Dimension (mm) | 29.8mm | 25.2mm | 30.4mm | 38.9mm x 29.7mm |
| Sensor Active<br>Imaging Area | 33.0mm x<br>26.0mm<br>with four<br>clipped<br>corners | 30.1mm x<br>20.2mm with<br>four clipped<br>corners | 36.0mm x<br>26.0mm with<br>four clipped<br>corners | 33.0 mm x 25.8 mm with four<br>clipped corners |
| Pixel Size | | 19.5um | | 19.5um |
| Dynamic Range | | 4,096:1 | | 16,384:1 |
| Image Resolution | 1692 x<br>1324 pixels | 1539 x 1026<br>pixels | 1842 x 1324<br>pixels | 1692 x 1324 pixels |
| USB Cable exit | 35° angled<br>cable exit | 0º parallel<br>cable exit | 0º parallel<br>cable exit | 35° angled cable exit |
| Corner design | Chamfered<br>corners | Rounded<br>corners | Rounded<br>corners | Chamfered corners |
| Sensor Cable Length | | 3 m | | 2.8 m |
| X-ray Resolution | | 20+ visible lp/mm | | 20+ visible lp/mm |
| Scintillator<br>Technology | Cesium Iodide (CsI) Scintillator | | | Cesium Iodide (CsI)<br>Scintillator |
| SW Features | USB 2.0 Communication<br>●<br>Noise Filtering<br>Binning<br>Basic Image Correction (Gain/Offset/Pixel<br>●<br>Calibration)<br>Monitoring Sensor Health/State<br>●<br>Image Transmission<br>● | | | USB 2.0 Communication<br>Noise Filtering<br>0<br>Binning<br>●<br>Basic Image Correction<br>0<br>(Gain/Offset/Pixel<br>Calibration)<br>Monitoring Sensor<br>0<br>Health/State<br>Image Transmission |
| Interface to PC | USB Type A Plug | | | USB Type A Plug |

# Table 5.3

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| Input electrical<br>power | 5.0V / 0.5W via USB | 5.0V / 350mA max via USB |
|------------------------------|----------------------------------------------------------------------------|------------------------------------------------|
| Exposure method | X-Ray Monitor Mode | X-Ray Monitor Mode |
| Communication<br>standard | USB 2.0 | USB 1.1 and 2.0 |
| Motion sensing<br>capability | Yes | N/A |
| Consensus Standards | IEC 60601-1<br>IEC 62366-1<br>IEC 60601-2-65<br>IEC 60601-1-2<br>IEC 62304 | IEC 60601-1<br>IEC 60601-2-65<br>IEC 60601-1-2 |

# Non-Clinical Test Data:

Performance bench testing according to international standards for Extra-oral source x-ray system (Sensors) has been conducted to determine conformance in regards to:

- Biocompatibility has been completed for the applicable components. .
- . Software documentation for moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices.
- . Electrical Safety testing, including Electromagnetic Compatibility, have been performed by Intertek Testing Services.
- . Comparative performance testing of the functions of the accessories as compared to the cleared stand-a-lone device.

Furthermore, the performance of the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors has been verified utilizing the following standards in Table 5.4 below:

| TABLE 5.4 | | | |
|-----------|--------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Standard | Year & Edition | Description |
| 1. | IEC 60601-1 | 2005 + CORR.<br>1:2006 + CORR.<br>2:2007 + AM1:2012 | Medical electrical equipment Part 1: General requirements for basic safety and essential<br>performance |
| 2. | AAMI / ANSI<br>ES60601-1 | 2005/(R)2012 and<br>C1:2009/ (R)2012<br>and, A2:2010/(r)2012 | Medical electrical equipment Part 1: General requirements for basic safety and essential<br>performance |
| 3. | CSA C22.2 #<br>60601-1 | 2014 (3rd) 2014-01-<br>01 | Medical Electrical Equipment - Part 1: General Req. for Basic Safety & Essential Perf.;<br>Cor. 2: 2011 |
| 4. | IEC 60601-1-2 | 2014 (4th Ed.) 2014-<br>02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and<br>essential performance - Collateral standard: Electromagnetic compatibility - Requirements<br>and tests. |
| 5. | IEC 60601-1-6 | 2010 | Medical electrical equipment - part 1-6: general requirements for basic safety and essential<br>performance - collateral standard: usability. |
| 6. | IEC 60601-2-65 | 2012 (1st Ed.) 2012-<br>09 | Medical electrical equipment Part 2-65: Particular requirements for the basic safety and<br>essential performance of dental intra-oral X-ray equipment. |
| 7. | ISO 10993-1 | 2009 (4th) 2009-10-<br>15 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk<br>management process [including: technical corrigendum 1 (2010)]. |
| 8. | ISO 10993-5 | 2009 – AAMI ANSI<br>ISO | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. |
| 9. | ISO 10993-10 | 2010 (3rd ed) 2010-<br>08-01 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin<br>sensitization. |
| 10. | AMMI / ANSI<br>IEC 62304 | 2006 | Medical device software - Software life cycle processes. |
| 11. | AMMI ANSI<br>IEC 62366 | 2007/(R)2013 +A1 | Medical devices - Application of usability engineering to medical devices. |
| 12. | ISO 14971 | 2007 | Medical devices - Application of risk management to medical devices. |

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Hence the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors demonstrates substantial equivalence.

# Clinical Performance Data:

Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.

# Conclusion as to Substantial Equivalence:

Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are deemed to be substantially equivalent to the predicate device.