Fujifilm Endoscope Models EC-600HL and EC-600LS

K162622 · Fujifilm Medical Systems U.S.A, Inc. · FDF · Oct 18, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162622
• Device Name: Fujifilm Endoscope Models EC-600HL and EC-600LS
• Applicant: Fujifilm Medical Systems U.S.A, Inc.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Oct 18, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

Device Story

Flexible video endoscopes (EC-600HL, EC-600LS) used for lower digestive tract visualization; observation, diagnosis, and treatment of rectum and large intestine. System comprises operation section, insertion portion, and umbilicus. Insertion portion contains glass fiber bundles for illumination and CMOS image sensor for image capture. Operates by connecting to video processor, light source, and peripheral devices (monitor, water tank, electrosurgical instruments). Physician controls distal end angulation via operation section; introduces accessories (e.g., biopsy forceps) through forceps channel. Output displayed on monitor for real-time clinical decision-making during endoscopic procedures. Modifications involve new epoxy resin in manufacturing. Benefits include diagnostic and therapeutic access to lower GI tract.

Clinical Evidence

Bench testing only. Performance testing conducted on modified EC-600HL and EC-600LS to ensure equivalence to predicates. Evaluated parameters included field of view, bending capability, air/water supply rates, suction rate, working length, forceps channel diameter, viewing direction, insertion portion width, resolution, and light guide output. All tests met pre-defined acceptance criteria.

Technological Characteristics

Flexible video endoscope; CMOS image sensor; glass fiber illumination. Components: operation section, insertion portion, umbilicus. Materials: new epoxy resin used in construction. Connectivity: connects to proprietary video processor (EPX-4440HD) and light source (XL-4450). Dimensions: EC-600HL (12.8mm distal/flexible diameter, 1690mm working length); EC-600LS (11.5mm distal/flexible diameter, 1690mm working length). Bending: 180 degrees up/down, 160 degrees left/right.

Indications for Use

Indicated for visualization of the lower digestive tract, including observation, diagnosis, and endoscopic treatment of the rectum and large intestine in patients requiring colonoscopy.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Fujifilm Endoscope Models EC-600HL and EC-600LS (K143732)

Reference Devices

• FUJIFILM 600 Series Endoscope EC-600HL and EC-600LS (K132210)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 18, 2016

Fujifilm Medical Systems USA, Inc. Shraddha Morc Specialist, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, New Jerscy 07470

Re: K162622

> Trade/Device Name: Fujifilm Endoscope Models EC-600HL and EC-600LS Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDF Dated: September 19, 2016 Received: September 20, 2016

Dear Shraddha Morc:

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, labcling, 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 mislcading.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Shraddha Morc

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/McdicalDcvices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sinccrely,

For Division

Douglas Silverstein -S 2016.10.18 13:53:51 -04'00'

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162622

Device Name

Fujifilm Endoscope Models EC-600HL and EC-600LS

Indications for Use (Describe)

This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

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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## 510(k) SUMMARY

## Fujifilm's EC-600HL and EC-600LS

#### Submitter's Information

Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293

#### Contact Person:

Shraddha More Specialist, Regulatory Affairs and Quality Assurance Telephone: [phone] Ext. 522627 Facsimile: [phone] E-Mail: [e-mail]

## Date Prepared: January 27, 2017

## ldentification of the Subject Device:

| Proprietary/Trade Name: | Fujifilm Endoscope Models EC-600HL and EC-600LS |
|-------------------------|-------------------------------------------------|
| Common Name: | Video Endoscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |

#### Classification Information:

Colonoscope and Accessories (Flexible/Rigid), 21 C.F.R. § 876.1500 Product Code: FDF

#### Primary Predicate

Fujifilm Endoscope Models EC-600HL and EC-600LS (K143732)

#### Purpose of the Special 510(k) notice

The EC-600HL and EC-600LS are modifications of predicate EC-600HL and EC-600LS respectively

#### Intended Use

This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

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#### Device Description

The modified Fujifilm Endoscope Models EC-600HL and EC-600LS are comprised of three main sections: an operation section, an insertion portion, and an umbilicus. The Table 5-1 describes the insertion and non-insertion portions of the devices. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains class fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water and provide suction, as well as a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The Figure 10-1 below shows main components of the endoscopes.

The subject device is used in combination with FUJIFILM's video processor, light source and peripheral devices such as water tank, endoscope accessories, monitor, printer, electrosurgical instruments, foot switch, and cart. All of these were previously cleared in K143732.

Image /page/4/Figure/4 description: The image shows a diagram of a system with various components and labels. The diagram includes pipes, valves, and other mechanical parts, all interconnected. The labels provide information about the function and purpose of each component within the system. The diagram appears to be technical in nature, possibly related to engineering or mechanics.

Figure 10-1: Components of the Endoscope EC-600HL and EC-600LS

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# Technological Characteristics

| Table 10-1: Comparison between technological characteristics of EC-600HL and its predicate | |
|--------------------------------------------------------------------------------------------|--|
| | |

| | | Predicate Device Model<br>EC-600HL | Proposed Device Model<br>EC-600HL |
|-------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Device Name | | Fujifilm Video Endoscope<br>EC-600HL | Fujifilm Video Endoscope<br>EC-600HL |
| 510(k) Number | | K143732 | Pending |
| Indications for Use<br>(IFU) | | This device is intended for the visualization<br>of the lower digestive tract, specifically for<br>the observation, diagnosis, and<br>endoscopic treatment of the rectum and<br>large intestine. | Same as K143732 |
| Viewing direction | | Forward/ 0 degree | Same as K143732 |
| Observation range | | 2-100mm | Same as K143732 |
| Field of View | | 170 degrees | Same as K143732 |
| Distortion<br>characteristics | | Orthogonal Projection | Same as K143732 |
| Image sensors | | CMOS | Same as K143732 |
| Distal end diameter | | 12.8mm | Same as K143732 |
| Flexible portion<br>diameter | | 12.8mm | Same as K143732 |
| Maximum insertion<br>diameter | | 14.3mm | Same as K143732 |
| | Up | 180 degrees | Same as K143732 |
| Bending | Down | 180 degrees | Same as K143732 |
| capability | Left | 160 degrees | Same as K143732 |
| | Right | 160 degrees | Same as K143732 |
| Forceps channel<br>diameter | | 4.2mm | Same as K143732 |
| Working length | | 1690mm | Same as K143732 |
| Total length | | 1990mm | Same as K143732 |
| WJ Function | | c | Same as K143732 |
| Location of WJ inlet | | On the light guide connector | Same as K143732 |
| Video Processor | | EPX-4440HD<br>- Light Source:XL-4450<br>- Processor:VP-4440HD | Same as K143732 |
| Peripherals | | Water Tank WT-2<br>Water Tank, WT-4 | Same as K143732 |
| | | Endoscopic Accessory(i.e. Forceps) | Same as K143732 |
| | | Monitor | Same as K143732 |
| | | Printer | Same as K143732 |
| | | None | Same as K143732 |
| | | Electrosurgical Instruments | Same as K143732 |
| | | Foot Switch | Same as K143732 |
| | | Cart | Same as K143732 |
| | Predicate Device Model<br>EC-600HL | Proposed Device Model<br>EC-600HL | |
| Accessories | Cleaning Brush WB11002FW2 | Same as K143732 | |
| | Channel Cleaning Brush<br>WB5021FW2 | Same as K143732 | |
| | Forceps Valve<br>(FOV-DV7) | Same as K143732 | |
| | Ventilation Adapter<br>(AD-7) | Same as K143732 | |
| | Cleaning Adapter Kit (CA-510/A)<br>Image: Cleaning Adapter Kit | Same as K143732 | |
| | J Tube (JT-500)<br>Image: J Tube | Same as K143732 | |
| | Air/Water button<br>(AW-500) | Minor material and design modifications | |
| | Suction button (SB-500) | Minor material and design modifications | |
| Optional items | Water Jet Inlet cap | Same as K143732 | |
| | Air leak tester LT-7F | Same as K143732 | |

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| | | Predicate Device Model<br>EC-600LS | Proposed Device Model<br>EC-600LS |
|-------------------------------|-------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Device Name | | Fujifilm Video Endoscope | Fujifilm Video Endoscope |
| | | EC-600LS | EC-600LS |
| 510(k) Number | | K143732 | Pending |
| Indications for Use<br>(IFU) | | This device is intended for the visualization<br>of the lower digestive tract, specifically for<br>the observation, diagnosis, and endoscopic<br>treatment of the rectum and large intestine. | Same as K143732 |
| Viewing direction | | Forward/ 0 degree | Same as K143732 |
| Observation range | | 2-100mm | Same as K143732 |
| Field of View | | 170 degrees | Same as K143732 |
| Distortion<br>characteristics | | Orthogonal Projection | Same as K143732 |
| Image sensors | | CMOS | Same as K143732 |
| Distal end diameter | | 11.5mm | Same as K143732 |
| Flexible portion<br>diameter | | 11.5mm | Same as K143732 |
| Maximum insertion<br>diameter | | 13.1mm | Same as K143732 |
| Bending<br>capability | Up | 180 degrees | Same as K143732 |
| | Down | 180 degrees | Same as K143732 |
| | Left | 160 degrees | Same as K143732 |
| | Right | 160 degrees | Same as K143732 |
| Forceps channel<br>diameter | | 3.8mm | Same as K143732 |
| Working length | | 1690mm | Same as K143732 |
| Total length | | 1990mm | Same as K143732 |
| WJ Function | | Yes | Same as K143732 |
| Location of WJ inlet | | On the light guide connector | Same as K143732 |
| Video Processor | | EPX-4440HD<br>Light Source: XL-4450<br>Processor:VP-4440HD | Same as K143732 |
| | | Water Tank WT-2<br>Water Tank, WT-4 | Same as K143732 |
| | | Endoscopic Accessory(i.e. Forceps) | Same as K143732 |
| Peripherals | | Monitor | Same as K143732 |
| | | Printer | Same as K143732 |
| | | None | Same as K143732 |
| | | Electrosurgical Instruments | Same as K143732 |
| | | Foot Switch | Same as K143732 |
| | | Cart | Same as K143732 |

# Table 10-2: Comparison between technological characteristics of EC-600LS and its predicate

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| | Predicate Device Model<br>EC-600HL | Proposed Device Model<br>EC-600HL |
|----------------|------------------------------------------------------------------|-----------------------------------------|
| Accessories | Cleaning brush WB11002FW2 | Same as K143732 |
| | Cleaning brush WB11002FW2 | Same as K143732 |
| | Channel Cleaning Brush<br>WB5021FW2 | Same as K143732 |
| | Cleaning Adapter Kit (CA-510/A)<br>Image: [Cleaning Adapter Kit] | Same as K143732 |
| | Forceps Valve<br>(FOV-DV7)<br>Ventilation Adapter<br>(AD-7) | Same as K143732 |
| | J Tube (JT-500)<br>Image: [J Tube] | Same as K143732 |
| Optional items | Air/Water button<br>(AW-500) | Minor material and design modifications |
| | Suction button (SB-500) | Minor material and design modifications |
| | Water Jet Inlet cap<br>Air leak tester LT-7F | Same as K143732 |

## Principles of Operation

The principles of operation of the FUJIFILM Endoscope Models EC-600HL and EC-600LS are identical to those of the predicate device, FUJIFILM 600 Series Endoscope EC-600HL and EC-600LS (K132210). All three devices utilize a retrograde approach for visualization of the areas of the lower digestive tracts.

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## Summary of the Design Modifications

The proposed devices have been modified from their corresponding predicate devices in their materials. A new epoxy resin will be used in modified devices instead of the current epoxy resin during their manufacturing. Both epoxy resins will be used for the repair of predicate as well as subject devices.

This material change does not affect the intended use or fundamental scientific technology of the proposed endoscopes; therefore the intended use and fundamental scientific technology of the proposed endoscopes remain the same as the legally marketed EC-600HL and EC-600LS (K143732). See Table 10-1 and Table 10-2 for a detailed similarities and differences comparison between the technological characteristics of proposed device and the legally marketed device.

## Performance Data

Fujifilm conducted the following performance testing of the modified EC-600HL and EC-600LS to ensure that the modified device performs equivalently to the predicate EC-600HL and EC-600LS:

- Field of view .
- Bending capability .
- Rate of air supply .
- Rate of water supply .
- . Rate of suction
- . Working length
- . Diameter of forceps channel
- . Viewing direction
- Maximum insertion portion width .
- Resolution ●
- . LG output

In all cases, the device met the pre-defined acceptance criteria for the test.

#### Substantial Equivalence

EC-600HL and EC-600LS has the same intended use and similar indications, principles of operation, and technological characteristics as their predicate devices EC-600HL and EC-600LS. The minor differences in the modified devices technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the EC-600HL and EC-600LS are as safe and effective as their predicate devices EC-600HL and EC-600LS respectively. Thus, the modified EC-600HL and EC-600LS are substantially equivalent to their respective predicate devices.