(85 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or algorithms.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "therapeutic procedures."
No
The device is intended for "access the sinus space and to dilate the sinus ostia and spaces...for diagnostic and therapeutic procedures" and "to illuminate within and transilluminate across nasal and sinus structures." While it aids in procedures that may involve diagnosis, the device itself performs mechanical actions (dilation, illumination) rather than analyzing data to provide a diagnosis.
No
The device description explicitly details physical components such as a handle, rail, balloon catheter, and sinus illumination system, indicating it is a hardware-based medical device.
Based on the provided information, the Relieva Scout™ Multi-Sinus Dilation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for accessing, dilating, and illuminating sinus cavities. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a physical device with a balloon catheter and illumination system designed for direct use within the sinus cavities. This is consistent with a surgical or therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Relieva Scout™ Multi-Sinus Dilation System is a medical device used for therapeutic and diagnostic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate across nasal and sinus structures.
Product codes (comma separated list FDA assigned to the subject device)
LRC
Device Description
The Relieva Scout™ Multi-Sinus Dilation System is a sterile, single-use system that is an integrated device with a handle, rail, balloon catheter, and sinus illumination system with an illuminated ball tip. The packaged device contains the sinus balloon catheter an angle selection tool to enable angular bends for multiple sinus access (sphenoid, frontal, maxillary). The device may be used to access the sinus space and the balloon inflated with sterile water or sterile or saline to dilate the sinus ostia and infandibulum. The inflation device is provided separately. The device may be used in Operating Room and physician office settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus space, sinus ostia, sphenoid, frontal, and maxillary sinus cavities, nasal and sinus structures
Indicated Patient Age Range
18 and older
Intended User / Care Setting
Operating Room and physician office settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, balloon burst, and bond separation. Testing in accordance with ISO 10993-1 AAMI ANSI ISO 10993-1:2009/(R) 2013 also showed that the Relieva Scout™ Multi-Sinus Dilation System is biocompatible.
The sterilization process was validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic".
Packaging shelf life was established per ASTM F1980-07.
The performance data demonstrated that the device performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RELIEVA SCOUT® Sinus Dilation System (K120280), XprESSTM Multi-Sinus Dilation Tool (K121174), RELIEVA® Spin Balloon Sinuplasty System (K111875)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Acclarent, Inc. James Patrick Garvey Senior Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, California 94025
Re: K153341
Trade/Device Name: Relieva Scout™ Multi-Sinus Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: November 18, 2015 Received: November 19, 2015
Dear Mr. Garvey:
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. 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 (reporting of medical devicerelated 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.
1
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 (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/MedicalDevices/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 (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153341
Device Name Relieva Scout™ Multi-Sinus Dilation System
Indications for Use (Describe)
For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate across nasal and sinus structures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black, except for the "ent" which is in purple. There is a purple curved line above the "ent".
Relieva Scout™ Multi-Sinus Dilation System
APPENDIX A: 510(k) SUMMARY
| [807.92(a)(1)] Submitter Information | |
|---|---|
| Sponsor/Submitter: | Acclarent, Inc. |
| 1525-B O'Brien Drive | |
| Menlo Park, California 94025 | |
| Contact Person: | Patrick Garvey |
| Sr. Manager, Regulatory Affairs | |
| Email: pgarvey@its.jnj.com | |
| Tel: 650-687-5888 | |
| Date Summary Prepared: | February 12, 2016 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name: | Relieva ScoutTM Multi-Sinus Dilation System |
| Common Name: | Sinus Balloon Catheter |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 874.4420 |
| Classification Name: | Ear, Nose, and Throat Manual Surgical Instrument (21 CFR 874.4420) |
| Product Code: | LRC |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Devices: | RELIEVA SCOUT® Sinus Dilation System (K120280) |
| XprESSTM Multi-Sinus Dilation Tool (K121174) | |
| RELIEVA® Spin Balloon Sinuplasty System (K111875) | |
| [807.92(a)(4)] Device Description |
The Relieva Scout™ Multi-Sinus Dilation System is a sterile, single-use system Device Description: that is an integrated device with a handle, rail, balloon catheter, and sinus illumination system with an illuminated ball tip. The packaged device contains the sinus balloon catheter an angle selection tool to enable angular bends for multiple sinus access (sphenoid, frontal, maxillary). The device may be used to access the sinus space and the balloon inflated with sterile water or sterile or saline to dilate the sinus ostia and infandibulum. The inflation device is provided separately. The device may be used in Operating Room and physician office settings.
[807.92(a)(5)] Intended Use
For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation Indications for Use: System is intended to provide a means to access the sinus space and to dilate
4
Image /page/4/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the "ent" portion of the word in purple. A purple arc extends over the "ent" portion of the word, adding a visual element to the logo.
Relieva Scout™ Multi-Sinus Dilation System
| | the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary
sinus cavities for diagnostic and therapeutic procedures. In addition, the
device is intended to illuminate within and transilluminate across nasal and
sinus structures. | | |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Difference in
Indications from
Predicate Device | The difference in indications for use between the subject and predicate devices
is supported is presented in Table 1. | | |
[807.92(a)(6)] Technical Characteristics
The Relieva Scout™ Multi-Sinus Dilation System combines features of a rail-Technological Characteristics: based balloon catheter with the tissue expansion effect of balloon dilation. The distal end of the device may be shaped with the angle selection tool to optimize sinus access. Light from an extendable integrated illumination system can be seen via transillumination.
See Table 1 for a comparison of the technological characteristics between the Relieva Scout and the predicate devices.
5
Image /page/5/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black font. There is a purple swoosh above the "ent" in Acclarent.
Relieva Scout™ Multi-Sinus Dilation System
| Attribute | Primary Predicate
Device:
RELIEVA SCOUTⓇ
Sinus Dilation System
(K120280) | Secondary Predicate
Device:
XprESS™ Multi-Sinus
Dilation Tool (K121174) | Predicate Device:
RELIEVA® Spin Sinus
Dilation System
(K111875) | Subject Device:
Relieva Scout ™ Multi-
Sinus (SMS) Dilation
System |
|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Acclarent, Inc. | Entellus Medical, Inc. | Acclarent, Inc. | Acclarent, Inc. |
| Common Name | Sinus Balloon Dilation
System | Sinus Balloon Dilation
System | Sinus Balloon Dilation
System | Sinus Balloon Dilation
System |
| Class | I | I | I | I |
| Product Code is LRC | LRC | LRC | LRC | LRC |
| Classification Section | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4420 | 21 CFR 874.4420 |
| Indications for Use | For patients aged 18 and
older, the Relieva Scout
Sinus Dilation System is
intended to provide a
means to access the frontal
sinus space and to dilate
the frontal recess, frontal
sinus ostia and spaces
within the frontal sinus
cavity for diagnostic and
therapeutic procedures. In
addition, the device is
intended to illuminate
within and transilluminate
across nasal and sinus
structures. | To access and treat the
frontal recesses, sphenoid
sinus ostia and maxillary
ostia/ethmoid
infundibula in adults using
a trans-nasal approach.
The bony sinus outflow
tracts are remodeled by
balloon displacement of
adjacent bone and
paranasal sinus structures. | Intended to provide a
means to access the sinus
space and to dilate the
sinus ostia and spaces
associated with the
paranasal sinus cavities for
diagnostic and therapeutic
procedures. For children
aged 17 and under, the
device is intended to dilate
sinus ostia and spaces
associated with the
maxillary sinus for
diagnostic and therapeutic
procedures. | For patients aged 18 and
older, the Relieva Scout
Multi-Sinus Dilation
System is intended to
provide a means to access
the sinus space and to
dilate the sinus ostia and
spaces associated with the
sphenoid, frontal, and
maxillary sinus cavities for
diagnostic and therapeutic
procedures. In addition,
the device is intended to
illuminate within and
transilluminate across
nasal and sinus structures. |
| Indicated for Children | No | No | Yes | No |
| Attribute | Primary Predicate
Device:
RELIEVA SCOUT®
Sinus Dilation System
(K120280) | Secondary Predicate
Device:
XprESS™ Multi-Sinus
Dilation Tool (K121174) | Predicate Device:
RELIEVA® Spin Sinus
Dilation System
(K111875) | Subject Device:
Relieva Scout TM Multi-
Sinus (SMS) Dilation
System |
| Single Patient Use | Yes | Yes | Yes | Yes |
| Direct Patient Contact | Yes | Yes | Yes | Yes |
| Labeled as Non-
Pyrogenic? | No | No | No | No |
| Technological
Characteristics | Combines features of a
frontal ostium seeker with
the tissue expansion effect
of balloon dilation. The
distal end of the device is
permanently curved to
optimize frontal ostium
access. Light from the
distal tip of the integrated
sinus illumination system
can be seen via
transillumination. The
device is connected to any
standard light source via a
light cable and an adapter. | Combines features of a
curved suction tip and a
frontal ostium seeker
(access) with the tissue
expansion effect of balloon
dilation (treat). The distal
end of the device is re-
shapeable. | Combines a sinus balloon
catheter and a sinus guide
catheter to access the sinus
space and dilate sinus
ostia.
A Sinus Illumination
System comes packaged
with the device and is pre-
loaded into the Spin Sinus
Dilation System. | Combines a sinus balloon
catheter with rail-based
balloon guidance to access
the sinus space and dilate
the sinus ostia. The
packaged device contains
an angle selection tool to
enable angular bends for
multiple sinus access.
Light from the distal tip of
the integrated sinus
illumination system can be
seen via transillumination. |
| Constructed of Materials
Commonly Used in Patient
Contacting Medical
Devices | Yes | Yes | Yes | Yes |
| Balloon Diameter | 6mm | 5mm to 7mm | 6mm | 6mm |
| Balloon Length | 24mm | 8-20mm | 16mm | 24mm |
| Attribute | Primary Predicate
Device:
RELIEVA SCOUT®
Sinus Dilation System
(K120280) | Secondary Predicate
Device:
XprESSTM Multi-Sinus
Dilation Tool (K121174) | Predicate Device:
RELIEVA® Spin Sinus
Dilation System
(K111875) | Subject Device:
Relieva Scout TM Multi-
Sinus (SMS) Dilation
System |
| Maximum Inflation
Pressure | 12 ATM | 12 ATM | 12 ATM | 12 ATM |
| Single-Handed Use | Yes | Yes | Yes | Yes |
| Balloon Slide Mechanism | Yes | Yes | Yes | Yes |
| Rail-Based Design | Yes, preset rail intended
for frontal sinus access
only | Yes, malleable rail | No | Yes, malleable rail |
| Handle and Slider System
to Facilitate Advancement
of a Balloon Catheter on
the Distal End | Yes | Yes | Yes | Yes |
| Uses a Bending Tool to
Achieve Target Angles for
Access into Targeted
Anatomy | No | Yes | No | Yes |
| Guidewire Capability
(Sinus Illumination
System) | Yes | Yes | Yes | Yes |
| Sinuses in which device is
intended for use:
[Sphenoid, Maxillary,
Frontal] | Frontal | Sphenoid, Maxillary,
Frontal | Sphenoid, Maxillary,
Frontal | Sphenoid, Maxillary,
Frontal |
| EtO Sterilized | Yes | Yes | Yes | Yes |
| Attribute | Primary Predicate
Device:
RELIEVA SCOUT®
Sinus Dilation System
(K120280) | Secondary Predicate
Device:
XprESSTM Multi-Sinus
Dilation Tool (K121174) | Predicate Device:
RELIEVA® Spin Sinus
Dilation System
(K111875) | Subject Device:
Relieva Scout TM Multi-
Sinus (SMS) Dilation
System |
| Packaging | Thermoformed tray in
pouch | Backer card in pouch | Backer card in pouch | Thermoformed tray in
pouch |
| Principles of Operation | Manually operated device.
Balloon inflated with
sterile saline or water to
mechanically dilate sinus
ostia. | Manually operated device.
Balloon inflated with
sterile saline or water to
mechanically dilate sinus
ostia. | Manually operated device.
Balloon inflated with
sterile saline or water to
mechanically dilate sinus
ostia. | Manually operated device.
Balloon inflated with
sterile saline or water to
mechanically dilate sinus
ostia. |
Table 1: Comparison of Technological Characteristics between the Relieva Scout" "Multi-Sinus Dilation System and predicate devices.
6
Image /page/6/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black font. To the right of the word is a purple design that looks like a swoosh.
Relieva Scout™ Multi-Sinus Dilation System
7
Image /page/7/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in black font. To the right of the word is a purple design that looks like a swoosh.
Relieva Scout™ Multi-Sinus Dilation System
8
Image /page/8/Picture/0 description: The image shows the word "Acclarent" in a stylized font. The first part of the word, "Acclar" is in black, while the "ent" is in purple. There is a purple curved line above the "ent" portion of the word.
Relieva Scout™ Multi-Sinus Dilation System
9
Image /page/9/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the last part in purple. There is a purple curved line above the last part of the word.
Relieva Scout™ Multi-Sinus Dilation System
[807.92(b) (1)] Determination of Substantial Equivalence
| Non-Clinical Performance
Data: | Bench testing met all acceptance criteria for attributes such as
dimensional attributes, cycle fatigue, balloon burst, and bond
separation. Testing in accordance with ISO 10993-1
AAMI ANSI ISO 10993-1:2009/(R) 2013 also showed that the
Relieva Scout™ Multi-Sinus Dilation System is biocompatible. |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The sterilization process was validated per AAMI/ANSI/ISO 11135-1:
2007 and demonstrated a sterility assurance level of 10-6. The method
used for sterilization validation was the overkill (half-cycle approach) in
a fixed chamber. Ethylene oxide residuals were tested and met ISO
10993-7:2008 requirements. The subject device is not tested nor
labeled as "non-pyrogenic". |
| | Packaging shelf life was established per ASTM F1980-07. |
| | The performance data demonstrated that the device performs as
intended. |
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the Relieva Scout™ Multi-Sinus
Dilation System. The performance data demonstrated that the device
performs as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-
Clinical and Clinical Tests | The Relieva Scout™ Multi-Sinus Dilation System is substantially
equivalent to the predicate devices. |