(442 days)
No
The device description focuses on hardware components (belts, sensors, cables) and the physical principle of Respiratory Inductive Plethysmography (RIP) to measure changes in inductance. The processing mentioned is the conversion of inductance changes to electrical or digital signals for connection to physiological recording equipment. There is no mention of AI, ML, or any form of algorithmic learning or complex data analysis beyond basic signal processing.
No
Explanation: The device is described as being for "diagnostics purposes only" and "is not intended to be used as an apnea monitor," indicating it measures and processes signals for diagnosis rather than providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only..." and "The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory effort..."
No
The device description explicitly details physical components like sensor belts, locks, cables, and snap sensors, which are hardware. It also mentions interfacing with external hardware like recording devices and PSG systems.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The XactTrace® Single Use Respiratory Effort Belt System measures physical changes in the body (circumference of the abdomen and thorax) to assess respiratory effort. It does not analyze biological samples.
- The intended use is to measure respiratory effort to assist in the diagnosis of sleep disorders. This is a physiological measurement taken directly from the patient, not an analysis of a sample.
The device is a medical device used for physiological monitoring and diagnosis, but it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The intended environments are hospitals, institutions, sleep centers, sleep clinics.
The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
Product codes
MNR
Device Description
The XactTrace Single Use Respiratory Effort Belt System subject device applies Respiratory Inductive Plethysmography (RIP) Sensor Belts to support respiratory effort signals used in the diagnosis of sleep disorders or sleep related respiratory disorders. The XactTrace Single Use Respiratory Effort Belt System subject device supports a measure of changes in inductance as a result of changes in abdominal, thorax circumference.
There are two variations of the XactTrace® Single Use Respiratory Effort Belt System:
-
XactTrace® Single Use Cut-to-Fit Respiratory Effort Belt System, and
-
XactTrace® Single Use Pre-Sized Respiratory Effort Belt System.
The XactTrace Single Use Cut-to-Fit Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Locks (belt connectors) with a cable that connects to a recording device. The system supports conversion of changes in inductance to a digital signal that provides both qualitative information of respiratory effort. The Sensor Belt of the XactTrace Single Use Cut-To-Fit Belt variation is cut by the medical professional to appropriate lengths to fit patient abdomen, thorax circumference.
The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Snap Sensors (Sensor Belt connectors) with a cable that connects to a recording device. The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation supports conversion of Sensor Belt changes in inductance to a signal that provides both qualitative and quantitative information of respiratory effort. XactTrace Single Use Pre-Sized Respiratory Effort belts are available in four sizes: Pediatric, Small, Medium and Large.
An optional Inductive Interface Cable (RIP Processor) is available to interface with PSG systems that accept the 1.5mm female touchproof connectors, and do not have internal RIP Sensor Belt technology.
Both variations of XactTrace Respiratory Effort Belts are interfaced with either an optional external Inductive Interface Cable or a RIP technology compatible Embla PSG system amplifier. Compatible Embla amplifiers are identified by keyhole connectors for Sensor Belt input.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen and Thorax
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Hospitals, institutions, sleep centers, sleep clinics.
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
Non-clinical, bench evaluations were conducted to confirm compliance with performance requirements:
- Dimensional requirements: Measurement of components. Result: Pass.
- Lock and Snap Sensor compatibility: Components connect properly and perform as intended. Result: Pass.
- Compatibility with Inductive Interface Cable and RIP technology compatible Embla PSG recording system input connections, key connector inputs: Interface with Inductive Interface Cables and Embla PSG recording system input connections, key connectors, recoding. Result: Pass.
- Resistance of XactTrace Single Use Cut-to-Fit Effort Belt, variation of XactTrace Single Use Respiratory Effort Belt System: Cut belts to size, confirm resistance measurement. Result: Pass.
- Resistance of XactTrace Single Use Pre-Sized Effort Belt, variation of XactTrace Single Use Respiratory Effort Belt System: Confirm resistance measurement. Result: Pass.
- Cleaning of reusable Snap Sensor and Locks: Recommended cleaning method does not cause damage. Result: Pass.
- Operational temperature and humidity range: No damage with operational temperature and humidity. Result: Pass.
- Equivalence of breathing effort signal output: Compare breathing effort signal output for the XactTrace Single Use Respiratory Effort Belt System technology under review to primary predicate Universal XactTrace for both Embla amplifier and Inductive Interface Cable. Result: Pass.
- Equivalence of breathing effort signal output for same displacement of both XactTrace Single Use Sized Effort Belt, variations: For the same displacement of Sensor Belt, the output from the XactTrace Single Use Cut-to-Fit Effort Belt is equivalent to the output from the XactTrace Single Use Pre-Sized Effort Belt. Result: Pass.
- EMC compliance with Inductive Interface Cables: Confirm compliance with IEC 60601-1-2, 4th edition. Result: Pass.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
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March 1, 2019
Embla Systems Sanjay Mehta Director, Quality Assurance & Regulatory Affairs 1 Hines Road. Suite 202 Kanata, k2k 3C7 Ca
Re: K173793
Trade/Device Name: XactTrace Single Use Respiratory Effort Belt System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: January 29, 2019 Received: January 30, 2019
Dear Sanjay Mehta:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173793
Device Name
The XactTrace® Single Use Respiratory Effort Belt System
Indications for Use (Describe)
The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The intended environments are hospitals, institutions, sleep centers, sleep clinics.
The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K173793 510(k) Summary
Submitter Information
| Submitter's Name: | Embla Systems |
|---|---|
| Submitter's Address: | 1 Hines Road, Suite 202 |
| Kanata, ON, CA, K2K 3C7 | |
| Submitter's Phone: | (905) 287-5055 |
| Contact Person: | Mr. Sanjay Mehta |
| Director, Quality Assurance & Regulatory Affairs | |
| Date Summary | |
| Prepared: | February 27, 2019 |
Subject Device
| Trade Name: | XactTrace® Single Use Respiratory Effort Belt System |
|---|---|
| Common Name: | Respiratory Effort Sensor |
| Classification Name: | 21 CFR 868.2375, Ventilatory Effort Recorder |
| Class II | |
| Product Code: | MNR |
Product Code:
Predicate Device(s)
| 510(k) Number: | K043132 (Primary Predicate) |
|---|---|
| Trade Name: | Universal XactTrace |
| Submitter Name: | Medcare Flaga |
| Classification Name: | 21 CFR 868.2375, Breathing frequency monitor |
| Product Code: | MNR |
K923402 Crystal Trace Piezo Respiratory Effort Sensor Pro-Tech, Inc. 21 CFR 868.2375 Breathing frequency monitor BZQ
510(k) Number: Trade Name: Submitter Name: Classification Name: Product Code:
K042253 SleepSense Sleep Sensors SLP Ltd. 21 CFR 868.2375, Breathing frequency monitor MNR
Reference Device(s)
| 510(k) Number: | K024322 | K0417 |
|---|---|---|
| Trade Name: | Embla N7000 | Compass |
| Submitter Name: | Medcare Flaga | Medcare |
| Classification Name: | 21 CFR 868.2375, Breathing frequency | |
| monitor | 21 CFR 868.2375, Breathing frequency | |
| monitor | ||
| Product Code: | MNR | MNR |
24 ss M10 System re Flaga R 868.2375, Breathing frequency MNR
Device Description
The XactTrace Single Use Respiratory Effort Belt System subject device applies Respiratory Inductive Plethysmography (RIP) Sensor Belts to support respiratory effort signals used in the diagnosis of sleep disorders or sleep related respiratory disorders. The XactTrace Single Use Respiratory Effort Belt System subject device supports a measure of changes in inductance as a result of changes in abdominal, thorax circumference.
There are two variations of the XactTrace® Single Use Respiratory Effort Belt System:
-
XactTrace® Single Use Cut-to-Fit Respiratory Effort Belt System, and
-
XactTrace® Single Use Pre-Sized Respiratory Effort Belt System.
The XactTrace Single Use Cut-to-Fit Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Locks (belt connectors) with a cable that connects to a recording device. The system supports conversion
4
of changes in inductance to a digital signal that provides both qualitative information of respiratory effort. The Sensor Belt of the XactTrace Single Use Cut-To-Fit Belt variation is cut by the medical professional to appropriate lengths to fit patient abdomen, thorax circumference.
The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Snap Sensors (Sensor Belt connectors) with a cable that connects to a recording device. The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation supports conversion of Sensor Belt changes in inductance to a signal that provides both qualitative and quantitative information of respiratory effort. XactTrace Single Use Pre-Sized Respiratory Effort belts are available in four sizes: Pediatric, Small, Medium and Large.
An optional Inductive Interface Cable (RIP Processor) is available to interface with PSG systems that accept the 1.5mm female touchproof connectors, and do not have internal RIP Sensor Belt technology.
Both variations of XactTrace Respiratory Effort Belts are interfaced with either an optional external Inductive Interface Cable or a RIP technology compatible Embla PSG system amplifier. Compatible Embla amplifiers are identified by keyhole connectors for Sensor Belt input.
Statement of Intended Use
The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory effort signatory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment. The intended environments are hospitals, institutions, sleep clinics. The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
Summary of Technological Characteristics and Comparison to Predicate and Reference Devices
The fundamental RIP technology of the XactTrace® Single Use Respiratory Effort Belt System is the primary predicate Universal XactTrace.
The comparison to the primary predicate Universal XactTrace Belt to create the XactTrace® Single Use Respiration Belt System under review are summarized as:
-
- Creation of two single use variations:
- XactTrace Single Use Pre-Sized Respiratory Effort Belt a. Equivalent to the predicate Universal XactTrace reusable belt sizes, the single use disposable belt is available in pediatric, small, medium, and large sizes.
- b. XactTrace Single Use Cut-to-Fit Respiratory Effort Belt A single use disposable belt the medical professional cuts to fit the patient size. The Cut-to-Fit RIP sensor belt with associated Locks (connectors) is the same as described in K024322 and K041724.
-
- The XactTrace Single Use Respiration Belts under review are either interfaced with RIP technology compatible Embla PSG systems or an external Inductive Interface Cable, which is an internal battery powered signal interface. The primary predicate Universal XactTrace is powered by a battery for interface within the Sensor Belt connector.
The following table provides a side-by-side comparison of the XactTrace Single Use Respiration Effort Belt System under review to the predicate devices applied to support this pre-market notification.
| Feature | XactTrace Single
Use Respiratory
Effort Belt
System
(under review) | Universal
XactTrace
(Primary
Predicate,
K043132) | Crystal Trace
Piezo Respiratory
Effort Sensor
(K923402) | SLP Ltd.
RIP Sensor, RIP
Processor
(K042253) | Equivalence
Comments,
Discussion |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The XactTrace®
Single Use
Respiratory Effort
Belt System is | Universal
XactTrace is
intended to
measure | The Crystal Trace
Piezo Respiratory
Effort Sensor is
intended for use | SleepSense sleep
sensors provide a
qualitative
measure of some | Identical to the
primary predicate
Universal XactTrace |
| | | | | | |
| Feature | XactTrace Single
Use Respiratory
Effort Belt
System
(under review) | Universal
XactTrace
(Primary
Predicate,
K043132) | Crystal Trace
Piezo Respiratory
Effort Sensor
(K923402) | SLP Ltd.
RIP Sensor, RIP
Processor
(K042253) | Equivalence
Comments,
Discussion |
| | intended to
measure
respiratory effort
to assist in the
diagnosis of sleep
disorders or sleep
related respiratory
disorders. The
respiratory effort
signals measured
are processed to
provide electrical
signals suitable for
connection to the
inputs of
physiological
recording
equipment. The
intended
environments are
hospitals,
institutions, sleep
centers, sleep
clinics. The
XactTrace Single
Use Respiratory
Effort Belt System
is intended for
diagnostics
purposes only and
is not intended to
be used as an
apnea monitor. | respiratory effort
to assist in the
diagnosis of sleep
disorders or sleep
related respiratory
disorders. The
respiratory effort
signals measured
are processed to
provide electrical
signals suitable for
connection to the
inputs of
physiological
recording
equipment. The
intended
environments are
hospitals,
institutions, sleep
centers, sleep
clinics, or other
test environments.
Universal
XactTrace is
intended for
diagnostics
purposes only and
is not intended to
be used as an
apnea monitor. | during sleep
disorder studies to
detect respiratory
effort for recording
onto a
physiological
recorder. | physiological
parameters for
recording onto an
FDA-cleared data
acquisition system.
Their target
population:
Children and adult
patients who are
screened during
sleep disorder
studies. Their
environment of use
is usually at a
sleep laboratory or
sometimes at the
patient's home. | with the exception of
product name change.
Equivalent to the
predicate Crystal
Trace Piezo
Respiratory Effort
Sensor and SLP Ltd.
RIP Sensor and RIP
Processor.
Note:
The SLP Ltd 510(k)
addresses various
sleep sensors and
interface cables,
including a RIP
Sensor and RIP
Processor. |
| Population of
use | Adult and pediatric | Adult and pediatric | Adult and pediatric | Children and
adults | Same |
| Environment of
Use | Hospitals,
institutions, sleep
centers, sleep
clinics. | Hospitals,
institutions, sleep
centers, sleep
clinics, or other
test environments. | Hospitals,
institutions, sleep
centers, sleep
clinics, or other
test environments. | Hospitals,
institutions, sleep
centers, sleep
clinics, or other
test environments. | Same |
| Single patient
use | Yes | No, reusable | No, reusable | No, reusable | The XactTrace®
Single Use
Respiratory Effort
Belt System, sensor
belts under review is
single patient use,
disposable |
| Duration of use | Duration of | Duration of | Duration of | Duration of | Same |
| | | | | | |
| Feature | XactTrace Single
Use Respiratory
Effort Belt
System
(under review) | Universal
XactTrace
(Primary
Predicate,
K043132) | Crystal Trace
Piezo Respiratory
Effort Sensor
(K923402) | SLP Ltd.
RIP Sensor, RIP
Processor
(K042253) | Equivalence
Comments,
Discussion |
| | anticipated to be ≤
12 hours. | anticipated to be ≤
12 hours. | anticipated to be ≤
12 hours. | anticipated to be ≤
12 hours. | |
| Fundamental
technology | Respiratory
Inductive
Plethysmography
(RIP) | RIP | Piezo | RIP | Both RIP and Piezo
technologies apply a
change in
circumference of a
flexible Sensor Belt
to provide a low level
signal that is related
to the change in
circumference. |
| Variations | Cut-to-Fit
Pre-sized | Pre-sized | Pre-sized | Pre-sized | Equivalent Pre-sized
variations. The cut-to-
fit variation was
included in the
Reference device
510(k) review. |
| Universal Rip
variations
(Use with non-
Embla System) | Yes (two)
Abdomen and
Thorax | Yes (two)
Abdomen and
Thorax | Not applicable | Yes (two)
Abdomen and
Thorax | Same |
| Patient applied
location | Abdomen and
Thorax | Abdomen and
Thorax | Abdomen and
Thorax | Abdomen and
Thorax | Same |
| User Adjustable
Sensor Belt
Lengths | Yes | Yes | Yes | Yes | Same |
| Pre-Sized Sensor
Belt
(Circumference) | XactTrace Single
Use Respiratory
Effort Belt
System: Pre-sized
variations of large,
medium, small and
pediatric (inches).
Large: 40 to 75
Medium: 30 to 55
Small: 16 to 35
Pediatric: 11 to 22 | XactTrace
Reusable Embla
RIP Belts: Pre-size
variations of large,
medium, small and
pediatric (inches).
Large: 47 to 66
Medium: 33 to 56
Small: 22 to 41
Pediatric: 19 to 28 | Yes
Adult Size:
28 to 80 inches
Pediatric (Ped)
Size: 10.5 to
34 inches | Disposable:
120 cm and 150
cm | Both the primary
predicate Universal
XactTrace and
XactTrace Single Use
Respiratory Effort
Belt System under
review may be
purchased in Pre-
Sized belt lengths.
The primary predicate
Universal XactTrace
510(k) is applied to
adult and pediatric
patient populations,
the same as the device
under review.
Variations are
medical professional
adjustable with regard
to Sensor Belt length. |
| Patient contact | Not in direct
contact with bare
skin. | Not in direct
contact with bare
skin. | Yes | Unknown | Same as the primary
predicate Universal
XactTrace. |
| Feature | XactTrace Single
Use Respiratory
Effort Belt
System
(under review) | Universal
XactTrace
(Primary
Predicate,
K043132) | Crystal Trace
Piezo Respiratory
Effort Sensor
(K923402) | SLP Ltd.
RIP Sensor, RIP
Processor
(K042253) | Equivalence
Comments,
Discussion |
| Belt connectors
and cables to
recorder | Touchproof safety
connection,
complying with
the 21 CFR 898
Performance
Standard for
Electrode Lead
Wires and Patient
Cables. | Touchproof safety
connection,
complying with
the 21 CFR 898
Performance
Standard for
Electrode Lead
Wires and Patient
Cables. | Recessed female
safety connection. | Recessed female
safety connection,
complying with
the 21 CFR 898
Performance
Standard for
Electrode Lead
Wires and Patient
Cables. | Same. |
| Sensor Belt
Material | Warp: Texturized
polyester raw
white
Weft: Texturized
polyester raw
white
Elasthane:
Dorlastan Filament
Type | Warped:
Texturized
polyester colored;
Weft: Cotton;
Elastic: Dorlastan
Filament Type | Unknown | Unknown | The Sensor Belt
material does not
contact the patient. |
| Power source | XactTrace Single
Use Respiratory
Effort Belt System,
Single Use Cut-to-
Fit and Pre-Sized
Universal RIP
Belts: Interface
with optional
Inductive Interface
Cable (RIP
processor)
(Non-replaceable 3
volt battery)
XactTrace Single
Use Respiratory
Effort Belt System,
Single Use Cut-to-
Fit and Pre-Sized
variations:
Interface with
Embla PSG system | XactTrace
Reusable
Universal RIP
Belts:
Non-replaceable 3
volt battery in
connector (Snap
Sensor)
XactTrace
Reusable Embla
RIP Belts:
Powered by Embla
PSG system | None
The piezo sensor
belt self generates
a small voltage in
response to
circumference
change. | Non-replaceable 3
volt battery in RIP
Processor | Same.
The RIP technology
power source is either
a non-replaceable 3
volt battery or the
Embla PSG system. |
| Maximum signal
amplitude
(peak to peak) | 10 mV
(Inductive
Interface Cable
(RIP Processor )) | 11.2 mV | Unknown | 10 mV | The medical
professional's
recording equipment
accommodates signal
amplitudes with
amplifier settings. |
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As noted, the differences do not affect substantial equivalence of safety and effectiveness.
- The Sensor Belt component is modified to support single patient use, disposable variations. The change to a single use disposable Sensor Belt does not raise new questions of safety or effectiveness.
- . Cut-to-Fit and Pre-Sized variations of the XactTrace Single Use Respiratory Effort Belt System are available. The user can cut the Sensor Belt length in the Cut-to-Fit variation. The Pre-Sized XactTrace variations are
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similar lengths as the primary predicate Universal XactTrace lengths. The selection and use of Sensor Belt length are at the discretion of the medical professional.
- . The XactTrace Single Use Respiratory Effort Belt System connectors to the Sensor Belt do not contain any battery or signal conditioning electronics. The battery and signal conditioning is performed in an external, commercially available Inductive Interface Cable or a RIP technology compatible amplifier.
Modifications were performed in compliance with the Embla Systems design control process.
Performance Testing
To establish the technical equivalency of the XactTrace Single Use Respiratory Effort Belt System, non-clinical, bench evaluations were conducted to confirm compliance with performance requirements, summarized in the following table.
| Requirement | Method | Result |
|---|---|---|
| Dimensional requirements | Measurement of components. | Pass |
| Lock and Snap Sensor compatibility | Components connect properly and perform as | |
| intended. | Pass | |
| Compatibility with Inductive Interface Cable and | ||
| RIP technology compatible Embla PSG recording | ||
| system input connections, key connector inputs | Interface with Inductive Interface Cables and Embla | |
| PSG recording system input connections, key | ||
| connectors, recoding. | Pass | |
| Resistance of XactTrace Single Use Cut-to-Fit | ||
| Effort Belt, variation of XactTrace Single Use | ||
| Respiratory Effort Belt System | Cut belts to size, confirm resistance measurement. | Pass |
| Resistance of XactTrace Single Use Pre-Sized | ||
| Effort Belt, variation of XactTrace Single Use | ||
| Respiratory Effort Belt System | Confirm resistance measurement. | Pass |
| Cleaning of reusable Snap Sensor and Locks | Recommended cleaning method does not cause | |
| damage. | Pass | |
| Operational temperature and humidity range | No damage with operational temperature and | |
| humidity. | Pass | |
| Equivalence of breathing effort signal output | Compare breathing effort signal output for the | |
| XactTrace Single Use Respiratory Effort Belt System | ||
| technology under review to primary predicate | ||
| Universal XactTrace for both Embla amplifier and | ||
| Inductive Interface Cable. | Pass | |
| Equivalence of breathing effort signal output for | ||
| same displacement of both XactTrace Single Use | ||
| Sized Effort Belt, variations. | For the same displacement of Sensor Belt, the output | |
| from the XactTrace Single Use Cut-to-Fit Effort Belt | ||
| is equivalent to the output from the XactTrace Single | ||
| Use Pre-Sized Effort Belt. | Pass | |
| EMC compliance with Inductive Interface Cables. | Confirm compliance with IEC 60601-1-2, 4th edition. | Pass |
Conclusion
The performance of the XactTrace Single Use Respiratory Effort Belt System is confirmed. All design verification and validation results meet requirements. No new questions of safety or effectiveness are raised by the XactTrace Single Use Respiratory Belt Systems XactTrace Single Use Respiratory Belt System is equivalent to the predicate devices.