(442 days)
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.
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.
Here's an analysis of the acceptance criteria and study detailed in the provided FDA 510(k) summary for the XactTrace Single Use Respiratory Effort Belt System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Requirement | Reported Device Performance (Result) |
|---|---|
| Dimensional requirements | Pass |
| Lock and Snap Sensor compatibility | Pass |
| Compatibility with Inductive Interface Cable and RIP technology compatible Embla PSG recording system input connections, key connector inputs | Pass |
| Resistance of XactTrace Single Use Cut-to-Fit Effort Belt, variation of XactTrace Single Use Respiratory Effort Belt System | Pass |
| Resistance of XactTrace Single Use Pre-Sized Effort Belt, variation of XactTrace Single Use Respiratory Effort Belt System | Pass |
| Cleaning of reusable Snap Sensor and Locks | Pass |
| Operational temperature and humidity range | Pass |
| Equivalence of breathing effort signal output (compared 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 (Cut-to-Fit vs. Pre-Sized) | Pass |
| EMC compliance with Inductive Interface Cables | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of human subjects or clinical data. The performance testing described is primarily bench-level evaluations.
Therefore:
- Sample size: Not applicable in the traditional sense of a clinical test set. The tests involved components and systems.
- Data provenance: Not applicable in the context of country of origin or retrospective/prospective clinical data. The data originates from laboratory/bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The reported performance tests are engineering and bench performance evaluations, not clinical studies requiring expert interpretation of ground truth in patient data.
4. Adjudication Method for the Test Set
Not applicable, as this was not a clinical study involving human judgment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a respiratory effort belt system, not an AI or imaging device that would typically be evaluated with MRMC studies or involve human readers in that capacity.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The XactTrace system is a sensor that produces electrical signals for physiological recording equipment; it does not include an "algorithm" in the sense of an AI or automated diagnostic tool that would have standalone performance.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established engineering specifications and the performance of the predicate device. For example:
- Dimensional requirements: Standard engineering measurements and specifications.
- Compatibility: Functional verification against established interface standards and predicate device behavior.
- Resistance: Direct electrical measurements against expected values.
- Equivalence of breathing effort signal output: Direct comparison of the electrical signal output from the new device and the predicate device under controlled conditions (e.g., same displacement).
- EMC compliance: Adherence to the IEC 60601-1-2, 4th edition standard.
Essentially, the ground truth is derived from engineering specifications, direct measurements, and comparative performance to the legally marketed predicate device under controlled bench conditions.
8. The Sample Size for the Training Set
Not applicable. The device is a hardware sensor system and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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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
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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
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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 202Kanata, ON, CA, K2K 3C7 |
| Submitter's Phone: | (905) 287-5055 |
| Contact Person: | Mr. Sanjay MehtaDirector, Quality Assurance & Regulatory Affairs |
| Date SummaryPrepared: | 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 RecorderClass 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 frequencymonitor | 21 CFR 868.2375, Breathing frequencymonitor |
| 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
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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 SingleUse RespiratoryEffort BeltSystem(under review) | UniversalXactTrace(PrimaryPredicate,K043132) | Crystal TracePiezo RespiratoryEffort Sensor(K923402) | SLP Ltd.RIP Sensor, RIPProcessor(K042253) | EquivalenceComments,Discussion |
|---|---|---|---|---|---|
| Indications forUse | The XactTrace®Single UseRespiratory EffortBelt System is | UniversalXactTrace isintended tomeasure | The Crystal TracePiezo RespiratoryEffort Sensor isintended for use | SleepSense sleepsensors provide aqualitativemeasure of some | Identical to theprimary predicateUniversal XactTrace |
| Feature | XactTrace SingleUse RespiratoryEffort BeltSystem(under review) | UniversalXactTrace(PrimaryPredicate,K043132) | Crystal TracePiezo RespiratoryEffort Sensor(K923402) | SLP Ltd.RIP Sensor, RIPProcessor(K042253) | EquivalenceComments,Discussion |
| intended tomeasurerespiratory effortto assist in thediagnosis of sleepdisorders or sleeprelated respiratorydisorders. Therespiratory effortsignals measuredare processed toprovide electricalsignals suitable forconnection to theinputs ofphysiologicalrecordingequipment. Theintendedenvironments arehospitals,institutions, sleepcenters, sleepclinics. TheXactTrace SingleUse RespiratoryEffort Belt Systemis intended fordiagnosticspurposes only andis not intended tobe used as anapnea monitor. | respiratory effortto assist in thediagnosis of sleepdisorders or sleeprelated respiratorydisorders. Therespiratory effortsignals measuredare processed toprovide electricalsignals suitable forconnection to theinputs ofphysiologicalrecordingequipment. Theintendedenvironments arehospitals,institutions, sleepcenters, sleepclinics, or othertest environments.UniversalXactTrace isintended fordiagnosticspurposes only andis not intended tobe used as anapnea monitor. | during sleepdisorder studies todetect respiratoryeffort for recordingonto aphysiologicalrecorder. | physiologicalparameters forrecording onto anFDA-cleared dataacquisition system.Their targetpopulation:Children and adultpatients who arescreened duringsleep disorderstudies. Theirenvironment of useis usually at asleep laboratory orsometimes at thepatient's home. | with the exception ofproduct name change.Equivalent to thepredicate CrystalTrace PiezoRespiratory EffortSensor and SLP Ltd.RIP Sensor and RIPProcessor.Note:The SLP Ltd 510(k)addresses varioussleep sensors andinterface cables,including a RIPSensor and RIPProcessor. | |
| Population ofuse | Adult and pediatric | Adult and pediatric | Adult and pediatric | Children andadults | Same |
| Environment ofUse | Hospitals,institutions, sleepcenters, sleepclinics. | Hospitals,institutions, sleepcenters, sleepclinics, or othertest environments. | Hospitals,institutions, sleepcenters, sleepclinics, or othertest environments. | Hospitals,institutions, sleepcenters, sleepclinics, or othertest environments. | Same |
| Single patientuse | Yes | No, reusable | No, reusable | No, reusable | The XactTrace®Single UseRespiratory EffortBelt System, sensorbelts under review issingle patient use,disposable |
| Duration of use | Duration of | Duration of | Duration of | Duration of | Same |
| Feature | XactTrace SingleUse RespiratoryEffort BeltSystem(under review) | UniversalXactTrace(PrimaryPredicate,K043132) | Crystal TracePiezo RespiratoryEffort Sensor(K923402) | SLP Ltd.RIP Sensor, RIPProcessor(K042253) | EquivalenceComments,Discussion |
| anticipated to be ≤12 hours. | anticipated to be ≤12 hours. | anticipated to be ≤12 hours. | anticipated to be ≤12 hours. | ||
| Fundamentaltechnology | RespiratoryInductivePlethysmography(RIP) | RIP | Piezo | RIP | Both RIP and Piezotechnologies apply achange incircumference of aflexible Sensor Beltto provide a low levelsignal that is relatedto the change incircumference. |
| Variations | Cut-to-FitPre-sized | Pre-sized | Pre-sized | Pre-sized | Equivalent Pre-sizedvariations. The cut-to-fit variation wasincluded in theReference device510(k) review. |
| Universal Ripvariations(Use with non-Embla System) | Yes (two)Abdomen andThorax | Yes (two)Abdomen andThorax | Not applicable | Yes (two)Abdomen andThorax | Same |
| Patient appliedlocation | Abdomen andThorax | Abdomen andThorax | Abdomen andThorax | Abdomen andThorax | Same |
| User AdjustableSensor BeltLengths | Yes | Yes | Yes | Yes | Same |
| Pre-Sized SensorBelt(Circumference) | XactTrace SingleUse RespiratoryEffort BeltSystem: Pre-sizedvariations of large,medium, small andpediatric (inches).Large: 40 to 75Medium: 30 to 55Small: 16 to 35Pediatric: 11 to 22 | XactTraceReusable EmblaRIP Belts: Pre-sizevariations of large,medium, small andpediatric (inches).Large: 47 to 66Medium: 33 to 56Small: 22 to 41Pediatric: 19 to 28 | YesAdult Size:28 to 80 inchesPediatric (Ped)Size: 10.5 to34 inches | Disposable:120 cm and 150cm | Both the primarypredicate UniversalXactTrace andXactTrace Single UseRespiratory EffortBelt System underreview may bepurchased in Pre-Sized belt lengths.The primary predicateUniversal XactTrace510(k) is applied toadult and pediatricpatient populations,the same as the deviceunder review.Variations aremedical professionaladjustable with regardto Sensor Belt length. |
| Patient contact | Not in directcontact with bareskin. | Not in directcontact with bareskin. | Yes | Unknown | Same as the primarypredicate UniversalXactTrace. |
| Feature | XactTrace SingleUse RespiratoryEffort BeltSystem(under review) | UniversalXactTrace(PrimaryPredicate,K043132) | Crystal TracePiezo RespiratoryEffort Sensor(K923402) | SLP Ltd.RIP Sensor, RIPProcessor(K042253) | EquivalenceComments,Discussion |
| Belt connectorsand cables torecorder | Touchproof safetyconnection,complying withthe 21 CFR 898PerformanceStandard forElectrode LeadWires and PatientCables. | Touchproof safetyconnection,complying withthe 21 CFR 898PerformanceStandard forElectrode LeadWires and PatientCables. | Recessed femalesafety connection. | Recessed femalesafety connection,complying withthe 21 CFR 898PerformanceStandard forElectrode LeadWires and PatientCables. | Same. |
| Sensor BeltMaterial | Warp: Texturizedpolyester rawwhiteWeft: Texturizedpolyester rawwhiteElasthane:Dorlastan FilamentType | Warped:Texturizedpolyester colored;Weft: Cotton;Elastic: DorlastanFilament Type | Unknown | Unknown | The Sensor Beltmaterial does notcontact the patient. |
| Power source | XactTrace SingleUse RespiratoryEffort Belt System,Single Use Cut-to-Fit and Pre-SizedUniversal RIPBelts: Interfacewith optionalInductive InterfaceCable (RIPprocessor)(Non-replaceable 3volt battery)XactTrace SingleUse RespiratoryEffort Belt System,Single Use Cut-to-Fit and Pre-Sizedvariations:Interface withEmbla PSG system | XactTraceReusableUniversal RIPBelts:Non-replaceable 3volt battery inconnector (SnapSensor)XactTraceReusable EmblaRIP Belts:Powered by EmblaPSG system | NoneThe piezo sensorbelt self generatesa small voltage inresponse tocircumferencechange. | Non-replaceable 3volt battery in RIPProcessor | Same.The RIP technologypower source is eithera non-replaceable 3volt battery or theEmbla PSG system. |
| Maximum signalamplitude(peak to peak) | 10 mV(InductiveInterface Cable(RIP Processor )) | 11.2 mV | Unknown | 10 mV | The medicalprofessional'srecording equipmentaccommodates signalamplitudes withamplifier 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 asintended. | Pass |
| Compatibility with Inductive Interface Cable andRIP technology compatible Embla PSG recordingsystem input connections, key connector inputs | Interface with Inductive Interface Cables and EmblaPSG recording system input connections, keyconnectors, recoding. | Pass |
| Resistance of XactTrace Single Use Cut-to-FitEffort Belt, variation of XactTrace Single UseRespiratory Effort Belt System | Cut belts to size, confirm resistance measurement. | Pass |
| Resistance of XactTrace Single Use Pre-SizedEffort Belt, variation of XactTrace Single UseRespiratory Effort Belt System | Confirm resistance measurement. | Pass |
| Cleaning of reusable Snap Sensor and Locks | Recommended cleaning method does not causedamage. | Pass |
| Operational temperature and humidity range | No damage with operational temperature andhumidity. | Pass |
| Equivalence of breathing effort signal output | Compare breathing effort signal output for theXactTrace Single Use Respiratory Effort Belt Systemtechnology under review to primary predicateUniversal XactTrace for both Embla amplifier andInductive Interface Cable. | Pass |
| Equivalence of breathing effort signal output forsame displacement of both XactTrace Single UseSized Effort Belt, variations. | For the same displacement of Sensor Belt, the outputfrom the XactTrace Single Use Cut-to-Fit Effort Beltis equivalent to the output from the XactTrace SingleUse 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.
§ 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).