Who is the manufacturer of XactTrace Single Use Respiratory Effort Belt System?

Embla Systems filed the 510(k) submission for XactTrace Single Use Respiratory Effort Belt System (K173793).

What is the FDA product code for XactTrace Single Use Respiratory Effort Belt System?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for XactTrace Single Use Respiratory Effort Belt System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for XactTrace Single Use Respiratory Effort Belt System?

Universal XactTrace (K043132); Crystal Trace Piezo Respiratory Effort Sensor (K923402); SleepSense Sleep Sensors (K042253).

Who can help prepare an FDA 510(k) submission like XactTrace Single Use Respiratory Effort Belt System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XactTrace Single Use Respiratory Effort Belt System

K173793 · Embla Systems · MNR · Mar 1, 2019 · Anesthesiology

Device Facts

Record ID	K173793
Device Name	XactTrace Single Use Respiratory Effort Belt System
Applicant	Embla Systems
Product Code	MNR · Anesthesiology
Decision Date	Mar 1, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Pediatric

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 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.

Device Story

Device uses Respiratory Inductive Plethysmography (RIP) to measure changes in abdominal and thoracic circumference; converts inductance changes into electrical signals for physiological recording equipment. Available in 'Cut-to-Fit' (disposable belt with locks) and 'Pre-Sized' (disposable belt with snap sensors) variations. Used in hospitals, sleep centers, and clinics by medical professionals. Interfaces with compatible Embla PSG system amplifiers or an optional external Inductive Interface Cable (RIP processor). Provides qualitative/quantitative respiratory effort data to assist clinicians in diagnosing sleep disorders. Benefits include disposable, single-patient use design reducing cross-contamination risks while maintaining signal equivalence to reusable predicate systems.

Clinical Evidence

Bench testing only. Evaluations confirmed dimensional requirements, component compatibility, resistance measurements, cleaning durability of reusable connectors, environmental robustness, and signal output equivalence compared to the primary predicate (Universal XactTrace) across both Embla amplifier and Inductive Interface Cable configurations. EMC compliance verified per IEC 60601-1-2, 4th edition.

Technological Characteristics

Respiratory Inductive Plethysmography (RIP) sensor. Materials: Texturized polyester (warp/weft) and Dorlastan filament (elastane). Connectivity: 1.5mm female touchproof connectors; compatible with Embla PSG systems or external Inductive Interface Cable. Power: Passive sensor; signal interface powered by external cable or PSG system. Form factor: Disposable belts (Cut-to-Fit or Pre-Sized). Complies with 21 CFR 898 performance standards for electrode lead wires/cables.

Indications for Use

Indicated for adult and pediatric patients requiring respiratory effort measurement during sleep disorder studies to assist in diagnosis of sleep-related respiratory disorders. Not for use as an apnea monitor.

Regulatory Classification

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.

Predicate Devices

Universal XactTrace (K043132)
Crystal Trace Piezo Respiratory Effort Sensor (K923402)
SleepSense Sleep Sensors (K042253)

Reference Devices

Embla N7000 (K024322)
Compass (K041724)

Related Devices

K242424 — Bluebird Single-Use Respiratory Effort Belt · Cadwell Industries, Inc. · Dec 18, 2024
K151361 — Nox RIP Belts & Cables · Nox Medical Ehf · Nov 6, 2015
K171304 — Maxxi Rip Sensor · Neurovirtual USA, Inc. · Jun 24, 2019
K043132 — UNIVERSAL XACTTRACE · Medcare Flaga · Dec 21, 2004
K982216 — ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 · Braebon Medical Corp. · Sep 11, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 Drug 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 contains the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a small registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, italicized, black sans-serif font. # 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: 1. XactTrace® Single Use Cut-to-Fit Respiratory Effort Belt System, and 2. 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: - 1. 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. - 2. 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. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is written in a teal, sans-serif font. Below it, the word "neurology" is written in a smaller, italicized, dark-colored font. The logo is simple and modern. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a small registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below that, the word "neurology" is in a smaller, black, italicized sans-serif font. 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 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for Natus Neurology. The word "natus" is in a larger, teal-colored font on the top line. Below it, "neurology" is written in a smaller, black font. The logo is simple and modern. 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.