The WatchPAT™ONE (WP1) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP1 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP1 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP1's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP1's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

Device Description

The WatchPAT™ONE (WP1) is a non-invasive home care device intended for use with patients suspected to have sleep related breathing disorders. The WP1 generates a PAT respiratory disturbance index (PRDI), Apnea Hypopnea Index (PAHI), Central Apnea Hypopnea Index (PAHIc), sleep stages (PSTAGES - REM Sleep, Light Sleep, Deep Sleep and Wake) and snoring level and body position discrete states. The WP1 device consists of the following: (1) same unified finger PAT probe that was used in WP300 to measure the PAT and oximeter signals; (2) same Actigraph which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) same electronics, except for an antenna added in the WP1's PCB to support BLE communication; (4) same chest sensor (RESBP) to measure snoring level, body position and chest movements; and (5) same zzzPAT Software and algorithm to analyze the data. The subject WP1 is a modified version of the predicate WP300 device (K180775). The proposed modifications mainly include: transition from a reusable device to a single use device; shifting the display and user interface from the device to a mobile application; and shifting of the data storage from main device to a web server.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document is a 510(k) premarket notification summary for the WatchPAT™ONE (WP1) device. It focuses on demonstrating substantial equivalence to a predicate device (Watch-PAT 300, K180775), rather than presenting a standalone clinical validation study with detailed performance metrics against specific acceptance criteria.

However, I can extract information related to performance testing and comparison with the predicate device.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or correlation coefficients) for the WatchPAT™ONE. Instead, it relies on demonstrating that the new device (WP1) has substantially equivalent performance to its predicate device (WP300) through bench testing and compliance with electrical safety, EMC, and software standards.

What is reported (indirectly, by demonstrating equivalence to predicate):

Performance Aspect	Predicate Device (Watch-PAT 300) Performance (Implied by equivalence)	Subject Device (WatchPAT™ONE) Performance (Implied by equivalence + testing)	Conclusion on Equivalence
Data Acquisition	Data acquired by WP300 via USB	Data acquired by WP1 via BLE, then to web server	Bench test shows data acquired on WP1 is identical to data downloaded by zzzPAT (from WP300 process).
Analysis Output (PRDI, PAHI, PAHIC, Sleep stages, Snoring, Body Position)	Same as WP1	Same as WP300	Identical algorithms (zzzPAT software) and output parameters.
Electrical Safety	Compliant with IEC 60601-1:2005, AM1:2012	Compliant with IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) and AM1:2012	Met standards.
Electromagnetic Compatibility (EMC)	Compliant with IEC 60601-1-2:2007	Compliant with IEC 60601-1-2:2014	Met standards.
Home Healthcare Environment	Compliant with 60601-1-11:2015	Compliant with 60601-1-11:2015	Met standards.
Biocompatibility (New materials)	Existing materials compliant	New housing and wrist strap materials tested for cytotoxicity, irritation, and sensitization.	Passed testing.
Software Verification & Validation	Software met design specifications	Software met design specifications	Performed and demonstrated compliance.
Measurement Consistency	Consistent with WP300	Same hardware components (uPAT finger probe, actigraph, controller, microphone, accelerometer, chest sensor) and zzzPAT software/algorithm for analysis.	Bench test confirms data acquired by WP1 is identical.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: The document does not specify a sample size for a clinical test set in the traditional sense of a performance study with patients. The "Performance Testing" section mentions "Bench test was conducted to show that the data acquired on the WP1 is identical to the data downloaded by zzzPAT at the physician computer." This implies a comparison focused on the integrity of data transmission and processing rather than a clinical performance evaluation on a patient cohort. No number of patients or recordings is provided for this bench test.
Data Provenance: Not specified. The document focuses on the mechanical/software changes and equivalence to the predicate, rather than a new clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. The document describes bench testing and adherence to standards, and states that the "zzzPAT Software and algorithm to analyze the data" remains the same as the predicate device. It does not refer to a study where human experts established ground truth for a test set.

4. Adjudication Method:

Not Applicable. As no expert-derived ground truth for a test set is discussed, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not mention an MRMC study or any study comparing human readers with and without AI assistance. The focus is on device equivalence, not clinical performance enhancement for human readers.

6. Standalone Performance Study:

No, not explicitly a standalone clinical performance study. The "Performance Testing" section describes bench tests to confirm data acquisition identity and compliance with various standards (electrical safety, EMC, software V&V, biocompatibility). It aims to show the WP1 is substantially equivalent to the predicate device in its fundamental operation and data output, which the predicate device presumably had its own standalone performance demonstrated previously (K180775). The current submission does not include a new standalone clinical study for sensitivity, specificity, etc., for the WP1.

7. Type of Ground Truth Used:

The document implies that the "ground truth" for its performance testing is the data output from the predicate device (Watch-PAT 300) processed by the zzzPAT software. The bench test establishes that the WP1 acquires data that is "identical" to what the zzzPAT software would process (which is the same software used by the predicate). There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this specific submission's performance evaluation.

8. Sample Size for the Training Set:

Not Applicable/Not Provided. The document explicitly states that the WP1 uses the "same zzzPAT Software and algorithm to analyze the data" as the predicate device. This suggests that any algorithm training would have been done for the predicate device, not the WP1 itself. The current submission does not describe a training set for the WP1.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable/Not Provided. Since no training set for the WP1 is discussed, the method for establishing its ground truth is also not provided. This information would likely be found in the K180775 filing for the predicate device if it involved algorithmic training.

In summary:

The document describes a 510(k) submission for the WatchPAT™ONE (WP1), demonstrating substantial equivalence to its predicate device (Watch-PAT 300). The "acceptance criteria" are primarily based on:

Functional equivalence: performing the same functions and producing the same outputs (PRDI, PAHI, etc.) using the same core technology and algorithms (zzzPAT software).
Data integrity: ensuring the data acquired by WP1 is "identical" to data handled by the predicate's process.
Compliance with relevant standards: electrical safety, EMC, home healthcare environment, biocompatibility of new materials, and software verification/validation.

It does not detail a clinical study with specific acceptance criteria (e.g., sensitivity/specificity targets) for diagnostic performance using a new patient test set with expert-derived ground truth. The performance testing mentioned is focused on verifying that the modified WP1 functions identically to the predicate device in terms of data acquisition and processing.

Summary

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June 5, 2019

Itamar Medical, Ltd. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109

Re: K183559

Trade/Device Name: WatchPATTM ONE (WP1) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: May 3, 2019 Received: May 3, 2019

Dear Jonathan Kahan:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183559

Device Name WatchPAT™ONE (WP1)

Indications for Use (Describe)

The WatchPAT™ONE (WP1) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP1 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP1 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIC"), PAT sleep staging identification (PSTAGES) and snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP1's PSTAGES and snoring level and body position provide supplemental information to its PRD/PAH/PAHIC. The WP1's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

× | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5.1 Applicant's Name: Itamar Medical Itd. 9 Halamish st. Caesarea 3088900, Israel Tel: +972 4 617 7000 Fax: +972 4 627 5598
5.2 Contact Person: Jonathan Kahan, Esq. Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910 Email: jonathan.kahan@hoganlovells.com
December 20, 2018 5.3 Date Prepared:
WatchPAT™ONE (WP1) 5.4 Trade Name:
5.5 Common or Usual Name: Ventilatory Effort Recorder
5.6 Classification Name: Breathing Frequency Monitor
5.7 Medical Specialty: Anesthesiology
5.8 Product Code: Ventilatory Effort Recorder, MNR
5.9 Device Class: Class II
5.10 Regulation Number: 868.2375
5.11 Panel: Anesthesiology

5.12 Predicate Device:

Watch-PAT 300 ("WP300") (Itamar Ltd), cleared under K180775; product code MNR (ventilatory effort recorder)

5.13 Intended Use / Indication for Use:

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supplemental information to its PRDI/PAHI/PAHIc. The WP1's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

5.14 Device Description:

The WP1 device consists of the following: (1) same unified finger PAT probe that was used in WP300 to measure the PAT and oximeter signals; (2) same Actigraph which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) same electronics, except for an antenna added in the WP1's PCB to support BLE communication; (4) same chest sensor (RESBP) to measure snoring level, body position and chest movements; and (5) same zzzPAT Software and algorithm to analyze the data.

The subject WP1 is a modified version of the predicate WP300 device (K180775). The proposed modifications mainly include: transition from a reusable device to a single use device; shifting the display and user interface from the device to a mobile application; and shifting of the data storage from main device to a web server. None of these changes alter the fundamental technology or its principles of operation. Moreover, the WP1 maintains the same capabilities of the cleared WP300 (K180775) and provides the user with the same output information.

5.15 Substantial Equivalence:

Intended Use/Indications for Use

The subject device WP1 is identical to the cleared WP300 in its intended use and indications for use, except for the minor modification of omitting the word 'optional' from the use of snoring and body position sensor (RESBP sensor).

Comparison of Technological Characteristics and principle of operation

The technological characteristics and principles of operation of the subject device are similar to the predicate device. The subject WP1, like its predicate, is a ventilatory effort recorder that utilizes PAT technology. In both systems, the controller part of the device is worn on the wrist and records the PAT signal and blood oxygen saturation levels by a finger-mounted probe based on an optical plethysmographic method, the wrist motion from an embedded actigraphy and snoring level, body position states and chest movements from the chest sensor (RESBP).

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The WP1 mainly differs from the WP300 by combining the key components into an undetachable monolith device. A mobile application also replaced the predicate WP300's user interface and communication. The WP1's monolithic package uses the same hardware as the predicate WP300 to measure patient data. In addition, the user interface of the mobile application was designed to provide similar display and input as the WP300. Although the patient data is transmitted and stored on a Web Server, the integrity of the patient data can be verified and validated. Furthermore, the cybersecurity risks were addressed according to FDA's cybersecurity guidance document'. As such, the differences in technological characteristics and principle of operation do not raise different questions of safety or effectiveness.

Performance Testing

The following consensus standards were used to evaluate the predicate device:

. Bench test was conducted to show that the data acquired on the WP1 is identical to the data downloaded by zzzPAT at the physician computer.
The WP1 was tested to ensure that the device complies with the Federal ● Communications Commission (FCC) rules.
Electrical safety testing per IEC 60601-1:2005 + CORR.1 (2006) + ● CORR.2 (2007) and AM1:2012
Electromagnetic compatibility testing per IEC 60601-1-2:2014
Home healthcare environment per 60601-1-11:2015
Cytotoxicity, irritation and sensitization testing of the new housing and wrist strap materials.
Software verification and validation testing was performed to demonstrate that the software in the subject device meets design specifications.

The testing above demonstrated that the WP1 has substantially equivalent performance as its predicate.

Summary

Based on the comparison of intended use, indications for use, technological characteristics and performance testing, Itamar Ltd. believes that the WP1 System is substantially equivalent to its predicate.

A summary of comparison between the subject and predicate devices is provided below.

1 FDA quidance document title, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 2, 2014

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	Predicate Device:	Subject Device:	Comparison
	Itamar Medical's Watch-PAT300 (K180775)	Itamar Medical's WP1
Intended Use	The Watch-PAT300 (WP300)device is a non-invasive homecare device for use with patientssuspected to have sleep relatedbreathing disorders. The WP300is a diagnostic aid for thedetection of sleep relatedbreathing disorders, sleepstaging (Rapid Eye Movement(REM) Sleep, Light Sleep, DeepSleep and Wake), snoring leveland body position. The WP300generates a peripheral arterialtonometry ("PAT") RespiratoryDisturbance Index ("PRDI"),Apnea-Hypopnea index ("PAHI"),Central Apnea-Hypopnea index("PAHIc"), PAT sleep stagingidentification (PSTAGES) andoptional snoring level and bodyposition discrete states from anexternal integrated snoring andbody position sensor. TheWP300's PSTAGES and snoringlevel and body position providesupplemental information to itsPRDI/PAHI/PAHIc. The WP300'sPSTAGES and snoring level andbody position are not intended tobe used as the sole or primarybasis for diagnosing any sleeprelated breathing disorder,prescribing treatment, ordetermining whether additionaldiagnostic assessment iswarranted.PAHIc is indicated for use inpatients 17 years and older. Allother parameters are indicatedfor 12 years and older	The WatchPAT™ONE (WP1)device is a non-invasive homecare device for use with patientssuspected to have sleep relatedbreathing disorders. The WP1 isa diagnostic aid for the detectionof sleep related breathingdisorders, sleep staging (RapidEye Movement (REM) Sleep,Light Sleep, Deep Sleep andWake), snoring level and bodyposition. The WP1 generates aperipheral arterial tonometry("PAT") Respiratory DisturbanceIndex ("PRDI"), Apnea-Hypopnea index ("PAHI"),Central Apnea-Hypopnea index("PAHIc"), PAT sleep stagingidentification (PSTAGES) andsnoring level and body positiondiscrete states from an externalintegrated snoring and bodyposition sensor. The WP1'sPSTAGES and snoring level andbody position providesupplemental information to itsPRDI/PAHI/PAHIc. The WP1'sPSTAGES and snoring level andbody position are not intended tobe used as the sole or primarybasis for diagnosing any sleeprelated breathing disorder,prescribing treatment, ordetermining whether additionaldiagnostic assessment iswarranted.PAHIc is indicated for use inpatients 17 years and older. Allother parameters are indicatedfor 12 years and older.	ldentical except fordevice name andomission of theword 'optional'
Channels	PAT, Pulse rate, Oximetry,Actigraphy, Snoring, BodyPosition, Chest Movement	PAT, Pulse rate, Oximetry,Actigraphy, Snoring, BodyPosition, Chest Movement	Identical
Intended UseEnvironment	Home Use	Home Use	Identical
Input uPATProbe	Designed to use Itamarproprietary probe only	Designed to use Itamarproprietary probe only	Identical
Analysis output	• pRDI• pAHI• pAHIc· Sleep stages· Snoring level· Body position discrete states	· pRDI• pAHI· pAHIc· Sleep stages· Snoring level· Body position discrete states	Identical
	Predicate Device:Itamar Medical's Watch-PAT300 (K180775)	Subject Device:Itamar Medical's WP1	Comparison
Components	• uPAT finger probe• actigraph• Controller• Microphone• Accelerometer• ZzzPAT software• Chest sensor (optional)• External Tamper-ProofBracelet (optional)	• uPAT finger probe• actigraph• Controller• Microphone• Accelerometer• ZzzPAT software• Chest sensor	Chest sensor wasalready cleared inthe predicate.Optional tamper-proof bracelet foridentification of apatient by means ofelectronic braceletis not available inWP1.
SensorsPlacement	Wrist, finger and chest (optional)	Wrist, finger and chest	Identical
AnalysisSoftware	zzzPAT	zzzPAT	Identical
Power Supply	One OTS 1.5V Alkaline AAAbattery OROne rechargeable AAA 1.2VNickel-metal hydride batteryrechargeable (NiMH) battery	One OTS 1.5V Alkaline AAAbattery	Single use batteryonly
Data AccessMethod	USB using FTDI	Internet access using sFTPprotocol	Same datadelivered to theanalysis softwarezzzPAT
Data Collection	• Sensors connect direct to maindevice.• Study data is stored on themain device and thenuploaded via USB cable uponreturn of the device.	• Sensors connect direct tomain device.• Study data is wirelesslytransferred (Bluetooth) frommain device to mobile phoneand from the mobile phone toa storage on a web server,over the Internet.	Same datadelivered to theanalysis softwarezzzPAT
Data Storage	Flash	Web Server	Data is stored inweb server insteadof on-board flashmemory.
Recording time	Approx. 10 hours	Approx. 10 hours	Identical
Motion Probe	1 axis (out of 3D accelerometer)	1 axis (out of 3D accelerometer)	Identical
Analog FrontEnd	AFE4404 (by TI)	AFE4404 (by TI)	Identical
Microprocessor	Nordic ARM	Nordic ARM	Identical
SampleResolution	PAT, Actigraphy, Snore: 12 bitsOximetry: 1%Body Position: 5 discrete states(supine, prone, right, left and sit)Chest Movements – 12 bits x 3axis	PAT, Actigraphy, Snore: 12 bitsOximetry: 1%Body Position: 5 discrete states(supine, prone, right, left and sit)Chest Movements - 12 bits x 3axis	Identical
OperatingVoltage	3.3 V	3.3 V	Identical
User InterfaceDisplay/Indicators	Via Main device: OLED	Via Smartphone User InterfaceVia Main device (LED)	Similar user displayand input

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Regulation Number and Section

§ 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).