INTELLIVUE CL RESPIRATION POD

K132320 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · BZQ · Mar 26, 2014 · Anesthesiology

Device Facts

Record IDK132320
Device NameINTELLIVUE CL RESPIRATION POD
ApplicantPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
Product CodeBZQ · Anesthesiology
Decision DateMar 26, 2014
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 868.2375
Device ClassClass 2
AttributesReal-World Evidence

Real-World Evidence

SubmissionDeviceSponsorRWD SourcesRWE Use SummaryKey Tags
K132320 · Mar 26, 2014INTELLIVUE CL RESPIRATION PODPhilips Medizinsysteme Boeblingen GmbH, Cardiac ANRetrospective clinical patient signal data setA retrospective clinical data set was used to perform a Bland-Altman statistical comparison between the modified device and the predicate device to validate algorithm changes.Bland-Altman analysis; Retrospective clinical data; Algorithm validation

Clinical Evidence

Study DesignPopulationComparatorKey Endpoints
Retrospective statistical comparison (Bland-Altman); Follow-up/Duration: 621h 10min of recorded data26 patients (21 male, 5 female) aged 17-86 years; Sample Size: 26 patientsPredicate device (IntelliVue CL Respiration Pod K122223)Respiration rate and pulse rate accuracy

Indications for Use

The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a need for intermittent or spot-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms. The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult patients. CL Respiration Pod is also intended for The IntelliVue acquisition of respiration rate and pulse rate data of adult patients for a clinical information management system. The Intellivue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device. The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm). The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor.

Device Story

Small, body-worn, battery-powered telemetry transceiver; attaches to patient chest via adhesive. Inputs: thoracic movement signals via internal accelerometer. Processing: accelerometer data transformed into respiration and pulse rate signals; detects patient activity and posture. Outputs: wireless transmission of physiological data to IntelliVue Patient Monitor or GuardianSoftware via Short Range Radio (SRR). Used by healthcare professionals in hospital wards/ER waiting areas; not for ICU/OR or home use. Provides intermittent/spot-check monitoring; generates alarms on compatible monitors. Benefits: enables wireless, non-invasive patient monitoring without continuous ECG requirement.

Clinical Evidence

Clinical validation performed using Bland-Altman statistical comparison against predicate device. Dataset included 26 patients (21 male, 5 female; ages 17-86) with 621 hours of recording, 2,276,855 ECG beats, and 255,307 breaths. Results demonstrated substantial equivalence in respiration and pulse rate measurement performance.

Technological Characteristics

Battery-powered, body-worn wireless transceiver. Sensing: internal accelerometer measuring thoracic movement. Connectivity: Short Range Radio (SRR) to IntelliVue monitors/software. Features: multicolor LED, single-key operation. Mechanical: shock/vibration tested to 7M3 class. Software: algorithm-based signal processing for respiration/pulse derivation.

Indications for Use

Indicated for adult patients in general medical/surgery wards and emergency room waiting areas requiring intermittent or spot-check monitoring of respiration and pulse rate. Contraindicated for patients with respiration rates >60 rpm, acutely ill cardiac patients prone to life-threatening arrhythmias, and patients with rapid, irregular heart rates >110 bpm.

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

Reference Devices

Submission Summary (Full Text)

{0}------------------------------------------------ KIJZ-320 Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in bold, black letters. The letters are large and fill most of the frame. The font is sans-serif and appears to be a standard typeface. The background is plain white, providing a high contrast that makes the word stand out. # 510 (k) Summary # MAR 2 6 2014 This summary of 510(k) safety and effectiveness information submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92. 1. The submitter of this premarket notification is: Johannes Schmid Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1315 Fax: ++49 7031 463-2442 e-mail: johannes.schmid@philips.com This summary was prepared on March 25, 2014. Philips IntelliVue CL Respiration Pod. 2. Trade name: Common name: Telemetry Transceiver | Device Panel | Classification | ProCode | Description | |---------------------------|----------------|---------|------------------------------------------------------------------------| | Anesthesiology<br>Devices | \$868.2375, II | BZQ | Monitor, Breathing<br>Frequency | | Cardiovascular<br>Devices | \$870.2910, II | DRG | Transmitters and<br>Receivers, Physiological<br>Signal, Radiofrequency | | | - | MSX | System, Network and<br>Communication,<br>Physiological Monitors | Classification of the modified IntelliVue CL Respiration Pod: 3. The modified Philips IntelliVue CL Respiration Pod is substantially equivalent to the previously cleared IntelliVue CL · Respiration Pod marketed pursuant to K122223. # 4. Description of the modified device CL Respiration Pod is a small body-worn, The IntelliVue cableless, battery powered, respiration rate and pulse rate measuring and monitoring device. It uses specifically designed adhesive attachment (Mobile CL Resp Attachment, cleared with K122223), which holds the CL Respiration Pod at the patient chest. The CL Respiration Pod provides and communicates measurements values and other information (e.g. battery state) wirelessly via Short Range Radio (SRR) to an assigned compatible IntelliVue Patient Monitor or IntelliVue GuardianSoftware. It can also provide information on basic posture (like supine, prone, upright etc.) and activity of the patient. The CL Respiration Pod can be controlled from the assigned IntelliVue Patient Monitor or IntelliVue GuardianSoftware. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The font appears to be slightly textured, giving it a slightly rough appearance. 5. Intended Use / Indications for Use The Intended Use and Indications for Use of the modified Philips IntelliVue CL Respiration Pod has not changed as a result of the device modification. The device has the following detailed Indications for Use Statement in its Instructions for Use: Intended Use / Indications for Use of the modified Philips IntelliVue CL Respiration Pod: The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a need for intermittent or spot-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms. The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult patients. CL Respiration Pod is also intended for The IntelliVue acquisition of respiration rate and pulse rate data of adult patients for a clinical information management system. The Intellivue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device. The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm). The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor. ### Warning: Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated. Rx only: US Federal Law restricts these devices to sale by or on the order of a physician. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "PHILIPS" in bold, black letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white. 6. Technological Characteristics The modified IntelliVue CL Respiration Pod has substantially equivalent technological characteristics, such as design, materials, energy source, portability, user interface, radio technology, measurement principle, as the legally marketed predicate device IntelliVue CL Respiration Pod. The CL Respiration Pod is a small, battery powered, wireless, and body worn respiration and pulse rate measuring and monitoring device. It is attached to the patient's left costal arch using a specialized accessory, the adhesive Mobile CL Resp Attachment. The CL Respiration Pod has a multicolor LED and a single key to display states and allow basic operation locally. The CL Respiration Pod is connected during its use wirelessly via SRR a compatible IntelliVue Patient Monitor or IntelliVue to GuardianSoftware. The CL Respiration Pod uses a measurement principle that is based the thoracic movements. Inclination changes of the on incorporated accelerometer sensor, caused by chest and abdomen movements during breathing and heart contraction, produce a voltage signal, from which respiration and pulse rate signals are derived. The modified Philips IntelliVue CL Respiration Pod uses the same measurement principle (respiratory effort and heart contraction/beating) to derive the respiration and pulse signal as the predicate Philips IntelliVue CL Respiration Pod. With the means of the built-in accelerometer sensor, the modified CL Respiration Pod also detects activity and basic posture of the patient. This is the same technology as used by the legally marketed Philips IntelliVue CL Respiration Pod (K122223). 7. Summary of V&V activities #### -Clinical Performance Tests A Bland-Altman statistical comparison between respiration rate and pulse rate performance measured by the modified IntelliVue CL Respiration Pod and the predicate IntelliVue CL Respiration Pod (K122223) has been performed based on clinical data. Two separate clinical data sets have been used. The identical data set of K122223 has been reused for the development of the modifications. An additional not yet used clinical data set with patient signals was used to validate the algorithm changes. The additional clinical data set consists of 21 male and 5 female patients between 17 and 86 years of age. A total duration of 621h 10min has been recorded. 2276855 ECG beats and 255307 breathes were used for the comparison. The results of the statistical comparison demonstrate the equivalency of of the modified IntelliVue CL substantial Respiration Pod with the predicate IntelliVue CL Respiration Pod (K122223). {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The text appears to be a logo or brand name, likely for the electronics company Philips. The image is simple and clear, focusing on the brand name. Non-Clinical Performance Tests (bench testing) : - Verification of respiration rate and pulse rate range, accuracy, resolution and signal quality, by comparison of the reported respiration and pulse rate with the simulated values. The test results have shown that the respiration rate and pulse rate accuracy, resolution, and signal quality met in the whole measurement range the defined specifications. The modified CL Respiration Pod is substantially equivalent to the predicate IntelliVue CL Respiration Pod with respect to these measurement parameters. - -Testing as identified in the Hazard Analysis. All specified pass/fail criteria have been met. The test results have the effectiveness of implemented design risk confirmed mitigation measures. - Functional testing of the Software modifications of the CL Respiration Pod combination IntelliVue in with its compatible, legally marketed devices, the IntelliVue Patient Monitors MP2, X2, MP5, MP5, MP5T, MP5SC and the IntelliVue GuardianSoftware. All specified criteria have been met. The test results have confirmed that the modified device has functioned substantially equivalent to the predicate device and according to the specifications and Instructions for Use in the intended environment of use. - Regression testing of the IntelliVue CL Respiration Pod in combination with the related, gunchanged parts of the IntelliVue Patient Monitors MP2, X2, MP5, MP5T, MP5SC and the IntelliVue GuardianSoftware. All specified criteria have been met. The test results have confirmed that the modified device functioned substantially equivalent to the predicate has device and according to the specifications and Instructions for Use in the intended environment of use. - Mechanical testing (shock, vibration, and free fall). All specified test requirements have been met. The test has confirmed that the modified CL Respiration Pod has functioned substantially equivalent to the predicate device and according to the specifications and the modified CL Respiration Pod can operate after shock and vibration tests for class 7M3. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is presented in all capital letters and is horizontally oriented. The font appears to be a standard typeface, and the overall image is clear and legible. # 8. Conclusion Verification and validation testing activities were conducted to establish the equivalence of the performance, functionality, effectiveness, and reliability characteristics of the modified device with respect to the subject device. V&V testing included clinical and bench performance tests, system level, functionality and regression and mechanical tests. All clinical and non-clinical tests were successfully completed. The results demonstrate that the modified Philips IntelliVue CL Respiration Pod has functioned substantially equivalent to the predicate device Philips IntelliVue CL Respiration Pod (K122223). The modified device is substantially equivalent in intended use and fundamental technological characteristics to the predicate device. The device introduces no new questions concerning the safety or effectiveness and is, therefore, substantially equivalent to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three curved lines or strokes, often interpreted as representing human life and well-being. Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 # March 26, 2014 Philips Medizin Systeme Boeblingen GmbH Johannes Schmid Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Re: K132320 Trade/Device Name: Philips IntelliVue CL Respiration Pod Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Class: II Product Code: BZQ Dated: February 20, 2014 Received: February 24, 2014 Dear Mr. Schmid: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must {6}------------------------------------------------ Page 2 - Mr. Schmid comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Mary-S. Runner -S Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### Indications Statements Indications for Use CL Respiration Pod 1.A.1 510(k) Number (if known): KL32320___ Philips IntelliVue CL Respiration Pod Device Name: IntelliVue CL Respiration Pod: IntelliVue CL Respiration Pod is indicated for use by health care The professionals whenever there is a need for intermittent or spor-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms. The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult pacients. The IntelliVue CL Respiration Pod is also intended for acquisition of respiration rate and pulse rate data of adult patients for a clinical information management system. The IntelliVue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device . The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm). The IntelliVue CL Respiration Pod is not intended for use on acurely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor. Warning: Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated. Rx only: US Federal Law restricts these devices to sale by or on the order of a physician. Over-The-Counter Use Prescription Use _Yes__________________________________________________________________________________________________________________________________________________________________________ AND/OR No (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) DU-FDA, ou People, cn=Anya C. Harry - 5. Anya DN. c=US, Harry -S 0.9.2342.19200300 100.1.1-0011315590 Date: 2014.03.26 06:53:34 -0400
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