The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI ECI I).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.

Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (I to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

Device Description

The IntelliVue Patient Monitors MX500 and MX550 are modification of the legally marketed IntelliVue Patient Monitor MP50.

The MX500 and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The models MX500 and MX550 differ only in the size of their flat panel displays: MX500 has a 12" and MX550 has a 15" display.

The MX500 and MX550 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module, any one of the M3012A. M3015A/B or M3016A Measurement Server Extensions. plug-in measurement modules M1006B Invasive Blood Pressure, M1011A Intravascular SQ2, M1012A C.O. /CCO, M1014A Spirometry, M1020B SpQ2, M1027A EEG, M1029A Temperature, 865383 NMT, 865115 IntelliBridge EC10, to the 865298 (TcG10) Transcutaneous Gas Module and to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO, Intravascular SO2, Spirometry, EEG and NMT.

The MX500 and MX550 acquire multiple physiological patient signals (via connected external measurement modules). display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The MX500 and MX550 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital.

The MX500 and MX550 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.

The MX500 and MX550 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or WLAN.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the acceptance criteria not in terms of specific performance metrics or a numerical table, but rather as meeting established standards and specifications. The reported device performance is stated generally as having met all these criteria.

Acceptance Criteria Category	Reported Device Performance
Recognized Consensus Standards	All applicable requirements met.
IEC 60601-1-2:2001 +A1:2004 (EMC)	Met
IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety)	Met
IEC 60601-1-8:2003 (Alarms)	Met
IEC 62304:2006 (Software life cycle processes)	Met
Environmental Testing	All specified test requirements met. Confirmed safe and according to specifications under general hospital conditions, handling, transport, and storage.
(Temperature, Humidity)	Met
(Mechanical testing: Shock, Vibration, Free Fall)	Met
Regression Testing	All specified criteria met. Demonstrated safe, effective, and correct functioning in accordance with specifications and labeling.
(Function tests of all physiological parameters)	Met
(Recorder module)	Met
(Display)	Met
(Battery functionality, operating & charging time)	Met
(Human interface)	Met
(External interfaces)	Met
(Alarming system)	Met
(Tests identified by hazard analysis)	Met
Pass/Fail Criteria	Based on specifications cleared for the predicate device. Test results showed substantial equivalence.

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

The document does not explicitly state a "test set" in the context of clinical data for performance evaluation in the typical sense (e.g., patient cases). Instead, the testing described is primarily focused on engineering verification and validation (V&V) of the hardware and software against technical standards and the predicate device's specifications.

Sample Size: Not applicable in the context of clinical patient data. The "sample" here refers to the number of IntelliVue Patient Monitor MX500 and MX550 devices tested during V&V activities. The exact number of devices tested is not specified, but it implies multiple units to ensure robustness across manufacturing.
Data Provenance: The testing was conducted internally by Philips, a German company (Philips Medizin Systeme Boeblingen GmbH). It is retrospective in the sense that it's testing the developed product against predefined engineering and safety standards, rather than a prospective clinical trial gathering new patient data. The document does not mention any data from specific countries of origin related to patient cases.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The "ground truth" in this context refers to engineering specifications and performance expectations, which would typically be established by product design and quality engineers, and regulatory specialists within Philips. There is no mention of external medical experts establishing ground truth for performance in a clinical validation study.

4. Adjudication Method for the Test Set:

This information is not provided. Given that the V&V activities are primarily engineering and safety compliance tests, the "adjudication method" would likely involve internal review and sign-off processes by engineering and quality assurance teams, rather than a clinical adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted or described in this document. The submission focuses on demonstrating substantial equivalence to a predicate device (IntelliVue Patient Monitor MP50) through engineering and safety testing, not on improving human reader performance with AI assistance. The devices are patient monitors, not AI diagnostic tools.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The devices are patient monitors which are inherently "human-in-the-loop" as they provide data for healthcare professionals. There isn't a standalone "algorithm-only" performance described, as the core function is to display physiological parameters for human interpretation and action.

7. The Type of Ground Truth Used:

The ground truth used for these V&V activities is primarily engineering specifications, recognized consensus standards, and the performance characteristics of the predicate device (IntelliVue Patient Monitor MP50). These standards and specifications define what is considered "correct" or "safe" performance for the device. There is no mention of pathology, expert consensus on patient cases, or outcomes data as a ground truth for this submission, as it's a device safety and performance submission, not a clinical diagnostic algorithm submission.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The IntelliVue Patient Monitors MX500 and MX550 are not AI/ML-based algorithms that require a "training set" in the computational sense. They are hardware devices with embedded software designed to acquire, process, and display physiological signals based on established medical science and engineering principles.

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

This information is not applicable as there is no "training set" for these patient monitors.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "K131872 Page 1 of 5" on the left side and the word "PHILIPS" in large, bold, black letters on the right side. The text on the left indicates a document identifier and page number. The word "PHILIPS" is prominently displayed, suggesting it is a logo or brand name.

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. Submitter of this premarket notification
  Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: +49 7031 463-2840 Fax: +49 7031 463-2442 e-mail: markus.stacha@philips.com

OCT 17 2013

This summary was prepared on June 21, 2013.

1. The name and classification of the device
  Trade name: IntelliVue Patient Monitor MX500 and MX550 Common name: Multiparameter Patient Monitor

Classification:

Device Panel	Classification	ProCode	Description
CardiovascularDevices	§870.2300, II	DRT	Monitor, Cardiac (incl. Cardiotachometer& Rate Alarm)
	§870.1025, II	DSI	Detector and alarm, arrhythmia
	§870.1025, II	MLD	Monitor, ST Segment with Alarm
	§870.1025, II	MHX	Monitor, Physiological, Patient (witharrhythmia detection or alarms)
	§870.1100, II	DSJ	Alarm, Blood Pressure
	§870.1110, II	DSK	Computer, Blood Pressure
	§870.1130, II	DXN	System, Measurement, Blood-Pressure.Non-Invasive
	§870.1435, II	DXG	Computer, Diagnostic, Pre-Programmed,Single-Function
	§870.1915, II	KRB	Probe, Thermodilution
	§870.2060, II	DRQ	Amplifier and Signal Conditioner,Transducer Signal
	§870.2340, II	DPS	Electrocardiograph
	§870.2340, II	MLC	Monitor, ST Segment
	§870.2350, II	DRW	Electrocardiograph, Lead SwitchingAdapter
	§870.2370, II	KRC	Tester, Electrode, Surface,Electrocardiograph
	§870.2600, I	DRJ	System, Signal Isolation
	§870.2700, II	DQA	Oximeter
	§870.2770, II	DSB	Plethysmograph, Impedance
	§870.2800, II	DSH	Recorder, Magnetic tape, Medical
	§870.2810, I	DSF	Recorder, Paper Chart

Page 138 of 142

{1}------------------------------------------------

K131872

Page 2 of 5

a de la

Device Panel	Classification	ProCode	Description
	§870.2850, II	DRS	Extravascular Blood Pressure Transducer
	§870.2900, I	DSA	Cable, Transducer and Electrode, incl.Patient Connector
		-	MSX
	§870.2910, II	DRG	Transmitters and Receivers, PhysiologicalSignal, Radiofrequency
AnesthesiologyDevices	§868.1400, II	CCK	Analyzer, Gas, Carbon Dioxide, Gaseous-Phase
	§868.1500, II	CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1500, II	NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
	§868.1500, II	NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
	§868.1500, II	NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1620, II	CBS	Analyzer, Gas, Halothane, Gaseous-Phase(Anesthetic Concentration)
	§868.1700, II	CBR	Analyzer, Gas, Nitrous Oxide, Gaseous-Phase (Anesthetic Concentration)
	§868.1720, II	CCL	Analyzer, Gas, Oxygen, Gaseous-Phase
	§868.1880, II	BZC	Data calculator Pulmonary-function
	§868.2375, II	BZQ	Monitor, Breathing Frequency
	§868.2480, II	LKD	Monitor, Carbon Dioxide, Cutaneous
	§868.2500, II	KLK	Monitor, Oxygen, Cutaneous, for Infantnot under Gas Anesthesia
	§868.2775 II	KOI	Electrical peripheral nerve stimulator
Neurological Devices	§882.1400, II	GWR	Electroencephalograph
	§882.1420, I	GWS	Analyzer, Spectrum,Electroencephalograph Sigmal
General Hospital andPersonal Use Devices	§880.2910, 11	FLL	Thermometer, Electronic, Clinical

1. The subject devices Philips IntelliVue Patient Monitors MX500 and MX550. software Rev. K.10, are substantially equivalent to the previously cleared Philips IntelliVue Patient Monitor MP50 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K 110622, K 102562, K 093268, K 083517, K 082633, K 082583, K 071426, K 063315, K062283, K061610, K061052, K060541, K060221, K053522, K052961, K052801, K050762. K050141, K042845, K041235, K040304, and K032858.
Description of the device 4.

The Intelli Vue Patient Monitors MX500 and MX550 are modification of the legally marketed IntelliVue Patient Monitor MP50.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the text "K131872 Page 3 of 5" on the left side and the word "PHILIPS" in large, bold letters on the right side. The text on the left appears to be a document identifier and page number. The word "PHILIPS" is the brand name.

The MX500 and MX550 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.

The MX500 and MX550 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or WLAN.

1. Intended Use
  The subject devices IntelliVue Patient Monitor MX500 and MX550 have the same intended use as the legally marketed predicate IntelliVue Patient Monitor MP50.

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI ECI I).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

Page 140 of 142

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text "K131872 Page 4 of 5" on the left side and the word "PHILIPS" in large, bold, black letters on the right side. The text on the left indicates a document number and page number. The word "PHILIPS" is prominently displayed, suggesting it is a brand name or title.

The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (I to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

Technological Characteristics 6.

The subject devices IntelliVue Patient Monitors MX500 and MX550 have the same range of functions as the legally marketed predicate IntelliVue Patient Monitor MP50. MX500 and MX550 reuse unchanged external measurement modules and measurement accessories as already used by the predicate MP50.

MX500 and MX550 have the same relevant-technological characteristics as the predicate MP50 with regard to energy sources. portability, user interface, and robustness.

Compared to the predicate MP50, the MX500 and MX550 have modified technological characteristics with regard to the usage of state of the art hardware components such as widescreen display, CPU. memories and interfaces, regarding a more compact form factor, resulting in slightly different dimensions and weight, regarding environmental conditions and operating time with internal battery.

The housing of the MX500 and MX550 is made of plastic whereas the housing of the predicate Intelli Vue Patient Monitor MP50 is made of plastic and partly of magnesium alloy. The MX500 and MX550 reuse plastic materials of the predicate MP50. Biocompatibility aspects are not affected because the devices do not have contact with patients.

The fundamental scientific technology of the new IntelliVue Patient Monitors MX500 and MX550 is the same as that of the predicate IntelliVue Patient Monitor MP50. The differences in technological characteristics between the subject devices MX500 and MX550 and the predicate device MP50 do not diminish safety or effectiveness.

{4}------------------------------------------------

K131872 Page 5 of 5

7. Summary of V&V activities

Testing according to the recognized consensus standards:
- IEC 60601-1-2:2001 +A1:2004 (EMC) .
- IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety) .
- IEC 60601-1-8:2003 (Alarms) ●
- . IEC 62304:2006 (Software life cycle processes)

All applicable requirements have been met.

Environmental testing (temperature, humidity), mechanical testing (shock, vibration, and free fall).
All specified test requirements have been met. The tests confirmed that the Intelli Vue Patient Monitor MX500 and MX550 worked safely and according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, and storage.
Regression testing on the IntelliVue Patient Monitor MX500 and MX550. The performed regression testing comprised function tests of all physiological measurement parameters (which remain unchanged in this submission), recorder module, display, battery functionality, battery operating and charging time, human interface, external interfaces, alarming system, and tests as identified by the hazard analysis.
All specified criteria have been met. The tests demonstrated that the Intelli Vue Patient Monitor MX500 and MX550 worked safely, effectively, and correctly in accordance with specifications and labeling claims in the intended environment of use.

8. Conclusion

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate.

Testing comprised regression tests, electrical and mechanical safety tests, EMC tests, and environmental tests.

Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
The results demonstrate that the Philips Intelli Vue Patient Monitor MX500 and MX550 meet all defined reliability requirements and performance claims.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2013

Philips Medizin Systeme Boblingen GmbH c/o Mr. Markus Stacha Sr. Regulatory Affairs Engineer Hewlett-Packard Str. 2 71034 Böblingen, Germany

Re: K131872

Trade/Device Name: IntelliVue Patient Monitors MX500 and MX550 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX, DRT, DSI, MLD, DSJ, DSK, DXN, DXG, KRB, DRQ, DPS, MLC, DRW, KRC, DRJ, DQA, DSP, DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KÖI, GWR, GWS, FLL Dated: September 20, 2013 Received: September 23, 2013

Dear Mr. Markus Stacha:

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

{6}------------------------------------------------

Page 2 - Mr. Markus Stacha

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 (2 ) CFR Part 807): labeling (21 CFR Part 801); medical device 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.fdagov/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/ReportaProblem/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.

Owen P. Faris -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: IntelliVue Patient Monitor MX500 and MX550

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alams for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI ECI 1).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

Continued on next page

Over-The-Counter Use Prescription Use Yes No AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clue

Digitally signed by Owen P. Faris -S Date: 2013.10.17 15:44:16 -04'00'

Page 17 of 142

{8}------------------------------------------------

Indications for Use (continued)

The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (I to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The Intelli Vue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.