SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 by PHILIPS MEDICAL SYSTEMS

The Philips SureSigns Series Patient Monitors, SureSigns VM4, VM6, and VM8 Patient Monitors are multi-parameter patient monitors. The modifications include a new OEM CO2 module, addition of an apnea alarm, a new main board, modified front end board, alternate internal component speaker, optional bar code reader, optional RS232 serial port adaptor, several new accessories, and software enhancements. Impedance respiration is added to SureSigns VM4.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The provided text only states that "Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence." It does not explicitly list specific acceptance criteria or quantitative performance metrics. It generally asserts that the device "meet all reliability requirements and performance claims."

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in the provided text, but implied to be based on predicate device specifications and subject device specifications for various physiological parameters like NBP, SpO2, CO2, impedance respiration, etc.)	"meets all reliability requirements and performance claims" and "supports a determination of substantial equivalence."

2. Sample Size and Data Provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly mentions "system level tests, performance tests, and safety testing from hazard analysis."

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. The type of device (patient monitor) and the nature of modifications (hardware and software enhancements to existing parameters, addition of alarms) suggest that "ground truth" might be established through comparisons with reference measurement devices or established clinical standards, rather than expert consensus on image interpretation, for example.

4. Adjudication Method

The document does not mention any adjudication method.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The evaluation focuses on technical performance and equivalence to a predicate device.

6. Standalone Performance (Algorithm Only)

The device itself is a standalone patient monitor, and its performance was evaluated. However, the term "standalone" in the context of AI often implies an algorithm's performance without any human-in-the-loop. In this case, the device monitors physiological parameters and provides alarms directly, so its performance is inherently standalone in generating these outputs. The text indicates that "testing activities establish the performance, functionality, and reliability characteristics of the subject devices."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for physiological monitoring devices, the ground truth would typically be established by:

Reference standard devices: Comparing the device's readings against highly accurate and calibrated reference instruments for each physiological parameter (e.g., a clinical-grade blood pressure cuff for NBP, a calibrated pulse oximeter for SpO2, a gas analyzer for CO2).
Physical simulators: For certain parameters, using simulators that can generate precise physiological waveforms or values.
Clinical standards/established norms: Ensuring basic functionality and alarm thresholds align with recognized clinical practices.

8. Sample Size for the Training Set

The document does not specify any training set sample size. This type of device (patient monitor with hardware and software modifications to existing parameters) is unlikely to have a "training set" in the sense of machine learning models requiring large datasets for training. Its development would involve engineering design, component testing, and system-level validation against specifications, not typically a data-driven training process in the modern AI sense.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

Summary

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K 101067

510K 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 CFR 807-92(c).

The submitter of this pre-market notification is: 1.
Peng Cui Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States

MAY - 7 2010

Tel: 978-659-7966 Fax: 978-659-3819 Email: peng.cui@philips.com

This summary was prepared on April 9, 2010.

1. The names of the subject devices are the Philips SureSigns Series Patient Monitors, SureSigns VM4, VM6, and VM8 Patient Monitors
The trade names of the devices are the SureSigns VM4, SureSigns VM6, SureSigns VM8 3. Patient Monitors.
1. The common usual name is multi-parameter patient monitor
ട. The Classification names are as follows:

Device Panel	Classification	ProCode	Description	ApplicableSubjectDevices
Circulatory SystemDevices	870.1025, II	MHX	Monitor, Physiological,Patient (with arrhythmiadetection or alarms)	VM4, VM6,VM8
	870.1110, II	DSJ	Alarm, Blood Pressure	VM4, VM6,VM8
	870.1110, II	DSK	Computer, Blood Pressure	VM4, VM6,VM8
	870.1130, II	DXN	System, Measurement,Blood Pressure, Non-Invasive	VM4, VM6,VM8
	870.2300, II	DRT	Monitor, Cardiac (incl.Cardiotachometer & RateAlarm	VM4, VM6,VM8
	870.2700, II	DQA	Oximeter	VM4, VM6,VM8
	870.2900, I	DSA	Cable, Transducer andElectrode, incl. Patientconnector	VM4, VM6,VM8
General Hospital andPersonal Use	880.2910, II	FLL	Thermometer, Electronic,Clinical	VM4
Anesthesiology &Respiratory Therapy	868.1400, II	CCK	Analyzer, Gas,	VM8

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1. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors marketed pursuant to K052707, K080495 and K090483.
1. The modifications are as follows:
. The OEM CO2 module, from Oridion Medical Ltd. is being changed to a new version of the Oridion miniMedi module. This module was cleared under FDA K060065. The subject device will include the SARA respiratory algorithm cleared in the predicate device SureSigns VM1 (K082280).
An apnea alarm is being added to the existing impedance respiration and CO2 measurements; . however, the device is not an apnea monitor.
A new main board will be used that is host to the previously cleared Philips NBP module . (previously cleared under K090483) and includes the addition of speaker malfunction detection capability.
. The Front end board has been modified to comply with China SFDA dielectric production test requirements.
. An alternate internal component speaker will be used.
An additional optional bar code reader has been made available. .
Optional RS232 serial port adaptor has been made available.
Several new accessories are being listed for use with the device. .
Software enhancements include: .
- the addition of two SpO2 technical alarms ।
- a speaker malfunction technical alarm -
- a new CO2 technical alarm -
- additional Patient ID fields have been added -
- roll-over tool tips for quick software icon identification
- an additional 7 second recording option has been added -
- battery reconditioning has been improved ।
- when connected to an external device the monitors can synchronize its trend database clock to a master device time, such as an EMR system
lmpedance respiration is added to SureSigns VM4 patient monitor, which is already in the . predicate device of SureSigns VM6 and SureSigns VM8 cleared under K052707.
. The Instructions for Use will include some additional warnings and cleaning instruction clarifications for the pTemp measurement.
. ج The Instructions for Use will include some additional information and warnings for the CO measurement.
. The device label will include the IPX1 symbol.
1. The subject devices have the same intended use as the legally marketed predicate device. The SureSigns VM Series Patient Monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.
1. The subject devices have the same fundamental technological characteristics as the legally marketed predicate devices. The subject devices use the same design as the predicate devices. The addition of the apnea alarms, the three new technical alarms and the use of the CO2 miniMedi board does not significantly change the fundamental characteristics over the predicate devices
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. Testing involved system level tests, performance tests, and safety testing from hazard analysis.

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Page 72 of 112

April 9, 2010

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Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VM4, VM6 and VM8 Patient Moritors meet all reliability requirements and performance claims and supports a determination of substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY - 7 2010

Philips Medical Systems c/o Mr. Peng Cui Senior Manager, Regulatory Affairs 3000 Minuteman Road Andover, MA 01810

Re: K101067

Trade/Device Name: SureSigns VM4, SureSigns VM6, SureSigns VM8 (reference numbers 863063, 863064, 863065, 863066, and 863068) Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: April 9, 2010 Received: April 16, 2010

Dear Mr. Cui:

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.

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.

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Page 2 - Mr. Peng Cui

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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

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

Enclosure

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Indications for Use

510 (k) Number (if known):

Device Name: SureSigns VM4 (reference number: 863063) SureSigns VM6 (reference numbers: 863064, 863065) SureSigns VM8 (reference numbers: 863066, 863068)

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

KID 1067

AND/OR over-the-counter Use: Prescription Use: YES NO (Part 21 CFFR 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)

W.N.

(Division Sign-Off) Division of Cardiovascular Devices Page of

510(k) Number_

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.