SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 by PHILIPS MEDICAL SYSTEMS

Intended Use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Device Description

The SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor. These changes include two new models, enhancements and bug fixes. The new models include the VM3 Series Patient Monitor which is a subset of the predicate devices but does not perform NBP and the SureSigns VS3 Vital Signs monitor which is a subset of the predicate device and performs continuous SpO2 and intermittent measurements of SpO2, NBP, and pTemp. The enhancements include improvements in the areas of Patient Records, the Administering Patients, Networking, Data Export, improved board hardware, adding a SpO2 sensor and NBP cuffs.

AI/ML Overview

The provided text is a 510(k) summary for the Philips SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor. It describes the devices, their intended use, and substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in a quantitative sense as typically expected for AI/CADe device submissions.

The document states:

"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate."
"Testing involved system level tests, performance tests, and safety testing from hazard analysis."
"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 SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence."

This indicates that testing was performed and specific criteria were used, but the document does not provide the specific numerical acceptance criteria, reported device performance metrics against those criteria, or the methodology of the studies in detail (e.g., sample sizes, ground truth establishment, expert involvement, MRMC studies, or standalone performance).

Given the information provided, I cannot populate all the requested fields. Here's what I can extract and what is missing:

Acceptance Criteria and Study Details (Based on Provided Text)

1. A table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criteria	Reported Device Performance
General	Based on specifications cleared for the predicate device (K052707)	"Meet all reliability requirements and performance claims" and "showed substantial equivalence."
System Level	Based on specifications cleared for the predicate device (K052707)	"Showed substantial equivalence."
Performance	Based on specifications cleared for the predicate device (K052707)	"Showed substantial equivalence."
Safety	Based on specifications cleared for the predicate device (K052707)	"Showed substantial equivalence."

Note: The document broadly mentions "specifications cleared for the predicate device" as the basis for acceptance criteria, but does not detail what those specific performance specifications were (e.g., accuracy for NBP, SpO2, ECG, etc.) or quantitative reported performance values.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "system level tests, performance tests, and safety testing," but not the nature of the data involved.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Ground truth establishment, if applicable to device performance testing, is not detailed. Given these are patient monitors for vital signs, the ground truth would likely be established by known physical standards, reference devices, or clinical measurements rather than expert consensus on images.

4. Adjudication method for the test set

Not applicable as the text describes testing against specifications rather than expert adjudicated cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided and is highly unlikely to be relevant. The devices are patient monitors, not AI/CADe systems for interpreting complex medical images or data. The "enhancements" mentioned are clinical features, not AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The devices themselves are standalone in terms of their primary function (monitoring vital signs). The testing described would inherently be standalone performance against specified requirements. However, the exact performance metrics and results are not detailed.

7. The type of ground truth used

Not explicitly stated, but for patient monitors, ground truth would typically come from:
- Reference standards/simulators: For electrical safety, accuracy of measurements (e.g., known pressure values for NBP, known SpO2 levels).
- Reference devices: Comparison against established, highly accurate medical devices.
- Clinical measurements: In some cases, direct physiological measurements.

8. The sample size for the training set

Not applicable. These are traditional medical devices, not machine learning or AI algorithms requiring a "training set" in the conventional sense. The "enhancements" mentioned are likely software and hardware improvements, not model training.

9. How the ground truth for the training set was established

Not applicable for the reasons stated above.

Summary:

The 510(k) summary provides a general overview of the devices and states that verification, validation, and testing were conducted. It confirms that the devices met "all reliability requirements and performance claims" and demonstrated "substantial equivalence" to a predicate device. However, it lacks the specific quantitative details regarding acceptance criteria, reported performance metrics, study methodologies (e.g., sample sizes, data provenance, ground truth details, expert involvement), or comparative effectiveness studies that would typically be found for AI-driven devices. This is consistent with a traditional medical device submission for vital signs monitors, which rely on meeting established performance standards rather than complex statistical validation studies against expert consensus for diagnostic accuracy.

Summary

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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).

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

Tel: 978-659-4932 Fax: 978-685-5624 Email: mary.kruitwagen@philips.com

This summary was prepared on February 15, 2008.

The names of the subject devices are the Philips SureSigns VM Series Patient Monitors and 2. SureSigns VS3 Vital Signs Monitor.
1. The trade names of the devices are the SureSigns VM Series Patient Monitors (VM3, VM4, VM6, VM8) and the SureSigns VS3 Vital Signs Monitor.
র্ব : The common usual name is multi-parameter patient monitor

Device Panel	Classification	ProCode	Description
Circulatory SystemDevices	870.1025, II	MHX	Monitor, Physiological, Patient(with arrhythmia detection oralarms)
	870.1110, II	DSJ	Alarm, Blood Pressure
	870.1110, II	DSK	Computer, Blood Pressure
	870.1130, II	DXN	System, Measurement, BloodPressure, Non-Invasive
	870.1435, II	DXG	Computer, Diagnostic, Pre-programmed, Single-function
	870.2300, II	DRT	Monitor, Cardiac (incl.Cardiotachometer & Rate Alarm
	870.2340, II	DPS	Electrocardiograph
	870.2700, II	DQA	Oximeter
	870.2850, II	DRS	Extravascular Blood PressureTransducer
	870.2900, I	DSA	Cable, Transducer and Electrode,incl. Patient connector
Anesthesiology &RespiratoryTherapy	868.1400, II	CCK	Analyzer, Gas,
General Hospitaland Personal Use	880.2910, II	FLL	Thermometer, Electronic, Clinical

1. The Classification names are as follows:
ം. The modified devices are substantially equivalent to previously cleared Philips device, M3046B Compact Configurable Portable Patient Monitor marketed pursuant to K052707.

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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters and words. The first line reads 'KU80495', which seems to be an identification number or code. The second line reads 'Page 2032', indicating a page number within a document. The handwriting is somewhat stylized, with distinct letterforms and spacing.

The modifications are changes to the SureSigns VM Series Patient Monitors and the 7. SureSigns VS3 Vital Signs Monitor. These changes include two new models, enhancements and bug fixes. The new models include the VM3 Series Patient Monitor which is a subset of the predicate devices but does not perform NBP and the SureSigns VS3 Vital Signs monitor which is a subset of the predicate device and performs continuous SpO2 and intermittent measurements of SpO2, NBP, and pTemp. The enhancements include improvements in the areas of Patient Records, the Administering Patients, Networking, Data Export, improved board hardware, adding a SpO2 sensor and NBP cuffs.
The modified devices have the same intended use as the legally marketed predicate device. 8. The SureSigns VS3 vital signs monitor is 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.
The modified devices have the same fundamental technological characteristics as the legally ு. marketed predicate devices. The subject devices use the same design as the predict device. The composition of the materials used for both devices is the same. There is no change to the chemical composition of the subject devices to the predicate devices. The energy source of the subject devices is essentially the same as the predicate device.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. 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 SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure. The symbol is composed of thick, black lines and curves, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2008

Philips Medical Systems c/o Ms. Mary Kruitwagen Regulatory Affairs Specialist 3000 Minuteman Rd. Andover, MA 01810

Re: K080495

Trade/Device Name: Philips SureSigns VM series Patient Monitors and SureSigns VS3 Vital Sign Monitor 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 Dated: February 15, 2008 Received: February 22, 2008

Dear Ms. Kruitwagen:

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 such 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 – Ms. Mary Kruitwagen

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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):	K080495
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Device Name: Philips SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor

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

Prescription Use:	YES	AND/OR over-the-counter Use:	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)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number: K080495

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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.