SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR by PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.

Indicated 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.

Device Description

The SureSigns VS2 Vital Signs monitor and the SureSigns VM1 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. The addition of the wireless functionality to the predicate VS3 does not change the intended use or indications for use. The subject 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 VS2 and the VM1 materials are different than the predicate device, however are made of a material previously used in other medical devices. The chemical composition of the subject devices has changed but is the same as material used in other predicate devices. The energy source of the subject device the VS2 is an external power supply, while the VM1 will use a power supply that is the same as the predicate device. The VS2 and the VM1 both can run on battery power with batteries similar to the predicate devices.

AI/ML Overview

The provided 510(k) summary for the Philips SureSigns VM1 Patient Monitors and SureSigns VS2 Vital Signs Monitor does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study proving the device meets specific acceptance criteria in the way typically expected for AI/ML device evaluations.

This document is a pre-market notification (510(k)) for physiological monitoring devices, specifically patient monitors, and their modifications. The evaluation for substantial equivalence in such devices often focuses on comparing technical characteristics and performance to legally marketed predicate devices, rather than establishing novel performance metrics against a defined ground truth using a clinical study with a specified sample size and expert review in the context of an algorithm.

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

The document states:
"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. 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 VM1 Patient Monitors and SureSigns VS2 Vital Signs monitor and the modification to the SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence."

This indicates that the "acceptance criteria" were essentially the specifications of the predicate device and the subject device, and the "study" was system-level, performance, and safety testing aimed at demonstrating substantial equivalence. However, specific numerical performance metrics are not provided in this summary.

Therefore, many parts of your request cannot be directly answered from the provided text.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Compliance with predicate device specifications and subject device specifications.	"Test results showed substantial equivalence." "The results demonstrate that the Philips SureSigns VM1 Patient Monitors and SureSigns VS2 Vital Signs monitor and the modification to the SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence."
Meeting reliability requirements.	Met.
Meeting performance claims.	Met.
Safety (based on hazard analysis).	Met.
Functionality.	Established.
Specific quantitative performance metrics (e.g., accuracy % for a particular parameter)	Not provided in this 510(k) summary. The summary states that "Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device," implying that performance metrics were assessed, but the actual numbers (e.g., blood pressure accuracy, heart rate accuracy, SpO2 accuracy) are not disclosed in this public summary.

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

Sample Size: Not specified. The document mentions "system level tests, performance tests, and safety testing," but does not give a sample size of patients or data records.
Data Provenance: Not specified. It's likely these tests were conducted internally by Philips Medical Systems (Andover, MA, United States), but the origin of any clinical data (if used) is not detailed. The distinction between retrospective or prospective data is not applicable given the type of testing described (device function/safety rather than algorithm performance on clinical data).

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

Not applicable / Not specified. This type of information (number and qualification of experts establishing ground truth) is typically relevant for studies evaluating an AI/ML diagnostic or prognostic system against a human standard. For a patient monitor, "ground truth" would be established by reference standards or direct physical measurements, not expert consensus on interpretations of images or signals.

4. Adjudication method for the test set

Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers when establishing ground truth. This is not typically part of the testing for a physiological monitor's basic functions.

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

Not applicable / Not done. This is a physiological monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI assistance effect size are not relevant to this device's evaluation.

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

Not applicable / Not mentioned in this context. While these devices contain algorithms for processing physiological signals (e.g., arrhythmia detection, NIBP calculation), the 510(k) summary does not describe a "standalone" algorithm performance study in the way it's typically understood for AI/ML devices where the algorithm's output is compared to a ground truth independent of human interaction. The testing described focuses on the integrated device's performance.

7. The type of ground truth used

Likely reference standards and direct physical measurements. For physiological monitors, ground truth for parameters like blood pressure, heart rate, or SpO2 would typically involve highly accurate reference devices or invasive measurements (e.g., arterial line for blood pressure) against which the monitor's readings are compared. The document does not explicitly state this but it's the standard practice for such devices.
Not pathology, outcomes data, or expert consensus in the context of diagnostic interpretation.

8. The sample size for the training set

Not applicable / Not specified. These devices are not described as employing machine learning models that require a "training set" in the modern sense. They rely on established signal processing algorithms. If any adaptive algorithms or calibrations exist, the "training" would be internal calibration processes rather than a distinct dataset.

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

Not applicable. As a traditional physiological monitor, the concept of a "training set" and associated ground truth establishment for a machine learning model is not relevant to the information provided in this 510(k) summary.

Summary

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K082280
pi/2

OCT 0 8 2008

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.
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 July 31, 2008.

The names of the subject devices are the Philips SureSigns VM1 Patient Monitors and 2. SureSigns VS2 Vital Signs Monitor.
ന The trade names of the devices are the SureSigns VM1 Patient Monitors (VM1) and the SureSigns VS2 Vital Signs Monitor.
The common usual name is multi-parameter patient monitor 4.
1. 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)	VS2, VM1
	870.1110, II	DSJ	Alarm, Blood Pressure	VS2
	870.1110, II	DSK	Computer, Blood Pressure	VS2
	870.1130, II	DXN	System, Measurement,Blood Pressure, Non-Invasive	VS2
	870.2300, II	DRT	Monitor, Cardiac (incl.Cardiotachometer & RateAlarm	VS2, VM1
	870.2700, II	DQA	Oximeter	VS2, VM1
	870.2900, I	DSA	Cable, Transducer andElectrode, incl. Patientconnector	VM1
General Hospital andPersonal Use	880.2910, II	FLL	Thermometer, Electronic,Clinical	VS2
Anesthesiology &Respiratory Therapy	868.1400, II	CCK	Analyzer, Gas,	VM1

The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors and SureSigns VS3 Patient Monitor marketed pursuant to K052707 and K080495.

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1. The modifications are as follows:
- . Introduction of the VM1 Patient Monitor (a subset of the predicate VM Series devices)
- Introduction of the VS2 Vital Signs monitor (a subset of the predicate device VS3) .
- . Modification of the predicate VS3 device to include the optional wireless bridge interface to transmit patient data records to an electronic medical record system.
1. The subject devices have the same intended use as the legally marketed predicate device. The SureSigns VS2 Vital Signs monitor and the SureSigns VM1 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. The addition of the wireless functionality to the predicate VS3 does not change the intended use or indications for use.
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 predict device. The composition of the VS2 and the VM1 materials are different than the predicate device, however are made of a material previously used in other medical devices. The chemical composition of the subject devices has changed but is the same as material used in other predicate devices. The energy source of the subject device the VS2 is an external power supply, while the VM1 will use a power supply that is the same as the predicate device. The VS2 and the VM1 both can run on battery power with batteries similar to 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. 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 VM1 Patient Monitors and SureSigns VS2 Vital Signs monitor and the modification to the 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/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Rc: K082280

Trade/Device Name: SureSigns VS2 (reference numbers: 863079,863080; 863081, 863082); SureSigns VM1 (reference number: 863078) SureSigns VS3 (reference number: 863069; 863070, 863071, 863072, 863073, 863074) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: II Product Code: MHX Dated: August 8, 2008 Received: August 11, 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 (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.

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Page 2 - Ms. Mary Kruitwagen

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 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 continue 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/dsma/dsmamain.html

Sincerely yours,

7 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 VS2 (reference numbers: 863079, 863080, 863081, 863082) SureSigns VM1 (reference number: 863078) SureSigns VS3 (reference numbers: 863069, 863070, 863071, 863072, 863073, 863074)

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	K082280
Page	of ___

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.