PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)

K070588 · Philips Medical Systems · MHX · Mar 20, 2007 · Cardiovascular

Device Facts

• Record ID: K070588
• Device Name: PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

Indicated for central monitoring of multiple adult, pediatric, and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Device Story

Philips SureSigns VSV (Vital Signs Viewer) is a central monitoring system designed for clinical environments. It aggregates physiological data from connected Philips SureSigns VM Series patient monitors. The system enables clinicians to remotely view vital signs and cardiac arrhythmia data for multiple patients simultaneously. By providing centralized oversight, the device assists healthcare providers in monitoring patient status, evaluating treatment adequacy, and identifying cardiac events. The system functions as a communication and display hub, allowing for efficient patient surveillance across a clinical unit. It does not alter the underlying physiological data but presents it to facilitate clinical decision-making and timely intervention.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, integration tests, environmental tests, and safety testing based on hazard analysis. Pass/Fail criteria were established against predicate device specifications, and results demonstrated substantial equivalence in functionality and reliability.

Technological Characteristics

Centralized physiological monitoring system. Connectivity: Networked communication with Philips SureSigns VM Series monitors. Software-based data aggregation and display. Functions as an arrhythmia detector and alarm system. Class II device.

Indications for Use

Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; used when clinicians require cardiac arrhythmia monitoring to inform treatment decisions, assess treatment efficacy, or exclude symptom causes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• M2350A and Model M2360A, Component Central Monitor (K921014)

Reference Devices

• Philips SureSigns VM Series Patient Monitors (K052707)
• M3290A IntelliVue Information center software (K062271)

Submission Summary (Full Text)

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## 8.0 510 (k) Summary

summary of 510(k) safety and effectiveness This information i s 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:

Philips Medical Systems

This summary was prepared on 22 February, 2007.

- 2. The name of this device is the Philips SureSigns VSV (Vital Signs Viewer). Classification names are as follows:

| Classification | ProCode | Description |
|----------------|---------|--------------------------------------------------------------|
| None | 74 MHX | Physiological Monitor, Patient<br>Monitor |
| 870.1025, II | 74 DSI | Arrhythmia Detector and Alarm |
| 870.2800, II | 74 DSH | Recorder, Magnetic Tape, Medical |
| 870.2300, II | 74 MSX | System, Network and Communication,<br>Physiological Monitors |

- 3. The new device is substantially equivalent to the previously cleared M2350A and Model M2360A, Component Central Monitor (K921014);
- 4. The modification is a change that provides support for the Philips SureSigns VM Series Patient Monitors (K052707)
- 5. The new device has the same Indications for Use as the legally marketed predicate device. For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
- 6. The new device has the same technological characteristics as the legally marketed predicate device; -Philips M2350A & M2360A (K921014), -SureSigns VM Series Patient Monitors (K052707), and -M3290A IntelliVue Information center software (K062271).
- 7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental 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 Philips SureSigns Vital Signs Viewer (VSV) functionality meets all reliability requirements and performance claims.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2007

Philips Medical Systems c/o Mr. Tapan D. Shah Regulatory Affairs Engineer Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810

Re: K070588

Trade Name: Philips SureSigns VSV (Vital Signs Viewer) Regulation Number: 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: February 28, 2007 Received: March 1, 2007

Dear Mr. Shah:

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. Iisting 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 - Mr. Tapan D. Shah

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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhumima for

Bram 9. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

K670588 510(k) Number (if known):

Device Name: Philips SureSigns VSV (Vital Signs Viewer)

Indications for Use:

Indicated for central monitoring of multiple adult, pediatric, and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Prescription Use yes Over-The-Counter Use No AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummina

Division Sign-Off Division of Cardiova 510(k) Number

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