SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3

K080495 · Philips Medical Systems · MHX · Mar 24, 2008 · Cardiovascular

Device Facts

• Record ID: K080495
• Device Name: SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 24, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for 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 Story

Philips SureSigns VM Series (VM3, VM4, VM6, VM8) and VS3 Vital Signs Monitor are multi-parameter patient monitors. Devices accept inputs from sensors including SpO2, NBP, pTemp, and ECG leads. System processes physiological signals to provide real-time monitoring, recording, and alarming of patient status. Used by healthcare professionals in clinical settings and during intra-facility transport. Output displayed on integrated screen for clinician review; alarms alert staff to parameter deviations. Enhancements include improved patient records, networking, data export, and updated hardware. Benefits include continuous or intermittent physiological monitoring to support clinical decision-making.

Clinical Evidence

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

Technological Characteristics

Multi-parameter patient monitor. Materials and energy sources identical to predicate. Features include SpO2 sensors, NBP cuffs, networking, and data export capabilities. Software-based monitoring and alarming. Class II device.

Indications for Use

Indicated for use by health care professionals for monitoring physiological parameters of adult, pediatric, and neonatal patients in healthcare environments, including transport within a facility.

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

• M3046B Compact Configurable Portable Patient Monitor (K052707)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

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.
- 3. 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 System<br>Devices | 870.1025, II | MHX | Monitor, Physiological, Patient<br>(with arrhythmia detection or<br>alarms) |
| | 870.1110, II | DSJ | Alarm, Blood Pressure |
| | 870.1110, II | DSK | Computer, Blood Pressure |
| | 870.1130, II | DXN | System, Measurement, Blood<br>Pressure, Non-Invasive |
| | 870.1435, II | DXG | Computer, Diagnostic, Pre-<br>programmed, Single-function |
| | 870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate Alarm |
| | 870.2340, II | DPS | Electrocardiograph |
| | 870.2700, II | DQA | Oximeter |
| | 870.2850, II | DRS | Extravascular Blood Pressure<br>Transducer |
| | 870.2900, I | DSA | Cable, Transducer and Electrode,<br>incl. Patient connector |
| Anesthesiology &<br>Respiratory<br>Therapy | 868.1400, II | CCK | Analyzer, Gas, |
| General Hospital<br>and Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |

- 5. 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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- 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.
- 10. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

HE

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 |
|----------------------------|---------|
|----------------------------|---------|

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.

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.

| 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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