INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00

K102974 · Philips Medical Systems · MSX · Jan 4, 2011 · Cardiovascular

Device Facts

• Record ID: K102974
• Device Name: INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
• Applicant: Philips Medical Systems
• Product Code: MSX · Cardiovascular
• Decision Date: Jan 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Philips Emergin Event Management software provides healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). The product can route all or subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.

Device Story

Software-only event management system; routes patient alarms, technical alarms, and nurse call messages from primary monitoring devices to remote secondary notification devices (pagers, phones, marquees). Operates in clinical environments; used by healthcare professionals. Does not provide real-time information; does not guarantee delivery of messages; secondary notification system only. Primary alarm notification remains the responsibility of the source device. Benefits include supplemental awareness of system events for clinical staff.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level and regression testing, as well as hazard analysis to confirm performance and reliability claims.

Technological Characteristics

Software-only event management system. Functions as a secondary notification router for alarm/event data. No hardware components. Connectivity via network integration with primary alarm-producing devices.

Indications for Use

Indicated for healthcare professionals to receive supplemental notifications of patient, technical, and nurse call alarms. Not for real-time monitoring or as a replacement for primary alarming devices.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Spacelabs device (K062278)
• Masimo Patient Safety Net (K061932)

Submission Summary (Full Text)

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## K102974 P1/2

· JAN - 4 2011

## 510 (k) 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 C.F.R. §807.92.

l. The submitter of this premarket notification is:

Gary Becker Philips Medical Systems Emergin 6400 N Congress Ave Suite 1050, Boca Raton, FL 33487 561 ·886-5124 581 361 -6991 Tel: Fax: e-mail: [e-mail]

This summary was prepared on September 30, 2010

The name of the device is the Philips Emergin Event 2. Management. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|---------------------------|----------------|---------|--------------------------------------------------------------------|
| Cardiovascular<br>Devices | §870.2300, II | MSX | Cardiac monitor (including<br>cardiotachometer and rate<br>alarm). |

- 3. The Philips Emergin Event Management product is substantially equivalent to previously cleared Spacelabs device marketed pursuant to K062278, and Masimo Patient Safety Net K061932.
- 4. The introduction of a software only event management product.
- 5. The intended use is:

The Philips Emergin Event Management software provides healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). The product can route all or subsets of this information to selective remote devices such as pagers, phones, Receipt of alarm messages or events by the external or marquees. device, is not confirmed and delivery to the end device is not The primary alarm notification is the device guaranteed. This product line is not intended producing the alarm or event. to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.

- 6. The product has the same technological characteristics as the legally marketed predicate devices.

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K102974 P2/2

7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the device. Testing involved system level and regression tests as well as testing from the hazard analysis. The results demonstrate that the Philips meets all reliability requirements and performance claims.

.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Philips Medical Systems c/o Mr. Gary Becker Manager, Quality and Regulatory Emergin 6400 N. Congress Ave Suite 1050 Boca Raton, FL 33487

14N - 4. 2011

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Re: K102974

Trade/Device Name: Philips Emergin Event Management System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MSX Dated: September 30, 2010 Received: October 6, 2010

Dear Mr. Becker:

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. Gary Becker

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.

ff 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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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): K102974

JAN - 4 2011

Device Name: Intellisphere Event Management

Indications for Use:

The intended use of the Intellisphere Event Management product is to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). The product can route all or subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.

Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

W. W. A.

(Division Sign-Off) (Division Sign-Sil,

510(k) Number K102574

Confidential