(90 days)
The intended use of 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.
The Philips Emergin Event Management product is a software only event management product.
The provided documentation for K102974 P1/2, Philips Emergin Event Management, does not contain specific acceptance criteria or detailed study results with performance metrics that can be extracted to populate the requested table directly. The submission states that "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." However, it does not quantitatively describe these requirements or claims, nor does it provide a table of observed performance values against them.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance (Quantitative/Qualitative) |
|---|---|
| Functional and Reliability Requirements: Meeting all reliability requirements and performance claims. (General statement) | "The results demonstrate that the Philips meets all reliability requirements and performance claims." (General statement, no specific metrics provided.) |
| System Level Functionality: (Implied from "system level tests") | Implied to have passed, but no details on specific functional criteria or performance. |
| Regression Test Performance: (Implied from "regression tests") | Implied to have passed, but no details on specific criteria or performance. |
| Hazard Analysis Compliance: Mitigation of identified hazards. (Implied from "testing from the hazard analysis") | Implied to have passed, but no details on specific hazard criteria or performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the provided text.
- Data provenance: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a software for routing alarms, not for diagnostic interpretation requiring expert ground truth for image/signal analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing described appears to be software and system functionality testing, not a clinical study requiring adjudication of expert interpretations.
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. The device is an event management system, not an AI-assisted diagnostic tool that aids human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The term "standalone" is not used in the context of diagnostic algorithms here. The device is a software application. The testing performed ("system level and regression tests as well as testing from the hazard analysis") evaluates the algorithm/software functionality directly, without a human-in-the-loop performance evaluation in a clinical setting for diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for an alarm routing system would relate to whether alarms are correctly processed and routed according to specifications, not clinical diagnoses. This would typically be assessed through functional testing against predefined system requirements.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI algorithm in the context of requiring a "training set" for model development. It is an event management software.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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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: gary.becker@philips.com
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 |
|---|---|---|---|
| CardiovascularDevices | §870.2300, II | MSX | Cardiac monitor (includingcardiotachometer and ratealarm). |
-
- The introduction of a software only event management product.
-
- 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.
-
- The product has the same technological characteristics as the legally marketed predicate devices.
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K102974 P2/2
- 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three parallel lines forming its body and wings. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
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
and the comments of the comments of the country of the country of the country of the country of the country of the country of the country of the country of the country of the
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 (800) 638-2041 or (301) 796-7100 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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).