(205 days)
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No
The summary describes a system for transmitting and displaying physiological data, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is a telemedicine server for viewing and distributing patient data from defibrillators, not directly applying therapy or treating a condition.
No
The device displays and archives patient vitals and 12-lead ECG information but does not state that it interprets or analyzes these to provide a diagnosis. It facilitates viewing, printing, and distribution of data, and forwards 12-lead ECG information to ECG management systems, but it is not explicitly performing a diagnostic function itself.
Yes
The device is described as "software" and its function is to receive, display, archive, and distribute data from external hardware (Philips HeartStart defibrillators). The description focuses on the software's capabilities and data handling, without mentioning any integrated hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the display, printing, archiving, and distribution of patient vital signs, waveforms, and ECG information. This is data collected from the patient's body, not data derived from a sample taken from the patient's body (like blood, urine, or tissue).
- Device Description: The device description reinforces that it facilitates the transmission of physiological data from defibrillators.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device handles data already collected from the patient's physiological state.
N/A
Intended Use / Indications for Use
The HeartStart Telemedicine Server software displays patient vitals, waveforms and 12-lead ECG information transmitted from Philips HeartStart defibrillators in remote locations. The HeartStart Telemedicine server allows viewing, diagnostic quality printing, archiving and further distribution of digitized clinical data. The HeartStart Telemedicine Server is also able to forward the 12-lead ECG information into ECG management systems that can process XML format ECG reports such as the TraceMasterVue ECG Management System
Product codes (comma separated list FDA assigned to the subject device)
74 MSX, MSX
Device Description
The HeartStart Telemedicine Server facilitates transmission of physiological data, waveforms and reports from Philips Defibrillators to a remote server that is located in a facility that is prepared to admit patients being transported by an ambulance.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification, validation, and testing activities establish the performance and functionality characteristics of the new device. Testing involved system level tests, integration tests and regression tests from hazard analysis. Pass/Fail criteria were based on the specifications and test results showed substantial equivalence. The results demonstrate that the functionality of the modified 12 lead transfer station meets all performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Image /page/0/Picture/1 description: The image shows the Philips logo. On the left is the Philips shield logo, which contains the word "PHILIPS" at the top and a circular design below. To the right of the shield is the word "PHILIPS" in large, bold, sans-serif font. The text is in all capital letters and is black.
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8. 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.
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- The submitter of this pre-market notification is:
Philips Medical Systems 3000 Minuteman Road Andover, MA 01810
- The submitter of this pre-market notification is:
NOV 1 3 2009
Contact Person: Mr. Paul Schrader Senior Regulatory Affairs Mgr Tel: 978-659-2404 Fax: 978-659-3610 Email: Paul.Schrader@philips.com
This summary was prepared on April 16, 2007.
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- The name of this device is the Philips HeartStart Telemedicine System. Classification names are as follows:
| Classification | Pro Code | Description |
|---|---|---|
| 870.2300 | 74 MSX | System, Network and Communication, |
| Physiological Monitors |
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- The HeartStart Telemedicine Server facilitates transmission of physiological data, waveforms and reports from Philips Defibrillators to a remote server that is located in a facility that is prepared to admit patients being transported by an ambulance.
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- The new device is substantially equivalent to the previously cleared Philips HeartStart 12 Lead transfer station.
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- The product has a similar clinical intended use as the legally marketed predicate device. The only difference is that this SW now adds the capability to receive patient vital sign data and physiologic waveforms in addition to 12-lead ECG information obtained from Philips defibrillator monitors.
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- The product utilizes the same basic technology (receipt of XML data format) as the legally marketed predicate device.
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- Verification, validation, and testing activities establish the performance and functionality characteristics of the new device. Testing involved system level tests, integration tests and regression tests from hazard analysis. Pass/Fail criteria were based on the specifications and test results showed substantial equivalence. The results demonstrate that the functionality of the modified 12 lead transfer station meets all performance claims.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle is blank. Inside the circle is an image of a bird with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
ﻴﻨﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ ﻳﺔ ﺍﻟﺘﻲ :
Philips Medical Systems c/o Mr. Paul Schrader Regulatory Affairs Manager Cardiac Care Business 3000 Minuteman Road, Mail Stop 220 Andover, MA 01810-1099
NOV 1 3 2009
Re: K091176
Trade/Device Name: Telemedicine Server/System Model 861441 Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Monitors Network and Communication System Regulatory Class: Class II (two) Product Code: MSX Dated: September 17, 2009 Received: September 21, 2009
Dear Mr. Schrader:
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. Paul Schrader
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If 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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Duna R. bechner
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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7. Indications for Use Statement
Page 1 of 1
510(k) Number (if known): KO9 \ 176
Device Name: HeartStart 12 Lead Transfer Station
Indications for Use:
Intended use of HeartStart Telemedicine Server:
The HeartStart Telemedicine Server software displays patient vitals, waveforms and 12-lead ECG information transmitted from Philips HeartStart defibrillators in remote locations. The HeartStart Telemedicine server allows viewing, diagnostic quality printing, archiving and further distribution of digitized clinical data. The HeartStart Telemedicine Server is also able to forward the 12-lead ECG information into ECG management systems that can process XML format ECG reports such as the TraceMasterVue ECG Management System
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Sume R. Revere
(Division Sign-Off)
Division of Cardiovascular Devices
Division of Cardiovascular Devices
Ko91176 510(k) Number_