(19 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on central monitoring and compatibility with other patient monitors.
No
The device is a central monitoring system that displays vital signs data from other patient monitors. While the data obtained might be used for treatment decisions, the device itself does not directly apply or facilitate therapy to the patient. It is a diagnostic and information display tool.
Yes
The device is indicated for monitoring cardiac arrhythmia of adult, pediatric, and neonatal patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "device for central monitoring of multiple patients" and a "modification is a change that provides support for the Philips SureSigns VM Series Patient Monitors." This indicates it is part of a larger system that includes hardware (patient monitors), not a standalone software-only device. The testing also includes "system level tests" and "environmental tests," which are typically associated with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring patients' vital signs and cardiac arrhythmia. This is a clinical monitoring function, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a "central monitoring of multiple patients." This aligns with a clinical monitoring system, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for the diagnosis of a disease or condition based on sample analysis.
The device is clearly designed for real-time patient monitoring in a clinical setting, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
MHX, DSI, DSH, MSX
Device Description
Philips SureSigns VSV (Vital Signs Viewer)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
clinician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
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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.
- The submitter of this premarket notification is:
Philips Medical Systems
This summary was prepared on 22 February, 2007.
-
- 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 |
| 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, |
| Physiological Monitors |
-
- The new device is substantially equivalent to the previously cleared M2350A and Model M2360A, Component Central Monitor (K921014);
-
- The modification is a change that provides support for the Philips SureSigns VM Series Patient Monitors (K052707)
-
- 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.
-
- 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.
1
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 (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 (800) 638-2041 or (240) 276-3150 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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