(19 days)
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.
The Philips SureSigns VSV (Vital Signs Viewer) is a device for central monitoring of multiple patients. The modification is a change that provides support for the Philips SureSigns VM Series Patient Monitors.
The provided text describes a 510(k) summary for the Philips SureSigns VSV (Vital Signs Viewer) and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria, study methodologies, or performance metrics in a quantitative sense. The summary primarily focuses on regulatory aspects, substantial equivalence, and general statements about testing.
Therefore, many of the requested details cannot be extracted from the provided input.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "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."
However, specific quantitative acceptance criteria (e.g., accuracy percentages, sensitivity, specificity, or error rates for arrhythmia detection) are not provided. Therefore, a table cannot be constructed with reported device performance against specific numerical criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 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)
This information is not provided in the text. The document refers to "verification, validation, and testing activities" but does not detail the methodology for establishing ground truth or the involvement of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
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
This information is not provided in the text. The device is a "Vital Signs Viewer" and "Arrhythmia Detector and Alarm," implying automated functions. The text does not mention any studies involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire submission is for a device with automated functions ("Physiological Monitor, Patient Monitor," "Arrhythmia Detector and Alarm"). The "verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." This implies a standalone assessment of the device's capabilities in detecting arrhythmias and monitoring vital signs. However, specific details of this "standalone" performance are not quantitatively reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the text.
8. The sample size for the training set
This information is not provided in the text.
9. How the ground truth for the training set was established
This information is not provided in the text.
Summary of available information:
The 510(k) summary indicates that the Philips SureSigns VSV underwent "Verification, validation, and testing activities" including "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." The "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." The overall conclusion is that "Philips SureSigns Vital Signs Viewer (VSV) functionality meets all reliability requirements and performance claims."
However, critically, the document lacks specific numerical acceptance criteria and detailed quantitative performance results that would allow for a comprehensive answer to your request. The provided text is a summary statement for regulatory approval, focusing on substantial equivalence rather than a detailed scientific study report.
{0}------------------------------------------------
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, PatientMonitor |
| 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.
{2}------------------------------------------------
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
{3}------------------------------------------------
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
Page __ 1 of _ 1 __
§ 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.