(29 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: NBP, SpO2, and Temperature. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.
The Philips SureSigns VS2* Vital Signs Monitor is a multi-parameter patient monitor. Standard and optional parameters include: NBP, SpO2, and Temperature. The energy source of the subject device is an internal power supply. The VS2* can run on battery power with batteries similar to the predicate device, however, with improved battery life.
The provided text is a 510(k) summary for the Philips SureSigns VS2 Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study with the kind of quantitative performance metrics, sample sizes, and expert adjudication described in the prompt. The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence." However, it does not provide these specific criteria or the detailed results of the performance tests.
Therefore, much of the requested information regarding specific acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device". However, the specific quantitative acceptance criteria (e.g., accuracy ranges for NBP, SpO2, Temperature) are not provided.
- Reported Device Performance: The document only generically states that "The results demonstrate that the Philips SureSigns VS2* Vital Signs monitor meets all reliability requirements and performance claims and supports a determination of substantial equivalence." Specific performance metrics (e.g., bias, precision, accuracy) for NBP, SpO2, or Temperature are not reported.
2. Sample sized 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 document. The text mentions "system level tests, performance tests, and safety testing" but does not detail the sample sizes for these tests or the nature of the data (e.g., patient data, simulated data).
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)
- Ground truth refers to a definitive correct answer, often established by experts in diagnostic studies. For a vital signs monitor, ground truth typically involves highly accurate reference devices. The document does not mention the use of experts or any process for establishing ground truth in terms of clinical interpretation, as it's a device measuring physiological parameters, not interpreting images or complex clinical scenarios requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication methods are relevant when multiple experts rate the same case and their opinions need to be reconciled. As no expert review or interpretation is described for the performance testing of this vital signs monitor, this information is not applicable/provided.
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
- An MRMC study is relevant for diagnostic devices that aid medical professionals in interpretation. This device is a vital signs monitor, not a diagnostic imaging or AI-assisted interpretation tool. Therefore, an MRMC study and related effect sizes are not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone monitor. The performance testing would inherently be the "algorithm only" performance (i.e., the device's ability to accurately measure vital signs). The document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device," implying standalone testing. However, specific details of this testing are not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For a vital signs monitor, ground truth typically refers to measurements obtained from highly accurate, calibrated reference devices (e.g., a reference NBP device, a co-oximeter for SpO2, a highly accurate thermometer). The document does not explicitly state the type of ground truth used for its performance testing, but it would logically be comparison to independent reference measurements.
8. The sample size for the training set
- This device is a hardware vital signs monitor. While it has embedded software/firmware (which might have been "trained" or developed), the concept of a "training set" as understood in machine learning/AI is likely not directly applicable in the same way. The document makes no mention of a training set.
9. How the ground truth for the training set was established
- Similar to point 8, the concept of a "training set" and its ground truth in the context of this traditional medical device is not applicable/provided.
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KIIII14 P1/2
MAY 2 0 2011
510K 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 CFR 807-92(c).
-
- The submitter of this pre-market notification is:
Kristen Lessard Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States
- The submitter of this pre-market notification is:
Tel: 978-659-4219 Fax: 978-659-4481 Email: kristen.lessard@philips.com
This summary was prepared on April 13, 2011
-
- The name of the subject device is the Philips SureSigns VS2 Vital Signs Monitor.
- The trade name of the device is the SureSigns VS2* Vital Signs Monitor. 3.
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- The common usual name is multi-parameter patient monitor
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- The Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | 870.1110, II | DSJ | Alarm, Blood Pressure |
| 870.1110, II | DSK | Computer, Blood Pressure | |
| 870.1130, II | DXN | System, Measurement, Blood Pressure,Non-Invasive | |
| 870.1435, II | DXG | Computer, Diagnostic, Pre-programmed,Single function | |
| 870.2700, II | DQA | Oximeter | |
| 870.2900, I | DSA | Cable, Transducer and Electrode, incl.Patient connector | |
| General Hospital andPersonal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |
- This submission is to introduce a new model, the Philips SureSigns VS2* Vital Signs Monitor 7. that compliments the existing VS2/VS3 Vital Signs monitors.
- ర్. The subject device has the same intended use and indications for use as the legally marketed predicate device. The SureSigns VS2* Vital Signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: NBP, SpO2, and Temperature. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults,
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pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.
- The subject device has the same fundamental technological characteristics as the legally 9. marketed predicate device. The subject device use the same design as the predict device. The energy source of the subject device is an internal power supply. The VS2* can run on battery power with batteries similar to the predicate device, however, with improved battery life.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VS2* Vital Signs monitor meets all reliability requirements and performance claims and supports a determination of substantial equivalence,
KUMI4
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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 eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Philips Medical Systems. c/o Ms. Kristen Lessard Quality & Regulatory Engineer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810
MAY 2 0 2011
Re: K11114
Trade/Device Name: SureSigns VS2+ Vital Signs Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Codes: DXN, DQA, DSJ, DSK, DXG, DSA, FLL Dated: April 15, 2011 Received: April 21, 2011
Dear Ms. Lessard:
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.
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
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Page 2 - Ms. Kristen Lessard
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.
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/CDRI-I/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/ReportaProblem/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.
Director
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): __ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: SureSigns VS2* (reference numbers: 863278, 863279)
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Standard and optional parameters include:
- . NBP
- SpO2 .
- Temperature .
| Prescription Use:(Part 21 CFFR 801 Subpart D) | YES |
|---|---|
| AND/OR over-the-counter Use:(21 CFR 807 Subpart C) | NO |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off)Division of Cardiovascular Devices | Page 1 of 1 |
|---|---|
| ----------------------------------------------------------- | ------------- |
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).