SureSigns VS3, SureSigns VS4

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 29, 2015 Phillips Medical Systems Greg Li Regulatory Affairs Specialist 3000 Minuteman Rd. Andover, Massachusetts 01810 Re: K151761 Trade/Device Name: SureSigns VS3, SureSigns VS4 Regulation Number: 21 CFR 870.1100 Regulation Name: Blood Pressure Alarm Regulatory Class: Class II Product Code: DSJ, DSK, FLL, CCK, DQA, DSA, DXN Dated: August 21, 2015 Received: August 28, 2015 Dear Greg Li: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mitchell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510 (k) Number (if known): ### Device Name: SureSigns VS3 (reference numbers: 863071, 863072, 863073, 863074) SureSigns VS4 (reference number: 863283) ### Indications for Use for SureSigns VS3 Vital Signs Monitor The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. | | Patient Types | | | |-------------|---------------|-----------|----------| | Parameter | Adult | Pediatric | Neonatal | | NBP | √ | √ | √ | | SpO2 | √ | √ | √ | | Temperature | √ | √ | √ | ### Indications for Use for SureSigns VS4 Vital Signs Monitor The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. | | Patient Types | | | |-------------|---------------|-----------|----------| | Parameter | Adult | Pediatric | Neonatal | | NBP | √ | √ | √ | | SpO2 | √ | √ | √ | | Temperature | √ | √ | √ | | CO2 | √ | √ | √ | | RRa | √ | √ | | | SpHb | √ | √ | | Prescription Use: YES NO (Part 21 CFFR 801 Subpart D) (21 CFR 807 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Page ____ of _________________________________________________________________________________________________________________________________________________________________ Page 1 of 1 Philips SureSigns VS3 and VS4 Special 510K 010 Indications for Use Statement {3}------------------------------------------------ # 011_510(k) Summary The following section contains the 510(k) Summary as defined by the Medical Devices Act of 1990 and 21 CFR 807-92(c). {4}------------------------------------------------ ## 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 CFR 807-92(c). - 1. The submitter and contact person of this pre-market notification is: Greg Li Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States Tel: 978-659-4227 Fax: 978-659-7323 Email: Greg.li@philips.com - 2. Date this summary is prepared: This summary is prepared on 10 June, 2015. - The names of the subject devices are as following: 3. SureSigns VS3 SureSigns VS4 - 4. The trade names of the devices are SureSigns VS3 and SureSigns VS4. - 5. The common usual name for both the VS3 and the VS4 is multi-parameter patient monitor - 6. The Classification names are as follows: | Device Panel | Classification | ProCode | Description | Applicable subject devices | |--------------------------------------|----------------|---------|----------------------------------------------------|----------------------------| | Cardiovascular | 870.1100, II | DSJ | Alarm, Blood Pressure | VS3, VS4 | | | 870.1110, II | DSK | Computer, Blood Pressure | VS3, VS4 | | | 870.1130, II | DXN | System, Measurement, Blood Pressure, Non-Invasive | VS3, VS4 | | | 870.2700, II | DQA | Oximeter | VS3, VS4 | | | 870.2900, II | DSA | Cable, transducer and electrode, patient connector | VS3, VS4 | | General Hospital and Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical | VS3, VS4 | | Anesthesiology & Respiratory Therapy | 868.1400, II | CCK | Analyzer, Gas | VS4 | {5}------------------------------------------------ - 7. The modified devices are substantially equivalent to previously cleared devices from Philips: SureSigns VS3 Vital Signs Monitor cleared under K133961 SureSigns VS4 Vital Signs Monitor cleared under K133961 - 8. The modifications are as follows: - a) The subject VS3 and VS4 will add connectivity to IntelliVue GuardianSoftware (IGS). This IGS connectivity includes new QuickCheck work flows, QuickAlert prompts, and configurable Modified Early Warning Scores (MEWS). IGS is a documentation, charting, and decision support software that can be configured to collect vital signs data from the VS3. VS4 monitors. The monitors validate the patient ID from IGS, send records to IGS, and receive early warning scores, single-parameter scores, and alert messages from IGS. The IGS connectivity to VS3 and VS4 is a change of software only. The IntelliVue GuardianSoftware (IGS) is a software medical device owned by Philips Medizine Systeme Boeblingen GmbH, in Germany. The IGS was FDA cleared through 510(k) K111905 for Rev. A and 510(k) K122223 for Rev. B. The IGS has been revised to Rev. C which will allow IGS and VS3, VS4 to be connected. Philips Medizine Systeme Boeblingen GmbH will submit its own 510(k) for the Rev. C of IGS. The VS3 and VS4 software is verified by Philips Medical Systems following out QMS process. The modified software for VS3 and VS4 is version A.06 and it complies with IEC 62304: 2006- Medical Device Software life-cycle processes. - b) Add Temporal Temperature measurement to VS3. This is achieved by using the OEM Exergen TemporalScanner Thermometer. This Exergen TemporalScanner Thermometer is FDA cleared under K011291. The OEM thermometer has a RS232 cable added to connect the thermometer to the VS3 monitor. This same Temporal Temperature measurement was implemented on VS4 which was 510(k) cleared in June 2014 through k133961. Both VS3 and VS4 use the same solution for this measurement. and both complies with ISO 80601-2-56: 2009 + CORR. 2 (2007). Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. - c) Other enhancements to VS3 and VS4 are described as following: - . Additional Title Bar Indicators - . Expanded Patients Records Pane - Display Patient Name or Primary ID {6}------------------------------------------------ - Expanded QuickCapture Entries ● - . Default CO2 Setting Alignment (VS4 only) - Temperature High and Low Alarms Color Change . - Increased SpO2 Alarm Delay Defaults - . Option to Prevent Inadvertently Clearing NBP Programs - RFID patient ID entry. - 9. The subject device VS3 has the same Intended Use and Indications for Use as the legally marketed predicate device, currently marketed VS3: ### Indications for Use for SureSigns VS3 Vital Signs Monitor The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. | | Patient Types | | | |-------------|---------------|-----------|----------| | Parameter | Adult | Pediatric | Neonatal | | NBP | | | | | SpO2 | | | | | Temperature | | | | The subject device VS4 has the same Intended Use and Indications for Use as the legally marketed predicate device, currently marketed VS4: ### Indications for Use for SureSigns VS4 Vital Signs Monitor The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. | | Patient Types | | | |-------------|---------------|-----------|----------| | Parameter | Adult | Pediatric | Neonatal | | NBP | √ | √ | √ | | SpO2 | √ | √ | √ | | Temperature | √ | √ | √ | | CO2 | √ | √ | √ | | RRa | √ | √ | | | SpHb | √ | √ | | {7}------------------------------------------------ - 10. The subject devices VS3 and VS4 have the same fundamental technological characteristics as the leqally marketed predicate devices VS3 and VS4. There are no specification change to VS4. The added Temporal Temperature measurement to VS3 will have the same specification with that from the predicate VS4. The subject devices use the same algorithms for the measurements as the predicate devices. - 11. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VS3 Vital Signs monitor and the Philips SureSigns VS4 Vital Signs monitor meet all safety and reliability requirements, performance claims and support a determination of substantial equivalence.