(29 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological parameter monitoring and hardware modifications.
No.
The devices are indicated for monitoring, recording, and alarming of physiological parameters, not for treating disease or maintaining health.
No
The device is described as a "multi-parameter patient monitor" intended for "monitoring, recording, and alarming of multiple physiological parameters." It does not state that it is used to diagnose a medical condition or disease.
No
The device description explicitly states it is a "multi-parameter patient monitor" and mentions the addition of an "internal radio module" and "new accessories (SpO2 sensor and tabletop mount)", indicating it is a hardware device with integrated software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The SureSigns VS2* and VSi Vital Signs Monitors are described as multi-parameter patient monitors that measure physiological parameters like NBP (Non-Invasive Blood Pressure), SpO2 (Oxygen Saturation), and Temperature. These are measurements taken directly from the patient's body, not from specimens in vitro (outside the body).
- Lack of Mention of Specimen Analysis: The provided text does not mention any analysis of biological specimens.
Therefore, the SureSigns VS2* and VSi Vital Signs Monitors fall under the category of patient monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.
The SureSigns VSi Vital Signs monitor is 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. The SureSigns VSi vital signs monitor is intended for measurement of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA, DSJ, DSK, DXG, DSA, FLL
Device Description
The name of the subject devices are the Philips SureSigns VS2* Vital Signs Monitor and the Philips SureSigns VSi Vital Signs Monitor. The trade names of the devices are the SureSigns VS2* Vital Signs Monitor and SureSigns VSi Vital Signs Monitor.
The common usual name for both devices is multi-parameter patient monitor.
This submission is to announce the following modifications to the predicate VS2* and VSi :
. Addition of an internal radio module
. Addition of several new accessories- SpO2 sensor and tabletop mount
. EMC Emissions Class changed to Class A
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
adults, pediatrics and neonates
Intended User / Care Setting
health care professionals whenever there is a need for monitoring the physiological parameters of patients; healthcare environments; transport situations within a healthcare facility.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. 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 devices, the specifications of the subject devices and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VS2* Vital Signs and the Philips SureSigns VSi Vital Signs monitors meet all reliability requirements and performance claims and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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).
0
K//2652
OCT 1 1 2011
510K Summarv
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:
Mary Kruitwagen Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States
- The submitter of this pre-market notification is:
-
Tel: 978-659-4932 Fax: 978-659-4481 Email: mary.kruitwagen@philips.com
This summary was prepared on September 7, 2011 -
- The name of the subject devices are the Philips SureSigns VS2* Vital Signs Monitor and the Philips SureSigns VSi Vital Signs Monitor.
The trade names of the devices are the SureSigns VS2* Vital Signs Monitor and SureSigns VSi Vital Signs Monitor.
- The name of the subject devices are the Philips SureSigns VS2* Vital Signs Monitor and the Philips SureSigns VSi Vital Signs Monitor.
The common usual name for both devices is multi-parameter patient monitor
- Device Panel Classification ProCode Description Cardiovascular 870.1110. Il DSJ Alarm, Blood Pressure 870.1110. Il DSK Computer, Blood Pressure 870.1130. Il System, Measurement, Blood Pressure, DXN Non-Invasive 870.1435. Il 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 and 880.2910, II FLL Thermometer, Electronic, Clinical Personal Use
-
- The Classification names are as follows for the SureSigns VS2+:
The Classification names are as follows for the SureSigns VSi:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | 870.1110, II | DSK | Computer, Blood Pressure |
| 870.1130, II | DXN | System, Measurement, Blood Pressure, Non-Invasive | |
| 870.2700, II | DQA | Oximeter | |
| General Hospital and | |||
| Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |
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Page 67 of 70
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-
- The modified devices are substantially equivalent to previously cleared Philips devices, SureSigns VS2* Vital Signs Monitor marketed pursuant to 510(k) K111114 cleared for software revision B.00 and for the VSi Vital Signs Monitor pursuant to 510(k) K110803 cleared for revision B.00. With this modification the software revision will be revision B.01. This is the first version of software that will be marketing on the SureSigns VS2* and the SureSigns VSi vital signs monitors. The radio module is substantially equivalent to the wireless bridge used with the predicate SureSigns VS3 marketed pursuant to 510(k) K082280.
-
- This submission is to announce the following modifications to the predicate VS2* and VSi :
- . Addition of an internal radio module
- . Addition of several new accessories- SpO2 sensor and tabletop mount
- . EMC Emissions Class changed to Class A
-
- The SureSigns VS2* subject device has the same intended use and indications for use as the legally marketed predicate SureSigns VS2* 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, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.
The SureSigns VSi subject device has the same intended use and indications for use as the legally marketed predicate SureSigns VSi device. The SureSigns VSi Vital Signs monitor is 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. The SureSigns VSi vital signs monitor is intended for measurement of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
- 7 . The subject devices have the same fundamental technological characteristics as the legally marketed predicate devices. The subject devices use the same design and algorithms as the predicate devices.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. 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 devices, the specifications of the subject devices and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VS2* Vital Signs and the Philips SureSigns VSi Vital Signs monitors meet all reliability requirements and performance claims and supports a determination of substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
CT 11 11 2011
Philips Medical Systems. c/o Ms. Mary Kruitwagen Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810
Re: K112652
Trade/Device Name: Philips SureSigns Vs2+ Vital Signs Monitor, and Philips SureSigns VS1 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: September 9, 2011 Received: September 12, 2011
Dear Ms. Kruitwagen:
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 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
3
Page 2 - Ms. Marv Kruitwagen
CFR Part 807); labeling (21 CFR Part 801); medical device 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/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 Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (k) Number (if known): k//2652
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 .
- Sp02 .
- Temperature ●
| Prescription Use: | YES |
|---|---|
| (Part 21, CFFR 801 Subpart D) | |
| AND/OR over-the-counter Use: | NO |
| (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)
(Division Sign-Off)
Page
Division of Cardiovascular Devices
510(k) Number K112652
5
Indications for Use
510 (k) Number (if known):
K//2652
Device Name: SureSigns VSi (reference numbers: 863275, 863276, 863267)
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 0
- Temperature
YES Prescription Use: _ AND/OR over-the-counter Use: (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)
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