(31 days)
Not Found
No
The document describes enhancements to existing patient monitors focused on hardware improvements, networking, data export, and adding sensors/cuffs. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a monitor that records and alarms on multiple physiological parameters. It is intended for monitoring, not for treating or preventing diseases.
No
The device is for "monitoring, recording, and alarming of multiple physiological parameters," which describes a monitoring function, not a diagnostic one. It provides data for healthcare professionals but does not state that it interprets that data to make a diagnosis.
No
The device description explicitly mentions "improved board hardware" and the addition of a "SpO2 sensor and NBP cuffs," indicating the inclusion of physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments." This describes a device that measures physiological signals directly from the patient's body (e.g., SpO2, NBP, pTemp).
- Device Description: The description mentions measuring parameters like SpO2, NBP, and pTemp, which are physiological measurements taken from the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention the analysis of any such specimens.
Therefore, the SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor are patient monitoring devices, not IVD devices.
N/A
Intended Use / Indications for Use
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. 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.
Product codes
MHX, DSJ, DSK, DXN, DXG, DRT, DPS, DQA, DRS, DSA, CCK, FLL
Device Description
The modifications are changes to the SureSigns VM Series Patient Monitors and the SureSigns VS3 Vital Signs Monitor. These changes include two new models, enhancements and bug fixes. The new models include the VM3 Series Patient Monitor which is a subset of the predicate devices but does not perform NBP and the SureSigns VS3 Vital Signs monitor which is a subset of the predicate device and performs continuous SpO2 and intermittent measurements of SpO2, NBP, and pTemp. The enhancements include improvements in the areas of Patient Records, the Administering Patients, Networking, Data Export, improved board hardware, adding a SpO2 sensor and NBP cuffs.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults, pediatrics and neonates
Intended User / Care Setting
health care professionals / healthcare environments, transport situations within a healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 modified 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 and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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:
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: 978-685-5624 Email: mary.kruitwagen@philips.com
This summary was prepared on February 15, 2008.
- The names of the subject devices are the Philips SureSigns VM Series Patient Monitors and 2. SureSigns VS3 Vital Signs Monitor.
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- The trade names of the devices are the SureSigns VM Series Patient Monitors (VM3, VM4, VM6, VM8) and the SureSigns VS3 Vital Signs Monitor.
- র্ব : The common usual name is multi-parameter patient monitor
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Circulatory System | |||
| Devices | 870.1025, II | MHX | Monitor, Physiological, Patient |
| (with arrhythmia detection or | |||
| alarms) | |||
| 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 | |||
| 870.2300, II | DRT | Monitor, Cardiac (incl. | |
| Cardiotachometer & Rate Alarm | |||
| 870.2340, II | DPS | Electrocardiograph | |
| 870.2700, II | DQA | Oximeter | |
| 870.2850, II | DRS | Extravascular Blood Pressure | |
| Transducer | |||
| 870.2900, I | DSA | Cable, Transducer and Electrode, | |
| incl. Patient connector | |||
| Anesthesiology & | |||
| Respiratory | |||
| Therapy | 868.1400, II | CCK | Analyzer, Gas, |
| General Hospital | |||
| and Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |
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- The Classification names are as follows:
- ം. The modified devices are substantially equivalent to previously cleared Philips device, M3046B Compact Configurable Portable Patient Monitor marketed pursuant to K052707.
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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters and words. The first line reads 'KU80495', which seems to be an identification number or code. The second line reads 'Page 2032', indicating a page number within a document. The handwriting is somewhat stylized, with distinct letterforms and spacing.
- The modifications are changes to the SureSigns VM Series Patient Monitors and the 7. SureSigns VS3 Vital Signs Monitor. These changes include two new models, enhancements and bug fixes. The new models include the VM3 Series Patient Monitor which is a subset of the predicate devices but does not perform NBP and the SureSigns VS3 Vital Signs monitor which is a subset of the predicate device and performs continuous SpO2 and intermittent measurements of SpO2, NBP, and pTemp. The enhancements include improvements in the areas of Patient Records, the Administering Patients, Networking, Data Export, improved board hardware, adding a SpO2 sensor and NBP cuffs.
- The modified devices have the same intended use as the legally marketed predicate device. 8. 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. 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 modified devices have the same fundamental technological characteristics as the legally ு. marketed predicate devices. The subject devices use the same design as the predict device. The composition of the materials used for both devices is the same. There is no change to the chemical composition of the subject devices to the predicate devices. The energy source of the subject devices is essentially the same as the predicate device.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified 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 and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence.
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure. The symbol is composed of thick, black lines and curves, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2008
Philips Medical Systems c/o Ms. Mary Kruitwagen Regulatory Affairs Specialist 3000 Minuteman Rd. Andover, MA 01810
Re: K080495
Trade/Device Name: Philips SureSigns VM series Patient Monitors and SureSigns VS3 Vital Sign Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: February 15, 2008 Received: February 22, 2008
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 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.
3
Page 2 – Ms. Mary Kruitwagen
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,
HE
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): | K080495 |
|---|---|
| ---------------------------- | --------- |
Device Name: Philips SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Intended Use: For monitoring, recording, and alarming 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.
| Prescription Use: | YES | AND/OR over-the-counter Use: | 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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number: K080495
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