(78 days)
No.
The document does not mention the use of AI, DNN, or ML. The only "advanced" calculation described is a simple arithmetic formula for Mean Arterial Pressure (MAP), which is not an AI model.
No.
The device is described as a multi-parameter patient monitor and does not mention any therapeutic function. Its intended use is for monitoring various physiological parameters.
No
The device is a multi-parameter patient monitor that measures physiological parameters. While monitoring these parameters can inform diagnosis, the device itself is described as a "multi-parameter patient monitor" and does not state it performs diagnostic functions or provides a diagnosis.
No
The device is described as a "wearable, battery-operated, multi-modular patient monitoring platform" and explicitly mentions hardware components and accessories like ECG electrodes and blood pressure cuffs. While a new software feature (MAP calculation) is being added, the core device is a hardware patient monitor.
No
The device monitors physiological parameters (e.g., ECG, NIBP, SpO2) directly from the patient's body. It does not perform tests on specimens derived from the human body.
N/A
Intended Use / Indications for Use
The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.
The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.
The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.
The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.
The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.
The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.
Devices with Masimo technology are only indicated for use with Masimo accessories.
Radius VSM Accessories:
-
Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.
-
Radius VSM Blood Pressure Cuffs are accessories intended to be used with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.
Product codes (comma separated list FDA assigned to the subject device)
MHX, BZQ, DQA, DPS, DPZ, DRT, DSJ, DXN, FLL, KMI, DSI, DQK, DXQ
Device Description
The Radius VSM and accessories are an FDA cleared (K223498), wearable, battery-operated, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of different monitoring technologies based upon the hospital and clinician's assessment of what technologies are appropriate.
As part of this submission, a MAP feature is being added to the Radius VSM. The feature is a software feature that uses the previously cleared systolic and diastolic measurement capabilities to automate the calculation of MAP using the following formula:
MAP = 1/3* Systolic + 2/3*Diastolic
The MAP is calculated by the Radius VSM NIBP Module and displayed on the Radius VSM Wearable Monitor. There were no other features added as part of this submission.
There were no changes made to the Radius VSM Wearable Monitor specifications from the previous clearance under K223498.
There were no changes made to the Radius VSM ECG Module specifications from the previous clearance under K223498.
Apart from the added MAP feature, there were no changes made to the specifications from the previous clearance under K223498.
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
Intended User / Care Setting
Hospital and healthcare facilities.
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)
- Performance Bench Testing: Bench testing was conducted to support the performance of the Mean Arterial Pressure (MAP) using a simulator.
- Biocompatibility Testing: As there were no changes made to the patient contacting materials of the subject device from the previous clearance under K223498, no new biocompatibility testing was included in this submission.
- Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning: As there were no hardware changes made to the subject device from the previous clearance under K223498, no new electrical safety, environmental, mechanical, and cleaning testing was included as part of this submission.
- Software Verification and Validation Testing: Software verification and validation testing were conducted and provided as part of this submission as recommended by the FDA Guidance, "Content of Premarket Submissions for Software Device Software Functions", June 2023 to support the software change to add the Mean Arterial Pressure (MAP) feature.
- Wireless Testing: As there were no changes to the wireless capabilities from the previous clearance under K223498, no new wireless testing was included as part of this submission.
- Cybersecurity Testing: As there were no changes made to the subject device that would affect its cybersecurity from the previous clearance under K223498, no new cybersecurity testing was included as part of this submission.
- Human Factors and Usability Testing: Previous human factors testing of the predicate device were found to support the acceptable human factors and usability risk of the subject device.
- Clinical Testing: Clinical study data was included as part of this submission to support the addition of the calculation of the mean arterial pressure (MAP) feature by Radius VSM. The clinical study used invasively measured MAP values from a 510(k) cleared reference device (K171801) as a comparator in accordance with the FDA recognized standard ISO 81060-2. The results of the testing supported the clinical performance of the MAP in accordance with ISO 81060-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 29, 2025
Masimo Corporation
Jazmin Laidet
Regulatory Affairs Specialist III
52 Discovery
Irvine, California 92618
Re: K250757
Trade/Device Name: Radius VSM and Accessories
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, BZQ, DQA, DPS, DPZ, DRT, DSJ, DXN, FLL, KMI, DSI, DQK, DXQ
Dated: March 12, 2025
Received: March 12, 2025
Dear Jazmin Laidet:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Page 2
K250757 - Jazmin Laidet
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K250757 - Jazmin Laidet
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K250757
Please provide the device trade name(s).
Radius VSM and Accessories
Please provide your Indications for Use below.
Radius VSM:
The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.
The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.
The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.
The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.
The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.
The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.
Devices with Masimo technology are only indicated for use with Masimo accessories.
Radius VSM Accessories:
-
Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.
-
Radius VSM Blood Pressure Cuffs are accessories intended to be used with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Radius VSM and Accessories
Page 1 of 1
Page 8 of 34
Page 5
510(k) Summary K250757
Submitter and Address of Manufacturing Facility:
Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
Date: May 20, 2025
Contact: Jazmin Laidet
Regulatory Affairs Specialist III
Masimo Corporation
Phone: (949) 577-2849
Trade Name: Radius VSM and Accessories
Common Name: Patient Monitor (with Arrhythmia Detection)
Classification Regulation/Product Code/Panel: 21 CFR 870.1025 / MHX / Cardiovascular
Regulatory Class: Class II
Additional Product Code:
- 21 CFR 868.2375/BZQ
- 21 CFR 870.2700/DQA
- 21 CFR 870.2340/DPS
- 21 CFR 870.2710/DPZ
- 21 CFR 870.2300/DRT
- 21 CFR 870.1100/DSJ
- 21 CFR 870.1130/DXN
- 21 CFR 880.2910/FLL
- 21 CFR 880.2400/KMI
- 21 CFR 870.1025/DSI
- 21 CFR 870.1425/DQK
- 21 CFR 870.1120/DXQ
Establishment Registration Number: 3011353843
Reason for Premarket Notification: Addition of Mean Arterial Pressure (MAP) feature
Primary Predicate: K223489 Radius VSM and Accessories
Reference Device: K171801 IntelliVue Multi-Measurement Module X3
1. Device Description
The Radius VSM and accessories are an FDA cleared (K223498), wearable, battery-operated, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of different monitoring technologies based upon the hospital and clinician's assessment of what technologies are appropriate.
Page 1 of 13
Page 6
510(k) Summary K250757
As part of this submission, a MAP feature is being added to the Radius VSM. The feature is a software feature that uses the previously cleared systolic and diastolic measurement capabilities to automate the calculation of MAP using the following formula:
MAP = 1/3 Systolic + 2/3Diastolic**
The MAP is calculated by the Radius VSM NIBP Module and displayed on the Radius VSM Wearable Monitor. There were no other features added as part of this submission.
There were no changes made to the Radius VSM Wearable Monitor specifications from the previous clearance under K223498. The specifications for the Radius VSM Wearable Module are provided in Table 1-1 below:
Table 1-1: Radius VSM Wearable Monitor Specifications
| Feature | Specifications |
|---|---|
| Display | |
| Display Type | Touchscreen |
| Alarms | |
| Type of Alarms | Visual/Audible Alarms |
| Technological Characteristics | |
| Measured Parameters | SpO2, PR, RRp, RRa |
| Calculated or Derived Parameters | PVi, Pi |
| Performance Specifications | |
| SpO2, No Motion | 70-100%, 1.5% Arms, Adults |
| SpO2, Motion | 70-100%, 1.5% Arms, Adults |
| SpO2, Low perfusion | 70-100%, 2% Arms, Adults |
| PR, No Motion | 25-240 bpm, 3 bpm, Adults |
| PR, Motion | 25-240 bpm, 5 bpm, Adults |
| PR, Low Perfusion | 25-240 bpm, 5 bpm, Adults |
| RRp, No Motion | 4-70, 3 rpm Arms, 1 rpm mean error, Adults |
| RRa | 4-70 rpm, 1 rpm Arms, Adults |
| Interfaces | |
| Physical | Modules, Charging Adapter |
| Wireless | Bluetooth LE, Wi-Fi |
| Electrical | |
| Internally Powered | Rechargeable, Lithium Ion Battery |
| Mechanical Specifications | |
| Dimensions | 10.9 cm x 5.8 cm x 2.1 cm (4.28" x 2.28" x 0.83") |
| Weight | 122 g (0.27 lbs.) |
| Ingress Protection | IPX4 |
| Environmental Specifications | |
| Operating Temperature | 0°C to 40°C (32°F to 104°F) |
Page 2 of 13
Page 7
510(k) Summary K250757
Table 1-1: Radius VSM Wearable Monitor Specifications (continued)
| Feature | Specifications |
|---|---|
| Storage Temperature | -20°C to 60°C (-4°F to 140°F) |
| Operating/Storage/Transport Humidity | 10% to 95%, non-condensing |
| Operating Atmospheric Pressure | 540 mbar to 1060 mbar |
| Classification per IEC 60601-1 | |
| Electrical Safety | IEC 60601-1 |
| EMC | IEC 60601-1-2 |
| Electrical Isolation Type | Class II (Internally Powered) |
| Applied Part Type | BF Applied Part |
| Ingress Protection | IP22 |
| Mode of Operation | Continuous |
There were no changes made to the Radius VSM ECG Module specifications from the previous clearance under K223498. The specifications for the Radius VSM ECG Module are provided in Table 1-2 below:
Table 1-2: Radius VSM ECG Module Specifications
| Feature | Specifications |
|---|---|
| Technical Characteristics | |
| Measured Parameters | ECG waveform, HR, RRe, Temperature, Time in Position, Patient Incline Angle |
| Calculated or Derived Parameters | Arrhythmia Detection, Fall Detection |
| Performance Specifications | |
| ECG, Monitoring Bandwidth | 0.67 Hz to 40 Hz |
| ECG, Diagnostic Bandwidth | 0.05 Hz to 150 Hz |
| HR (15bpm to 300 bpm) | 1% or ± 2 bpm (whichever is greater) |
| RRe (4-120 rpm) | ≤1 rpm mean error |
| Patient Incline Angle (-180° to 180°C) | ±1° |
| Laboratory Accuracy (77°F to 109.4°F (25°C to 43°C)) | ± 0.3°C (±.54°F) |
| Lethal Arrhythmias Detected | Asystole, Ventricular Fibrillation/Ventricular Tachycardia, Ventricular Tachycardia (greater than 30s) |
| Non-Lethal Arrhythmias Detected | Atrial Fibrillation greater than 30 seconds, Ventricular Tachycardia (less than 30s) |
| Interface | |
| Physical | Module connector |
| Electrical | |
| DC Powered | Radius VSM Module |
| Mechanical | |
| Dimensions | 4.7 cm x 4.06 cm (1.85" x 1.60") |
| Weight | 20 g (0.04 lbs.) |
| Ingress Protection | IPX4 |
Page 3 of 13
Page 8
510(k) Summary K250757
Table 1-2: Radius VSM ECG Module Specifications (continued)
| Feature | Specifications |
|---|---|
| Environmental | |
| Operating Temperature | 0°C to 40°C (32°F to 104°F) |
| Storage/Transport Temperature | -20°C to 60°C (-4°F to 140°F) |
| Operating/Storage/Transport Humidity | 10% to 95%, non-condensing |
| Operating Atmospheric Pressure | 540 mbar to 1060 mbar (540 hPa to 1060 hPa) |
Apart from the added MAP feature, there were no changes made to the specifications from the previous clearance under K223498. The specifications for the Radius VSM NIBP Module are provided in Table 1-3 below.
Table 1-3: Radius VSM NIBP Module Specifications
| Feature | Specifications |
|---|---|
| Technical Characteristics | |
| Measured Parameters | Systolic, Diastolic, Pulse Rate |
| Calculated or Derived Parameters | Mean Arterial Pressure (MAP) |
| Performance Specifications | |
| Pressure Transducer (Between 0 mmHg and 300 mmHg) | ±3 mmHg |
| Blood Pressure | Meets ISO 81060-2 (Mean difference of ≤5 mmHg with a standard deviation of ≤8 mmHg) |
| Interface | |
| Physical | Module connector |
| Electrical | |
| DC Powered | Radius VSM Module |
| Mechanical | |
| Dimensions | 9.3 cm x 5.5 cm x 2.9 cm (3.66" x 2.17" x 0.86") |
| Weight | 111 g (0.24 lbs.) |
| Ingress Protection | IPX2 |
| Environmental | |
| Operating Temperature | 0°C to 40°C (32°F to 104°F) |
| Storage/Transport Temperature | -20°C to 60°C (-4°F to 140°F) |
| Operating/Storage/Transport Humidity | 10% to 95%, non-condensing |
| Operating Atmospheric Pressure | 540 mbar to 1060 mbar (540 hPa to 1060 hPa) |
2. Intended Use/ Indications for Use
There are no changes to the intended use for the subject device, Radius VSM, from the previous clearance under K223498. The intended use statement is provided below for ease of reference:
Radius VSM:
The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.
Page 4 of 13
Page 9
510(k) Summary K250757
The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.
The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.
The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.
The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.
The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.
Devices with Masimo technology are only indicated for use with Masimo accessories.
Radius VSM Accessories:
Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.
Radius VSM Blood Pressure Cuffs are accessories intended to be used with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.
3. Technological Characteristics
Principle of Operation
As part of this submission, Masimo is requesting the addition of a mean arterial pressure (MAP) calculation feature. The MAP feature relies on the calculation of the mean arterial pressure using the established weighted average of the systolic and diastolic blood pressure values. The Radius VSM automates the calculation to output an MAP value.
Mechanism of Action for Achieving the Intended Effect
Page 5 of 13
Page 10
510(k) Summary K250757
There were no changes to the mechanism of action of the Radius VSM and Accessories in the addition of the MAP feature from the previous clearance under K223498.
The MAP value from the Radius VSM is provided along with the previously cleared systolic and diastolic values without any additional user actions. To obtain the MAP value and the other NIBP parameter data, the Radius VSM NIBP module is attached to the Radius VSM NIBP cuff which is applied to the patient. The Radius VSM NIBP module determines the Systolic Pressure, Diastolic Pressure, Pulse Rate, and MAP values that are communicated to the Radius VSM Wearable Monitor for display and wireless communication.
4. Discussion of Similarities and Differences Between Primary Predicate and Subject Device
Similarities and Differences between Primary Predicate and Subject Device
The subject device, Radius VSM and Accessories, and the predicate device, Radius VSM and Accessories (K223498) have the following key similarities:
- Both devices have the same intended use.
- Both devices have the same principle of operation and mechanism of action.
- Both devices are indicated for the same patient population.
The subject device, Radius VSM and Accessories, and the predicate device, Radius VSM and Accessories (K223498), have the following key difference:
- The subject device includes the Mean Arterial Pressure (MAP) feature.
The purpose of this submission is the addition of a Mean Arterial Pressure (MAP) feature to the predicate device, Radius VSM (K223498). The subject and the predicate device have the same intended use. To support the addition of MAP feature does not raise different questions of safety and effectiveness, clinical testing is provided to support its performance. The testing supports the substantial equivalence of the subject device.
Refer to Table 4-1 below for the detailed comparison between the subject and predicate devices.
Page 6 of 13
Page 11
510(k) Summary K250757
Table 4-1 Comparison between Subject and Predicate Devices
| Feature | Subject Predicate Radius VSM | Predicate Device Radius VSM (K223498) | Comparison to Predicate |
|---|---|---|---|
| Intended Use | The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities. | The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities. | Same. |
| Indications for Use | The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults. |
The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.
The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.
The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.
The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi. | The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.
The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.
The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.
The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.
The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi. | Same. |
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Table 4-1 Comparison between Subject and Predicate Devices (continued)
| Feature | Subject Predicate Radius VSM | Predicate Device Radius VSM (K223498) | Comparison to Predicate |
|---|---|---|---|
| Devices with Masimo technology are only indicated for use with Masimo accessories. |
Radius VSM ECG Electrodes are disposable, single-patient ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.
Radius VSM Blood Pressure Cuffs are accessories intended to be use with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions. | Devices with Masimo technology are only indicated for use with Masimo accessories.
Radius VSM ECG Electrodes are disposable, single-patient ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.
Radius VSM Blood Pressure Cuffs are accessories intended to be use with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions. | |
| Primary Classification Regulation/Product Code | 21 CFR 870.1025/ MHX | 21 CFR 870.1025/ MHX | Same. |
| Additional Classification Regulation/Product Code(s) | 21 CFR 868.2375/ BZQ
21 CFR 870.2700/ DQA
21 CFR 870.2340/ DPS
21 CFR 870.2710/ DPZ
21 CFR 870.2300/ DRT
21 CFR 870.1100/ DSJ
21 CFR 870.1130/ DXN
21 CFR 880.2910/ FLL
21 CFR 870.1025/ DSI
21 CFR 870.1425/ DQK
21 CFR 880.2400/ KMI
21 CFR 870.1120/ DXQ | 21 CFR 868.2375/ BZQ
21 CFR 870.2700/ DQA
21 CFR 870.2340/ DPS
21 CFR 870.2710/ DPZ
21 CFR 870.2300/ DRT
21 CFR 870.1100/ DSJ
21 CFR 870.1130/ DXN
21 CFR 880.2910/ FLL
21 CFR 870.1025/ DSI
21 CFR 870.1425/ DQK
21 CFR 880.2400/ KMI
21 CFR 870.1120/ DXQ | Same. |
| Pulse Oximetry Monitored Parameters/Features | SpO2, PR, PVi, RRp | SpO2, PR, PVi, RRp | Same. |
| ECG Monitored Parameters/Features | ECG waveform, Heart Rate, Impedance Respiration Rate, Arrhythmia Detection. | ECG waveform, Heart Rate, Impedance Respiration Rate, Arrhythmia Detection. | Same. |
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Table 4-1 Comparison between Subject and Predicate Devices (continued)
| Feature | Subject Predicate Radius VSM | Predicate Device Radius VSM (K223498) | Comparison to Predicate |
|---|---|---|---|
| NiBP Monitored Parameters/Features | Systolic Pressure, Diastolic Pressure and Pulse Rate, Mean Arterial Pressure (MAP) | Systolic Pressure, Diastolic Pressure and Pulse Rate | Different. The subject device supports a Mean Arterial Pressure (MAP) feature. |
Clinical performance validation is provided to support the feature does not raise different questions of safety and effectiveness. |
| Thermometer Monitored Parameters/Features | Temperature | Temperature | Same. |
| Acoustic Respiration Rate Monitored Parameters/Features | RRa | RRa | Same. |
| Position/Orientation Monitored Parameters/Features | Time in Position, Patient Incline Angle | Time in Position, Patient Incline Angle | Same. |
| Aggregate Respiration Rate | Yes | Yes | Same. |
| Indicated population | Adult | Adult | Same. |
| Type of display | LCD, Touchscreen | LCD, Touchscreen | Same. |
| Battery Internal Power | Rechargeable, Lithium ion | Rechargeable, Lithium ion | Same. |
| Alarms Notifications | Audible and visual | Audible and visual | Same. |
| Physical Characteristics | | | |
| Dimensions | 10.9 cm x 5.8 cm x 2.1 cm | 10.9 cm x 5.8 cm x 2.1 cm | Same. |
| Weight | 0.27 lbs | 0.27 lbs | Same. |
| Performance Specifications | | | |
| SpO2, No Motion Accuracy | 1.5% Arms, 70-100% | 1.5% Arms, 70-100% | Same. |
| SpO2, Motion Accuracy | 1.5% Arms, 70-100% | 1.5% Arms, 70-100% | Same. |
| SpO2, Low perfusion | 2% Arms, 70-100% | 2% Arms, 70-100% | Same. |
| PR, No motion | 3 bpm, 25-240 bpm | 3 bpm, 25-240 bpm | Same. |
| PR, Motion | 5 bpm, 25-240 bpm | 5 bpm, 25-240 bpm | Same. |
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510(k) Summary K250757
Table 4-1 Comparison between Subject and Predicate Devices (continued)
| Feature | Subject Predicate Radius VSM | Predicate Device Radius VSM (K223498) | Comparison to Predicate |
|---|---|---|---|
| PR, Low Perfusion | 5 bpm, 25-240 bpm | 5 bpm, 25-240 bpm | Same. |
| RRa | 1 rpm Arms, 4-70 rpm | 1 rpm Arms, 4-70 rpm | Same. |
| RRp, No Motion | 3 rpm Arms, 1 mean error, 4-70 rpm | 3 rpm Arms, 1 mean error, 4-70 rpm | Same. |
| Heart Rate | ≤1% or ≤2 bpm (whichever is greater) | ≤1% or ≤2 bpm (whichever is greater) | Same. |
| Impedance Respiration Rate | ≤1 rpm Arms, 4-120 rpm | ≤1 rpm Arms, 4-120 rpm | Same. |
| Pressure Transducer (Between 0 mmHg and 300 mmHg) | ±3 mmHg | ±3 mmHg | Same. |
| NIBP Performance Standards | ANSI/AAMI SP10 and ISO 81060-2 | ANSI/AAMI SP10 and ISO 81060-2 | Same. |
| Temperature | ±0.3°C,77°F to 109.4°F (25°C to 43°C) | ±0.3°C,77°F to 109.4°F (25°C to 43°C) | Same. |
| Patient Incline Angle | -180° to 180° | -180° to 180° | Same. |
| Environmental Specifications | |||
| Operating conditions | |||
| Temperature | 0º C to 40 º C | 0º C to 40 º C | Same. |
| Humidity | 10% to 95%, non-condensing | 10% to 95%, non-condensing | Same. |
| Storage conditions | |||
| Temperature | -20°C to 60°C | -20°C to 60°C | Same. |
| Humidity | 10% to 95%, non-condensing | 10% to 95%, non-condensing | Same. |
| ECG General | |||
| Lead Configurations Supported | 3 | 3 | Same. |
| Pacemaker Pulse Rejection Capability | ± 2 mV to ± 700 mV | ± 2 mV to ± 700 mV | Same. |
| ECG Monitoring Bandwidth | 0.67 Hz to 40 Hz | 0.67 Hz to 40 Hz | Same. |
| ECG Diagnostic Bandwidth | 0.05 Hz to 150 Hz | 0.05 Hz to 150 Hz | Same. |
| Supported Arrhythmia Classifications | lethal and non-arrhythmia | lethal and non-arrhythmia | Same. |
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Table 4-1 Comparison between Subject and Predicate Devices (continued)
| Feature | Subject Predicate Radius VSM | Predicate Device Radius VSM (K223498) | Comparison to Predicate |
|---|---|---|---|
| Thermometer Validation Method | ISO 80601-2-56 | ISO 80601-2-56 | Same. |
| Thermometer Application Site(s) | Chest | Chest | Same. |
| Temperature Measurement Mode | Continuous | Continuous | Same. |
| NIBP Measurement Method | Oscillometric | Oscillometric | Same. |
| Sensor Technology | 3-axis accelerometer | ||
| 3-axis gyroscope | 3-axis accelerometer | ||
| 3-axis gyroscope | Same. | ||
| Mode of Operation per IEC 60601-1 | |||
| Mode of Operation | Continuous | Continuous | Same. |
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510(k) Summary K250757
5. Performance Data
As part of this submission, clinical and non-clinical testing was included to support the addition of the Mean Arterial Pressure (MAP) Feature.
Performance Bench Testing
Bench testing was conducted to support the performance of the Mean Arterial Pressure (MAP) using a simulator.
Biocompatibility Testing
As there were no changes made to the patient contacting materials of the subject device from the previous clearance under K223498, no new biocompatibility testing was included in this submission.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
As there were no hardware changes made to the subject device from the previous clearance under K223498, no new electrical safety, environmental, mechanical, and cleaning testing was included as part of this submission.
Software Verification and Validation Testing
Software verification and validation testing were conducted and provided as part of this submission as recommended by the FDA Guidance, "Content of Premarket Submissions for Software Device Software Functions", June 2023 to support the software change to add the Mean Arterial Pressure (MAP) feature.
Wireless Testing
As there were no changes to the wireless capabilities from the previous clearance under K223498, no new wireless testing was included as part of this submission.
Cybersecurity Testing
As there were no changes made to the subject device that would affect its cybersecurity from the previous clearance under K223498, no new cybersecurity testing was included as part of this submission.
Human Factors and Usability Testing
Previous human factors testing of the predicate device were found to support the acceptable human factors and usability risk of the subject device.
Clinical Testing
Clinical study data was included as part of this submission to support the addition of the calculation of the mean arterial pressure (MAP) feature by Radius VSM. The clinical study used invasively measured MAP
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510(k) Summary K250757
values from a 510(k) cleared reference device (K171801) as a comparator in accordance with the FDA recognized standard ISO 81060-2.
The results of the testing supported the clinical performance of the MAP in accordance with ISO 81060-2.
6. Conclusion
The data provided as part of this submission was found to support the substantial equivalent of the subject device.
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