(154 days)
iBSM is a wireless monitoring system intended for the display of electrocardiography (ECG) waveform, heart rate measurements, respiratory rate measurement and waveform, functional oxygen saturation of arterial hemoglobin (SpO2), activity, body position, fall detection, skin temperature and Blood Pressure parameter measurements by qualified healthcare professionals in healthcare settings. iBSM continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the patient's position has not changed from a preset time threshold.
The iBSM device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment.
The iBSM device is not intended for use on critical care patients.
The iBSM BP cuff is not intended for subjects that are considered special populations.
The iBSM device is indicated for monitoring ECG waveforms and heart rate on non-ambulatory patients.
The iBSM device is intended to be used in wards and patient rooms in professional healthcare facility environment hospital settings.
The iBSM device is not intended to be used in Home environment or special environment.
The iBSM device is not intended to be used in an ambulatory environment for noninvasive blood pressure, respiratory rate and SpO2 measurement parameters.
The iBSM device is not intended to monitor or measure respiratory rate, SpO2, or noninvasive blood pressure while the patient undergoes significant motion or is active.
The iBSM device is not intended to be used in the ICU/CCU or Surgery/OT rooms
iBSM is compatible with third-party, FDA cleared devices such as ANNE Chest from Sibel Health Inc, for ECG, HR, RR, body position and skin temperature measurements; and ANNE Limb from Sibel Health Inc. for SpO2 and skin temperature measurements.
iBSM is compatible with third-party, FDA-cleared BP devices such as BP2A from Shenzhen Viatom, for non-invasive blood pressure measurements.
The iBSM device communicates with an external server for patient data communication and storage.
The iBSM device includes the ability to notify healthcare professionals when physiological data fall outside selected parameters with the use of audio and visual alarms.
The iBSM chest sensor is not intended to be used to provide diagnostic or or interpretive statements to either the patient or the clinician. The iBSM chest sensor is NOT intended to be used on critical care patients and is not a remote diagnostic device. The iBSM chest sensor is NOT intended for use on patients with implanted pacemakers. The iBSM Chest sensor is NOT intended for use on patients with known allergies, or hypersensitivities to, adhesives or nickel. The iBSM Chest Sensor is NOT intended for patients with significant cardiorespiratory disease including patients that are oxygen dependent. The iBSM Chest Sensor is NOT intended for patients with significant respiratory muscle weakness due to an underlying neuromuscular condition (e.g., myasthenia gravis, amyotrophic lateral sclerosis, or muscular dystrophies)
The data and results provided by the BP cuff device are for precheck screening purposes only and cannot be directly used for diagnosis or treatments.
The iBSM device is a wireless vital sign and physiological data monitoring device that streams real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate(HR), respiratory rate(RR), body position, SpO2 and skin temperature. The waveforms of ECG, Respiration and PPG are also displayed.
The ECG signal is not intended for automated arrhythmia detection or classification. Rather it is intended for manual interpretation, and the automated computation of heart rate through QRS identification using the well-known Pan-Tomkins beat detection algorithm. The displayed waveform is only intended for display as a check for normal ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or cardiac conditions.
The system features two third party FDA cleared skin-mounted, bio-integrated sensors that pair with the iBSM View application for the continuous display and storage of vital sign measurements and physiological waveforms. The two sensors viz. iBSM chest (Anne Chest from Sibel Health Inc) and iBSM limb (Anne Limb from Sibel Health Inc) sensors are used along with their respective biocompatible iBSM chest sensor adhesive and iBSM limb sensor adhesives and attached to the patient. The adhesives are intended for a single use, whereas the sensors are intended for multiple reuse with the predefined processing.
Both the chest and the limb sensors along with their adhesives are third party FDA cleared devices. The system is also compatible with a third-party FDA cleared non-invasive blood pressure measurement device (Blood Pressure monitor BP2A from Shenzhen Viatom Technologies).
The iBSM device consists of a mains powered Docking station that provides the mechanical base station for the iBSM Tablet and has a provision to charge the tablet when docked.
The USB connector provided on the Docking station is intended only to power up the sensor charger accessory and any data transfer to the USB device is disabled.
The iBSM View Application runs on the iBSM tablet in a secure Kiosk mode and is intended to display the patient's physiological parameters and waveforms. The iBSM tablet with the iBSM View Application together is termed as iBSM hub.
The physiological data obtained by the sensors are wirelessly transmitted to their respective SDK's that are part of the iBSM hub with Bluetooth (BLE) connectivity, for continuous display of waveforms and parameters on the iBSM View Application. When connected to WiFi, vital signs data can be transferred in real-time from the iBSM hub to an external Server for data storage. The iBSM system provides an FHIR-compatible interface for patient data communication and storage to an external Server.
iBSM is intended to be used only in an hospital environment within the wards or patient rooms and not in ICU/CCU nor in Surgery/OT rooms. It is intended to be used for monitoring of non critical patients. iBSM is not intended to be used in a home environment.
iBSM uses the third party FDA cleared sensors such as ANNE Chest and ANNE Limb from Sibel Health Inc. and BP2A BP Cuff from Shenzhen Viatom, that fulfill the requirements of performance parameters in the signal acquisition before transmitting the data to their SDK's integrated with the iBSM Application in the iBSM hub for displaying the waveforms and the parameters.
The provided FDA 510(k) clearance letter details the acceptance criteria for the iBSM device and largely refers to its "substantial equivalence" to predicate and reference devices, rather than a standalone clinical study report with detailed performance data derived from a specific test set. The document outlines performance specifications and cites numerous consensus standards and bench testing used to demonstrate this equivalence.
It's important to note that 510(k) clearances typically rely on demonstrating substantial equivalence, and often do not require new, full-scale clinical trials if performance can be shown through bench testing, existing clinical data for predicate devices, or limited clinical validation. This document is a summary of that submission, not a detailed clinical study report.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document specifies performance attributes for the iBSM system. These are presented as acceptance criteria and also implicitly as the reported performance, as the clearance is granted based on meeting these specifications.
| Parameter | Acceptance Criteria (Specified in the 510(k) summary) | Reported Device Performance (Implied as met for clearance) |
|---|---|---|
| Heart Rate | Range: 30-270 bpm | |
| Accuracy: ±5 bpm or ±10%, whichever is greater | ||
| Resolution: 1 bpm | Met (Implied by clearance and stated specifications - "Similar as the HR specs of subject iBSM device are contained within the wider range of specs of the predicate device") | |
| Respiratory Rate | Range: 8-35 brpm | |
| Accuracy: ±3 brpm | ||
| Resolution: 1 brpm | Met (Implied by clearance and stated specifications - "Equivalent as in K223711") | |
| SpO2 | Detection Range: 70-100% | |
| Resolution: 1% | ||
| Accuracy: ±3% ARMS (transmissive mode, 70-100%) | Met (Implied by clearance and stated specifications - "Equivalent as in K223711") | |
| Skin Temperature | Accuracy: ±0.54°F over 73.2-109.4°F (±0.3°C over 23-43°C) | Met (Implied by clearance and stated specifications - "Equivalent as in K223711") |
| Non-Invasive Blood Pressure (NIBP) | Range: 0-300 mmHg | |
| Accuracy: ±3 mmHg | Met (Implied by clearance and stated specifications - "Equivalent as in K223711 and K193348") | |
| ECG Waveform Display | Compliant to IEC 60601-2-27 and IEC 60601-2-47 | Met (Implied by clearance and stated specifications - "Equivalent as in K223711") |
| ECG Sampling Frequency | 512 Hz | Met (Implied by clearance and stated specifications - "Equivalent as in K223711") |
| ECG Streaming Frequency | 256 Hz | Met (Implied by clearance and stated specifications - "Equivalent as in K223711") |
| ECG Resolution | 18 bit | Met (Implied by clearance and stated specifications - "Equivalent as in K223711") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size in terms of number of subjects for a new clinical study. Instead, it refers to performance verification through bench testing and compliance with various consensus standards.
- Sample Size: Not explicitly stated as a number of subjects for a clinical test set. The evaluation seems to rely on an aggregation of compliance with standards and performance data from predicate devices. For specific parameters like BP, compliance with ISO standards (e.g., IEC 80601-2-30) implies certain subject numbers were used for validation of the reference device (BP2A from Shenzhen Viatom, K193348), and the iBSM device demonstrates equivalence to its performance.
- Data Provenance: The document does not specify a country of origin for a new clinical test set. The company, iOrbit Digital Technologies Private Limited, is based in India. The predicate/reference devices are from Sibel Health Inc. and Shenzhen Viatom Technology Co. Ltd. The studies referenced for predicate devices (e.g., K240251 for ANNE Chest, K240305 for ANNE Limb, K193348 for BP2A) would have their own data provenance. The assessment presented appears to be a summary of bench testing, software verification, and compliance with standards. There is no mention of a primary prospective clinical study for the iBSM itself.
3. Number of Experts and their Qualifications for Ground Truth Establishment
The document does not describe the establishment of ground truth by human experts for a specific test set. The validation methodology relies on:
- Bench testing against defined specifications.
- Compliance with international standards (e.g., IEC, ISO, ANSI/AAMI), which often have their own established methods for ground truth, such as calibrated instruments for physiological measurements.
- Equivalence to legally marketed predicate devices (ANNE One, ANNE View, BP2A, ANNE Chest), whose ground truth would have been established during their own clearances.
Therefore, there is no mention of "experts" in the context of establishing ground truth for a diagnostic AI system, as the iBSM is a monitoring device that focuses on accuracy of physiological measurements, not diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable, as a new clinical test set requiring expert adjudication for a diagnostic output is not described. The validation focuses on the accuracy of physiological parameter measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or cited. The iBSM system is a physiological monitoring device that provides objective measurements, waveforms, and alerts based on preset parameters. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance to assess an effect size. The chest sensor explicitly states: "The iBSM chest sensor is not intended to be used to provide diagnostic or interpretive statements to either the patient or the clinician."
6. Standalone Performance (Algorithm Only)
The performance described (accuracy of HR, RR, SpO2, Temperature, NIBP) is the "standalone" performance of the device's algorithms for calculating these physiological parameters based on sensor inputs. The acceptance criteria table directly reflects these algorithmic capabilities.
7. Type of Ground Truth Used
The ground truth used for validating the iBSM's performance parameters is implicitly defined by:
- Reference measurement devices/calibrated instruments: This is standard for validating physiological monitoring device accuracy (e.g., a highly accurate reference ECG machine for heart rate, a pulse oximeter for SpO2, a validated sphygmomanometer for NIBP, and a calibrated thermometer for temperature).
- Compliance with international consensus standards: These standards specify accepted methods for determining accuracy and often involve phantom studies or direct comparison with reference methods.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the device's primary physiological measurement functions.
8. Sample Size for the Training Set
The document does not refer to a "training set" in the context of validating a device using machine learning or AI models with a distinct training phase. The iBSM device's core functionality appears to be based on established signal processing algorithms (e.g., Pan-Tompkins beat detection algorithm for HR) rather than deep learning requiring large, labeled training datasets in the manner of medical image analysis AI. The performance is validated through specified accuracy metrics against known physiological ranges.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specifically mentioned "training set" for an AI/ML model for which ground truth would need to be established. The core algorithms for physiological parameter extraction (e.g., ECG waveform display, HR, RR, SpO2 calculation) rely on known signal processing methods and are validated through standard performance tests, not through an AI training paradigm.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).