(126 days)
The Zoe Medical Nightingale Monitoring System is indicated for use in adult & pediatric patient populations.
The Zoe Medical Nightingale Monitoring System facilitates the monitoring of:
- ECG -
- Impedance respiration -
- Non-Invasive blood pressure -
- Invasive blood pressure -
- Body temperature "
- Functional arterial oxygen saturation (SpO2) -
- -End-tidal & inspired CO2
The Zoe Medical Nightingale Monitoring System is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
The Zoe Medical Nightingale Monitoring System (NMS) facilitates the monitoring of patient physiological parameters both at the bedside on the Nightingale PPM3 monitor and remotely on the Nightingale MPC central station. The physiological parameters monitored by the NMS include: ECG. impedance respiration, non-invasive blood pressure, invasive blood pressure, body temperature, functional arterial oxygen saturation (SpO2), and end-tidal & inspired CO2 (capnography). The Nightingale Monitoring System as described in this submission is a new device, and will be marketed as the next generation product superseding the original and previously cleared Zoe Medical NMS (K001775).
The part numbers for the four Nightingale PPM3 variants and their associated configurations are given below.
179-0003 NIGHTINGALE PPM3 (with NIBP, SPO2, ECG, and Temp)
179-1000 NIGHTINGALE PPM3 WITH IBP (with NIBP, SPO2, ECG, Temp, & IBP)
179-1001 NIGHTINGALE PPM3 WITH ETCO2 (with NIBP, SPO2, ECG, Temp, & Microstream ETCO2)
179-1002 NIGHTINGALE PPM3 (with NIBP, SPO2, ECG, Temp, IBP, & Microstream ETCO2)
The Nightingale MPC central station (171-0001) will be sold as an option available to all customers based on their needs.
The provided document describes the Zoe Medical Nightingale Monitoring System, a patient physiological monitor. Here's an analysis of its acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device (Spacelabs Healthcare Vital Signs Monitoring System, K090556) rather than detailing specific numerical acceptance criteria for each physiological parameter. The acceptance criteria are broadly defined by compliance with applicable standards and demonstration that the device's performance meets its predetermined specifications.
| Category | Acceptance Criteria (Implied) | Reported Device Performance and Compliance |
|---|---|---|
| Software | Designed and developed according to Zoe Medical processes; verified and validated. | Software was designed and developed in accordance with Zoe Medical software development processes, and was verified and validated. Test results indicated that the Nightingale Monitoring System complies with its predetermined specification. |
| Electrical Safety | Compliance with specified electrical safety standards (e.g., AAMI ES 60601-1:2005, IEC 60601-2-XX series). | Tested for patient safety in accordance with AAMI ES 60601-1:2005, ANSI/AAMI SP10:2002 / A1:2003, IEC 60601-1-4:2000, IEC 60601-1-8:2006, IEC 60601-2-27:2011, IEC 80601-2-30:2009, IEC 60601-2-34:2011, ISO 80601-2-55:2011, ISO 80601-2-56:2009, ISO 80601-2-61:2011, IEC 62366:2007, IEC 62304:2006. Test results indicated compliance with predetermined specification. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2007. | Tested for EMC in accordance with IEC 60601-1-2:2007. Test results indicated that the Nightingale Monitoring System complies with its predetermined specification. |
| Bench Performance | Compliance with Zoe Medical internal requirements and procedures; functional, environmental, and shipping/transportation performance. | Tested in accordance with Zoe Medical internal requirements and procedures. Test results indicated that the device complies with the predetermined requirements, including performance, functional, environmental, and shipping/transportation testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of device performance data beyond the compliance testing. The performance and safety validations were primarily based on engineering and laboratory testing against established standards and internal requirements. Therefore:
- Sample Size: Not applicable in terms of a clinical dataset for a test set. The samples would be the physical devices and components undergoing the various safety and performance tests.
- Data Provenance: The data comes from internal testing conducted by Zoe Medical, Inc., as part of their design and development processes. It is retrospective in the sense that the testing was completed before submission for clearance. The country of origin of this internal testing data is likely the USA (Topsfield, MA, where the company is located).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device's performance is assessed against recognized industry standards and internal specifications, not against a "ground truth" established by experts in the typical sense of a clinical diagnostic study. The "ground truth" for electrical safety would be the requirements of the IEC 60601 series, and for EMC, the IEC 60601-1-2 standard. Internal engineering experts and certified testing laboratories would be involved in verifying compliance.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of a "test set" in the context of human interpretation or clinical data requiring adjudication. Compliance with standards is typically a pass/fail outcome based on measurements and observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission relies on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for a physiological monitor, not on assessing the improvement of human readers with this AI-assisted technology. This device is a monitor, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The Zoe Medical Nightingale Monitoring System is a physiological patient monitor, a hardware device with embedded software. Its performance is inherent to the device itself and its sensors, not a standalone algorithm in the AI sense. Its intended use involves healthcare professionals continuously monitoring the patient via the device.
7. The Type of Ground Truth Used
The "ground truth" for the performance and safety testing is based on:
- Pre-determined specifications: Internal requirements established by Zoe Medical.
- International and National Standards: Compliance with recognized standards such as AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-XX series, ISO 80601-2-XX series, IEC 62366, and IEC 62304. These standards define acceptable levels of safety and performance for physiological monitors.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physiological monitor, not an AI/ML algorithm that requires a "training set" in the machine learning context. Its functionality is based on established engineering principles and signal processing, not on learning from a large dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no "training set."
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).