(137 days)
The DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000-7000 Series bedside monitor, or patient worn telemetry transmitter where remote, central station monitoring is desired. This system is not intended for home use.
The Fukuda Denshi model LX-7230KM/7230N is a patient worn Transmitter that transmits physiological data such as ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate from a patient to a Fukuda Denshi Central Monitor. The front LCD display information such as ECG, heart rate, respirogram, respiration rate, SpO2, plethysmograph, pulse rate, pulse amplitude level, battery level, and the conditions of the ECG electrodes and SpO2 sensor. For the SpO2 measurement, the LX-7230N utilizes Nellcor SpO2 module technology (K060576) and the LX-7230KM utilizes Konica-Minolta SpO2 module technology (K053419). Both transmitters can only be used as an interface device of the previously cleared Fukuda Denshi Central Monitor (K970585, K000746, K020084) utilizing the central telemetry receiver (K980728). Both transmitters utilize digital FSK (frequency shift keying) technology and operate in the WMTS 608 to 614 MHz transmission frequencies. One or two channel ECG waveforms are selectable with lead selection available using the two buttons (Enter and down arrow) on the front panel. (In case of using a 3-electrode lead cable or a 5-electrode chest lead cable). Both transmitters are battery powered using 2 AA alkaline batteries with available continuous operation for 6 days (LX-7230KM) or 3 days (LX-7230N). The LX-7230KM/7230N is small and lightweight at 190 grams including batteries. The physical dimensions of the device are 72 mm (W) x 98 mm (H) x 24.8(D) mm.
This is a summary of the acceptance criteria and study information based on the provided text.
This submission describes a telemetry transmitter (Fukuda Denshi Model LX-7230KM/7230N) which is an interface device that transmits physiological data (ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate) from a patient to a central monitor. The core technology (ECG and Respiration measurement) is the same as the predicate device (LX-5630, [K033711](https://510k.innolitics.com/search/K033711)). The SpO2 measurement function integrates OEM modules from Konica Minolta (PULSOX-300/300i, [K053419](https://510k.innolitics.com/search/K053419)) and Nellcor (N-600x Pulse Oximeter, [K060576](https://510k.innolitics.com/search/K060576)), without modification to these modules or their sensors. The submission focuses on demonstrating substantial equivalence to the predicate device and the previously cleared OEM SpO₂ modules rather than presenting new clinical study data with specific performance metrics.
Acceptance Criteria and Device Performance
The provided document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the Fukuda Denshi Model LX-7230KM/7230N Transmitter. Instead, the claim for substantial equivalence is based on the device incorporating identical fundamental technology for ECG and Respiration measurement as a predicate device and utilizing pre-cleared, unmodified SpO₂ modules whose performance has already been established and accepted by the FDA.
The "reported device performance" indicated is that the device "demonstrates that this device is as safe and effective as and performs as well as the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711." This implies that the device meets the performance standards already established for the predicate device and the incorporated OEM SpO₂ modules.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy (equivalent to predicate device) | "demonstrates that this device is as safe and effective as...the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711." |
| Functional Performance (equivalent to predicate device) | "performs as well as the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711." |
| SpO₂ Measurement Performance (equivalent to OEM modules) | The device utilizes unmodified Konica Minolta SpO₂ module technology (cleared under K053419) and unmodified Nellcor SpO₂ module technology (cleared under K060576). Performance is inherently linked to these previously cleared modules. "host tested at the previously noted OEM engineering test facility to insure that performance and functional specifications for their supplied module were met." |
| ECG and Respiration Measurement Performance (equivalent to predicate device) | "The new modified device, LX-7230KM, utilizes the same fundamental technology of ECG and Respiration measurement as the current patient worn transmitter LX-5630 (K033711)." "The new modified device, LX-7230N, utilizes the same fundamental technology of ECG and Respiration measurement as the current transmitter LX-5630 (K033711)." |
| Compliance with Safety, Environmental, and Performance Standards | "The Fukuda Denshi model LX-7230KM/7230N Transmitter has been subjected to extensive safety, environmental and performance testing. Final testing for the device included various performance tests for the device designed to insure that all functional and performance specifications were met." |
Study Details
The provided text describes a 510(k) submission seeking substantial equivalence for a medical device by demonstrating that its core technology is the same as a predicate device and that its SpO2 components are pre-cleared, unmodified OEM modules. Therefore, the "study" described is not a new clinical trial with specific performance endpoints, but rather a set of tests to confirm the new device's functionality and safety consistent with its predicate and incorporated components.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a patient-based sample size. The document mentions "extensive safety, environmental and performance testing" and "various performance tests." For the SpO2 modules, it states they were "host tested at the previously noted OEM engineering test facility."
- Data Provenance: Not specified in terms of country of origin or whether it was retrospective or prospective. The testing appears to be internal validation ("laboratory testing, validation and risk Analysis") and OEM engineering testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The submission relies on technical equivalence to established, cleared devices and modules rather than new ground truth establishment by experts for a new dataset.
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Adjudication method for the test set: Not applicable. There is no mention of an adjudication process for expert consensus on a test set.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a telemetry transmitter and does not involve AI or human interpretation of medical images or data requiring an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed as a "standalone" performance study in the context of an algorithm. The device itself is a standalone transmitter. Its performance is demonstrated through its hardware and software functionality as an interface for physiological data, relying on the established performance of its component parts (ECG/Respiration from predicate, SpO2 from OEM modules).
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The type of ground truth used: The "ground truth" for this submission is based on the performance established for:
- The predicate device (Fukuda Denshi model LX-5630 Transmitter, K033711) for ECG and Respiration measurement.
- The pre-cleared OEM SpO₂ modules (Konica Minolta "Pulsox-300/300i" K053419 and Nellcor "OxiMax N-600x Pulse Oximeter" K060576).
The ground truth is implicit in the regulatory clearance of these prior devices and modules.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that would typically involve a "training set" for an algorithm. The device's functionality uses established physiological measurement technologies.
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How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm.
§ 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.