(32 days)
The Dash™ 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash™ 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator' s manual.
The Dash™ 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK™ indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash™ 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.
The DASH 3000/4000/5000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end- tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. The DASH 3000/4000/5000 Patient Monitor is a portable patient monitor manufactured in various fixed configurations. 3/5/10-leadwire ECG, impedance respiration, pulse oximetry, noninvasive blood pressure (NBP), four invasive pressures, two temperatures, thermal dilution cardiac output, and CO2 parameters can be monitored in a stand alone configuration (BP, CO, and CO2 are software enabled options). The DASH 3000/4000/5000is designed to monitor and present patient data on a color display. Three screen sizes are available: 8.4, 10.4, and 12.1 inches. The screen displays patient information, and the Trim Knob control and remote control provides single control operations of virtually all monitor functions. The operator can adjust parameter alarm settings that give audible and visual indication when a violation occurs. It also provides an option for printing information by a paper recorder. The software comes in a base feature set. Additional software options are provided in the following packages: 12SL ECG analysis, Acute Cardiac Ischemia - Time Insensitive Instrument (ACI-TIP), high-resolution CRG trends, network connectivity, cardiac package, and cardio-pulmonary package. The IntelliRate feature is an optional feature that uses the most accurate of the three existing heart rate calculations (ECG, invasive blood pressure, and pulse oximetry) as the primary estimate of patient heart rate. The Atrial Fibrillation algorithm is an optional feature of the EKPro ECG analysis program. It is an update to the existing Irregular arrhythmia call. The Dash 3000/4000/5000 interfaces with patients through accessories (cables / sensors). Each parameter on the Dash receives signals from the patient through the accessories. The Dash 3000/4000/5000 is compatible with GE Healthcare's Unity Network. An optional wireless LAN radio connection to the Unity Network can be built into the monitor. The Dash 3000/4000/5000 also includes auxiliary communication and defibrillator synchronization/analog output interfaces. The auxiliary communication interface can be connected to a Rac 2A Module Housing, providing interface to a SAM Module or ICG Module. The SAM Module provides the display features required to monitor anesthetic agents. O2, N2O, and CO2, and the ICG Module provides impedance cardiography. The auxiliary communication interface can also be connected to an external Aspect Medical BISx Bi-Spectral Index monitor, a remote alarm interface to a nurse call system, used for software updates, or as an interface to an information system. The DASH 3000/4000/5000 was developed to interface with other manufacturer's peripheral bedside devices via a networked, multi-serial port data accessory unit. The DASH 3000/4000/5000 monitor displays information sent from the peripheral devices. These connected devices may consist of, but are not limited to, yentilators, anesthesia machines, urimeters, and infusion pumps. The DASH 3000/4000/5000 can interface to a Nellcor 395 pulse oximeter without using the networked, multi-serial port data accessory unit. Other optional components that interface to the DASH 3000/4000/5000 Patient Monitor include a central station, thermal printer and alarm light.
This
510(k) summary describes a resubmission for the Dash 3000/4000/5000 Monitor and accessories. The purpose of the resubmission is to clarify the indications for use statement and specify that intra-hospital transport mode is supported. The submission also analyzes changes to the device with V6.6 software and compares the specifications to the predicate device, Dash 3000/4000/5000 V6 (K051367).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or specific measurement tolerances for physiological parameters).
Instead, the acceptance criteria are implicitly defined by compliance with various national and international standards, and substantial equivalence to the predicate device. The "reported device performance" is summarized as the device being "as safe and effective" and "substantially equivalent" to the predicate.
Given the nature of the device (a multi-parameter patient monitor), the "acceptance criteria" discussed are largely related to safety, effectiveness, and functional equivalence to a legally marketed predicate device as demonstrated through verification and validation against established standards.
| Acceptance Criteria Category | Details from Submission |
|---|---|
| Functional Equivalence to Predicate Device | "A detailed analysis in this submission analyzes the changes to the Dash 3000/4000/5000 monitor and accessories with V6.6 software and compares the specifications to the predicate Dash 3000/4000/5000 V6 (K051367). It demonstrates the functional equivalence of the products and shows the device does not raise new issues of safety and effectiveness." |
| Safety and Effectiveness | "The DASH 3000/4000/5000 monitor with V6.6 software is as safe and effective, and is substantially equivalent to the predicate DASH 3000/4000/5000 V6 Monitor (K051367)." |
| Verification and Validation Testing | "Verification and validation testing demonstrate that no adverse effects have been introduced by these differences." "The Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories has been assessed against the standards below and details of conformity are presented in the attached 510(k) notification. The device has been thoroughly tested through validation and verification of specifications." This includes compliance with standards such as FDA 21 CFR Part 898, IEC 60601 series, ANSI/AAMI, EN ISO, and FDA Guidance for Software. |
| No New Issues of Safety and Effectiveness | "It demonstrates the functional equivalence of the products and shows the device does not raise new issues of safety and effectiveness." This is a core tenet of the 510(k) pathway. |
| Intended Use & Indications for Use | The updated device's intended use and indications for use must align with (or be clarified from) the predicate device, confirming it's for monitoring adult, pediatric, and neonatal patients in various medical facilities, including intra-hospital transport, and displaying physiological parameters like ECG, NIBP, SpO2, Temp, etc. The document states: "The intended use and the indications for use for the device... is basically the same (with clarification) as compared to the predicate..." and "We have clarified the indications for use statement to indicate that only intra-hospital transport mode is supported..." |
2. Sample Size Used for the Test Set and Data Provenance
The document focuses on a non-clinical performance study as part of verification and validation. It states: "The Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories has been assessed against the standards below and details of conformity are presented in the attached 510(k) notification. The device has been thoroughly tested through validation and verification of specifications."
- Sample Size for Test Set: Not explicitly stated in this summary. The testing appears to be comprehensive engineering and performance testing against standards, rather than a clinical trial with a "test set" of patient data in the typical sense.
- Data Provenance: Not specified. Given the nature of a 510(k) for a patient monitor and the focus on "verification and validation of specifications" and compliance with engineering standards, the "data" would likely originate from laboratory bench testing, simulated patient scenarios, and possibly some preclinical or limited clinical data if specific sensing technologies were involved, but this summary does not provide details. It is unlikely to be country-specific "patient data" as in a large-scale clinical study for a novel device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a patient monitor, "ground truth" for technical parameters (e.g., accuracy of a blood pressure reading or ECG waveform) is often established by reference devices or calibrated instruments, rather than human experts in an adjudication process. If there were specific algorithms (e.g., arrhythmia detection), their performance would typically be validated against annotated datasets, but such details are not present here.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned. Given the type of device and the summary provided, it describes verification and validation against technical standards and specifications, not a clinical study involving human adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC comparative effectiveness study, nor does it discuss human readers or improvement with AI assistance. This device is a physiological patient monitor, and the premarket submission focuses on its technical performance, safety, and equivalence to a predicate device, not on diagnostic interpretation or AI-driven decision support that would typically involve MRMC studies.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, implicitly. The entire summary describes the standalone performance of the device itself. The verification and validation testing against numerous standards (e.g., IEC 60601 series, ANSI/AAMI for ECG, NIBP, etc.) are evaluating the algorithm's and hardware's performance directly, independent of a human operator, to ensure it accurately measures and presents physiological data and alarms. For example, testing of the "Atrial Fibrillation algorithm" would be a standalone evaluation.
7. Type of Ground Truth Used
The ground truth used for technical validation would be:
- Reference Standards/Calibrated Instruments: For physiological measurements (e.g., NIBP, SpO2, temperature, ECG parameters).
- Engineering Specifications: The device's performance is compared against its own design specifications and industry standards.
- Predicate Device Performance: The primary "ground truth" for equivalence in this 510(k) is the established safety and effectiveness of the legally marketed predicate device (Dash 3000/4000/5000 V6, K051367).
This document does not indicate the use of pathology, outcomes data, or expert consensus in relation to a specific clinical diagnostic claim.
8. Sample Size for the Training Set
Not applicable/Not mentioned. This information is typically relevant for machine learning or AI-driven diagnostic algorithms that undergo a training phase. While the device contains software (e.g., IntelliRate, Atrial Fibrillation algorithm), the summary does not detail the development or training of such algorithms in terms of "training sets." The focus is on the verification and validation of the entire system's performance against established standards.
9. How Ground Truth for the Training Set Was Established
Not applicable/Not mentioned. As no "training set" is described, the method for establishing its ground truth is also not provided.
§ 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.