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510(k) Data Aggregation
(217 days)
The device is intended to provide ambulatory and nonambulatory monitoring of ECG and SpO2 parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use. The intended use is unaffected by the modification.
The indications for use of the Viridia Telemetry System are:
- Condition: The licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient.
- Prescription versus over-the-counter: Viridia Telemetry System is a prescription device.
- Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient's skin. The SpO2 signal is obtained from an accessory sensor in contact with the patient's skin.
- Frequency of use: As prescribed by licensed clinician.
- Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a licensed clinician.
- Patient population: Adult and pediatric patients.
The Hewlett-Packard HP M2600A Viridia Telemetry System consists of a pocket sized digital synthesized transmitter, synthesized that a and receiver, accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device. The modification allows the user to utilize an EtO Sterilization process for the purpose of cross-infection prevention and changes the labeling to reflect a change in battery life specification and in the device name.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, recognizing that this is a 510(k) summary for a product modification, not a comprehensive clinical study report:
Analysis of the Provided Document:
The provided document is a 510(k) summary for a modification to the HP M2600A Viridia Telemetry System. The primary modification being described is the enablement of EtO sterilization for the device, and a change in battery life specification and device name. This is a pre-market submission to demonstrate substantial equivalence to a legally marketed predicate device, not a comprehensive clinical study proving new clinical efficacy or performance against defined acceptance criteria in the typical sense of a novel device.
Therefore, the "acceptance criteria" and "study" described herein are primarily focused on demonstrating that the modification does not adversely affect the safety and effectiveness of the device, particularly concerning the new sterilization process, and that the device remains equivalent to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety Post-Sterilization | The device's safety (including electrical safety, biocompatibility of materials, etc.) must not be degraded by EtO sterilization. | "Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process...and is that safety was not degraded. The test results support that purpose." The 510(k) clearance further confirms FDA's agreement that the modified device is "safe and effective when used as intended and indicated." |
| Performance Post-Sterilization | The device must continue to perform to its specifications (e.g., ECG and SpO2 monitoring accuracy) after EtO sterilization. | "Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process." "The device was thoroughly tested to verify that performance claims in the labeling are met." |
| Functionality (General) | The device functions as intended for ECG and SpO2 monitoring. | Implied to be maintained as the modification only concerns sterilization and labeling, not the core monitoring function. The statement "The device was thoroughly tested to verify that performance claims in the labeling are met" applies here. |
| Substantial Equivalence (Overall - Key Criterion) | The modified device must be substantially equivalent to the predicate device in terms of safety, effectiveness, and intended use. | "The comparison shows the device to be substantially equivalent in safety, effectiveness, and intended use to a legally marketed device." "Based on comparison to the predicated device and on the test results, the Viridia Telemetry System is substantially equivalent to the HP M 1403A." FDA concluded the device is "substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for devices tested. It mentions "The device was thoroughly tested to verify that performance claims in the labeling are met." and "Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process."
- Data Provenance: The data is generated from prospective testing conducted by the manufacturer (Hewlett-Packard) and "A qualified independent laboratory" specifically for this 510(k) submission to demonstrate the impact of the modification. There's no indication of country of origin for the data other than the manufacturer being in Andover, MA, USA. It's a technical validation, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this 510(k) submission. The "ground truth" for this modification is the device's original specifications and safety profiles. The testing is to verify that the modification (EtO sterilization) does not alter these. This is a technical performance verification, not a diagnostic or AI-based assessment requiring expert consensus on a clinical condition.
4. Adjudication Method for the Test Set
Not applicable in the traditional sense. The "adjudication" is implied to be the validation process itself, where test results are compared against predefined performance specifications and safety standards for the device. An independent laboratory was involved in performing tests related to EtO sterilization. The ultimate 'adjudication' is the FDA's review and determination of substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission pertains to a modification (sterilization process, battery life, name change) of an existing medical device, not a new diagnostic algorithm or an AI-assisted system that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physiological monitoring system (telemetry for ECG and SpO2), not an AI algorithm. Its performance is intrinsic to its hardware and software for signal acquisition and display, which was already established with previous 510(k) clearances. The current submission focuses on the impact of a new sterilization process.
7. The Type of Ground Truth Used
The "ground truth" for this submission refers to the established performance specifications and safety requirements of the HP M2600A Viridia Telemetry System prior to the modification, and by extension, the characteristics of its predicate device (HP M1403A). The testing aimed to confirm that the modified device still met these existing benchmarks.
8. The Sample Size for the Training Set
Not applicable. This submission does not involve an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI algorithm or training set, this question is irrelevant to the provided document.
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(46 days)
Viridia Wave Viewer may be used to provide limited ECG and SpO2 information to the clinician. Patient assessment includes uses similar to:
- Determination of a patient's tolerance to exercise during ambulation (e.g. while walking down a hallway).
- Patient assessment while waiting for monitoring equipment to arrive (e.g. a patient collapses in the hallway).
- Additional input to a routine physical assessment of a patient (e.g. for use on rounds).
Patient assessment does not include uses such as:
- Continuous monitoring of a patient (not intended for use as a bedside monitor).
- Determining detailed ECG diagnosis such as ST segment values, R-R variability or any other diagnostic ECG values.
The patient population is adult and pediatric patients.
There are no alarms. The device turns off after 10 minutes to prevent long term "monitoring" use. Viridia Wave Viewer is not intended to be a patient monitor.
In the USA, Federal law restricts Viridia Wave Viewer to sale by or on the order of a physician.
It is intended to be used in a professional health care facility. It is not intended for home use.
The device is intended to be used as an assessment tool that enables licensed clinicians in a clinical environment to determine the quality of ECG and SpO2 signals at the location of telemetry monitored patients. In addition, limited assessment of patients ECG and SpO2 vital signs can be determined. Viridia Wave Viewer is not intended for monitoring and has no alarm functions. The device is not intended for home use and is not suitable for patient monitoring.
Viridia Wave Viewer is a software application that executes on a palmtop computer. Viridia Wave Viewer software enables the palmtop computer to communicate with the M2601A transmitter using an infrared link for the purpose of displaying ECG waveform, or an SpO2 pleth waveform, and numerics for SpO2 and Pulse. Viridia Wave Viewer also allows the user to estimate the heart rate, HR, by using electronic calipers to measure the distance between two R-peaks. Viridia Wave Viewer does not operate on the information received except to format it for display on the palmtop screen. It performs no calculations except for estimating HR. It has no detection capability. It can not, therefore, annunciate any alarms.
This document, K974567, details a 510(k) submission for the Hewlett-Packard M2605A Viridia Wave Viewer. However, it does not contain specific acceptance criteria, performance metrics, or a detailed study description that would allow for a complete response to your request. The document acts as a summary for FDA clearance, not a full scientific study report.
The "Verification and Validation" section (6.0) states: "Viridia Wave Viewer has been verified and validated to provide the test results needed to show substantial equivalence to legally marketed devices." This implies that testing was performed, but the details are not provided within this summary.
Therefore, I can only provide information based on what is available in the provided text. Many sections of your request cannot be answered due to the lack of detailed study information.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The document states that verification and validation were performed to show substantial equivalence, but it does not list specific numeric acceptance criteria (e.g., accuracy, precision) or the results of those tests.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the provided document. The document refers to "extensive testing" but does not specify sample sizes or data origin (country, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not present in the provided document.
4. Adjudication Method for the Test Set
This information is not present in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device, Viridia Wave Viewer, is described as a software application for a palmtop computer that displays ECG and SpO2 waveforms and numerics. It specifically states: "Viridia Wave Viewer does not operate on the information received except to format it for display on the palmtop screen. It performs no calculations except for estimating HR. It has no detection capability. It can not, therefore, annunciate any alarms." This functionality suggests a display-only device with a simple HR estimation, not one that would typically be involved in a comparative effectiveness study of AI assistance for human readers in decision-making.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This document does not report a standalone performance study. While testing certainly occurred to ensure proper display and basic HR estimation, the nature of this device (a display and rudimentary HR estimation tool) means that "standalone performance" in the sense of a complex algorithm's diagnostic accuracy is not applicable or elaborated upon here. Its function is to present data from existing monitoring equipment.
7. Type of Ground Truth Used
This information is not explicitly stated in the provided document. Given the device's function to display ECG and SpO2 waveforms and numerics from existing monitoring equipment, the "ground truth" for its verification and validation would likely involve:
- Comparison to the source monitoring equipment: Ensuring the displayed waveforms and numerics accurately reflect what the M2601A transmitter is sending.
- Manual calculation verification: For the estimated heart rate, comparison to a manually calculated heart rate derived from the displayed ECG.
8. Sample Size for the Training Set
This information is not present in the provided document. As the device mainly displays information and performs a simple HR estimation, it is unlikely to have a "training set" in the sense of a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not present in the provided document. As mentioned above, a "training set" in the context of device learning is likely not applicable to this particular device's functionality.
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