(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.
§ 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.