(53 days)
The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.
The modified device, MRI Patient Monitoring System (Model 865214), is substantially equivalent to the cleared device. Invivo has marketed the cleared device. MRI Patient Monitoring System (Model 865214), since 2009. Invivo identified the opportunity to reduce healthcare costs by replacing the current temperature option which is an Ethylene Oxide (EO) sterilized single-use temperature sensor with a reusable temperature sensor that utilizes single-use gamma irradiated sterilized jackets (sheath). The modified device. MRI Patient Monitoring System (Model 865214) and the previously cleared device, also identified as MRI Patient Monitoring System (Model 865214) which received clearance to market under 510(k) K090785 on December, 15 2009, are identical with respect to indications for use, intended use, fundamental scientific technology, software architecture and design. Both devices are multi-parameter patient monitors intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. Both devices provide patient monitoring data for ECG, SpO2, respiration, non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, oxygen (02), end-tidal carbon dioxide (EtCO2), and anesthetic agents. The modifications to the previously cleared device are only in regards to the temperature parameter. The primary differences between the MRI Patient Monitoring System (Model 865214) and the previously cleared device are listed below: - Body temperature measurement is completed with a reusable sensor that is . covered with a sterilized jacket (sheath)(rather than a single-use sterilized sensor). - Sterilization method is Gamma Radiation (rather than Ethylene Oxide (EO)). ● - The reusable sensor is not sterilized. Labeling of the sensor including the . instructions for use (IFU) identify the need to use a sterile jacket (sheath). - Product labeling and the IFU have been updated to reflect the modifications . accordingly
Here's a summary of the acceptance criteria and study information for the MRI Patient Monitoring System (Model 865214) based on the provided text, structured according to your request:
Device: MRI Patient Monitoring System (Model 865214)
Modification: Replacement of single-use, EO-sterilized temperature sensor with a reusable sensor using single-use, gamma-irradiated sterilized jackets.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details the verification and validation (V&V) activities performed for the modified device. Rather than a specific "acceptance criteria" table with performance metrics, the document focuses on compliance with recognized standards and successful V&V of performance specifications and MRI conditions of use.
| Acceptance Criteria Category | Specific Criteria / Standards Complied | Reported Device Performance |
|---|---|---|
| I. Voluntary Standards | IEC 60601-1 (Safety) | Results of testing demonstrated that the modified device is as safe and effective as the previously cleared device. |
| IEC 60601-1-2 (EMC) | ||
| IEC 60601-1-6 (Usability) | ||
| IEC 60601-2-49 (Multifunction Patient Monitoring) | ||
| ASTM E1112-00 (Electronic Thermometer) | ||
| ISO 14971 (Risk Management) | ||
| ASTM F2503-08 (MR Safety Marking) | ||
| ASTM F2052-06 (MR Induced Displacement) | ||
| BS EN 12470-4 (Clinical Thermometers) | ||
| ISO 10993-1 (Biocompatibility) | ||
| ISO 10993-5 (In Vitro Cytotoxicity) | ||
| ISO 10993-10 (Irritation & Hypersensitivity) | ||
| II. Performance Specifications | Temperature measurement parameters defined by Invivo Corporation according to national/international standards, market needs, risk management, and intended use. | Results of complete V&V indicate that the modified device operates as intended within the performance specifications. |
| III. MRI Conditions of Use | MR conditions of use defined by Invivo Corporation according to national/international standards, intended use, risk management, and market needs. | Test results demonstrate that the MRI Patient Monitoring System (Model 865214) meets the MR conditions of use as defined in the modified device labeling. |
| Overall Safety & Effectiveness | Safety and effectiveness equivalent to the previously cleared device. | No new safety or effectiveness questions were raised. Performance data supports claims of safety and effectiveness and substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient data or case numbers. The testing appears to be primarily device-centric, focusing on engineering verification and validation of the modified temperature component and its interaction with the MRI environment.
- Data Provenance: The document does not mention the use of patient or clinical data for the V&V of the modified device. It states, "The results do not raise issues regarding the safety and effectiveness of the device and clinical data was not required to substantiate claims of safety and effectiveness."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The ground truth for the verification and validation appears to be based on compliance with established engineering and medical device standards, and the device's own defined performance specifications, rather than expert interpretation of clinical cases.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of a human-centric adjudication process for evaluating the device's performance, as the study is device-focused rather than clinical.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission specifically states that "clinical data was not required to substantiate claims of safety and effectiveness."
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone performance assessment was conducted for the device's temperature measurement capabilities and its compliance with MR conditions. This included:
- Verification and validation of temperature measurement parameters against Invivo's defined performance specifications.
- Evaluation of the reusable temperature sensor for magnetically induced displacement force, proton emissions, image artifact, and RF heating in an MRI environment.
- Compliance with numerous voluntary standards related to safety, EMC, usability, patient monitoring, electronic thermometers, risk management, MR safety markings, MR induced displacement, and biocompatibility.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for this submission is based on:
- Compliance with recognized voluntary standards: (e.g., IEC, ASTM, ISO standards).
- Manufacturer-defined performance specifications: These specifications were established according to national standards, international standards, market needs, risk management, and intended use.
- Worst-case environment testing: The device was verified using a worst-case environment.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This submission does not describe a machine learning algorithm or an AI-based device that would require a "training set." The device is a traditional patient monitoring system for which hardware and software modifications were made to a temperature sensor.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there was no training set for an AI/ML algorithm.
§ 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).