(214 days)
The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is a modification of the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device described in 510(k) submission K061128. Similar to the MEDRAD predicate device, the system is designed for patients requiring medications and other fluids during an MR imaging procedure. Both are designed for use in MR environments up to the 2000 Gauss line in magnet strengths up to and including 3T and are not intended to provide long-term patient care. Both systems connect to the existing patient administration line by the addition of a proprietary disposable and replace the bedside pump during the MR procedure. The proposed device and the predicate device are intended to be used by trained healthcare professionals, medical physicians, and critical care, emergency room, and radiology nursing staff. Neither is intended for the delivery of blood, blood products or nitroglycerine.
The MEDRAD Continuum MR Infusion System included in the proposed device has a similar design, similar materials of construction, similar components and similar infusion pump technology as the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device. The primary difference between the two MEDRAD devices is the addition of the remote accessory and wireless radio technology.
The document provided is a 510(k) Pre-market Submission for the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials as would be required for a PMA (Pre-Market Approval). Therefore, the study described is primarily for bench testing and verification/validation against established standards and to confirm design specifications, rather than a clinical study evaluating device performance in humans or against a true "ground truth" derived from patient data.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present specific acceptance criteria in a quantified table with corresponding performance results. Instead, it states that testing will be conducted against applicable standards, and satisfactory test results are required prior to release of the product. The implicit acceptance criterion is successful compliance with the listed standards and internal design specifications.
The document does provide a comparative table (Table 2 and 3) that lists various parameters of the proposed device against predicate devices. While this isn't "acceptance criteria" in the traditional sense of a performance study, it highlights how the proposed device aims to meet or exceed the predicate's specifications.
| Parameter | Predicate Device (K061128) - Acceptance Criteria (Implicit) | Proposed Device - MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Reported Performance) |
|---|---|---|
| Flow Rate | Continuous: 0.1 to 99.9 ml/h in 0.1 ml/h increments, 100 to 1200 ml/h in 1 ml/h increments | Same |
| KVO Infusion Rate | 1 to 5 ml/h | 0 to 5 ml/h (lowered from 1 to 0 ml/h) |
| System Accuracy | +/- 10% | Same |
| Occlusion Pressure | User selectable: Low - 0.3 bar (5 psi), Medium - 0.5 bar (7.5 psi), High - 0.7 bar (10 psi) | Same |
| Pump Battery Operation | 4 hrs at 1200 ml/h | > 8 hrs at 125 ml/h (> 5 hrs at 1200 ml/h) - Slightly higher battery life |
| Pump Battery Charging | ~6 hrs to 95% maximum battery capacity | Same |
| Total Time Setting | 100 hours | Same |
| Prime Rate | 1600 to 1800 ml/h | Same |
| Bolus Flow Rate | 0.1 to 1200 ml/h | Same |
| Bolus Volume | 0.1 to 100 ml | Same |
| Alarm Conditions Options | Air in line, Down occlusion, Pump unattended, Low battery, End battery, Fatal error, End program, Missing key, Lock mode | Same, plus "Program Nearing End" alarm |
| MR Compatible | Yes (up to 2000 Gauss) | Same |
| Usability Software Features | Yes | New features added: Bolus Review Screen, Screen dimming, Reset behavior for "Total Volume Infused", Dose Rate Units setting |
| RF Wireless Technology | Operates at 2.4 GHz (for Iradimed predicate) | Operates at 2.4 GHz; IEEE 802.11b/g |
Study Proving Acceptance Criteria:
The study described is a performance testing program against applicable industry standards.
- Standards: IEC 60601-2-24, IEC 60601-1, UL 60601-1, and IEC 60601-1-2. These standards address safety and performance for medical electrical equipment, particularly infusion pumps.
- Testing Conducted by: Third-party certified test labs.
- Outcome: "Satisfactory test results required prior to release of the product."
- Purpose: To confirm that design specifications have been met and that the device meets the applicable requirements of the cited safety and performance standards. This also serves to confirm substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This is a device performance study (bench testing), not an AI or clinical study with patient data. Therefore, there is no "test set" in the context of patient data. The "test set" would refer to the physical devices or components subjected to testing. The sample size for these engineering tests is not specified in the document, but it typically involves a representative number of units to ensure manufacturing consistency and reliability, as governed by engineering and quality assurance protocols.
Data provenance (country of origin, retrospective/prospective) is not applicable here as it pertains to patient or clinical data, which is not the focus of this 510(k) submission's described study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. "Ground truth" typically refers to verified diagnoses or outcomes in clinical studies, often established by expert consensus or pathology. For this device, the "ground truth" equivalent is compliance with engineering specifications and regulatory standards. The "experts" involved are the engineers, regulatory specialists, and third-party testers who verify adherence to these standards. Their specific number and qualifications (e.g., years of experience) are not detailed in this submission but would be internal to the device manufacturer and the testing labs.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human reviewers assess cases and discrepancies are resolved by a tie-breaker or consensus. For engineering bench testing, "adjudication" is the process of comparing test results against predefined functional and safety specifications, with clear pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an MRMC or comparative effectiveness study. It's a technical verification and validation of a medical device against safety and performance standards and comparison to predicate devices, not an AI or diagnostic imaging product comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. It is an infusion pump system. The "performance" being evaluated is the physical and functional operation of the pump, not an algorithm's diagnostic output.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance study is adherence to predefined engineering specifications, safety standards (e.g., IEC 60601 series, UL 60601-1), and functional requirements for an infusion pump. This is confirmed through bench testing and verification/validation activities. It does not involve expert consensus on clinical cases, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (infusion pump), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).