(93 days)
The MEDRAD Intego™ PET Infusion System for 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) is intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. The MEDRAD Intego™ PET Infusion System is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 (18F) radiation exposure during nuclear medicine diagnostic procedures.
The MEDRAD Intego™ PET Infusion System is a self-contained, shielded mobile cart. 18F-Fluorodeoxyglucose (19F-FDG) or 18F-Sodium Fluoride (18F-NaF) is stored within a shielded chamber within the body of the MEDRAD Intego™ PET Infusion System in a bulk container until the time of infusion. A multi-patient Source Administration Set (SAS) is installed within the shielded chamber at the same time a new bulk container of 187-Fluorodeoxyglucose (18F-FDG) or 18F-Sodium Fluoride (18F-NaF) is installed. Just prior to the infusion, the MEDRAD Intego™ PET Infusion System measures a dosage of ¹8F-Fluorodeoxyglucose (18F-FDG) or ™F-Sodium Fluoride (18F-NaF) and a volume of saline flush in the dose calibrator. Once the correct radiation level is achieved, the dose of 18F-Fluorodeoxyglucose (18F-FDG) or 18F-Sodium Fluoride (18 F-NaF) / saline is injected into the patient via a disposable patient administration set (PAS).
The MEDRAD Intego™ PET Infusion System is intended to deliver accurate doses of 18F-Fluorodeoxyglucose (18F-FDG) or 18F-Sodium Fluoride (18F-NaF) and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It also provides effective radiation shielding to medical personnel from Fluorine-18 (18F) radiation exposure.
Here's an analysis of the acceptance criteria and study information provided in the 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| a. For a typical 15mCi infusion per patient, 18F radiation exposure for medical personnel will be less than 6mRem finger dose and 0.3 mRem whole body dose. | (Not explicitly stated in the provided text as a specific test result, but implied that the device "meets the following performance requirements," indicating it fulfills this criterion.) The system is intended to provide effective radiation shielding. |
| b. Flexibility to program the required dose either by activity only or by activity per patient weight. | (Implied as a feature of the device that it "meets the following performance requirements.") The device is described as "measur[ing] a dosage... Once the correct radiation level is achieved..." indicating programmable dosage. |
| c. Ability to deliver 18F radiopharmaceuticals within +/- 10% of the prescribed dose and within +/- 2% of the measured dose, excluding ionization chamber calibration factor. | (Not explicitly stated in the provided text as a specific test result, but implied that the device "meets the following performance requirements.") The system is intended to "dispense accurate dose." |
| d. Capability to retain and print infusion history and dispensing records. | (Implied as a feature of the device that it "meets the following performance requirements.") |
Note: The provided 510(k) summary states that the "MEDRAD Intego™ PET Infusion System meets the following performance requirements." However, it does not provide specific study results or data to quantify how these acceptance criteria were met. It merely lists the criteria themselves as statements of compliance.
Study Details:
Based on the provided text, a detailed study report proving the device meets the acceptance criteria is not included in this 510(k) summary. The document outlines the device's intended use and performance requirements but does not present data from specific studies.
Therefore, the following information cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as no external "ground truth" for diagnostic accuracy or expert consensus is relevant for an infusion pump's performance. The ground truth for this device would be its actual physical output and radiation shielding efficacy, measured directly.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/imaging diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a device like this, the "ground truth" would be established via direct physical measurements using calibrated equipment (e.g., dose calibrators, radiation detectors) and engineering tests. The text does not detail these measurements.
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) document outlines the performance requirements that the MEDRAD Intego™ PET Infusion System is stated to meet. However, it does not include a description of the studies, data, or specific results that demonstrate how these requirements were scientifically verified. The FDA's letter simply confirms that the device has been found substantially equivalent to a predicate device based on the information submitted by MEDRAD, Inc.
§ 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).