(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.
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510(k) SUMMARY
OFFICIAL CONTACT:
Susan Lynn Felix Sr. Regulatory Affairs Specialist MEDRAD, Inc. One MEDRAD Drive Indianola, PA 15051 (412) 767-2400 ext. 3115
UN 2'3 2010
CLASSIFICATION NAME: COMMON NAME(S): PROPRIETARY NAME: PREDICATE DEVICE(S):
Infusion Pump, FRN PET Infusion Pump MEDRAD Intego™ PET Infusion System MEDRAD Intego™ PET Infusion System
INTENDED USE: The MEDRAD Intego™ PET Infusion System in intended to deliver accurate doses of 18F-Fluorodeoxyglucose (18F-FDG) or 18F-Sodium Fluoride (19F-NaF) 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 (48) radiation exposure during nuclear medicine diagnostic procedures.
CONTRAINDICATIONS: None known.
DEVICE DESCRIPTION: 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).
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The infusion system fulfills the following clinical needs:
- Dispense accurate dose of 18F-Fluorodeoxyglucose (18F-FDG) or 18F-Sodium Fluoride a. (18 F-NaF) radiopharmaceuticals and commonly used flushing solutions to patients during nuclear medicine diagnostic procedures.
- b. Provide effective radiation shielding to medical personnel from Fluoride-18 (187) radiation exposure during nuclear medicine diagnostic procedures.
The MEDRAD Intego™ PET Infusion System meets the following performance requirements:
- 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.
- b. Flexibility to program the required dose either by activity only or by activity per patient weight.
- Ability to deliver 18F radiopharmaceuticals within +/- 10% of the prescribed dose and C. within +/- 2% of the measured dose, excluding ionization chamber calibration factor.
- d. Capability to retain and print infusion history and dispensing records.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three diagonal lines that curve and converge at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUN 2 3 2010
Ms. Susan Lynn Felix Senior Regulatory Affairs Specialist MEDRAD, Inc. One MEDRAD Drive INDIANOLA PA 15051
Re: K100798
Trade/Device Name: MEDRAD Intego™ PET Infusion System for 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF)
Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: FRN Dated: March 19, 2010 Received: March 22, 2010
Dear Ms. Felix:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Amold J. Roth
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100798
Device Name:
Indications for Use:
MEDRAD Intego™ PET Infusion System for 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF)
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert R. Becker
(Division Sic Division of Radiological D 510K
Page 1 of 1
§ 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).