(134 days)
The MEDRAD Intego™ PET Infusion System is intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) 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. FDG is stored within a shielded chamber within the body of the MEDRAD Intego PET Infusion System in a bulk container until the time of the infusion. A multi-patient Source Administration Set (SAS) is installed within the shielded chamber at the same time a new bulk container of FDG is installed. Just prior to an infusion, the MEDRAD Intego PET Infusion System measures a dosage of FDG and a volume of saline flush in the dose calibrator. Once the correct radiation level is achieved, the dose of FDG / saline is injected into the patient via a disposable patient administration set.
The MEDRAD Intego™ PET Infusion System is intended to deliver accurate doses of $^{18}$F Fluorodeoxyglucose (FDG) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures, and to provide effective radiation shielding to medical personnel from Fluorine-18 ($^{18}$F) radiation exposure during nuclear medicine diagnostic procedures.
Here's a breakdown of the acceptance criteria and performance, along with details from the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For a typical 15 mCi infusion per patient, $^{18}$F radiation exposure for medical personnel will be less than 6 mRem finger dose and 0.3 mRem whole body dose. | The document states, "For a typical 15 mCi infusion per patient, $^{18}$F radiation exposure for medical personnel will be less than 6 mRem finger dose and 0.3 mRem whole body dose." This implies the device is designed to meet and perform within these limits. The 510(k) summary does not provide specific numerical results from a performance study for radiation exposure, but rather states this as a performance requirement that the system meets. The FDA clearance suggests this requirement was deemed met. |
| Ability to deliver $^{18}$F radiopharmaceuticals within +/- 10% of the prescribed dose and within +/- 2% of the measured dose, excluding ionization chamber calibration factor. | The document states, "Ability to deliver $^{18}$F radiopharmaceuticals within +/- 10% of the prescribed dose and within +/- 2% of the measured dose, excluding ionization chamber calibration factor." This is stated as a performance requirement that the system meets. Similar to the radiation exposure, the exact numerical results from a performance study are not explicitly provided in the summary, but its inclusion as a met requirement in the 510(k) suggests testing confirmed this. |
| Flexibility to program the required dose either by activity only or by activity per patient weight. | The document describes this as a functional capability: "Flexibility to program the required dose either by activity only or by activity per patient weight." This is a design feature/functionality rather than a quantifiable performance metric that needs a numerical "reported performance" value. The device's design is assumed to incorporate this flexibility. |
| Capability to retain and print infusion history and dispensing records. | The document describes this as a functional capability: "Capability to retain and print infusion history and dispensing records." This is a design feature/functionality and not a quantifiable performance metric requiring a numerical "reported performance" value. The device is expected to have this capability built-in. |
Regarding the study that proves the device meets the acceptance criteria:
The provided 510(k) summary does not detail the specific studies, methodologies, or results that prove these acceptance criteria were met. Instead, it states them as "performance requirements" that the system "meets." In a 510(k) submission, the manufacturer is expected to have conducted these studies, and the FDA's clearance (as indicated by the letter) means they have accepted the manufacturer's data showing the device meets these performance specifications. However, the summary itself doesn't provide the study specifics.
Therefore, for the following points, based solely on the provided text, the answer is that this information is not detailed in the 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the 510(k) summary. Performance testing for medical devices, particularly for dispensing accuracy and radiation shielding, typically involves laboratory evaluations and may include animal or simulated human studies, but the specifics are absent here.
3. 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 for this type of device. The "ground truth" for an infusion system like this would be established through precise physical measurements (e.g., activity measurements using calibrated equipment, radiation dosimetry readings). It does not involve expert interpretation of images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of device. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints that require consensus.
5. 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 device is an infusion system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical infusion system, not a standalone algorithm. Its performance is measured by its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the dose accuracy, the ground truth would be established by controlled measurements using highly calibrated reference instruments (e.g., dose calibrators, mass scales for volume) to verify the actual dispensed amount against the programmed/prescribed amount. For radiation shielding, the ground truth would be established by dosimetry measurements using calibrated radiation detectors to quantify exposure levels.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI that requires a "training set." Its operation is based on established physical and engineering principles.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this device.
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K080297
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510(K) SUMMARY
OFFICIAL CONTACT:
Troy A. Jack Sr. Regulatory Affairs Specialist MEDRAD, Inc. One MEDRAD Drive Indianola, PA 15051 (412) 767-2400 ext. 3305
| CLASSIFICATION NAME: | Infusion Pump |
|---|---|
| COMMON NAME(S): | PET Infusion System |
| PROPRIETARY NAME: | MEDRAD Intego™ PET Infusion System |
| PREDICATE DEVICES: | MEDRAD Continuum MR Infusion System (K032771)Cal/Rad Mark VI/VDC-05 Dose Calibrator, Model 34-165 (K030066)Personnel Protective Shield (Class I exempt)Radionuclide Rebreather System (Class II)MEDRAD Avanta Fluid Management Injection |
JUN 1 7 2008
System [Patient Administration Set] (K050456)
INTENDED USE: The MEDRAD Intego PET Infusion System is intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) 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 (MF) radiation exposure during nuclear medicine diagnostic procedures.
CONTRAINDICATIONS: This device should not be used for pediatric patients.
DEVICE DESCRIPTION: The MEDRAD Intego PET Infusion System is a self-contained, shielded mobile cart. FDG is stored within a shielded chamber within the body of the MEDRAD Intego PET Infusion System in a bulk container until the time of the infusion. A multi-patient Source Administration Set (SAS) is installed within the shielded chamber at the same time a new bulk container of FDG is installed. Just prior to an infusion, the MEDRAD Intego PET Infusion System measures a dosage of FDG and a volume of saline flush in the dose calibrator. Once the correct radiation level is achieved, the dose of FDG / saline is injected into the patient via a disposable patient administration set.
This infusion system fulfills the following clinical needs:
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- Dispense accurate doses of 18F Fluorodeoxyglucose (FDG) radiopharmaceuticals a. and commonly used flushing solutions to patients during nuclear medicine diagnostic procedures.
- Provide effective radiation shielding to medical personnel from Fluorine-18 (18F) b. radiation exposure during nuclear medicine diagnostic procedures.
The MEDRAD Intego PET Infusion System meets the following performance requirements:
- For a typical 15 mCi infusion per patient, 18F radiation exposure for medical a. personnel will be less than 6 mRem finger dose and 0.3 mRem whole body dose.
- Flexibility to program the required dose either by activity only or by activity per b. patient weight.
- Ability to deliver 18F radiopharmaceuticals within +/- 10% of the prescribed dose C. and 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 Department of Health & Human Services - USA. 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 image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2008
Mr. Troy A. Jack Senior Regulatory Affairs Specialist Medrad, Inc. One Medrad Drive INDIANOLA PA 15051-0780
Re: K080297
· Trade/Device Name: MEDRAD Intego™ PET Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: FRN Dated: May 1, 2008 Received: May 2, 2008
Dear Mr. Jack:
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the won't product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.
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, permorte your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, release contact CDRH 3 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of amer Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2441 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.born1 or
Sincerely yours,
Nancy Brogdo
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: MEDRAD Intego™ PET Infusion System
Indications for Use: The MEDRAD Intego™ PET Infusion System is intended to deliver accurate doses of 197 Fluorodeoxyglucose (FDG) 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 Fluorinc-18 (16F) radiation exposure during nuclear medicine diagnostic procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080297
§ 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).