MEDRAD INTEGO PET INFUSION SYSTEM

K080297 · Medrad, Inc. · FRN · Jun 17, 2008 · General Hospital

Device Facts

• Record ID: K080297
• Device Name: MEDRAD INTEGO PET INFUSION SYSTEM
• Applicant: Medrad, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jun 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Indications for 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 (18F) radiation exposure during nuclear medicine diagnostic procedures.

Device Story

Mobile, shielded cart system for automated delivery of 18F-FDG radiopharmaceuticals; stores bulk FDG in shielded chamber; utilizes multi-patient Source Administration Set (SAS). Prior to infusion, system measures FDG dosage and saline flush volume via integrated dose calibrator; injects dose into patient via disposable patient administration set. Operated by medical personnel in clinical settings; provides radiation shielding to reduce finger/whole-body exposure. System allows programming by activity or activity-per-weight; retains/prints infusion history and dispensing records. Benefits include accurate dosing and reduced radiation exposure for staff.

Clinical Evidence

Bench testing only. Performance requirements verified: 18F radiation exposure for personnel < 6 mRem finger dose and < 0.3 mRem whole body dose; delivery accuracy within +/- 10% of prescribed dose and +/- 2% of measured dose; capability to program by activity or weight; and data logging/printing functionality.

Technological Characteristics

Mobile shielded cart; integrated dose calibrator; multi-patient Source Administration Set (SAS); disposable patient administration set. Connectivity includes printing capability. Software-controlled infusion and dose measurement. Sterilization method not specified.

Indications for Use

Indicated for adult patients undergoing molecular imaging (nuclear medicine) diagnostic procedures requiring 18F Fluorodeoxyglucose (FDG) radiopharmaceuticals. Contraindicated for pediatric patients.

Regulatory Classification

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.

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 System [Patient Administration Set] (K050456)

Submission Summary (Full Text)

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K080297
pg. 1 of 2

# 510(K) SUMMARY

OFFICIAL CONTACT:

Troy A. Jack Sr. Regulatory Affairs Specialist MEDRAD, Inc. One MEDRAD Drive Indianola, PA 15051 [phone] ext. 3305

| CLASSIFICATION NAME: | Infusion Pump |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMMON NAME(S): | PET Infusion System |
| PROPRIETARY NAME: | MEDRAD Intego™ PET Infusion System |
| PREDICATE DEVICES: | <ul><li>MEDRAD Continuum MR Infusion System (K032771)</li><li>Cal/Rad Mark VI/VDC-05 Dose Calibrator, Model 34-165 (K030066)</li><li>Personnel Protective Shield (Class I exempt)</li><li>Radionuclide Rebreather System (Class II)</li><li>MEDRAD Avanta Fluid Management Injection</li></ul> |

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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K080297
Pg. 2 of 2

- 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 [phone] or [phone] 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