MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C

K100798 · Medrad, Inc. · FRN · Jun 23, 2010 · General Hospital

Device Facts

• Record ID: K100798
• Device Name: MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
• Applicant: Medrad, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jun 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Indications for 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.

Device Story

Mobile, shielded cart system for automated delivery of 18F-FDG or 18F-NaF radiopharmaceuticals. Bulk radiopharmaceutical stored in shielded chamber; multi-patient Source Administration Set (SAS) installed with bulk container. Prior to infusion, system measures dose and saline flush volume via integrated dose calibrator. Once target radiation level achieved, system injects dose into patient via disposable patient administration set (PAS). Operated by medical personnel in clinical settings. System provides radiation shielding to reduce personnel exposure; allows programming by activity or activity-per-weight. Outputs include 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 <6mRem finger dose and 0.3 mRem whole body dose per 15mCi infusion; dose delivery accuracy within +/- 10% of prescribed and +/- 2% of measured dose; capability to retain/print infusion history.

Technological Characteristics

Self-contained mobile cart with integrated shielded chamber and dose calibrator. Infusion pump mechanism for radiopharmaceuticals and saline. Connectivity includes printing capability for records. Software-controlled dose measurement and delivery.

Indications for Use

Indicated for patients undergoing molecular imaging (nuclear medicine) diagnostic procedures requiring administration of 18F-Fluorodeoxyglucose (FDG) or 18F-Sodium Fluoride (NaF).

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.

Submission Summary (Full Text)

{0}------------------------------------------------

K100798

510(k) SUMMARY

OFFICIAL CONTACT:

Susan Lynn Felix Sr. Regulatory Affairs Specialist MEDRAD, Inc. One MEDRAD Drive Indianola, PA 15051 [phone] 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).

{1}------------------------------------------------

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.

{2}------------------------------------------------

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

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

## 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