GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER

K990753 · Cook, Inc. · JAQ · May 27, 1999 · Radiology

Device Facts

• Record ID: K990753
• Device Name: GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
• Applicant: Cook, Inc.
• Product Code: JAQ · Radiology
• Decision Date: May 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is intended for remote afterloading of a radiation source. To be used with the GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.

Device Story

The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is a 5.6 French, 129cm long, single-lumen catheter with a closed distal end. It features shaft markings for accurate pre-treatment positioning. The device functions as a conduit for the remote afterloading of a radiation source when used with the GammaMed 12i Remote High Dose Rate Afterloader system. It is intended for clinical use by healthcare professionals to facilitate radiation therapy delivery. The device is designed to withstand internal friction and radiation exposure while maintaining structural integrity during the afterloading process.

Clinical Evidence

Bench testing only. Testing included internal friction force, radiation exposure, leak testing, tensile strength, and biocompatibility to ensure design and performance conformance.

Technological Characteristics

5.6 French, 129cm long, single-lumen catheter with closed distal end. Features shaft markings for positioning. Compatible with GammaMed 12i Remote High Dose Rate Afterloader. Non-electronic, mechanical device.

Indications for Use

Indicated for remote afterloading of a radiation source in conjunction with the GammaMed 12i Remote High Dose Rate Afterloader system. Patient population not specified.

Regulatory Classification

Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Predicate Devices

• Cook Incorporated remote afterloading catheter (K945383)
• Cook Incorporated remote afterloading catheter (K981886)

Submission Summary (Full Text)

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MAY 27 1999

K990753

:

VII.1

:

510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED

# APPENDIX VII

SMDA SUMMARY

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510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED

### Safety and Effectiveness Information

April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 [phone]

| Device: | Trade Name: | GRAC High Dose Rate (HDR) Remote<br>Afterloading Catheter |
|-------------------------------|-------------|-----------------------------------------------------------|
| Proposed Classification Name: | | Remote Controlled Radionuclide Applicator<br>System |

#### Intended Use:

The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is intended for remote afterloading of a radiation source. To be used with the GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.

#### Predicate Devices:

The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as remote afterloading catheters.

#### Device Description

The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is a 5.6 French , 129cm long, single lumen catheter. The distal end of the catheter is closed. The outside diameter of the shaft has placement markings to facilitate accurate pre-treatment positioning of the catheter. The catheter is compatible with the GammaMed 12i Remote High Dose Rate Afterloader supplied by Frank Barker Associates, of Tuwaco, New Jersey.

#### Substantial Equivalence

The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is similar to other Cook Incorporated remote afterloading catheters which were found substantially equivalent under

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#### 510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED

510(k) #D.C. K945383 and D.C. K981886. The similar indications for use and technological characteristics of the GRAC High Dose Rate (HDR) Remote Afterloading Catheter as compared to the predicate devices supports a determination of substantial equivalency.

## Test Data

The GRAC High Dose Rate (HDR) Remote Afterloading Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:

- Internal Friction Force જુન
- 参 Radiation Exposure
- જુન Leak Test
- 参 Tensile Strength
- 必 Biocompatibility

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 1000

April Lavender Vice President, Regulatory Affairs Cook. Inc. 925 South Curry Pike Bloomington, IN 47402

Re: K990753

> GRAC High Dose Rate (HDR) Remote Afterloading Catheter Dated: March 4, 1999 Received: March 8, 1999 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAQ

Dear Ms. Lavender:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 manical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

BART David S. Schulte, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED

510(k) Number (if known): _ K 9 90 7 53

High Dose Rate (HDR) Remote Afterloading Catheter Device Name:

Indications for Use:

Used for remote afterloading of a radiation source. To be used with the GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﮐﮯ Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

Daniel A. Severson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number