VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER

K981886 · Cook, Inc. · JAQ · Nov 3, 1998 · Radiology

Device Facts

• Record ID: K981886
• Device Name: VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
• Applicant: Cook, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used for remote afterloading of a radiation source. To be used with the Varian VariSource Remote High Dose Rate Afterloader system, supplied by Varian Oncology Systems of Palo Alto, California.

Device Story

VRAC High Dose Rate (HDR) Remote Afterloading Catheter; 4.6 French, 150cm long, single lumen catheter with closed distal end; features shaft placement markings for accurate pre-treatment positioning. Device functions as conduit for radiation source delivery; compatible with Varian VariSource Remote High Dose Rate Afterloader. Used in clinical settings by medical professionals for brachytherapy procedures. Facilitates precise radiation source placement to target tissue; enables remote afterloading to minimize radiation exposure to clinical staff. Benefits patient through accurate, controlled radiation delivery.

Clinical Evidence

Bench testing only. Tests included coefficient of friction comparison/simulated use, fluid ingress, tensile strength, and biocompatibility. No clinical data provided.

Technological Characteristics

4.6 French, 150cm single lumen catheter; closed distal end; shaft placement markings. Mechanical device; no energy source or software. Sterilization method not specified.

Indications for Use

Indicated for remote afterloading of a radiation source in conjunction with the Varian VariSource Remote High Dose Rate Afterloader system.

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)

Reference Devices

• Varian VariSource Remote High Dose Rate Afterloader

Submission Summary (Full Text)

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NOV က 1998

510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED

VII.2
K98/884

## 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] May 27, 1998

VRAC High Dose Rate (HDR)Remote Trade Name: Device: Afterloading Catheter Remote Controlled Radionuclide Applicator Proposed Classification Name: System

## Predicate Devices:

The VRAC 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 VRAC High Dose Rate (HDR) Remote Afterloading Catheter is a 4.6 French , 150cm 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 Varian VariSource Remote High Dose Rate Afterloader manufactured by Varian Oncology Systems, Palo Alto, California.

#### Substantial Equivalence

The VRAC High Dose Rate (HDR) Remote Afterloading Catheter is similar to another COOK INCORPORATED remote afterloading catheter which was found substantially equivalent under 510(k) #D.C. K945383. The similar indications for use and technological characteristics of the VRAC High Dose Rate (HDR) Remote Afterloading Catheter as compared to the predicate device supports a determination of substantial equivalency.

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

# Test Data

The VRAC 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:

- Co-Efficient of Friction Comparison/Simulated Use 参
- 彩 Ingress of Fluids
- � Tensile Strength
- � 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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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/2/Picture/15 description: The image shows a partial view of a seal or emblem, featuring the text "DEPARTMENT OF HEALTH & HUMAN". The text is arranged in a circular fashion, suggesting it is part of a larger circular design. To the right of the text, there are three stylized, curved lines, possibly representing a symbol or abstract design element within the emblem.

3 1998 NOV

April Lavender, RAC Vice President Regulatory Affairs Cook Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 Re: K981886

VRAC High Dose Rate (HDR) Remote Afterloading Catheter Dated: August 7, 1998 Received: August 10, 1998 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAO

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 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). 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 (OS) 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 vitn 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/oddf/dsmadsmam.html".

Sincerely yours,

Lillian Yih, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Thro 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):

981886

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 Varian VariSource Remote High Dose Rate Afterloader system, supplied by Varian Oncology Systems of Palo Alto, California.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

ﺮﺓ، ﻭ

David A. Syreem

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