VARISOURCE IX HDR AFTERLOADER

K071467 · Varian Medical Systems, Inc. · JAQ · Jul 16, 2007 · Radiology

Device Facts

• Record ID: K071467
• Device Name: VARISOURCE IX HDR AFTERLOADER
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VariSource iX System is a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specified clinical purpose in a patient. The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into needles or applicators within or on the patient. The length of time and position that the High Dose Rate source spends within the needle or applicator is controlled in accordance with an Irradiation Treatment Prescription.

Device Story

VariSource iX HDR Afterloader is a computer-controlled remote electro/mechanical system for brachytherapy. It delivers a NiTiNol wire containing an irradiated iridium seed into needles or applicators previously placed in or near a tumor. System features up to 20 treatment channels. Operated by clinical staff in a treatment environment; console provides real-time wire position and system status. Receives treatment plans from external planning software via USB or network. Device controls source dwell time and position within applicators per treatment prescription. Benefits patients by enabling precise, remote-controlled delivery of high-dose radiation to malignant or benign tissue while minimizing clinician radiation exposure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Remote-controlled electro/mechanical afterloader; NiTiNol wire with iridium seed; 20-channel capacity. Hardware: PC-based control console (Windows OS) and embedded Intel 188 processor for firmware. Connectivity: USB2 and network interface for treatment plan transfer. Peripherals: Printer for delivery records.

Indications for Use

Indicated for treatment of benign and malignant disease, for curative and palliative intent, via remote-controlled high dose-rate brachytherapy for conditions anywhere in the body where brachytherapy is indicated.

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

• VariSource (K061582)

Submission Summary (Full Text)

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K07/467

# JUL 16 2007

### 510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the VariSource iX HDR Brachytherapy Afterloader.

1. Submitter: Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] Fax: [phone] Email: [e-mail] Date summary was prepared: May 25th, 2007

| 2. Name of the Device: | VariSource iX HDR Afterloader |
|-------------------------|-------------------------------------------------------------------------------------------|
| Trade/Proprietary Name: | VariSource iX HDR Afterloader |
| Common or Usual Name: | VariSource iX HDR Afterloader |
| Classification Name: | Radiological Image Processing System<br>21 CFR §892.5700<br>Class II<br>Product Code: JAQ |

- 3. Predicate Device to claim substantial equivalence: VariSource K061582
- 4. Description of the Device: The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.

## Hardware Platform and Operating System

The console control application runs on validated PCs under a Microsoft®¹ windows operating system. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 188 processor.

### Peripherals and Accessories

The iX Series control console provides real time information of wire position and system status and interfaces with a printer in order to provide a hard copy of a treatment prescriptions and delivery records. In addition the iX Series control console can receive treatment plans from a treatment planning application (not part of this submission), this information is transferred either manually using a USB2 drive, or via a network interface.

Registered Trade Mark of Microsoft Corporation

² USB- Universal Serial Bus

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- 5. Intended Use Statement: The VariSource iX System is a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specified clinical purpose in a patient.
The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into needles or applicators within or on the patient.

The length of time and position that the High Dose Rate source spends within the needle or applicator is controlled in accordance with an Irradiation Treatment Prescription.

- 6. Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 9 of the submission.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The overall design is simple and conveys a sense of government authority.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# JUL 16 2007

Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems 3100 Hansen Way M/S E-110 PALO ALTO CA 94304

Re: K071467

Trade/Device Name: VariSource iX HDR Brachytherapy Afterloader Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: May 25, 2007 Received: May 29, 2007

### Dear Ms. Tran:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "DA" are in the center of the logo in a stylized font. The word "Centennial" is written below the letters "DA" in a cursive font. There are three stars at the bottom of the logo.

Presocing and Promoting Publio Hoath

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Enclosure

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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 promated 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology 240-276-0115 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--------------|
| 21 CFR 884 xxx --------------------------------------------------------------------------------------------------------------------------------------------------------------- | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K071467
Device Name: VariSource iX HDR Brachytherapy Afterloader

### Indications For Use:

The VariSource iX is indicated, in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled high dose-rate Brachytherapy for conditions anywhere in the body when brachytherapy treatment is indicated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Helene Reem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __