VARISOURCE 200 HDR AFTERLOADER

K061582 · Varian Medical Systems, Inc. · JAQ · Jul 25, 2006 · Radiology

Device Facts

• Record ID: K061582
• Device Name: VARISOURCE 200 HDR AFTERLOADER
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VariSource 200 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 200 is a computer-controlled remote HDR brachytherapy afterloader. It uses a NiTiNol wire containing an enriched iridium radioactive source. The device drives the source through coupling catheters into needles or applicators previously placed in or on a patient's tumor or tumor bed. Operation is controlled by a console running DOS on an Intel PC, with firmware on an embedded Intel 188 processor. The system receives treatment plans via floppy disk. It provides real-time wire position and system status, with hard-copy output of prescriptions and delivery records. The device includes safety features like emergency source retraction, battery backup, and interlocks. It is used in clinical settings by healthcare professionals to deliver precise radiation doses, potentially benefiting patients by treating malignant tumors while minimizing radiation exposure to surrounding healthy tissue.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included verification of source positioning accuracy, mechanical life (1000 extensions), and compliance with IEC 601-2-17 safety standards for surface dose requirements.

Technological Characteristics

Materials: Tungsten alloy, NiTiNol wire. Energy: Enriched Iridium radioactive source. Dimensions: 610mm x 560mm x 1070mm. Connectivity: Floppy disk for treatment plan transfer. Control: Intel 486 50MHz PC (DOS) and embedded Intel 188 processor. Safety: Electro-mechanical channel indexer, UPS, manual crank, LED-photo transistor catheter detection. Standards: IEC 601-2-17.

Indications for Use

Indicated for treatment of lesions, tumors, and conditions in the body where radiation is indicated. Prescription use only.

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 (K945383)

Submission Summary (Full Text)

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#### K061582 510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the VariSource 200 HDR Brachytherapy Afterloader.

- Varian Medical Systems 1. Submitter: 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] [phone] Fax: Email: [e-mail] Date summary was prepared: June 1, 2006

| 2. Name of the Device: | VariSource 200 HDR Afterloader |
|-------------------------|----------------------------------------------------------------------------------------------|
| Trade/Proprietary Name: | VariSource 200 HDR Afterloader |
| Common or Usual Name: | |
| Classification Name: | Radiological Image Processing System<br>21 CFR §892.5700<br>Class II<br>Product Code: 90 JAQ |

- 3. Predicate Devices to claim substantial equivalence: a. VariSource K(945383)
- 4. Description of the Device: The VariSource 200 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.

## Hardware Platform and Operating System

The console control application runs on standard Intel PCs under a DOS operating systems. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 188 processor.

### Peripherals and Accessories

The 200 Series control console provides real time information of wire position and system status and interfaces with a printer in order to provide a hard copies of a treatment prescriptions and delivery records. In addition the 200 Series control

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console can receive treatment plans from a treatment planning application (not part of this submission), this information is transferred via a floppy disk.

5. Intended Use Statement: The VariSource 200 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.

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

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Image /page/2/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in bold, uppercase letters. The "I" in "VARIAN" is stylized with a curved line extending above the letter. Below the word "VARIAN" are the words "medical systems" in a smaller font.

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## Varian Brachytherapy

## HDR Product Comparison Chart

The following table represents information as known to Varian from a review of published information available about competing products and the predicate device.

| Description | Varian VariSource<br>Remote High Dose Rate<br>Afterloader<br>(Predicate Device) | VariSource 200 |
|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K945383 | |
| Intended Use | High Dose Rate<br>Brachytherapy | High Dose Rate<br>Brachytherapy |
| Safe<br>(Maximum source strength) | Tungsten Alloy<br>370GBq | Tungsten Alloy<br>407GBq. Safe and Unit<br>tested to meet Surface<br>Dose Requirement |
| Maximum Surface Dose<br>(IEC 601-2-17: 1µGy/h @ 1m) | <0.5 µGy/h @ 1m | <0.5 µGy/h @ 1m |
| Radiation Detector | Installed in room<br>Built into unit - and<br>connected to system<br>interlocks | Installed in room<br>Built into unit - and<br>connected to system<br>interlocks |
| Dimension<br>Length<br>Width<br>Height | 635mm<br>533 mm<br>1097 mm | 610 mm<br>560 mm<br>1070 mm |
| Weight | 148Kg | 142 kg |
| Power Requirements | 110/220 V +/- 10% | 110/220 V +/- 10% |
| Power Consumption | 550 VA, peak | 550 VA, peak |
| UPS | Yes | Yes |
| Ambient Temperature | 15 - 35°C | 15 - 35°C |
| Relative Humidity | 30% - 75% | 30% - 75% |
| Atmospheric Pressure | 70kPa - 110kPa | 70kPa - 110kPa |
| Rotation of head | No (rotate unit) | No (rotate unit) |
| Variable Height head | No | No |
| Number of patient<br>connection Channels | 20 | 20 |
| Channel Indexer Locking<br>Mechanism | Mechanical | Electro-Mechanical |
| Method of Correct Catheter<br>connection Detection | LED - Photo Transistor Pair | LED - Photo Transistor Pair |
| Treatment Length in<br>Catheter | 70 cm to 150cm | 70 cm to 150cm |
| Authorized Access: | Yes | Yes |
| Key Switch | Yes | Yes |
| Password | Yes - 3 levels | Yes - 3 levels |
| Power Fail | UPS takes over - operator<br>can choose to continue or<br>interrupt treatment.<br>An interrupted treatment<br>may be completed at<br>operator option at any time.<br>UPS will power unit safely<br>for 30 minutes - new patient<br>treatment may not be<br>initiated during power fail | UPS takes over - operator<br>can choose to continue or<br>interrupt treatment.<br>An interrupted treatment<br>may be completed at<br>operator option at any time.<br>UPS will power unit safely<br>for 30 minutes - new patient<br>treatment may not be<br>initiated during power fail |
| Description | Varian VariSource<br>Remote High Dose Rate<br>Afterloader<br>(Predicate Device) | VariSource 200 |
| Emergency Source Retraction: | | |
| Battery Back-up | Yes | Yes |
| Battery test prior to source<br>extension | Yes | Yes |
| DC Motor | Yes | Yes |
| Separate Motor | Yes | Yes |
| Manual Crank | Yes | Yes |
| Manual Crank Access | On side of unit | On side of unit |
| Crank method | Handle on wheel | Handle on wheel |
| Source: | | |
| Source Wire No | SL 777V | VS2000 |
| Source Capsule Length | 11mm | 6 mm |
| Source Active Length | 10mm | 5 mm |
| Source Diameter | 0.59mm | 0.59 mm |
| Source Material | Iridium | Enriched Iridium |
| Source Wire | Solid Nickel-Titanium Alloy | Solid Nickel-Titanium Alloy |
| Turning Radius | 17 mm in 4.7 Fr thick wall<br>catheter, at 120 cm from<br>turret | 17 mm in 4.7 Fr thick wall<br>catheter, at 120 cm from<br>turret |
| Source Mechanical Life | Interlocked at 500<br>extensions | Interlocked at 1000<br>extensions |
| QA Tool | | |
| Source Position<br>Verification. Video image<br>via frame grabber with plain<br>paper print out. | Yes - External, allows daily<br>QA of source positioning<br>accuracy, including dummy<br>positioning - recorded on a<br>single sheet of paper. | Yes - Internal, allows daily<br>QA of source positioning<br>accuracy, including dummy<br>positioning - recorded on a<br>single sheet of paper. |
| User Interface | | |
| Graphical User interface | DOS | DOS |
| Operating System | | |
| Prescription Record<br>Transfer | Floppy disk | Floppy disk |
| Standard Plans | On floppy disk | On floppy disk |
| Prescription & Reports | Printed on Paper | Printed on Paper |
| PC Hardware* | Intel 486 50MHz, IBM<br>Compatible | Intel 486 50MHz, IBM<br>Compatible |
| Monitor* | 15" CRT | 15" CRT |
| Printer* | Laser Printer | Laser Printer |
| Independent Treatment<br>Control Panel | Yes | Yes |
| Regulations:<br>IEC 601-2-17 | Yes | Yes |

| (:

CTD Section 5

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# HDR Product Comparison Chart

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*Minimum Specification

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| Department | VBT Project Manager | Date: | 16th December 2005 |
|------------|---------------------|------------|--------------------|
| Name | Chris Heath | Signature: | |

CTD Section 5

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and 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 image of what appears to be a human figure embracing or protecting another figure, possibly representing care or support.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 25 2006

Ms. Vy Tran Director, Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way M/S E-110 PALO ALTO CA 94304-1129

Re: K061582

Trade/Device Name: VariSource 200 HDR Brachytherapy Afterloader Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 2, 2006 Received: June 7, 2006

## 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/4/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a bold, sans-serif font. Above the letters, the numbers "1906 - 2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. The logo is surrounded by a circular border with small stars and text.

roting Public J

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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 electronic form in the quind 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) I mo loket notification. The FDA finding of substantial equivalence of your device to a legally premaince modicate 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogden

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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PAGE 1 of 1

K061582 510(k) Number (if known): Device Name: VariSource 200 HDR Brachytherapy Afterloader

#### Indications For Use:

The VariSource 200 System is a High Dose Rate Brachytherapy Afterloader used to treat lesions, tumors and conditions in the body where radiation 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)

Tamye Snugden
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K061582

Prescription Use _ (Per 21 CFR 801.109)