VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER

K122236 · Varian Medical Systems, Inc. · JAQ · Nov 16, 2012 · Radiology

Device Facts

• Record ID: K122236
• Device Name: VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Nov 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VariSource iX and VariSource iX(t) are indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.

Device Story

VariSource iX and iX(t) are computer-controlled remote afterloading systems for HDR brachytherapy. Device utilizes a high-activity Iridium-192 source fixed to a flexible metal cable; cable is driven via guide tubes into applicators or needles placed in or near a tumor or tumor bed. System allows remote delivery of radiation, minimizing clinician exposure. Operated by clinical staff in a controlled environment. Software manages treatment planning, plan importing, partial treatment options, fraction editing, and remote service access. Output is the precise positioning of the radioactive source to deliver prescribed radiation doses. Benefits include targeted treatment of malignant or benign disease with remote control safety.

Clinical Evidence

No clinical data included. Verification and validation testing performed to confirm conformance to requirements and specifications.

Technological Characteristics

Remote-controlled afterloading system. Utilizes high-activity Iridium-192 source fixed to a flexible metal cable. System includes source guide tubes and applicators/needles. Computer-controlled operation. Software manages treatment delivery and planning parameters.

Indications for Use

Indicated for patients requiring High Dose Rate (HDR) brachytherapy for the treatment of benign or malignant disease, for curative or palliative intent.

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 iX HDR Afterloader (K071467)

Submission Summary (Full Text)

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# PREMARKET 'NOTIFICATION

## 510(k) Summary

## VariSource iX and VariSource iX(t) Afterloaders

## As required by 21 CFR 807.92

Submitter's Name:

Varian Medical Systems 911 Hansen Way, M/S C-255 Palo Alto CA94304

Contact Name: Ms Vy Tran, Vice President, Regulatory Affairs and Quality Systems Phone: [phone] Fax:[phone] [e-mail] Date: 30 April 2012

Proprietry Name:

VariSource iX VariSource iX(t)

Classification Name:

Common/Usual Name:

Predicate Device:

Device Description:

Indications for Use:

Remote controlled radionuclide applicator system 21CFR892.5700 Class II

VariSource iX afterloader, VariSource iX Series afterloaders, VariSource IX series afterloader systems, VariSource iX Series

VariSource iX HDR Afterloader (K071467)

The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or turnor bed in a practice known as brachytherapy.

The VariSource iX Series is indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.

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## Substantial Equivalence Discussion

#### Intended Use

The VariSource iX Series is indicated for use in the treatment of both benign and malignant disease for both curative and palliative intent, in the delivery of remote controlled High Dose Rate (HDR) brachytherapy ..

## Differences

The differences with respect to the predicate are listed in the substantial equivalence chart.

With respect to the previous version of this device, which contained Console software Version 1.1, the changes are to Plan Importing, Partial treatment Options, Fraction Editing and Remote Service Access.

## Technological Characteristics

Both the current device and the predicate are remote-controlled afterloading devices for brachytherapy. The systems both utilize a small, high activity Iridium-192 source that is fixed to a flexible metal cable and driven via one or more source guide tubes into an applicator(s) or needle(s) inserted for a specified clinical purpose into a patient.

## Argument for Substantial Equivalence to the Predicate Device

There are few differences between the VariSource IX Series afterioaders and the predicate. Varian therefore believes that the VariSource iX Series afterloaders are substantially equivalent to the predicate.

#### Non Clinical Tests

Results of Verification and Validation Testing showed conformance to applicable requirements and specifications and assured hazard safeguards functioned properly.

## Clinical Tests

No Clinical Tests have been included in this pre-market submission

#### Conclusions

All the tests that were performed met the applied pass criteria. Varian considers the device to be safe and effective and to perform as well or better than the predicate

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

**NOV** 1 6 2012

Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304

Re: K122236

Trade/Device Name: VariSource iX and VariSource iX(t) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 26, 2012 Received: October 4, 2012

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 (PMA), it may be subject to 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.

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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 Diagnostics and Radiological Health 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 Yours,

Machal D. Offair 11:55:20 -05'00'

Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K122236

Device Name: VariSource iX and VariSource iX(t)

Indications for Use:

The VariSource iX and VariSource iX(t) are indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.

Yes Prescription Use (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 Diagnostics and Radiological Health (OIR)

Michael D. O'Hara 2012.11.16
11:56:44 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K122236

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