RADIONICS VARILINK 2

K023519 · Radionics, A Division of Tyco Healthcare Group LP · IYE · Jan 16, 2003 · Radiology

Device Facts

• Record ID: K023519
• Device Name: RADIONICS VARILINK 2
• Applicant: Radionics, A Division of Tyco Healthcare Group LP
• Product Code: IYE · Radiology
• Decision Date: Jan 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VariLink 2 MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' Treatment Planning Software, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. The VariLink 2 MMLC can be used as part of IMRT (Intensity Modulated Radiotherapy) or general conformal radiation.

Device Story

VariLink 2 is an accessory for the Radionics Mini-Multileaf Collimator (MMLC) mounted on Varian C-Series Linear Accelerators (Linac). It enables Intensity Modulation Radiation Therapy (IMRT) by facilitating segmented beam delivery. The device interfaces with the Varian gating board to suspend the radiation beam between segments, allowing the MMLC to reconfigure field shapes. Operated by radiation oncology teams in clinical settings, it transforms treatment plans generated by Radionics software into physical beam shapes. By enabling non-constant intensity across the irradiation field, it allows for precise dose delivery to target volumes while sparing healthy tissue.

Clinical Evidence

Bench testing only. Functionality of the VariLink 2 was verified using a Varian C-Series Linac with the Gating Board Interface to ensure proper beam suspension and MMLC field shaping.

Technological Characteristics

Accessory for Mini-Multileaf Collimator (MMLC); interfaces with Varian C-Series Linear Accelerator gating board; enables segmented beam delivery for IMRT; hardware-based beam suspension control.

Indications for Use

Indicated for patients requiring stereotactic, conformal, computer-planned, LINAC-based radiation therapy. Assists radiation oncology teams in delivering radiation to defined target volumes while sparing surrounding normal tissue and critical organs.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Radionics ConforMAX MMLCVR1 (K993594)

Submission Summary (Full Text)

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# K023519

### 12 510(k) Summary

## JAN 1 6 2003

### Radionics VariLink 2 510(k) Summary

This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.

1.0 The submitter of this premarket notification is:

Kevin J. O'Connell Senior Regulatory Associate Radionics, a division of Tyco Healthcare Group LP 22 Terry Avenue Burlington, MA 01803 Tel .: [phone] Fax: [phone]

This summary was prepared on October 16, 2002.

- 2.0 The name of the device is the Radionics VariLink 2. The common name is Radiotherapy beam shaping block, and its classification name is Medical charged-particle radiation therapy system.
- 3.0 The above device is substantial equivalent to the Radionics ConforMAX MMLCVR1 was cleared via 510(k), K993594, on December 15, 1999.
- 4.0 The device is an optional accessory for the Radionics Mini-Multileaf Collimator (MMLC), mounted on a Varian C-Series Linear Accelerator (Linac). VariLink 2 allows Intensity Modulation Radiation Therapy (IMRT) functionality to be used on a Varian Linac. The Radionics' Treatment Planning software generates treatment plans with segmented beams, in which the intensity within the irradiation field is not constant (as in conventional treatments) but varies across the field. This requires the LINAC to suspend the beam between segments to allow the MMLC to change fields. VariLink 2 uses the Varian gating board to suspend the beam to allow MMLC to change the shape of the field.
- 5.0 The device is intended for use in stereotactic, conformal, computer planned, LINAC (linear accelerator) based radiation. The indications for use are: The VariLink 2 MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' Treatment Planning Software, the MMLC enables static conformal treatments to be performed with finely shaped field patterns.

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- 6.0 System testing verifies that the device is ready for clinical use. A rigorous test of the functionality of VariLink 2 was conducted using a Varian C-Series Linac with the Gating Board Interface.
-

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 6 2003

Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics. A Division of Tyco Healthcare 22 Terry Avenue BURLINGTON MA 01803-2516 USA

Re: K023519

Trade/Device Name: Radionics VariLink 2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system

Regulatory Class: II Product Code: 90 IYE Dated: October 17, 2002 Received: October 21, 2002

Dear Mr. O'Connell:

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. Iisting 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 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.

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

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

Page 2

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# ODE Indications for Use Statement

510(k) Number (if known): K023519

Device Name: Radionies VariLink 2 MMLC

indicalions for Use:

The Varilink 2 MMLC is intended to assist the radiation oncologist team in the The Varithe 2 Wirise 15 method target volumes while sparing surrounding normal the world critical organs from excess radiation. The Varilink 2 MMLC can be used s part of IMKT (Intensity Modulated Radiotherapy) or general conformal radiation цていたけどのし

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prevengstion Use (ther 21 CFR \$ 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

David A. Seymon
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number