RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC

K982549 · Radionics, Inc. · IYE · Dec 30, 1998 · Radiology

Device Facts

• Record ID: K982549
• Device Name: RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC
• Applicant: Radionics, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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. This is accomplished through 31 pairs of opposing tungsten leaves, which allow the MMLC to shape the xray beam according to a treatment plan generated by a planning system such as the RSA XPlan software. XPlan is a stereotactic LINAC-based radiation treatment planning software and was previously cleared under 510(k) K972905. In this application, the MMLC performs the same function as customized beam shaping blocks or stereotactic collimators, which have been used for many years.

Device Story

MMLC is a conformal radiation therapy/radiosurgery device mounted to a standard LINAC; shapes x-ray beams (max 10cm x 12cm) using 31 pairs of opposing tungsten leaves. Input: treatment plan data from external planning software (e.g., RSA XPlan). Operation: stand-alone computer communicates with MMLC to position leaves via individual motors; switching power supply provides power. Output: shaped radiation field. Used in clinical radiation oncology settings by oncology teams. Benefits: enables precise beam shaping equivalent to customized blocks/collimators, sparing healthy tissue/critical organs during treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Conformal radiation therapy device; 31 pairs of opposing tungsten leaves; max field size 10cm x 12cm. Stand-alone computer control; individual motor per leaf; switching power supply. Standards: EN55011, EN 60601-1-2, EN 60601-1, UL 2601. Non-sterile.

Indications for Use

Indicated for radiation oncology teams to deliver radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs. Used for static conformal treatments in patients requiring radiation therapy.

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

• Brainlab Micro Multi-Leaf Collimator (K970586)

Reference Devices

• RSA XPlan (K972905)

Submission Summary (Full Text)

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General Device Summary Section I:

K982549

Proprietary Name:

. .

Model MMLC Radionics Mini Multi-Leaf Collimator

Common Name:

Radiotherapy beam shaping block

Product Code/Classification Panel:IYE / Radiology

Classification:

Class II \$892.5710

### Summary of Safety and Effectiveness

The 510(k) Summary of Safety and Effectiveness is provided in Appendix A.

#### Performance Standards

No applicable performance standards have been issued under section 514 of the Food, Drug, and Cosmetic Act.

#### Voluntary Standards

- EN55011: Electromagnetic Disturbances . Class A, Group 1, ISM
- EN 60601-1-2: Collateral Standard . Electromagnetic Compatibility Medical Electrical Equipment
- . EN 60601-1: Medical Electrical Equipment
- UL 2601: Medical Electrical Equipment . Part 1: Requirements for Safety

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#### General Device Summary (Continued) Section I:

## Establishment Registration

## Manufacturing Facility Address:

Radionics, Inc. 22 Terry Avenue Burlington, MA 01803

#### FDA Establishment Registration No.: 1219140

#### Sterilization Site:

No part of this device is supplied sterile.

#### Predicate Devices

Brainlab Micro Multi-Leaf Collimator (K970586) manufactured by Brainlab Medical Computersysteme GmbH (hereafter referred to as "Brainlab MLC")

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#### General Device Summary (Continued) Section I:

### 1.0 Indications for Use

The 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. This is accomplished through 31 pairs of opposing tungsten leaves, which allow the MMLC to shape the xray beam according to a treatment plan generated by a planning system such as the RSA XPlan software. XPlan is a stereotactic LINAC-based radiation treatment planning software and was previously cleared under 510(k) K972905. In this application, the MMLC performs the same function as customized beam shaping blocks or stereotactic collimators, which have been used for many years.

### 1.1 Device Characteristics

The MMLC is a conformal radiation therapy and radiosurgery device. The MMLC is mounted to a standard radiation therapy LINAC and is capable of shaping the x-ray field (maximum field treatment of 10 cm x 12 cm). A stand-alone computer controls the MMLC unit. The computer communicates with the MMLC to position the leaves according to the treatment plan. An individual motor controls each leaf. Power to the motors and electronics is provided by a switching power supply.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEC 30 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David Cromwick Director of Regulatory Affairs and Quality Assurance Radionics® Inc. 22 Terry Avenue Burlington, MA 01803-2516

Re:

K982549 Mini Multileaf Collimator Dated: October 23, 1998 Received: October 26, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Cromwick:

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 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). 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 dass 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 (QS) 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. Fallure 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 vitro 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt, Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Section II:

# 2.0 Indications for Use:

The 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 XPlan Conformal Treatment Planning Software on any treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.

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

**Prescription Use**
(Per 21 CFR 801.109)