TOPSLANE DMLC

K060187 · Topslane International, LLC · IXI · Jul 27, 2006 · Radiology

Device Facts

• Record ID: K060187
• Device Name: TOPSLANE DMLC
• Applicant: Topslane International, LLC
• Product Code: IXI · Radiology
• Decision Date: Jul 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5710
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Device Story

TOPSLANE DMLC is a dynamic multileaf collimator (DMLC) accessory for linear accelerators. It consists of multiple motorized tungsten leaves. The device receives input from a treatment planning system (TPS) to position leaves precisely. It enables static field shaping, step-and-shoot IMRT, and sliding window IMRT. Operated by radiation oncology staff, the device shapes radiation beams to match target volumes, sparing surrounding healthy tissue and critical organs. It functions as a beam-shaping component in radiation therapy delivery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dynamic multileaf collimator; motorized tungsten leaves; mounts to linear accelerator; supports static, step-and-shoot, and sliding window IMRT field shaping modes.

Indications for Use

Indicated for use by radiation oncologists to shape radiation fields in static or dynamic modes during radiotherapy for patients requiring treatment of well-defined target volumes while sparing surrounding healthy tissue and critical organs.

Regulatory Classification

Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Predicate Devices

• m3 (micro-Multileaf Collimator) (K004022, K020860)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

Compliance with 513(i) of the Federal Food, Drug and Cosmetic Act

660187

January 18, 2006

JUL 27 2006

## 1. Submitter's Information

| Common/Usual Name: | DYNAMIC MULTILEAF COLLIMATOR |
|--------------------|------------------------------------------------------------------------------------------|
| Proprietary Name: | TOPSLANE DMLC |
| Applicant Address: | Topslane International, LLC<br>15375 Roosevelt Blvd. Suite #300,<br>Clearwater, FL 33760 |
| Contact Person: | Jim Marsh, President |
| Telephone: | 727-507-8500 |
| Fax: | 727-507-9192 |

### 2. Predicate Devices

m3 (micro-Multileaf Collimator) (K004022, K020860)

Therapeutic X-Ray Collimator Device Classification Name: Regulatory Class: Class II (according to 21 CFR 892.5050)

#### 3. Performance Standards

No applicable standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.

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#### 4. Device Description

K60187

TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the various linear accelerator. It comprises multiple motorized tungsten leafs and By controlling each leaf to the designed position according to the software. treatment planning system (TPS), TOPSLANE DMLC is intended to shape the specific field, either in static or dynamic mode. TOPSLANE DMLC can perform different field shaping methods, such as Static Field Shaping, or Step and Shoot IMRT Field Shaping or Sliding Window IMRT Field Shaping.

#### 5. Intended Use

TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

The intended use is the same as the predicate device.

### 6. Summary of Substantial Equivalence

This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device. It utilizes materials that are already in use in other medical devices. No new issues of safety or effectiveness are introduced by using this device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 27 2006

Mr. James N. Marsh President TOPSLANE International. LLC 15375 Roosevelt Blvd.. Suite #300 CLEARWATER FL 33760

Re: K060187

Trade/Device Name: TOPSLANE DMLC Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE. IXI Dated: June 16. 2006 Received: June 20, 2006

Dear Mr. Marsh:

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.

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*Protecting and Promoting Public Health*

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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 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 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 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.Bogdon

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

510(k) Number (if known): K[60187]

Device Name:

#### Indications for Use:

TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109) (Division Sign-Off), Division of Reproductive, Ab

> and Padiological Devices 510(k) Number _