STEREOTACTIC BODY FRAME, MODEL COD. 70-1A

K031631 · 3D Line USA, Inc. · IYE · Jul 18, 2003 · Radiology

Device Facts

• Record ID: K031631
• Device Name: STEREOTACTIC BODY FRAME, MODEL COD. 70-1A
• Applicant: 3D Line USA, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jul 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is intended for use in the planning and conduct of 3 dimensional radiation therapy with a linear accelerator.

Device Story

Stereotactic Body Frame is an external spatial reference system for patient positioning during radiotherapy. It consists of a base plate connected to the patient via a thermoconformable mask or cushion and secured to a linear accelerator (LINAC) couch. The device uses copper indicators to determine target coordinates on CT scans, allowing spatial registration between diagnostic images and the treatment plan. It enables precise patient fixation and localization for stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT). Clinicians use the system to reproduce target coordinates, ensuring accurate radiation delivery to tumoral lesions. The device benefits patients by facilitating 3D radiation therapy planning and conduct.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Carbon-fiber and plexiglass. Sensing/Actuation: Spatial reference system using copper indicators for coordinate determination. Connectivity: Compatible with ERGO-SCT software. Form factor: Base plate with fixation accessories (mask/cushion).

Indications for Use

Indicated for patient fixation, localization, and centering for radiotherapy treatments of tumoral lesions in the body during stereotactic radiosurgery and 3D 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

• Stereotactic Body Frame (K960338)

Submission Summary (Full Text)

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## JUL 18 2003

PENDIX 6: 510 (K) SUMMARY

K031631

## 510(k) Summary As required by 807.92 For ERGO SRS Prepared on January 17, 2003

Submitted by: 3D Line USA, Inc. 11419 Cronridge Drive, Suite 15 Owings Mills, MD 21117

Tel. [phone]

Fax: [phone]

Contact Person: Nader Salehi Vice President

Device Trade Name: Stereotactic Body Frame

Common Name: Stereotactic patient positioning system

Classification: Medical charged-particle radiation therapy system, Class II Sec. 21 CFR 892.5050

Predicate Device: Stereotactic Body Frame, K960338

Manufactured by: Elekta Instrument AB, St. Larsgatan 8 S-582, Linkoping, Sweden

Description of the Device: Stereotactic Body Frame is a spatial reference system external to the body of a patient undergoing radiotherapy treatment that provides accurate positioning of the patient in spatial registration with diagnostic images and a radiotherapy treatment plan.

Intended Use for the Device: It is intended for use in the planning and conduct of 3 dimensional radiation therapy with a linear accelerator.

Substantial Equivalence to Predicate Device: 3D line's Stereotactic Body Frame is substantially equivalent to Elekta Instrument AB's Stereotactic Body Frame. A comparison of clinically relevant characteristics is given below.

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## Statement of Substantial Equivalence to Stereotactic Body Frame of Electa Instrument AB (K960338)

| Characteristics | Body Frame | Elekta Body Frame |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indication<br>(Intended Use & Device<br>Description) | The intended use of the body frame is<br>patient fixation, localization and centering<br>for radiotherapy treatments of tumoral<br>lesions in the body. These functions are<br>obtained by means of a fixation plate (the<br>base plate) that is both connected to the<br>patient (with thermoconformable mask or<br>cushion) and to the LINAC couch. | Same intended use. |
| Characteristics | Material: Carbon-fiber and plexiglass<br>Image: Body Frame | Material: Plastic and<br>aluminum<br>Image: Elekta Body Frame |
| Compatibility with software | Compatible with ERGO-SCT | Compatible with<br>commercially available<br>software planning. |
| Similarities in Design | ➤ Usage of reference system that is<br>external to the patient's body<br>➤ Usage of stereotactic coordinates to<br>reproduce the coordinates of a target in<br>both diagnostic and treatment<br>procedures<br>➤ Copper indicators for determination of<br>targte coordinates on CT<br>➤ Can be used for stereotactic<br>radiosurgery (SRS) or stereotactic<br>radiotherapy (SRT). | |
| Differences in Design | ➤ To be used with CT only<br>➤ No arc ruler used, but a frame with<br>coordinates scales<br>➤ Localization is achieved without | ➤ Can be used with CT<br>and MRI |

:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2003

Mr. Nader Salehi Vice President 3D Line USA, Inc. 11419 Cronridge Drive Suite 15 OWINGS MILLS MD 21117

Re: K031631 Trade/Device Name: Stereotactic Body Frame Cod. 70-1A Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: April 14, 2003

Received: May 27, 2003

Dear Mr. Salehi:

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

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Image /page/4/Picture/0 description: The image is a logo with the text "3D LINE USA" stacked on top of each other. The "3D" is in a larger, bolder font and appears to be three-dimensional. The word "LINE" is smaller and placed below "3D", and "USA" is at the bottom, slightly offset to the right. The logo has a simple, geometric design and is in black and white.

Applicant: _3D Line USA. Inc.___

| 510(k) Number (if known): | K03163/1 |
|---------------------------|----------|
|---------------------------|----------|

Device Name: __Stereotactic Body Frame Cod. 70-1A ____________________________________________________________________________________________________________________________

Indications For Use:

Stereotactic Body Frame Cod. 70-1A is patient localization system for use in stereotactic radiosurgery. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning and conduct of 3 dimensional radiation therapy.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Daniel A. Legnon

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number

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