ERGO SRS

K031281 · 3D Line USA, Inc. · MUJ · Dec 23, 2003 · Radiology

Device Facts

• Record ID: K031281
• Device Name: ERGO SRS
• Applicant: 3D Line USA, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

It is intended for use in the planning of 3 dimensional radiation therapy.

Device Story

ERGO SRS is a stereotactic radiosurgery treatment planning software module integrated into the 3D Line USA ERGO radiotherapy treatment planning system. It functions as an accessory to linear accelerators. The software enables clinicians to perform 3D radiation therapy planning. By providing tools for spatial planning, it assists healthcare providers in determining radiation delivery parameters. The output is used by clinicians to guide radiation therapy procedures, potentially improving the precision of treatment delivery to target areas.

Technological Characteristics

Stereotactic radiosurgery treatment planning software module. Operates as an integrated component of the ERGO radiotherapy treatment planning system. No specific hardware materials, energy sources, or connectivity standards are detailed beyond its function as a software module for linear accelerator planning.

Indications for Use

Indicated for use in the planning of 3 dimensional radiation therapy as an accessory to linear accelerators used for 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

• PLATO SRS V2 (K010784)

Reference Devices

• ERGO radiotherapy treatment planning system (K001163)

Submission Summary (Full Text)

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APPENDIX 6: 510 (K) SUMMARY

K03/281

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

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

Tel. [phone]

Fax: [phone]

Contact Person: Nader Salehi Vice President

Device Trade Name: ERGO SRS

Common Name: Stereotactic radiosurgery treatment planning module

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

Predicate Device: PLATO SRS V2, K010784

Manufactured by: Nucletron Corporation, 7080 Columbia Gateway Drive, Columbia, MD 21046-2133

Description of the Device: ERGO SRS is a stereotactic radiosurgery treatment planning software module for 3D Line USA's ERGO radiotherapy treatment planning system (K001163).

Intended Use for the Device: It is intended for use in the planning of 3 dimensional radiation therapy.

Substantial Equivalence to Predicate Device: ERGO SRS is identical to PLATO SRS V2. It is the same software integrated with 3D Line USA's ERGO system rather than Nucletron's PLATO system.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 2 3 2003

Mr. Nader Salehi Vice President 3D Line USA, Inc. Reston Executive Center 12100 Sunset Hills Road, Suite 150 RESTON VA 20190

Re: K031281 Trade/Device Name: ERGO SRS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: December 4, 2003 Received: December 8, 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, 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 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.

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. Brygdon

Nancy C. B rogdon 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/3/Picture/0 description: The image shows a logo with the text "3D LINE USA". The "3D" is stacked on top of "LINE", and "USA" is below "LINE". The "3D" is large and bold, and the "LINE" and "USA" are smaller. The logo is black and white.

Applicant: _3D Line USA, Inc.__

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ ERGO SRS______________________________________________________________________________________________________________________________________________________

Indications For Use:

ERGO SRS is stcreotactic radiosurgery module for DMLCIV-ERGO (K001163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Daniel R. Ingram
(Division Sign-Off)

Division of Reproductive, Abdor and Padiological Devices 510(k) Number _

Prescription Use

3D Line USA, Inc. 11419 Cronridge Drive / Suite 15 / Owings Mills, Maryland 21117 / Office: 410-581-6701 / Fax: [phone]