ERGO++ VERSION 1.7

K080601 · 3D Line Medical Systems S.R.L. · MUJ · Jun 6, 2008 · Radiology

Device Facts

• Record ID: K080601
• Device Name: ERGO++ VERSION 1.7
• Applicant: 3D Line Medical Systems S.R.L.
• Product Code: MUJ · Radiology
• Decision Date: Jun 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

ERGO++ is a treatment planning system. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.

Device Story

ERGO++ is a software-based treatment planning system (TPS) used as an accessory to linear accelerators in radiation oncology. It assists clinicians in the planning of 3D radiation therapy. The device processes patient data to generate treatment plans, which are then used by radiation therapy equipment to deliver radiation. It is intended for use by qualified medical professionals in a clinical setting. By facilitating precise 3D planning, the device aims to improve the accuracy and effectiveness of radiation therapy delivery, potentially benefiting patients by optimizing dose distribution to target tissues while sparing healthy anatomy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical testing and software documentation.

Technological Characteristics

Software-based treatment planning system running on a standard computer. No patient-contacting materials; no sterilization required. Functions as an accessory to linear accelerators for 3D radiation therapy planning.

Indications for Use

Indicated for use in the planning of 3-dimensional radiation therapy for patients undergoing radiation therapy via linear accelerators.

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

• ERGO (K001163)
• ERGO SRS (K031281)
• ERGO EVTOOL (K013535)

Submission Summary (Full Text)

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Koxoco/

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JUN ~ 6 2008

## COVER LETTER and 510(k) SUMMARY of ERGO++

February, 28th 2008

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850

Reference : TRADITIONAL 510(k) for ERGO++

Dear Madam/Sir:

The 3D Line Research and Development S.r.1. hereby submits this Traditional 510(k) for our ERGO++ Treatment Planning System. ERGO++ is a modification of ERGO, ERGO SRS and ERGO EVTOOL (3D Line USA, Inc) (K001163, K031281. K013535). The modifications are listed in Appendix 8. We believe these modifications are not eligible for the Special 510 (k) process.

We consider our intent to market this device as confidential commercial information and requests that it be treated as such by FDA. We have taken precautions to protect the confidentiality of the intend to market these devices. We understand that the submission to the government of false information is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q).

Thank you in advance for your consideration of our application.

Sincerely,

Marco Luzzara
Managing Director

3D LINE RESEARCH AND DEVELOPMENT S.R.L. - VIA BERNARDO RUCELLAI, 23 - 20126 - MILANO (MI) TEL [phone] - FAX [phone] REGISTRO IMPRESE DI MILANO - CODICE FISCALE E PARTITA IVA 05730090965 - R.E.A. N. 1843687 -CAPITALE SOCIALE € 10.000 I.V. SOCIETA' SOGGETTA A DIREZIONE E COORDINAMENTO DI ELEKTA AB (publ.), STOCCOLMA, SVEZIA – SOCIO UNICO

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Section 1: required elements for all types of 510(k) submissions

- . 510(k) holder name: 3D Line Research and Development S.r.l.
- address: Via Bernardo Rucellai, 23, Milano, Italy, 20126 .
- . phone: [phone]
- . fax: [phone]
- . facility registration number: 9617259
- . Trade name of the device: ERGO++
- � Common name: Treatment Planning System
- . Classification Name: system, planning, radiation therapy treatment (21CFR 892 5050, Product Code MUJ)
- Classification: Class II .
- name of contact persons: Marco Luzzara .
- date the summary was prepared: February, 28th 2008
- . A statement of substantial equivalence to ERGO, ERGO SRS and ERGO EVTOOL (3D Line USA, Inc) (K001163, K031281, K013535) manufactured by 3D Line USA, Inc is Appendix 7 of this notification.
- . description of the device such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant

3D LINE RESEARCH AND DEVELOPMENT S.R.L. - VIA BERNARDO RUCELLAI, 23 - 20126 - MILANO (MI) TEL [phone] - FAX [phone] REGISTRO IMPRESE DI MILANO - CODICE FISCALE E PARTITA IVA 05730090965 - R.E.A. N. 1843687 -

CAPITALE SOCIALE € 10.000 I.V.

SOCIETA' SOGGETTA A DIREZIONE E COORDINAMENTO DI ELEKTA AB (publ.), STOCCOLMA, SVEZIA – SOCIO UNICO

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physical and performance characteristics of the device, such as device design, material used, and physical properties is in Appendix 2 and Appendix 3 of this notification.

- . the intended use of the device including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended, is in Appendix 2 of this notification.
- . the indication statement is a subset of those of the predicate device. See Appendix 7 for additional information.
- . the conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device are in Appendix 6 of this notification.

3D LINE RESEARCH AND DEVELOPMENT S.R.L. – VIA BERNARDO RUCELLAI, 23 – 20126 – MILANO (MI) TEL [phone] ~ FAX [phone] REGISTRO IMPRESE DI MILANO - CODICE FISCALE E PARTITA IVA 05730090965 - R.E.A. N. 1843687 -CAPITALE SOCIALE € 10.000 I.V. SOCIETA' SOGGETTA A DIREZIONE E COORDINAMENTO DI ELEKTA AB (publ.), STOCCOLMA, SVEZIA – SOCIO UNICO

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Image /page/3/Picture/1 description: The image shows a logo for ELEKTA. The logo consists of a black circle with a white line extending from the center to the upper right. There is a small black circle in the upper right corner of the larger circle. The word "ELEKTA" is written in block letters below the circle.

Section 2: required elements for a TRADITIONAL 510(k) submission:

- . Biocompatibility data for all patient-contacting materials, OR certification of identical material/formulation: not applicable as this device is a SW running on a computer not in touch with the patient.
- . Sterilization and expiration dating information: not applicable as this device is a SW running on a computer which does not need any sterilization.
- Software Documentation is in Appendix 5 of this notification ●

## Additional information:

- . Relationship between Elekta and 3D Line: 3D Line Research and Development has been recently acquired by Elekta AB (see www.elekta.com), one of the market leaders in Radiation Oncology, so it is now part of this group that includes manufacturing sites (such as Elekta Oncology Systems Ltd in Crawley - UK, Elekta Instruments AB in Stockholm - Sweden, Medical Intelligence in Schwabmunchen - Germany) as well as business units all over the world. Our US agent is Elekta Inc. 4775 Peachtree Industrial Blvd. Building 300, Suite 300, Norcross, GA 30092.
3D LINE RESEARCH AND DEVELOPMENT S.R.L. - VIA BERNARDO RUCELLAI, 23 - 20126 - MILANO (MI) TEL [phone] – FAX [phone] REGISTRO IMPRESE DI MILANO - CODICE FISCALE E PARTITA IVA 05730090965 - R.E.A. N. 1843687 -CAPITALE SOCIALE € 10.000 I.V. SOCIETA' SOGGETTA A DIREZIONE E COORDINAMENTO DI ELEKTA AB (publ.), STOCCOLMA, SVEZIA – SOCIO UNICO

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- Page numbering: we believe we have followed FDA guidelines in terms of . page numbering, in order to have a punctual identification of all pages. In respect to certain documents, we kept the original page numbering that must be used in addition to the Document ID. The document ID is then identified at the beginning of each section/appendix. So punctual identification can be achieved by looking at the document ID (e.g. for the system requirement specification document, the ID is SRS-201-3 and can be seen on the top right part of the page) together with the page numbering (bottom left part of the page).
We believe that the enclosed information is sufficient for the Food and Drug Administration to make a determination of substantial equivalence for ERGO++. If you have any questions or require any additional information, please contact me (telephone # [phone], email address: marco.luzzara(@elekta.com, and facsimile #: [phone]). You can also contact our US agent: Thomas Valentine, Director Quality Assurance and Regulatory Affairs, Elekta Inc. 4775 Peachtree Industrial Blvd. Building 300, Suite 300, Norcross, GA 30092. Phone (770)

3D LINE RESEARCH AND DEVELOPMENT S.R.L. - VIA BERNARDO RUCELLAI, 23 - 20126 - MILANO (MI) TEL [phone] - FAX [phone] REGISTRO IMPRESE DI MILANO - CODICE FISCALE E PARTITA IVA 05730090965 - R.E.A. N. 1843687 -CAPITALE SOCIALE € 10.000 I.V. SOCIETA' SOGGETTA A DIREZIONE E COORDINAMENTO DI ELEKTA AB (publ.), STOCCOLMA, SVEZIA -SOCIO UNICO

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670-2548 direct, [phone] mobile, [phone] fax, email Thomas. [e-mail].

Information contained in this notification is confidential, proprietary, and trade secret until released by 3D Line Research and Development S.r.I.. Release of this information is subject to applicable provisions of the Food, Drug, and Cosmetic Act, the Freedom of Information Act, and pertinent regulations in 21 CFR Parts 20 and 800. Should FDA contemplate release of any part of this notification to any third party, 3D Line Research and Development S.r.l. requests a consultation prior to any such release under the provisions of 21 CFR 20.15 and sections affording similar rights.

3D LINE RESEARCH AND DEVELOPMENT S.R.L. - VIA BERNARDO RUCELLAI, 23 - 20126 - MILANO (MI) TEL [phone] - FAX [phone] REGISTRO IMPRESE DI MILANO - CODICE FISCALE E PARTITA IVA 05730090965 - R.E.A. N. 1843687 -CAPITALE SOCIALE € 10.000 I.V. SOCIETA' SOGGETTA A DIREZIONE E COORDINAMENTO DI ELEKTA AB (publ.), STOCCOLMA, SVEZIA – SOCIO UNICO

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard -Rockville MD 20850

JUN - 6 2008

3D Line Research and Development S.r.1. % Mr. Thomas Valentine Director Quality Assurance and Regulatory Affairs Elenta, Inc. Peachtree Industrial Blvd., Building 300, Suite 300 NORCROSS GA 30092

Rc: K080601

Trade/Device Name: ERGO++ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: February 28, 2008 Received: March 10, 2008

Dear Mr. Valentine:

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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

nclosure

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Appendix 2 - Indications for Use Statement and Technical Description of ERGO++

510(k) Number (if known): K080601

Device Name: ERGO++

Indications for Use:

ERGO++ is a treatment planning system. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joan M. Whay

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

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