K Number
K061140
Device Name
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
Date Cleared
2006-05-15

(21 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trilogy™ Radiotherapy Delivery System and Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The Trilogy™ Radiotherapy Delivery System and Trilogy Tx Delivery System are indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Device Description
The Trilogy TM Radiotherapy Delivery System, K033343, is a dual-energy, high dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The Trilogy system allows for stereotactic treatments that may be intracranial or extracranial and consist of single-session or multisession ("fractionated") treatment delivery.
More Information

Not Found

No
The document does not mention AI, ML, or related terms, and the device description focuses on traditional linear accelerator technology.

Yes
The device is used for radiotherapy and radiosurgery, which are medical treatments for lesions, tumors, and other conditions, indicating a therapeutic purpose.

No
The device is described as a "Radiotherapy Delivery System" and a "medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications." Its purpose is to "provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated," indicating it is for treatment delivery, not diagnosis.

No

The device description explicitly states it is a "medical linear accelerator," which is a hardware device used for radiation therapy. The summary describes a physical system, not just software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Device Description: The provided description clearly states that the Trilogy system is a "medical linear accelerator" used for "radiotherapy" and "radiosurgery." These are treatments that deliver radiation to the body, not devices that analyze samples from the body.
  • Intended Use: The intended use is to "provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body." This describes a therapeutic intervention, not a diagnostic test performed on a specimen.

The Trilogy system is a therapeutic device used for delivering radiation treatment.

N/A

Intended Use / Indications for Use

The Trilogy™ Radiotherapy Delivery and the Trilogy Tx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The Trilogy™ Radiotherapy Delivery System and Trilogy Tx Delivery System are indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Product codes

90 IYE

Device Description

The Trilogy TM Radiotherapy Delivery System, K033343, is a dual-energy, high dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The Trilogy system allows for stereotactic treatments that may be intracranial or extracranial and consist of single-session or multisession ("fractionated") treatment delivery.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anywhere in the body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K033343, K041315

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

MAY 15 2005

Kobe 1140
Page 1 of 4

VARIAN
medical systems

Varian Medical Systems, In 3100 Hansen Way Palo Alto, CA 94304-1038 el +1 650 493 4000 www.varian.com

510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the Trilogy Radiotherapy Delivery System

  1. Submitter: Varian Medical Systems 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date summary was prepared: April 21, 2006
    1. Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
      Trilogy Radiotherapy Delivery System and Trilogy Tx Trilogy Radiotherapy Delivery System Trilogy system Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II Product Code: 90 IYE
  • Predicate Devices to claim substantial equivalence: 3.

    • a. Varian Medical Systems'Trilogy Radiotherapy Delivery System -K033343
    • Accuray's CyberKnife K041315 b.
  • Description of the Device: The Trilogy TM Radiotherapy Delivery System, K033343, ব . is a dual-energy, high dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The Trilogy system allows for stereotactic treatments that may be intracranial or extracranial and consist of single-session or multisession ("fractionated") treatment delivery.

  • Intended Use Statement: The Trilogy™ Radiotherapy Delivery and the Trilogy Tx is 5. intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

  • Substantial Equivalence The Trilogy Radiotherapy Delivery is substantially equivalent 6. to the predicate devices. The intended use, principles of operation, and technological characteristics are the same.

1

stantial Equivalence Comparison

The Triley "" Radiotheray Delivery System and the Trilogy Tx Delivery System are Sybtent on the CyberKni
System, K041315 for Intended Use and Indications for Use and are subs

revised Intended Use and Indications for Use statements are equivalent to those used by CyberKni

| Intended Use | CyberKnife® System for
Stereotactic
Radiosurgery/Radiotherapy,
K041315 | Trilogy™ Radiotherapy
Delivery System,
K033343 | Trilogy™ Radiotherapy Delivery
System | Trilogy Tx Delivery
System |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The CyberKnife System for
Stereotactic
Radiosurgery/Radiotherapy
is intended to provide
treatment planning and
image-guided stereotactic
radiosurgery and precision
radiotherapy for lesions,
tumors, and conditions
anywhere in the body when
radiation treatment is
indicated. | The Trilogy™
Radiotherapy Delivery
System is a radiation
therapy accelerator
intended to deliver
megavoltage x-ray
treatments for
conventional
radiotherapy (three
dimensional conformal
radiotherapy and
intensity modulated
radiotherapy) and
stereotactic radiosurgery
and radiotherapy.
Stereotactic treatments
are intended for therapy
of lesions, e.g.,
arteriovenous | The Trilogy™
Radiotherapy Delivery
System is intended to
provide stereotactic
radiosurgery and
precision radiotherapy
for lesions, tumors, and
conditions anywhere in
the body when
radiation treatment is
indicated. | The Trilogy Tx
Delivery System is
intended to provide
stereotactic
radiosurgery and
precision radiotherapy
for lesions, tumors, and
conditions anywhere in
the body when
radiation treatment is
indicated. |

Page right

2

| Indications
for Use | The CyberKnife System for
Stereotactic
Radiosurgery/Radiotherapy
is indicated for treatment
planning and image-guided
stereotactic radiosurgery and
precision radiotherapy for
lesions, tumors, and
conditions anywhere in the
body when radiation
treatment is indicated. | The TrilogyTM
Radiotherapy Delivery
System is a radiation
therapy accelerator
intended to deliver
megavoltage x-ray
treatments for
conventional
radiotherapy (three
dimensional conformal
radiotherapy and
intensity modulated
radiotherapy) and
stereotactic radiosurgery
and radiotherapy.
Stereotactic treatments
are intended for therapy
of lesions, e.g.,
arteriovenous
malformations, primary
tumors and metastases.
Stereotactic treatments
may be intracranial or
extracranial and consist
of single-session or
fractionated delivery. | The TrilogyTM
Radiotherapy Delivery
System is indicated for
stereotactic
radiosurgery and
precision radiotherapy
for lesions, tumors, and
conditions anywhere in
the body when
radiation treatment is
indicated. | The Trilogy Tx
Delivery System is
indicated for
stereotactic
radiosurgery and
precision radiotherapy
for lesions, tumors, and
conditions anywhere in
the body when
radiation treatment is
indicated. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | of single-session or fractionated delivery. | | | |
| Isocenter | Not Applicable | ≤1.5mm for all three rotational axes | ≤1.5mm for all three rotational axes | ≤1.5mm for all three rotational axes |
| Energy used | Not Applicable | 4-25MV | 4-25MV | 4-25MV |
| Dose rate | Not Applicable | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min |
| Maximum
field size | Not Applicable | 3DCRT: 40cm x 40cm.
IMRT: 34cm x 40cm.
SRS: 15cm x 15cm | 3DCRT: 40cm x 40cm.
IMRT: 34cm x 40cm.
SRS: 15cm x 15cm | 3DCRT: 40cm x 40cm.
IMRT: 34cm x 40cm.
SRS: 15cm x 15cm |
| Remote
touch motion | Not Applicable | Small, corrective motions ( $\leq$ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. | Small, corrective motions ( $\leq$ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. | Small, corrective motions ( $\leq$ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. |

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4

the state of the comments of the state of the states the states DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 15 2006

Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K061140

Trade/Device Name: Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System Regulation Number: 21 CFR 892,5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 20, 2006 Received: April 25, 2006

Dear Ms. Tran:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roteweary our becare ined 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 it your a vice is che subject to such additional controls. Existing major regulations affecting your I tpp. o an 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.

Image /page/4/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The logo features the letters "FDA" in a bold, stylized font. There are three stars below the word Centennial. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.

Preventing and Promoting Public Health

5

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 (OS) 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.xxxx(Gastroenterology/Renal/Urology) 240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology);240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

6

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. Same in the

510(k) Number (if known): _ |