(30 days)
K9845432
No
The description explicitly states the device uses an "inverse planning algorithm" and "automatically optimize[s] the dose distribution" based on user-defined constraints, which are characteristic of traditional optimization techniques, not AI/ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as an "inverse planning tool" and "software" that assists clinicians in creating radiation treatment plans. It does not directly administer therapy to the patient.
No
The device is an inverse planning tool for creating radiation treatment plans, not for diagnosing medical conditions. It assists clinicians in shaping and modulating field intensities for therapy, based on user-specified clinical dose-volume constraints.
Yes
The device is described as "inverse planning software" and an "option" to an existing computer-based treatment planning system (Eclipse). While it integrates with a system that includes hardware (computer, display, plotter), the Helios Option itself is presented as a software component that performs calculations and optimization, without mentioning any dedicated hardware included with the Helios Option itself.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Function: The Eclipse Helios Option is a software tool used for radiation treatment planning. It takes patient anatomy information and clinical constraints to calculate and optimize the delivery of radiation therapy. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "creating a highly conformal radiation treatment plan" and "assisting the clinician by shaping and modulating the field intensities according to the clinical constraints and patient anatomy." This is a treatment planning function, not a diagnostic function performed on in vitro samples.
Therefore, the Eclipse Helios Option falls under the category of medical device software for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Eclipse Helios Option is an inverse planning tool for creating a highly conformal radiation treatment plan using intensity modulated photon fields, and is an option to Eclipse (K010975). Helios creates in-field intensity modulated beam profiles that result in precisely shaped dose distributions inside the patient. Helios computes the in-field intensities based on user-specified clinical dose-volume constraints corresponding to the desired dose distribution inside target volumes and critical organs. Helios implements an inverse planning algorithm and supports dynamic MLC treatments for Intensity Modulated Radiation Therapy (IMRT). The Helios option is used to assist the clinician by shaping and modulating the field intensities according to the clinical constraints and patient anatomy.
The Varian Eclipse Helios Option software is used to inversely plan photon radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1 -- 50 MV.
Product codes
90 MUJ
Device Description
Eclipse Helios Option is an inverse planning software used to generate complicated radiation (megavoltage photon) therapy treatment plans for Linear accelerators having dynamic MLC capabilities. The physician defines the desired treatment outcome in terms of dose-volume constraints: Helios uses the dose-volume information to automatically optimize the dose distribution within the patient by modulating the radiation fluences for each treatment field. Helios requires a user interface in order to define the regions of interest within the patient and to add treatment fields to be used for the radiation therapy treatment. Helios 6.5 will use Varian's Eclipse device as the front-end interface to its optimization engine. Varian Eclipse is a computer-based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of radiation therapy. The system consists of a computer with graphics display, and plotter output.
Eclipse Helios Option is an integral part of the Eclipse (K010975) treatment planning system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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)
CadPlan Helios Option Version 6.0, K9845432
Reference Device(s)
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 2 2 2002
Page 1 of 2
Palo Alto, CA 94304-1038
Oncology Systems 3100 Hansen Way
tel +1 650 493 4000 www.varian.com
USA
VARIAN
medical systems
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
April 16, 2002
Submitter's Name:
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
Contact Person:
Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Phone (650) 424-6990 (650) 842-5051 FAX E-mail linda.nash@varian.com
Device Name:
Eclipse, Helios Option
Classification Name:
System, Planning, Radiation Therapy Treatment
Predicate Device:
CadPlan Helios Option Version 6.0, K9845432
1
K 021268
Page 2 of 2
Product Description:
Eclipse Helios Option is an inverse planning software used to generate complicated radiation (megavoltage photon) therapy treatment plans for Linear accelerators having dynamic MLC capabilities. The physician defines the desired treatment outcome in terms of dose-volume constraints: Helios uses the dose-volume information to automatically optimize the dose distribution within the patient by modulating the radiation fluences for each treatment field. Helios requires a user interface in order to define the regions of interest within the patient and to add treatment fields to be used for the radiation therapy treatment. Helios 6.5 will use Varian's Eclipse device as the front-end interface to its optimization engine. Varian Eclipse is a computer-based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of radiation therapy. The system consists of a computer with graphics display, and plotter output.
Eclipse Helios Option is an integral part of the Eclipse (K010975) treatment planning system.
Intended Use:
The Eclipse Helios Option is an inverse planning tool for creating a highly conformal radiation treatment plan using intensity modulated photon fields, and is an option to Eclipse (K010975). Helios creates in-field intensity modulated beam profiles that result in precisely shaped dose distributions inside the patient. Helios computes the in-field intensities based on user-specified clinical dose-volume constraints corresponding to the desired dose distribution inside target volumes and critical organs. Helios implements an inverse planning algorithm and supports dynamic MLC treatments for Intensity Modulated Radiation Therapy (IMRT). The Helios option is used to assist the clinician by shaping and modulating the field intensities according to the clinical constraints and patient anatomy.
Technological Characteristics:
See the attached "Specification Comparison Chart", Tab F
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines.
Public Health Service
MAY 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Nash Corporate Director, Regulatory Affairs and Quality Assurance VARIAN Medical Systems 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K021268
Trade/Device Name: Varian Eclipse, Helios Option 6.5 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II
Product Code: 90 MUJ Dated: April 16, 2002 Received: April 22, 2002
Dear Ms. Nash:
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 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 (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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K021268
Device Name: ECLIPSE, HELIOS OPTION
Indications For Use:
The Varian Eclipse Helios Option software is used to inversely plan photon radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1 -- 50 MV. ..
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Division of Reproductive and Radiological Devic 510(k) Numb