(63 days)
No
The document describes a radiotherapy treatment unit with safety interlocks and motion zone rules. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The changes described relate to safety features based on predefined rules, not learning algorithms.
Yes
The device is described as a "radiotherapy treatment unit" intended to provide "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated," clearly indicating its use in treating medical conditions.
No
The device is described as a "radiotherapy treatment unit" intended to "provide stereotactic radiosurgery and precision radiotherapy," which are therapeutic rather than diagnostic actions. Its description focuses on generating a treatment beam and safety interlocks for therapy delivery.
No
The device description explicitly states that the UNIQUE is a radiotherapy treatment unit consisting of hardware components such as a gantry, couch, stand, control console, and linear accelerator assembly. The changes described relate to motion zone rules for the couch and gantry, which are physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the UNIQUE is a "radiotherapy treatment unit" that generates a "radiotherapy treatment beam" using a linear accelerator. This is a device that treats the body with radiation, not one that tests samples from the body.
- Intended Use: The intended use is for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated." This describes a therapeutic application, not a diagnostic one.
The device is a therapeutic medical device used for delivering radiation treatment.
N/A
Intended Use / Indications for Use
The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Varian UNIQUE is 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 UNIQUE is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.
An extensive system of interlocks is designed to prevent or terminate beam-on unless essential treatment parameters are in place and system operating conditions relevant to safe operation are correct.
The changes to the UNIQUE establish motion zone rules, which limit the motions of couch and gantry that can be initiated or directed from outside the treatment room. The purpose of the zone rules is to increase patient safety by reducing the possibility of collision between the gantry and the patient.
All other features and technological characteristics of the UNIQUE remain as cleared by K101751.
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)
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.
Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian therefore considers UNIQUE to be safe and effective and to perform at least as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
UNIQUE K101751
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.
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OCT 3 1 2013
K132705
Page 1 of 3
Varian Medical Systems, Inc 3100 Hansen Wat Palo Alto CA 943
August 27, 2013
510(k) Summary
The information below is provided for the UNIQUE. following the format of 21 CFR 807.92.
-
- 510(k) Owner: Varian Medical Systems 3100 Hansen Way, M/S C 260 Palo Alto, CA 94304 Contact Name: Peter J. Coronado - Director, Regulatory Affairs Phone: 650/424.6320 Fax: 650/842.5040 E-mail: submissions.support@varian.com
| 2. Name of the Device: | UNIQUE |
|---|---|
| Trade/Proprietary Names: | UNIQUE Power Edition |
| UNIQUE Performance Edition | |
| Common Name: | Medical Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation Therapy System |
| 21 CFR §892.5050 | |
| Class II | |
| Product Code 90 IYE |
3. Predicate Device: UNIQUE K101751
- Description of the Device:
The UNIQUE was most recently cleared as the Varian UNIQUE, K101751.
The UNIQUE is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.
An extensive system of interlocks is designed to prevent or terminate beam-on unless essential treatment parameters are in place and system operating conditions relevant to safe operation are correct.
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K132705
page 2 of 3
The changes to the UNIQUE establish motion zone rules, which limit the motions of couch and gantry that can be initiated or directed from outside the treatment room. The purpose of the zone rules is to increase patient safety by reducing the possibility of collision between the gantry and the patient.
All other features and technological characteristics of the UNIQUE remain as cleared by K101751.
-
- Intended Use Statement
The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Intended Use Statement
-
- Indications for Use Statement
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Indications for Use Statement
-
- Substantial Equivalence
The modified device, the UNIQUE, is substantially equivalent to the predicate device, the UNIQUE (K101751). The Intended Use and Indications for Use are unchanged.
- Substantial Equivalence
Compared with the predicate device, the UNIQUE (K101751), the basic operation and technological characteristics are the same. Operational differences are described in the Instructions for Use for the UNIQUE. A comparison table illustrating the substantial equivalence of the modified device to the predicate device appears below.
| Feature and/or Specification | CLEARED DEVICE
(UNIQUE K101751) | DEVICE WITH CHANGE
(UNIQUE) |
|-----------------------------------|------------------------------------|--------------------------------|
| C-Series Software release version | 8.0 | 9.1 |
| Dose Rates (MU/minute) | | |
| - Photons | 100 - 600 | 100 - 600 |
| - Electrons | none | none |
| Energy Levels | | |
| - Photons | 6 MV | 6 MV |
| - Electrons | none | none |
| Arc Therapy | | |
| - Photons | Standard | Standard |
| - Electrons | none | none |
Changes in Technological characteristics:
510(k) Summary - UNIQUE
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KJ32705
Page 3 of 3
| Feature and/or Specification | CLEARED DEVICE
(UNIQUE K101751) | DEVICE WITH CHANGE
(UNIQUE) |
|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Couch | Exact Couch
IGRT Couch Top | Exact Couch
IGRT Couch Top |
| RapidArc (Varian VMAT) | Optional | Optional |
| Multileaf Collimator | Standard | Optional |
| PortalVision - MV Imaging System | Standard | Optional |
| 4D Integrated Treatment Console | Standard | Standard |
| Real-Time Position Management (RPM) | Optional | Optional |
| Collision protection between the Gantry
& couch, when the couch is outside the
boundary conditions set by the user | For gantry rotation from
outside the treatment
room, motion rules are
enforced when the
imaging arm is extended. | For gantry rotation from
outside the treatment room,
motion rules are enforced
whether the imaging arm is
extended or retracted. |
| Extended Travel Range Zone includes
the 10 cm additional height needed to
support the Third-party Prone Breast
Couch Insert | No | Yes |
| Interlock preventing additional dose from
being delivered after beam hold has been
set | Hardware control | Hardware control plus
additional secondary
software check |
| Gantry and Couch rotation from outside
the treatment room are prevented or
limited within Exclusion Zone areas
defined by Zone Rules. | No | Yes |
8. Summary of Non-Clinical Testing
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.
Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.
9. Conclusions from Non-Clinical testing
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian therefore considers UNIQUE to be safe and effective and to perform at least as well as the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31. 2013
Varian Medical Systems. Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K132705
Trade/Device Name: UNIOUE Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: August 27, 2013 Received: August 29, 2013
Dear Mr. Coronado:
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. Please note: CDRH does not evaluate information related to contract liability warrantics. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2- Mr. Coronado
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132705
Device Name: UNIQUE
Indications For Use:
The Varian UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ,
Concurrence of Center for Devices and Radiological Health (CDRH)
Michael D. O'Hara
(Division Sign-Off) . Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _______________________________________________________________________________________________________________________________________________________________________ K132705_______________________________________________________________________________________________________________________________________________________________________
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