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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Varian UNIQUE device:

The provided document (K132705) is a 510(k) summary for a medical linear accelerator, the Varian UNIQUE. It focuses on demonstrating substantial equivalence to a predicate device (UNIQUE K101751) due to specific changes primarily related to enhanced patient safety features concerning gantry and couch motion.

Key takeaway: This document describes a modification to an existing medical device where the primary focus is on safety features (motion zone rules and interlocks). It is not a study demonstrating the diagnostic or therapeutic performance of an AI-powered device, but rather a verification and validation of engineering changes to a linear accelerator.

Therefore, many of the requested elements (like AI-specific performance, MRMC studies, expert ground truth for imaging, training set details) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Feature	Reported Device Performance/Status
C-Series Software release version	Updated to 9.1 (from 8.0 in predicate)
Dose Rates (MU/minute) - Photons	100 - 600 (unchanged from predicate)
Dose Rates (MU/minute) - Electrons	None (unchanged from predicate)
Energy Levels - Photons	6 MV (unchanged from predicate)
Energy Levels - Electrons	None (unchanged from predicate)
Arc Therapy - Photons	Standard (unchanged from predicate)
Arc Therapy - Electrons	None (unchanged from predicate)
Couch	Exact Couch, IGRT Couch Top (unchanged from predicate)
RapidArc (Varian VMAT)	Optional (unchanged from predicate)
Multileaf Collimator	Optional (changed from Standard in predicate) - This appears to be a change in offering, not performance.
PortalVision - MV Imaging System	Optional (changed from Standard in predicate) - This appears to be a change in offering, not performance.
4D Integrated Treatment Console	Standard (unchanged from predicate)
Real-Time Position Management (RPM)	Optional (unchanged from predicate)
Collision protection between the Gantry & couch (outside boundaries when imaging arm extended)	For gantry rotation from outside the treatment room, motion rules are enforced whether the imaging arm is extended or retracted. (Predicate: motion rules enforced only when imaging arm is extended). Improvement in safety.
Extended Travel Range Zone for 10 cm additional height for Third-party Prone Breast Couch Insert	Yes (Predicate: No). New capability/safety feature.
Interlock preventing additional dose after beam hold	Hardware control plus additional secondary software check. (Predicate: Hardware control only). Improvement in safety/redundancy.
Gantry and Couch rotation from outside the treatment room prevented/limited within Exclusion Zone areas defined by Zone Rules.	Yes (Predicate: No). New safety feature.
Overall Performance and Functionality	"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."
Safety and Effectiveness	"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."

Study Details (as applicable to this type of device modification)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document does not describe a "test set" in the context of imaging data or a diagnostic algorithm.
- The "test set" for this modification would refer to testing of the device's hardware and software functionalities.
- Provenance: Not specified, but generally, Varian Medical Systems, Inc. is a U.S.-based company, and such engineering tests are typically conducted internally at their facilities.
- Retrospective/Prospective: The testing described (Verification and Validation) is inherent to the product development lifecycle and would be considered prospective in relation to the design changes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable in the sense of medical image interpretation.
- Ground Truth: For device functionality, the "ground truth" is defined by the design input requirements and technical specifications for the motion zone rules and interlocks.
- Experts: "Qualified personnel" performed the validation testing. These would be engineers, QA specialists, and potentially clinical representatives experienced with linear accelerators, but not radiologists establishing ground truth for disease.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an imaging or diagnostic study requiring expert consensus. The testing would follow engineering test protocols.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done.
- The device is a medical linear accelerator; it does not involve human readers interpreting images with or without AI assistance for diagnostic purposes. The changes are to hardware/software interlocks for patient safety during treatment delivery.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself (the linear accelerator) operates in conjunction with human operators (radiotherapy technologists, dosimetrists, radiation oncologists). The "motion zone rules" and "interlocks" are algorithmic components within the device's software that automatically prevent unsafe operations.
- Standalone testing of these sub-systems (e.g., verifying the interlock logic in isolation) would have been part of the verification process, but not as a standalone AI diagnostic tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this type of device modification is established by engineering design specifications, safety standards, and validated functional requirements. For example, the ground truth for the expanded "collision protection" is that the gantry should not collide with the couch in specified scenarios, regardless of imaging arm position, and the system correctly prevents such collisions.
The sample size for the training set
- Not applicable. This is not an AI/machine learning model where a "training set" is used to develop an algorithm for diagnosis or prediction. The changes are deterministic software and hardware logic.
How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the AI/ML sense.

Summary

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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.

1. 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 EditionUNIQUE Performance Edition
Common Name:	Medical Linear Accelerator
Classification Name:	Medical Charged Particle Radiation Therapy System21 CFR §892.5050Class IIProduct Code 90 IYE

3. Predicate Device: UNIQUE K101751

Description of the Device:

The UNIQUE was most recently cleared as the Varian UNIQUE, K101751.

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K132705
page 2 of 3

All other features and technological characteristics of the UNIQUE remain as cleared by K101751.

1. 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.
1. 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.
1. 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.

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 CouchIGRT Couch Top	Exact CouchIGRT 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 theboundary conditions set by the user	For gantry rotation fromoutside the treatmentroom, motion rules areenforced when theimaging arm is extended.	For gantry rotation fromoutside the treatment room,motion rules are enforcedwhether the imaging arm isextended or retracted.
Extended Travel Range Zone includesthe 10 cm additional height needed tosupport the Third-party Prone BreastCouch Insert	No	Yes
Interlock preventing additional dose frombeing delivered after beam hold has beenset	Hardware control	Hardware control plusadditional secondarysoftware check
Gantry and Couch rotation from outsidethe treatment room are prevented orlimited within Exclusion Zone areasdefined 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.

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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

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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

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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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Regulation Number and Section

§ 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.