INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)

• K Number: K123788
• Device Name: INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
• Manufacturer: VARIAN MEDICAL SYSTEMS, INC.
• Date Cleared: 2013-01-15 ( 36 days)
• Product Code: IYE
• Regulation Number: 892.5050

Intended Use

The Integrated Conical Collimator Verification and Interlock system (ICVI) is an accessory device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy on intra-cranial and extra cranial lesions or tumors.

Device Description

Integrated Conical Collimator Verification and Interlock system (ICVI) is a secondary collimation system. It also has a security feature that verifies the correct selection of a conical collimator and prevents the radiation treatment device from commencing irradiation when the selected conical collimator is out of conformance with the treatment plan. Integrated Conical Collimator Verification and Interlock system (ICVI) consists of a collimator mount that attaches to the accessory plate (Slot 2) of the linear accelerator, conical collimators that insert into the mount and are capable of being read electronically by the mount, and a locking ring that locks the conical collimator to the mount.

Predicate Devices

K971893

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical verification and interlock based on electronic reading of the collimator, with no mention of AI/ML terms or image processing.

Therapeutic

No
The device is described as an "accessory device indicated for use with a Linear Accelerator" to perform treatments, and its function is to provide secondary collimation and a security feature for radiation treatment, rather than directly providing therapy itself.

Diagnostic

No
The device is described as an "accessory device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy." Its function is to verify the correct selection of a conical collimator and prevent irradiation if it's out of conformance with the treatment plan. This indicates it's a treatment delivery and safety device, not one used for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of hardware components: a collimator mount, conical collimators, and a locking ring.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
• Device Function: The ICVI system is an accessory for a Linear Accelerator used in radiotherapy. Its function is to verify and interlock the correct selection of conical collimators for radiation treatment. It directly interacts with the radiation delivery system and the patient's body (indirectly, through the radiation beam), not with biological specimens.
• Intended Use: The intended use is to perform Stereotactic Radiosurgery and precision Radiotherapy on lesions or tumors. This is a therapeutic application, not a diagnostic one.

The device's purpose is to ensure the accurate delivery of radiation therapy, which is a treatment, not a diagnostic test performed on a sample outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Integrated Conical Collimator Verification and Interlock system (ICVI) is an accessory device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy on intra-cranial and extra cranial lesions or tumors.

The Integrated Conical Collimator Verification and Interlock system is intended for use with a Linear Accelerator to perform Stereotactic Radiosurgery or precision Radiotherapy on intracranial and extra cranial lesions or turnors that require a conical collimator to shape the radiation beam.

Product codes (comma separated list FDA assigned to the subject device)

IYE

Device Description

Integrated Conical Collimator Verification and Interlock system (ICVI) is a secondary collimation system. It also has a security feature that verifies the correct selection of a conical collimator and prevents the radiation treatment device from commencing irradiation when the selected conical collimator is out of conformance with the treatment plan.

Integrated Conical Collimator Verification and Interlock system (ICVI) consists of a collimator mount that attaches to the accessory plate (Slot 2) of the linear accelerator, conical collimators that insert into the mount and are capable of being read electronically by the mount, and a locking ring that locks the conical collimator to the mount.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intra-cranial and extra cranial lesions or tumors, benign or malignant

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)

Testing was performed to demonstrate

• That the device functions correctly with the specified Linear Accelerators.
• That the device meets mechanical specifications.
• Usability was assessed to the requirements of IEC 62366:2007.

Results of verification and validation testing showed conformance to applicable requirement specifications and assured hazard safeguards functioned properly.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K971893

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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K 123788

JAN 1 5 2013

510(k) Summary SUMMARY OF SAFETY AND EFFECTIVENESS

Integrated Conical Collimator Verification and Interlock system (ICVI)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Submitted by:

Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304

Phone: [phone] Fax: [phone]

Contact Person: Peter J. Coronado, Director, Regulatory Affairs

Date summary prepared: December 7, 2012

Trade Name: Integrated Conical Collimator Verification and Interlock system (ICVI)

Common Name: Integrated Conical Collimator Verification and Interlock system (ICVI)

Classification Name: Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product Code: IYE

Predicate Devices: SNT Linac Accessories, K971893

Device Description:

Integrated Conical Collimator Verification and Interlock system (ICVI) is a secondary collimation system. It also has a security feature that verifies the correct selection of a conical collimator and prevents the radiation treatment device from commencing irradiation when the selected conical collimator is out of conformance with the treatment plan.

Integrated Conical Collimator Verification and Interlock system (ICVI) consists of a collimator mount that attaches to the accessory plate (Slot 2) of the linear accelerator, conical collimators that insert into the mount and are capable of being read electronically by the mount, and a locking ring that locks the conical collimator to the mount.

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Indications for Use:

The Integrated Conical Collimator Verification and Interlock system (ICVI) is an accessory device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy on intra-cranial and extra cranial lesions or turnors.

Intended Use:

The Integrated Conical Collimator Verification and Interlock system is intended for use with a Linear Accelerator to perform Stereotactic Radiosurgery or precision Radiotherapy on intracranial and extra cranial lesions or turnors that require a conical collimator to shape the radiation beam.

Characteristic	Predicate Device	Subject Device	Equivalent
	SNT Linac Accessories, K971893	Integrated Conical Collimator
Verification and Interlock
system (ICVI)	or Better?
Intended Use	The SNT Linac Accessories are
indicated for use with a Linear
Accelerator to perform Stereotactic
Radiosurgery or Radiotherapy on
cranial lesions. The accessories
include a secondary collimation
system, components to mount a
patient in a stereotactic headring to
a linear accelerator's treatment
couch, and components to position
the patient relative to the isocenter
of a linear accelerator in
conjunction with a laser alignment
system	The Integrated Conical
Collimator Verification and
Interlock system is intended
for use with a Linear
Accelerator to perform
Stereotactic Radiosurgery or
precision Radiotherapy on
intra-cranial and extra cranial
lesions or tumors that require
a conical collimator to shape
the radiation beam.	Yes
Indications for
Use	The SNT Linac Accessories are
indicated for use with a Linear
Accelerator to perform Stereotactic
Radiosurgery or Radiotherapy on
cranial lesions. The accessories
include a secondary collimation
system, components to mount a
patient in a stereotactic headring to
a linear accelerator's treatment
couch, and components to position
the patient relative to the isocenter
of a linear accelerator in
conjunction with a laser alignment system	The Integrated Conical
Collimator Verification and
Interlock system is an
accessory device indicated for
use with a Linear Accelerator
to perform Stereotactic
Radiosurgery and precision
Radiotherapy on intra-cranial
and extra cranial lesions or
tumors.	Yes
	system
Duration of Use	The patient would usually receive a
series of treatments with a linear
accelerator.	The patient would usually
receive a series of treatments
with a linear accelerator.	Yes
Collimator
mount	Yes	Yes	Yes
Collimators	Yes, comes with collimators	Yes, comes with collimators	Yes
Design
Dimensions	Mount
Not published	Mount
476 x 350 x 100 mm without
the conical collimator
476 x 350 x 180 mm with the
conical collimator	Yes
Design
Dimensions	Conical Collimators
118 mm base diameter
73 mm conical collimator
diameter
14 mm length	Conical Collimators
118 mm base diameter
73 mm conical collimator
diameter
14 mm length	Yes
Design Material	Mount
Not published	Mount
Aluminum, Stainless Steel,
Brass, Copper, PCB, Cabling	Yes
	Conical Collimators
Tungsten & Aluminum	Conical Collimators
Tungsten & Aluminum
Anatomical
Sites	Cranial lesions	Intra-cranial and extra-cranial
lesions or tumors, benign or
malignant	Yes
Mount &
conical
collimators
electronically
verifiable	No	Yes	Yes
Provides
verification that
the correct
conical
collimator has
been selected for
patient treatment
based on the
patient's	No	Yes	Yes
treatment plan.
Patient Contact	None	None	Yes
Biocompatibility	N/A no patient contact	N/A no patient contact	Yes

Technological Characteristics:

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Summary of Performance Testing:

Testing was performed to demonstrate

• That the device functions correctly with the specified Linear Accelerators .
• . That the device meets mechanical specifications
• Usability was assessed to the requirements of IEC 62366:2007 .

Results of verification and validation testing showed conformance to applicable requirement specifications and assured hazard safeguards functioned properly.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 15, 2013

Mr. Peter J Coronado Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304

Re: K123788

Trade/Device Name: Integrated Conical Collimator Verification and Interlock System (ICVI)

Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 7, 2012 Received: December 10, 2012

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 warranties. 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

5

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.htm 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 [phone] or [phone] 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): K123788

Device Name: Integrated Conical Collimator Verification and Interlock System (ICVI)

Indications for Use:

The Integrated Conical Collimator Verification and Interlock system (ICVI) is an accessory device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy on intra-cranial and extra cranial lesions or tumors.

Prescription Use X (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 CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123788 510(k) =======================================================================================================================================================================

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