INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)

K123788 · Varian Medical Systems, Inc. · IYE · Jan 15, 2013 · Radiology

Device Facts

• Record ID: K123788
• Device Name: INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jan 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

ICVI is a secondary collimation system accessory for linear accelerators used in stereotactic radiosurgery and precision radiotherapy. It consists of a collimator mount (attaching to the accelerator's accessory slot), interchangeable conical collimators, and a locking ring. The system features electronic verification: the mount reads the inserted conical collimator and checks it against the patient's treatment plan. If the selected collimator does not conform to the plan, the system triggers an interlock to prevent radiation delivery. Used in clinical radiation therapy settings by trained personnel, the device ensures correct beam shaping, reducing the risk of treatment errors and improving precision for intracranial and extracranial lesions.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed the device functions correctly with specified linear accelerators, meets mechanical specifications, and complies with usability requirements per IEC 62366:2007.

Technological Characteristics

Mount materials: Aluminum, stainless steel, brass, copper, PCB, cabling. Collimator materials: Tungsten and aluminum. Dimensions: Mount (476 x 350 x 100 mm without collimator; 476 x 350 x 180 mm with collimator); Collimators (118 mm base diameter, 73 mm diameter, 14 mm length). Features electronic verification of collimator selection via mount-to-collimator sensing. Interlock system prevents irradiation upon non-conformance. No patient contact.

Indications for Use

Indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy on intra-cranial and extra cranial lesions or tumors.

Regulatory Classification

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.

Predicate Devices

• SNT Linac Accessories (K971893)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

### 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<br>Verification and Interlock<br>system (ICVI) | or Better? |
| Intended Use | The SNT Linac Accessories are<br>indicated for use with a Linear<br>Accelerator to perform Stereotactic<br>Radiosurgery or Radiotherapy on<br>cranial lesions. The accessories<br>include a secondary collimation<br>system, components to mount a<br>patient in a stereotactic headring to<br>a linear accelerator's treatment<br>couch, and components to position<br>the patient relative to the isocenter<br>of a linear accelerator in<br>conjunction with a laser alignment<br>system | The Integrated Conical<br>Collimator Verification and<br>Interlock system is intended<br>for use with a Linear<br>Accelerator to perform<br>Stereotactic Radiosurgery or<br>precision Radiotherapy on<br>intra-cranial and extra cranial<br>lesions or tumors that require<br>a conical collimator to shape<br>the radiation beam. | Yes |
| Indications for<br>Use | The SNT Linac Accessories are<br>indicated for use with a Linear<br>Accelerator to perform Stereotactic<br>Radiosurgery or Radiotherapy on<br>cranial lesions. The accessories<br>include a secondary collimation<br>system, components to mount a<br>patient in a stereotactic headring to<br>a linear accelerator's treatment<br>couch, and components to position<br>the patient relative to the isocenter<br>of a linear accelerator in<br>conjunction with a laser alignment system | The Integrated Conical<br>Collimator Verification and<br>Interlock system is an<br>accessory device indicated for<br>use with a Linear Accelerator<br>to perform Stereotactic<br>Radiosurgery and precision<br>Radiotherapy on intra-cranial<br>and extra cranial lesions or<br>tumors. | Yes |
| | system | | |
| Duration of Use | The patient would usually receive a<br>series of treatments with a linear<br>accelerator. | The patient would usually<br>receive a series of treatments<br>with a linear accelerator. | Yes |
| Collimator<br>mount | Yes | Yes | Yes |
| Collimators | Yes, comes with collimators | Yes, comes with collimators | Yes |
| Design<br>Dimensions | Mount<br>Not published | Mount<br>476 x 350 x 100 mm without<br>the conical collimator<br>476 x 350 x 180 mm with the<br>conical collimator | Yes |
| Design<br>Dimensions | Conical Collimators<br>118 mm base diameter<br>73 mm conical collimator<br>diameter<br>14 mm length | Conical Collimators<br>118 mm base diameter<br>73 mm conical collimator<br>diameter<br>14 mm length | Yes |
| Design Material | Mount<br>Not published | Mount<br>Aluminum, Stainless Steel,<br>Brass, Copper, PCB, Cabling | Yes |
| | Conical Collimators<br>Tungsten & Aluminum | Conical Collimators<br>Tungsten & Aluminum | |
| Anatomical<br>Sites | Cranial lesions | Intra-cranial and extra-cranial<br>lesions or tumors, benign or<br>malignant | Yes |
| Mount &<br>conical<br>collimators<br>electronically<br>verifiable | No | Yes | Yes |
| Provides<br>verification that<br>the correct<br>conical<br>collimator has<br>been selected for<br>patient treatment<br>based on the<br>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:

{2}------------------------------------------------

.

:

.

.

.

{3}------------------------------------------------

### 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.

{4}------------------------------------------------

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

{6}------------------------------------------------

# 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) =======================================================================================================================================================================

Page 1 of