CURA COLLIMATOR

K123893 · Cura Medical Technologies, LLC · IXI · Mar 4, 2013 · Radiology

Device Facts

• Record ID: K123893
• Device Name: CURA COLLIMATOR
• Applicant: Cura Medical Technologies, LLC
• Product Code: IXI · Radiology
• Decision Date: Mar 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5710
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cura Collimator is a solid, machine-shaped brass aperture intended to shape an external radiation beam to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area. The Cura Collimator may be used as an accessory whenever external beam radiation therapy is indicated for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

Device Story

Cura Collimator is a custom-machined high-lead brass aperture; used as an accessory in external beam radiation therapy. Device receives treatment plan parameters from hospital personnel via DICOM network transmission; Cura machining centers manufacture custom cutouts based on these plans. Collimator fits into radiation therapy applicator/nozzle; blocks radiation from critical structures/healthy tissue; guides beam to targeted area. Used in clinical radiation therapy settings; operated by radiation therapy staff. Benefits include precise radiation delivery to tumors while sparing surrounding healthy tissue. No software is integral to the device itself.

Clinical Evidence

Bench testing only. Testing included material performance, adherence of machine tool instructions to treatment plans, and DICOM network transmission integrity. Physical comparison of manufactured collimators to treatment plans and beam tests (capturing delivered field on digital film) confirmed accuracy of delivered beam line field versus treatment plan.

Technological Characteristics

Solid, high-lead content brass aperture; custom-machined to hospital specifications. Dimensions/form factor sized to fit specific radiation therapy applicators/nozzles. No software included. Passive device; no energy source.

Indications for Use

Indicated for patients with localized tumors or other conditions requiring external beam radiation therapy; used as an accessory to shape radiation beams and protect healthy tissue.

Regulatory Classification

Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Predicate Devices

• .Decimal Aperture (K071077)

Submission Summary (Full Text)

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K123893

Image /page/0/Picture/2 description: The image shows a logo for "CURA MEDICAL TECHNOLOGIES". The logo consists of the word "CURA" in large, bold letters above the words "MEDICAL TECHNOLOGIES" in smaller letters. The logo also includes three circular designs, one above and two below the text, that appear to be stylized representations of spirals or coils.

Cura Medical Technologies LLC 23 Rancho Circle Lake Forest, CA 92630 949-716-2447 www.curamedtech.com MAR 0 4 2013 :

December 14, 2012

## PTS-250. Proton Radiation Beam Therapy System Premarket Notification (510(k)) Summary, as required by 21 CFR 807.92(c)

#### Introduction

This document provides a summary of the safety and effectiveness information contained in the Cura Collimator Premarket Notification (510(k)). This Premarket Notification (510(k)) Summary contains no confidential or trade secret information and is intended for full public disclosure and distribution. For addition information, please contact the Establishment's contact listed below, Thomas H. Faris.

#### Premarket Notification Information

Previous Notificaton Information:

Previous Submission #: Previous FDA Clearance Date Product Name

None, Initial Submission None Cura Collimator

Submitter's Information :

Cura Medical Technologies 23 Rancho Circle ·Lake Forest, CA 92630

Contact Person:

Thomas Faris Consultant for Quality and Regualtory Affairs C/O Mevion Medical Systems, Inc. 300 Foster Street Littleton, MA 01460 Phone: [phone] Fax: [phone] Email: [e-mail]

Trade Name:

Cura Collimator

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Image /page/1/Picture/1 description: The image shows a logo for Cura Medical Technologies. The logo features the word "CURA" in a stylized font, with the words "MEDICAL TECHNOLOGIES" written in a smaller font underneath. The logo also includes three swirling shapes arranged around the word "CURA", creating a circular design. The logo is black and white.

Cura Medical Technologies LLC .. 23 Rancho Circle Lake Forest, CA 92630 949-716-2447 www.curamedtech.com

Classification Information: Classification Name .Proudct Code CFR Reference Product Classification Review Panel

Customer Beam Block IXI 21 CFR892.5710 Class II Office of In Vitro Diagnostic Device Evaluation and Safety

Predicate Device:

.Decimal Aperture K071077

#### Intended Use/Indications for use

· The Cura Collimator is a solid, machine-shaped brass aperture intended to shape an external radiation beam to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area. The Cura Collimator may be used as an accessory whenever external beam radiation therapy is indicated for the treatment of patients with localized turnors or other conditions susceptible to treatment by radiation.

#### Summary Device Description

Cura Collimators are custom beam blocks with machined cutout to allow beam passage per prescription and sized to snugly fit the applicator or nozzle and block all remaining beam in the radiation therapy fraction delivery. The Collimator is made of high lead content brass with notch orientation to match radiation manufacturer use specifications. No software is included in this device.

#### Summary of Technological Characteristics

Cura Collimators, sometimes also called apertures, are made of brass, custom cut to hospital users' specifications, and used for external beam radiation therapy treatments. The brass aperture cutouts are designed according to the Treatment Plan parameters designated by hospital personnel and then transmitted to Cura machining centers for custom manufacture and delivery back to the hospital.

The device features of Cura Collimators are similar to the predicate device, Dot Decimal's Apertures. Thev both are made of brass, custom cut to hospital users' specifications, and used for external beam radiation therapy treatments. They both are used to block radiation and guide it to affected areas. The target population is identical and the use parameters are also very similar.

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Image /page/2/Picture/1 description: The image shows a logo for Cura Medical Technologies. The logo features the word "CURA" in a stylized font, with the words "MEDICAL TECHNOLOGIES" written in a smaller font underneath. The logo also includes three swirling shapes arranged in a circular pattern around the word "CURA". The logo is black and white.

Cura Medical Technologies LLC 23 Rancho Circle Lake Forest, CA 92630 949-716-2447 www.curamedtech.com

## Summary of Non-Clinical Testing

Cura Collimators were tested for:

1. Material performance

- 2. Machine tool instructions adherence to Treatment Plan direction
- 3. DICOM Network Transmission system integrity

Treatment plans were created at Washington University, in St. Louis, Missouri. The treatment plans were transmitted to Cura via Cura's DICOM Network Transmission application. Cura manufactured the Cura Collmators, based upon the communicated treatment plan. Cura distributed the test Cura Collimators to Washington University, who physically compared the · Cura Collimators to the actual treatment plan and conducted beam tests with the Cura Collimators. Cura Collimators were also sent to Mevion Medical Systems, Inc. for physical inspection and beam test. For beam test, the Cura Collimators were placed in beam and the delivered field was captured on digital film. Both Mevion and Washington confirmed the accuracy of the delivered beam line field versus the treatment plan.

All tests PASSED, with no contingencies or other considerations.

Conclusion

In conclusion, the non-clinical test demonstrates that Cura Collimators function as intented, and are Safe and Effective to accomplish their intended use.

## Summary of Technological Characteristics Substantial Equivalence Analysis

The Cura Collimator is substantially equivalent to .decimal Aperture. Brass apertures have been used for beam shaping in radiation therapy for many decades. The Brass apertures effectively shape radiotherapy treatment beams - proton, electron, and photon beams - to precisely deliver radition to intended treatment targets. Cura Collimator is equivalent in intended use, materials used, creation and use processes, and performance. The Cura Collimator poses no new, novel, or different safety or efficacy risks or efficacies. As such, the Cura Collimator is Substantially Equivalent to the .decimal Aperture.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2013

Mr. Thomas H. Faris Regulatory Counsel Cura Medical Technologies, LLC 23 Rancho Circle LAKE FOREST CA 92630

Re: K123893

Trade/Device Name: Cura Collimator Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: October 27, 2012 Received: December 18, 2012

Dear Mr. Faris:

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 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.

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Page 2-Mr. Faris

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

the FDA Hara for

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 Statement

510(k) Number (if known): |< 12 3 893

Device Name: Cura Collimator

Indications for Use:

The Cura Collimator is a solid, machine-shaped brass aperture intended to shape an external radiation beam to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area. The Cura Collimator may be used as an accessory whenever external beam radiation therapy is indicated for the treatment of patients with localized tumors or other conditions susceptible to treatment by radition.

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 Diagnostic Device Evaluation and Safety

Michi FDA Hara

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

123893 510(k)

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