(98 days)
Not Found
No
The device description explicitly states "No software is included in this device," and there are no mentions of AI, DNN, or ML in the summary.
Yes
The device is used to attenuate external radiation and block radiation from hitting critical structures during external beam radiation therapy, which is a treatment for conditions susceptible to radiation. Therefore, it directly contributes to the therapeutic process.
No
The device, a Cura Compensator, is used to attenuate radiation and block it from critical structures during radiation therapy; it does not diagnose conditions or diseases.
No
The device description explicitly states "No software is included in this device." and describes a physical, solid block.
Based on the provided information, the Cura Compensator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The Intended Use and Device Description clearly state that the Cura Compensator is a physical block used to modify external radiation beams applied to the patient's body during radiation therapy. It does not interact with or analyze any biological samples.
- The device's function is physical attenuation and blocking of radiation. This is a mechanical function, not a diagnostic test performed on a sample.
The description aligns with a medical device used in radiation therapy, specifically for beam shaping and blocking, which is an in vivo treatment process, not an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The Cura Compensator is a solid, machine-shaped acrylic block intended to attenuate external radiation beam and block radiation from hitting critical structures and healthy tissue while allowing the radiation dose to the targeted area. The Cura Compensator 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.
Product codes (comma separated list FDA assigned to the subject device)
IXI
Device Description
Cura Compensators are custom beam blocks with machined cutout to allow beam passage per prescription and block all remaining beam in the Compensator. The Compensator is made of acrylic or wax with notch sized to match radiation machine manufacturer use specifications. No software is included in this device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
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
§ 892.5710 Radiation therapy beam-shaping block.
(a)
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.(b)
Classification. Class II.
0
K 131150
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S10(K) Summary
Cura Medical Technologies LLC 23 Rancho Circle Lake Forest, CA 92630 949-716-2447 www.curamedtech.com April 17, 2013
JUL 3 0 2013
Range Compensator, Radiation Beam Shaping Device 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 Compensator 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 Compensator
Submitter's Information :
Cura Medical Technologies 23 Rancho Circle Lake Forest, CA 92630
Contact Person:
Thomas Faris Regulatory Counsel C/O Mevion Medical Systems, Inc. 300 Foster Street Littleton, MA 01460 Phone: 650-996-1192 Email: thomfaris@yahoo.com
Trade Name:
Cura Compensator
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1
K131150
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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
Custom Beam Block IXI 21 CFR892.5710 Class II Office of In Vitro Diagnostic Device Evaluation and Safety
Predicate Device:
decimal Range Compensator K071078
Proton Systems Proton radiation therapy beam-shaping aperture and range compensator K121657
Intended Use/Indications for use
The Cura Compensator is a solid, machine-shaped acrylic or wax block intended to attenuate The Cula Compensator is a sonal masmition from hitting critical structures and healthy tissue external radiation ocan and orook facilation from the Cura Compensator may be used as an withe anowing the faultion about is the the app is indicated for the treatment of patients accessory whenever oxtential occarditions susceptible to treatment by radiation.
Summary Device Description
Cura Compensators are custom beam blocks with machined cutout to allow beam passage per Cura Compellators are custom boain orocks with maszle and block all remaining beam in the prescription and sized to magis in the Compensator is made of acrylic or wax with notch radiation to match radiation machine manufacturer use specifications. No software is included in this device.
Summary of Technological Characteristics
Cura Compensators, sometimes also called range compensators, are made of acrylic, custom cut Cura Compensations, sometimes and used for external beam radiation therapy treatments. The to nospital users "specifications, and according to the Treatment Plan parameters designated act your compensator carouts are doctgotted to Cura machining centers for custom manufacture and delivery back to the hospital.
The device features of Cura Compensators are similar to the predicate device, .decimal Tissue The device readines of Cara Compensation of acrylic, custom cut to hospital users'
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Image /page/2/Picture/1 description: The image shows the word "CURA" in large, bold letters. Below the word "CURA" is smaller text that appears to say "ultimaker technologies". The text is in a simple, sans-serif font and is black on a white background. The image is clear and easy to read.
Cura Medical Technologies LLC 23 Rancho Circle Lake Forest, CA 92630 949-716-2447
www.curamedtech.com
specifications, and used for external beam radiation therapy treatments. They both are used to specifications, and assures of onternal ocaras. The target population is identical and the use parameters are also very similar.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three lines representing its wings, and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle symbol is a common emblem used by the U.S. government to represent strength and national identity. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Poblic Health Service
Food and Drug Administration 10903 New Hampshue Avenue Document Control Center - WO66-(iblis) Silver Spring, MD 20993-0002
July 30. 2013
Cura Medical Technologies, LLC % Mr. Thomas H. Faris Regulatory Counsel 23 Rancho Circle LAKE FOREST CA 92630
Re: K131150
Trade/Device Name: Cura Compensator Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: H Product Code: IXI Dated: April 17, 2013 Received: May 7, 2013
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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic 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/CentersOfTices/CDRH/CDRH(){fices/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/ReportalProblem/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 (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
for
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):
Device Name:
Cura Range Compensator
Indications for Use:
The Cura Compensator is a solid, machine-shaped acrylic block intended to attenuate external radiation beam and block radiation from hitting critical structures and healthy tissue while allowing the radiation dose to the targeted area. The Cura Compensator 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.
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
· K131150 510(k) =
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