(90 days)
Not Found
No
The description focuses on the physical manufacturing and function of a beam-shaping device based on designs from a separate treatment planning system. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to shape and focus a proton beam for radiation therapy, which is a therapeutic intervention for treating targeted areas.
No
The device description indicates that the .decimal Proton Aperture is a beam-shaping block used in proton radiation therapy to guide radiation to a targeted area and block it from critical structures. It is custom-designed for each patient based on a treatment planning system or physician's specifications. This function is therapeutic, not diagnostic, as it is used to deliver treatment, not to identify or characterize a disease or condition.
No
The device description explicitly states the device is a "Brass Core encased in a reusable steel ring" with a "2D hole cut from it," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The .decimal Proton Aperture is a physical device used in vivo (within the treatment process of a patient's body) to shape and block a proton radiation beam. It directly interacts with the radiation delivered to the patient.
- Intended Use: The intended use is to modify the delivery of external beam proton radiation therapy, not to analyze biological samples for diagnostic information.
- Device Description: The description clearly outlines a physical aperture used in a radiation therapy gantry.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, diagnostic information, or any of the typical characteristics of an IVD.
Therefore, the .decimal Proton Aperture falls under the category of a therapeutic device used in radiation therapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
.decimal's Aperture manufacturing service manufactures the ring and solid core apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Product codes (comma separated list FDA assigned to the subject device)
IXI
Device Description
The .decimal Proton Aperture is a Brass Core encased in a reusable steel ring (or material with similar attenuating properties) with a 2D hole cut from it, which defines the area that is to be treated with a proton beam. The design for a .decimal Proton Aperture is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping block. The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. As radiation is passed through the gantry, the beam passes through aperture and it will be blocked. The opening of the aperture where there is no brass, the radiation will pass through targeted area defined by the radiation therapy professional.
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)
Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in house by .decimal personnel where Proton Apertures were deemed safe and effective for clinical use. The tests show that .decimal Proton Apertures performed as well as the predicate device.
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.
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Image /page/0/Picture/0 description: The image shows the word ".decimal" in a bold, sans-serif font. A small circle is located above and to the right of the word. Below the word ".decimal" is the phrase "The benchmark for custom radiation therapy" in a smaller, regular font.
K132236
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Section 5 510(k) Summary
Section 807.87 (h) A 510(k) Summary as described in Section 807.92
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
July 17, 2013
Submitter's Name:
.decimal, Inc. 121 Central Park Pl Sanford, Florida 32771
Contact Person:
Kimberly Rupp Quality and Regulatory Affairs Manager Phone: 407-330-3300 407-322-7546 Fax: --Email: krupp@dotdecimal.com
Device Name:
.decimal Proton Aperture
Classification Name:
IXI 21 CFR 892.5710 "Radiation Therapy Beam Shaping Block" Class II
Device Description:
The .decimal Proton Aperture is a Brass Core encased in a reusable steel ring (or material with similar attenuating properties) with a 2D hole cut from it, which defines the area that is to be treated with a proton beam. The design for a .decimal Proton Aperture is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping
OCT 16 2013
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block. The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. As radiation is passed through the gantry, the beam passes through aperture and it will be blocked. The opening of the aperture where there is no brass, the radiation will pass through targeted area defined by the radiation therapy professional. The operating principles are explained in section 12 of this submittal.
Predicate Device(s):
.decimal Proton Aperture (K121657), .decimal Inc., . decimal, Inc.
Intended Use:
.decimal's Aperture manufacturing service manufactures the ring and solid core apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Indications for Use:
.decimal's Aperture manufacturing service manufactures the ring and solid core apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Summary of Technological Characteristics:
The device features of .decimal's Apertures are similar to the predicate device .decimal Proton Aperture. They both are 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.
A detailed comparison can be found in section 10 of this submittal.
Summary of Non-Clinical Testing:
Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in house by .decimal personnel where Proton Apertures were deemed safe and effective for clinical use. The tests show that .decimal Proton Apertures performed as well as the
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K132236
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predicate device. A declaration of conformity to this requirement can be found in section 18 of this document.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern 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 16, 2013
.decimal, Inc. % Ms. Kimberly Rupp Ouality & Regulatory Affairs Manager 121 Central Park Place SANFORD FL 32771
Re: K132236
Trade/Device Name: .decimal Proton aperture Regulation Number: 21 CFR 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: Class II Product Code: IXI Dated: July 17, 2013 Received: July 18, 2013
Dear Ms. Rupp:
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 (2 l 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
4
Page 2- Ms. Kimberly Rupp
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.fda.gov/MedicalDevices/ResourcesforYou/Industry/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.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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
t. D/offara 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
510(k) Number (if known): K132236
.decimal Proton Aperture Device Name:
Indications for Use:
.decimal's Aperture manufacturing service manufactures the ring and solid core apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
રા ભૂત (K) K132236
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