(54 days)
Not Found
No
The document describes a physical device (Photon Block) manufactured based on designs from a treatment planning system or physician specifications. There is no mention of AI or ML being used in the design, manufacturing process, or function of the device itself. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a Photon Block used in radiation therapy to shape and focus the radiation beam, blocking healthy tissue and guiding radiation to the targeted area. It does not directly provide therapy but rather assists in the delivery of radiation therapy.
No
The device is a Photon Block used in radiation therapy to shape and focus a photon beam to treat cancerous tissue, not to diagnose a condition.
No
The device description clearly states that the device is a "Cerrobend block (or material with similar attenuating properties)" which is a physical object, not software. The software mentioned is the customer's treatment planning system which designs the block, but the device itself is the physical block.
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 used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The .decimal Photon Block is a physical device made of Cerrobend that is used to shape and block radiation beams during external beam photon radiation therapy. It is inserted into a linear accelerator and directly interacts with the radiation beam, not with a biological specimen from the patient.
- Intended Use: The intended use is to block radiation from critical structures and healthy tissue and guide it to the targeted area during radiation therapy for cancer. This is a therapeutic application, not a diagnostic one.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It is a device used in the delivery of a medical treatment.
N/A
Intended Use / Indications for Use
.decimal's Photon Block manufacturing service manufactures Photon Blocks for external beam photon radiation therapy. The Photon Block is designed by the customer's treatment planning system or physician specifications to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Photon Blocks are intended for use by healthcare professionals.
In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block.
The Photon Block is inserted into the gantry's collimator to shape and focus the beam as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon beam. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.
Product codes (comma separated list FDA assigned to the subject device)
IXI
Device Description
The .decimal Photon Block is a Cerrobend block (or material with similar attenuating properties) with a 2D pattern/hole made from it, which defines the area that is to be treated with a photon beam. The design for a .decimal Photon Block 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 block fits into a customer's linear accelerator. As radiation is passed through the collimator, the beam passes through cerrobend and it will be blocked the opening of the photon block where there is no ccrrobend, 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
healthcare professionals
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 excelled in house by .decimal personnel including a Board Certified Medical Physicist where Photon Blocks were deemed safe and effective for clinical modical modical The tests show that .decimal Photon Blocks 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.
0
Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', '1', '2', '3', '0', '1', and 'S'. The characters are written in a simple, handwritten style.
Image /page/0/Picture/1 description: The image shows the word "decimal" in bold, black font. There is a small circle with a line through it to the right of the word. Below the word "decimal" is the phrase "The benchmark for custom radiation th" in a smaller font.
enchmark for custom radiation therapy
NOV 2 1 2012
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:
September 26, 2012
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 Photon Block
Classification Name:
IXI 21 CFR 892.5710 "Radiation Therapy Beam Shaping Block" Class II
Device Description:
The .decimal Photon Block is a Cerrobend block (or material with similar attenuating properties) with a 2D pattern/hole made from it, which defines the area that is to be treated with a photon beam. The design for a .decimal Photon Block 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 block fits into a
1
customer's linear accelerator. As radiation is passed through the collimator, the beam passes through cerrobend and it will be blocked the opening of the photon block where there is no ccrrobend, 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 Electron Aperture (K111759), .decimal Inc.
Intended Use:
.decimal's Photon Block manufacturing service manufactures Photon Blocks for external beam photon radiation therapy. The Photon Block is designed by the customer's treatment planning system or physician specifications to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Photon Blocks are intended for use by healthcare professionals.
Indications for Use:
In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block.
The Photon Block is inserted into the gantry's collimator to shape and focus the beam as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon bean. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.
Summary of Technological Characteristics:
The device features of the .decimal Photon Block are similar to the predicate device (.decimal Electron Aperture K111759 cleared in 2011). They both are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Whereas the previous version was made using brass used solely in proton radiation therapy, this version is made using cerrobend and is used for photon radiation therapy. Like .decimal Apertures used in proton therapy, each .decimal Photon Block must be validated and approved by the radiation therapy professional prior
2
to use on a patient. The target population is identical and the use parameters are also very a 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 excelled in house by .decimal personnel including a Board Certified Medical Physicist where Photon Blocks were deemed safe and effective for clinical modical modical The tests show that .decimal Photon Blocks performed as well as the predicate device. A declaration of conformity to this requirement can be found in section 18 of this document.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO-66 Silver Spring, MD 20993-002
November 21, 2012
Ms. Kym Rupp Ouality & Regulatory Affairs Manager decimal. Inc. 121 Central Park Place SANFORD FL 32771
Re: K123015
Trade/Device Name: . DECIMAL Photon Block Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping device Regulatory Class: II Product Code: IXI Dated: September 26, 2012 Received: September 28, 2012
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:
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
4
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to (2017) 196 - 150. Thiss 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 I ou may ovain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Michael D. O'Hara
2012.12.03
07:27:41 -05'00'
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K123015
Device Name: . decimal Photon Block
Indications for Use:
In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block.
The Photon Block is inserted into the gantry's collimator to shape and focus the beam as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon beam. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.
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)
William Jung 2012.11.21 13:54:00
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123015 510(k)
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