(64 days)
Not Found
No
The description focuses on the physical manufacturing process of a brass compensator based on pre-generated treatment plans, with no mention of AI or ML in the design or manufacturing process.
Yes
The device directly modulates the intensity of the radiation beam during radiation therapy to treat the patient, making it a therapeutic device.
No
The device is a compensator used to modulate beam intensity during radiation therapy to ensure precise radiation delivery to tumors while sparing healthy tissue. It is a therapy delivery device, not a diagnostic one.
No
The device is a physical brass compensator that is manufactured based on software design files. The description clearly details the physical manufacturing process, QA of the physical device, and its use as a physical component in a LINAC. While software is used in the design and manufacturing process, the device itself is a physical object.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Symtium Corporation precision milled brass compensators are used during radiation therapy to modulate the intensity of the radiation beam directed at the patient. They are a physical component used in the treatment delivery process, not for analyzing biological samples.
- Intended Use: The intended use clearly states "modulation of beam intensity during radiation therapy." This is a therapeutic application, not a diagnostic one.
The device is a component used in a therapeutic procedure (radiation therapy), not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Syntium Corporation Mod I Compensator for Radiation Beam Therapy is designed specifically for application in external beam radiation therapy in cancer treatment. The device could be used in this application for all types of cancer treatable by external beam radiation therapy, with a miversal application to this patient population.
The Symtium Corporation precision milled brass compensators are used for modulation of beam intensity during radiation therapy.
Product codes (comma separated list FDA assigned to the subject device)
IXI
Device Description
The Symtium Corporation Mod1 Compensators for Radiation Beam Therapy are used for modulation of beam intensity during radiation therapy (IMRT). Initially, a plan for the compensator design is generated by the staff of the Cancer Center using treatment planning software such as Pinnacle, Eclipse, or CMS (and others). This compensator design file is then transferred to Symtum Corporation via secure online data transfer, and imported into their custom designed manufacturing software. Typically, a brass round is used as a basis for the compensator. It is placed into the milling machine and worked into precise X, Y and Z dimensions to match the treatment planning output. It is then removed from the milling machine and subjected to an extensive QA process to verify the accuracy of the process non the match between the physical dimensions of the compensator and the treatment planing outputs. The device is then mounted onto a carrier specific to the linear accelerator (LINAC) used for patient treatment. The finished device is then packaged and mailed to the Cancer Center via commercial package transport companies.
Once received by the Cancer Center, the compensator is unpackaged and once again undergoes a QA process to confirm the accuracy of the manufacturing process in onec ugain andiation fluency map as well as radiation dose. At this point, the device is moved into the LINAC vault for patient freatient The compensator is then locked into place on the LINAC in the accessory collect
During patient treatment, a photon beam is generated by the LINAC and directed toward the patient. The compensator attenuates the photon beam based upon the thickness and shape of the brass. In general, the device shields sensitive portions of the treatment, and may. Of the was. In of the radiation on the tumor. Brass is a heavy, dense material with the ability to "attenuate" or block the amount of radiation that passes through it. When the milled brass compensator is mounted in the accessory collar of the LINAC, the photon beam aimed at the patient is "attenuated" is the area according to the thickness of the brass. Thicker areas "attenuate" or block more photon bean than the thinner areas. Generally, the thinner areas of the compensator would correspond to the tumor, while the thicker areas would overly surrounding "normal" tissue. In this way the tumor receives a maximum, effective dose of radiation while surrounding areas receive little or no radiation, sparing them from damage and the patient from side effects of the treatment.
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
Cancer Center staff
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)
The determination of substantial equivalence was based on assessment of clinical data sets. The compensator production was verified through a QA process. Using a treatment plan adopted from a prostate case, brass compensators were milled to specification and shipped to the participating Cancer Center site for testing. Each compensator was tested using equivalent dose rates with two separate industry standard QA devices specifically for 1MRT measurements. These test results are shown in Step 20 - Clinical Test Results. Measured composite dose was within 2% of the expected value. Ison one lives and distance to agreement were within industry standard Van Dyke criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measured composite dose was within 2% of the expected value.
Ison one lives and distance to agreement were within industry standard Van Dyke criteria.
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/1 description: The image shows the logo for Symtium Corporation. The logo consists of a stylized graphic to the left of the company name. The graphic appears to be a stylized letter 'S'. The text 'Symtium Corporation' is written in a simple, sans-serif font.
Sean Comer, President and CEO SYMTIUM CORPORATION 11503 Jones Maltsberger Suite 710 San Antonio TX 78216
NOV 2 1 2006
Summary
Trade Name: Mod1 Compensators for Radiation Beam Therapy
Common Name: Compensator
Classification Name: block, beam shaping, radiation therapy
Predicate Device: The predicate device is Southeastern Radiation Products, Inc. K040804, ".Decimal Tissue Compensator/Intensity Modulator".
Device Description:
The Symtium Corporation Mod1 Compensators for Radiation Beam Therapy are used for modulation of beam intensity during radiation therapy (IMRT). Initially, a plan for the compensator design is generated by the staff of the Cancer Center using treatment planning software such as Pinnacle, Eclipse, or CMS (and others). This compensator design file is then transferred to Symtum Corporation via secure online data transfer, and imported into their custom designed manufacturing software. Typically, a brass round is used as a basis for the compensator. It is placed into the milling machine and worked into precise X, Y and Z dimensions to match the treatment planning output. It is then removed from the milling machine and subjected to an extensive QA process to verify the accuracy of the process non the match between the physical dimensions of the compensator and the treatment planing outputs. The device is then mounted onto a carrier specific to the linear accelerator (LINAC) used for patient treatment. The finished device is then packaged and mailed to the Cancer Center via commercial package transport companies.
Once received by the Cancer Center, the compensator is unpackaged and once again undergoes a QA process to confirm the accuracy of the manufacturing process in onec ugain andiation fluency map as well as radiation dose. At this point, the device is moved into the LINAC vault for patient freatient The compensator is then locked into place on the LINAC in the accessory collect
During patient treatment, a photon beam is generated by the LINAC and directed toward the patient. The compensator attenuates the photon beam based upon the thickness and shape of the brass. In general, the device shields sensitive portions of the treatment, and may. Of the was. In of the radiation on the tumor. Brass is a heavy, dense material with the ability to "attenuate" or block the amount of radiation that passes through it. When the milled brass compensator is mounted in the accessory collar of the LINAC, the photon beam aimed at the patient is "attenuated" is the area according to the thickness of the brass. Thicker areas "attenuate" or block more photon bean than the thinner areas. Generally, the thinner areas of the compensator would correspond to the tumor, while the
© 2006 Symtium Corporation. All Rights Reserved.
11503 Jones Maltsberger, Suite W-710 San Antonio, Texas 78216 - lar 866.492.9803 - symtium.com
1
Image /page/1/Picture/0 description: The image shows the logo for Symtium Corporation. The logo consists of a stylized graphic to the left of the company name. The graphic appears to be an abstract design, possibly representing interconnectedness or a network. The text "Symtium Corporation" is written in a simple, sans-serif font.
thicker areas would overly surrounding "normal" tissue. In this way the tumor receives a maximum, effective dose of radiation while surrounding areas receive little or no radiation, sparing them from damage and the patient from side effects of the treatment.
Intended Use of the Device:
The Syntium Corporation Mod I Compensator for Radiation Beam Therapy is designed specifically for application in external beam radiation therapy in cancer treatment. The device could be used in this application for all types of cancer treatable by external beam radiation therapy, with a miversal application to this patient population.
Technological Characteristics of the Device:
The predicate device for comparison purposes is the Southeastern Radiation Products, Inc. K040804, " Decimal Tissue Compensator/Intensity Modulator". The design and material composition of the Symtium Corporation Radiation Beam Therapy Compensator is identical to those of the predicate device.
Determination of Substantial Equivalence:
The determination of substantial equivalence was based on assessment of clinical data sets. The compensator production was verified through a QA process. Using a treatment plan adopted from a prostate case, brass compensators were milled to specification and shipped to the participating Cancer Center site for testing. Each compensator was tested using equivalent dose rates with two separate industry standard QA devices specifically for 1MRT measurements. These test results are shown in Step 20 - Clinical Test Results. Measured composite dose was within 2% of the expected value. Ison one lives and distance to agreement were within industry standard Van Dyke criteria.
© 2006 Symtium Corporation. All Rights Reserved.
11503 Jones Maltsberger, Suite W-710 San Antonio, Texas 78216 rel 210.745.2065 fax 866.492.9803 symtium.com
2
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV 2 1 2006
Mr. Sean Comer President and CEO SYMTIUM Corporation 11503 Jones Maltsberger Suite 710 SAN ANTONIO TX 78216
Re: K062781
Roo2781
Trade/Device Name: Mod 1 Compensators for Radiation Beam Therapy Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: September 12, 2006 Received: September 18, 2006
Dear Mr. Comer:
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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a black and white logo. The logo is circular and contains the text "1906-2006" at the top. Below the text is the letters "FDA" in a bold font. Below the letters is the word "Centennial" in a cursive font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
3
Page 2 --
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); 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.
This fetter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Symtium Corporation. The logo consists of a stylized letter 'S' on the left, followed by the text "SymtiumCorporation" on the right. The text is in a simple, sans-serif font. The logo appears to be in black and white.
Scan Comer, President and CEO SYMTIUM CORPORATION 11503 Jones Maltsberger Suite 710 San Antonio TX 78216
A. Indications for Use
510(k) Number (if known):
Device Name: Mod1 Compensators for Radiation Beam Therapy
Indications for Use:
The Symtium Corporation precision milled brass compensators are used for modulation of beam intensity during radiation therapy.
Daniela Guzman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
© 2006 Symtium Corporation. All Rights Reserved.
11503 Jones Maltsberger, Suite W-710 San Antonio, Texas 78216 tel 210.745.2065 fax 866.492.9803 symtium.com