(64 days)
The Symtium Corporation precision milled brass compensators are used for modulation of beam intensity during radiation therapy.
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.
The Symtium Corporation Mod1 Compensators for Radiation Beam Therapy's acceptance criteria and the study proving it meets these criteria are outlined in the "Determination of Substantial Equivalence" section of the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Measured composite dose within 2% of the expected value | Measured composite dose was within 2% of the expected value. |
| Isodose lines and distance to agreement within industry standard Van Dyke criteria | Isodose lines and distance to agreement were within industry standard Van Dyke criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that "brass compensators were milled to specification" based on "a treatment plan adopted from a prostate case." This implies that at least one prostate case was used to generate compensators for testing, but a specific number of compensators or total patient treatment plans tested is not provided.
- Data Provenance: The testing was conducted at a "participating Cancer Center site." No specific country of origin is mentioned, but the company address is in San Antonio, TX, USA. The data appears to be prospective as the compensators were manufactured and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The description implies that the "staff of the Cancer Center" generated the initial compensator design and would likely be involved in verifying the results. Given the context, these would likely be radiation oncologists, medical physicists, or dosimetrists, but no specific professional credentials or years of experience are listed.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that the "compensator production was verified through a QA process" and that "Each compensator was tested using equivalent dose rates with two separate industry standard QA devices." This suggests instrumental verification rather than human adjudication for establishing the direct performance metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The study focuses on the physical accuracy and performance of the device (compensator) itself, not on how human readers' interpretation or effectiveness might improve with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was conducted. The device (compensator) is designed to modulate beam intensity based on a treatment plan, and its performance was evaluated instrumentally against established physical standards (composite dose and Van Dyke criteria). This is a standalone evaluation of the device's output. While a human designs the compensator initially, the test itself assesses the manufactured compensator's adherence to that design, independent of real-time human intervention during the test.
7. The Type of Ground Truth Used
The ground truth used was instrumental measurements and industry standards.
- The "expected value" for composite dose and "industry standard Van Dyke criteria" serve as the ground truth against which the device's performance was compared.
- The comparison was enabled by specialized QA devices for IMRT measurements.
8. The Sample Size for the Training Set
The document does not mention a training set. This is not an AI/machine learning device that requires a training set. The device is a physical compensator milled to specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used or described.
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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
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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
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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.
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Protecting and Promoting Public Health
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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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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
§ 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.