(78 days)
The Oncology Tech precision milled brass/aluminum compensators with tungsten fillings in the compensator walls are used for modulation of beam intensity during radiation therapy.
The Oncology Tech Mod1T Compensators for Radiation Beam Therapy are used for modulation of beam intensity during radiation therapy. Typically, a brass or aluminum 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. The new design of Oncology Tech Mod1T compensators mills out the compensator brass or aluminum walls and adds a high density material. The higher density of the fill material in the compensator walls provides for more attenuation and less radiation transmission at the field edges.
The provided text describes the Oncology Tech Mod1T Compensators for Radiation Beam Therapy and its substantial equivalence determination. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets those criteria.
Here's an analysis of what can and cannot be extracted from the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies an acceptance criterion related to "improvement of the attenuation under the compensator walls" and "greater attenuation of the photon beam at the field edge and less dose outside the field." However, no specific quantitative acceptance criteria or thresholds are stated.
- Reported Device Performance: The document states: "The measurement results show an improvement of the attenuation under the compensator walls for both the 6X and 18X beams. The addition of the high density fill to the compensator walls at the field edge provides greater attenuation of the photon beam at the field edge and less dose outside the field."
- Quantitative results are referenced as being in "Appendix A, located within the step 20 clinical testing section of this submission," which is not provided in the input text. Without Appendix A, specific performance values cannot be extracted.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "Each compensator was irradiated." The number of compensators tested is not explicitly stated.
- Data Provenance: Not specified. The description of the testing procedure (linear accelerator, Sun Nuclear profiler) suggests a controlled laboratory setting, but the location, whether it was retrospective or prospective, etc., is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical compensator for radiation therapy. Its performance is measured directly (attenuation), not diagnosed by experts. Therefore, there is no "ground truth" established by experts in the context of diagnostic performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As above, this is direct physical measurement, not a diagnostic assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/diagnostic imaging device. It's a physical component used in radiation therapy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The "study" described is a standalone physical measurement of the device's attenuation properties. The measurements were "recorded and compared to the brass compensator baseline."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for comparison was the "brass compensator baseline." The goal was to show improvement over this baseline in terms of attenuation.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above.
Summary of available information:
Acceptance Criteria and Device Performance:
| Criterion Category | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Attenuation | Implied: Improved attenuation under compensator walls and greater attenuation at field edge compared to predicate device. | "improvement of the attenuation under the compensator walls for both the 6X and 18X beams." "greater attenuation of the photon beam at the field edge and less dose outside the field." |
Study Details:
- Test Set Sample Size: Not explicitly stated (refers to "Each compensator").
- Data Provenance: Not specified (likely laboratory/controlled environment).
- Experts for Ground Truth: Not applicable (physical measurement).
- Adjudication Method: Not applicable.
- MRMC Study: Not applicable.
- Standalone Performance: Yes (physical measurement of device's attenuation properties).
- Type of Ground Truth: Comparison against "brass compensator baseline" (predicate device).
- Training Set Sample Size: Not applicable.
- Training Set Ground Truth Establishment: Not applicable.
Additional Study Information from the Text:
- Measurement Method: Sun Nuclear profiler in the transverse plane.
- Setup: Compensator locked in tray holder, linear accelerator gantry at 0°, collimator rotation at 0°.
- Irradiation: 100 monitor units of radiation.
- Comparison: Compared to a brass compensator baseline.
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Image /page/0/Picture/0 description: The image shows the logo for Oncologytech. The logo consists of a circular graphic to the left of the text "Oncologytech". The circular graphic is made up of several concentric circles.
Sean Comer, President Oncology Tech, L.L.C. 5608 Business Park San Antonio TX 78218 210-497-2100
JUL 2 8 2009
Summary
Trade Name: Mod1T Compensators for Radiation Beam Therapy
Common Name: Compensator
Classification Name: block, beam shaping, radiation therapy
Predicate Device: The predicate device is "Mod1 Compensators for Radiation Beam Therapy", by Symtium Corporation, FDA number: K062781.
Device Description:
The Oncology Tech Mod1T Compensators for Radiation Beam Therapy are used for modulation of beam intensity during radiation therapy. Typically, a brass or aluminum 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. The new design of Oncology Tech Mod1T compensators mills out the compensator brass or aluminum walls and adds a high density material. The higher density of the fill material in the compensator walls provides for more attenuation and less radiation transmission at the field edges.
Intended Use of the Device:
The Oncology Tech Mod1T Radiation Beam Therapy Compensator 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 universal application to this patient population.
Technological Characteristics of the Device:
The predicate device for comparison purposes is the "Mod1 Compensators for Radiation Beam Therapy", by Symtium Corporation, FDA number: K062781. The Oncology Tech Mod1T Radiation Beam Therapy Compensator has the same intended use and similar characteristics to the predicate device.
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Determination of Substantial Equivalence:
The attenuation was measured with a Sun Nuclear profiler in the transverse or cross table plane. Each compensator was locked in place in the tray holder accessory for the linear accelerator. The gantry of the linear accelerator was set at 0° so that it was pointing directly towards the floor. A collimator rotation was also at 0°. The test device was placed on the table used to treat patients and carefully aligned with the collimator crosshairs. The table was raised to the distance that was normally used for standard QA measurements according to the manufacturer instructions. Each compensator was irradiated with 100 monitor units of radiation. The transverse plane attenuation for each compensator was then recorded and compared to the brass compensator baseline: These test results are shown in Appendix A, located within the step 20 clinical testing section of this submission. The measurement results show an improvement of the attenuation under the compensator walls for both the 6X and 18X beams. The addition of the high density fill to the compensator walls at the field edge provides greater attenuation of the photon beam at the field edge and less dose outside the field.
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Johnie McConnaughhay Vice President of Engineering Oncology Tech, L.L.C. 5608 Business Park SAN ANTONIO TX 78218
JUL 2 8 2009
Re: K091403
Trade/Device Name: ModiT 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: May 12, 2009 Received: May 12, 2009
Dear Mr. McConnaughhay:
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
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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sean Comer, President Oncology Tech, L.L.C. 5608 Business Park San Antonio TX 78218 210-497-2100
Indications for Use
510(k) Number (if known): K091403
Device Name: _ Mod1T Compensators for Radiation Beam Therapy _
Indications for Use:
The Oncology Tech precision milled brass/aluminum compensators with tungsten fillings in the compensator walls are used for modulation of beam intensity during radiation therapy.
Prescription Use (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)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
210.497.2100 F 210.497.210
.oncologytech.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.