(15 days)
The use of standard CT scanners in Radiation Treatment Planning environments requires a higher geometric accuracy of anatomical data. For the Siemens SOMATOM Emotion CT systems, a dedicated RTP package (including both hardware and software components) will be offered and provides the following features: improved gantry tilt accuracy, reduced table top deflection, externally adjustable gantry laserlights, increased tube positioning accuracy, simplified horizontal positioning of the table, optimized field coverage using extended Field of View. Radiation Treatment Planning (RTP) Package will be used to prepare geometric and anatomical data, which may assist the physician with proposed external beam radiotherapy treatment planning.
A dedicated RTP package for the SOMATOM Emotion CT Systems includes both hardware and software components and further improves the geometric accuracy of anatomical data. The RTP package will provide the following: Improved gantry tilt accuracy, Reduced table top deflection, Externally adjustable gantry laserlights, Increased x-ray tube positioning accuracy, Simplified horizontal positioning of the table, Optimized field coverage using extended Field of View (FOV).
This 510(k) summary (K042229) is for a "Radiation Treatment Planning (RTP) Package" for Siemens SOMATOM CT systems. It focuses on improving the geometric accuracy of anatomical data for radiation therapy.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a formal table of acceptance criteria or quantitative performance metrics for the device. Instead, it describes feature improvements intended to enhance geometric accuracy. The closest information to performance metrics are the qualitative improvements listed and one quantitative measurement for the "Simplified horizontal positioning of the table".
| Feature/Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Improved gantry tilt accuracy | The gantry tilt angle is displayed in 0.5-degree increments. |
| Reduced table-top deflection | Tabletop deflection is reduced by replacing the CT table, allowing for more accurate patient positioning. |
| Externally adjustable gantry laser lights | A position adjustment of the gantry laser lights is possible without opening the gantry, allowing easier installation and synchronization with room RTP lasers. |
| Increased x-ray tube positioning accuracy | The accuracy of x-ray tube positioning for Topogram scans is improved to a range of ± 2 degrees. |
| Simplified horizontal positioning of the table | During an examination, a table feed position can be stored, enabling fast and easy repositioning of a patient back to the previous table position (tolerance of ± 1 mm). |
| Optimized field coverage using extended Field of View (FOV) | The FOV is extended to 70 cm for maximum anatomical visualization and improved RTP positioning. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify a test set sample size, country of origin of data, or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention any experts used to establish ground truth or their qualifications. The device described appears to be a hardware/software upgrade to a CT system, and the "performance" described relates to the precision and physical capabilities of the system itself, rather than diagnostic accuracy that would typically require expert ground truth.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is an accessory to a CT system focused on improving physical accuracy for radiation treatment planning, not an AI-based diagnostic tool requiring human-in-the-loop performance evaluation.
6. Standalone (Algorithm only without human-in-the-loop performance) Study:
A standalone study as typically understood for an algorithm's diagnostic performance was not conducted or reported. The performance metrics described relate to the physical accuracy of the CT system components, which would have been validated through engineering tests and measurements rather than a "standalone algorithm" study.
7. Type of Ground Truth Used:
The ground truth for this device's "performance" would likely be established through engineering measurements and calibration standards for physical accuracy (e.g., measuring gantry tilt with precise instruments, measuring table deflection under load, measuring laser alignment, and tube positioning with reference phantoms). The document does not explicitly state the type of ground truth used, but given the nature of the device, it would not be expert consensus, pathology, or outcomes data in the typical sense.
8. Sample Size for the Training Set:
The document does not mention or imply a training set sample size. This device is an upgrade to a CT system, not an AI model that undergoes a training phase with a dataset.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a "training set" or AI model in the conventional sense, the establishment of ground truth for a training set (or lack thereof) is not applicable to this submission.
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510(K) SUMMARY Kd42229
F(){{ SIEMENS RADIATION TREATMENT PLANNING (RTP) PACKAGE
Submitted by:
Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355
August 17, 2004
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Contact Person:
Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 Malvern, PA 19355 Phone: (610) 448-1769 Fax: (610) 448-1787 Email: nealie.hartman@siemens.com
Device Name and Classification 2.
| Product Name: | SOMATOM Radiation Treatment Planning (RTP) |
|---|---|
| package | |
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
3. Importer/Distributor Establishment:
Registration Number: 2240869 Siemens Medical Solutions, Inc. USA 51 Valley Stream Pkwy Malvern, PA 19355
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Manufacturing Facility: 4.
Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany
Substantial Equivalence 5.
The Radiation Treatment Planning (RTP) Package, addressed in this premarket notification, is substantially equivalent to the following commercially available software package:
| Predicate Device Nume | ' FDA Clearance Number FDA Clearance Date | |
|---|---|---|
| Siemens SOMATOM Emotion 6 (P10) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------K023687 | 11/22/02 |
Device Description 6.
A dedicated RTP package for the SOMATOM Emotion CT Systems includes both hardware and software components and further improves the geometric accuracy of anatomical data. The RTP package will provide the following:
- Improved gantry tilt accuracy: . The gantry tilt angle is displayed in 0.5 degree increments.
- Reduced table top deflection: . The tabletop deflection is reduced, by replacing the CT table, allowing for more accurate patient positioning.
- Externally adjustable gantry laserlights: . A position adjustment of the gantry laserlights is possible without opening the gantry thus allowing easier installation and synchronization with room RTP lasers.
- Increased x-ray tube positioning accuracy: . The accuracy of x-ray tube positioning for Topogram scans is improved to a range of ± 2 degrees.
- Simplified horizontal positioning of the table: . During an examination, a table feed position can be stored enabling fast and easy repositioning of a patient back to the previous table position (tolerance of ± 1mm).
- Optimized field coverage using extended Field of View (FOV): . The FOV is extended to 70 cm for maximum anatomical visualization and improved RTP positioning.
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Ko42229
Indications for Use 7.
The use of standard CT scanners in Radiation Treatment Planning environments requires a r it as or banian accuracy of anatomical data. For the Siemens SOMATOM Emotion CTs and all further CT devices a dedicated RTP package (including both hardware and software components) will be offered and provides the following features:
- improved gantry tilt accuracy .
- reduced table top deflection .
- externally adjustable gantry laserlights .
- increased tube positioning accuracy .
- simplified horizontal positioning of the table .
- optimized field coverage using extended Field of View .
Radiation Treatment Planning (RTP) Package will be used to prepare geometric and anatomical data, which may assist the physician with proposed external beam radiotherapy treatment planning.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2004
Ms. Nealie Hartman Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355
Re: K042229
Trade/Device Name: SOMATOM Radiation Treatment Planning (RTP) Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
Regulatory Class: II Product Code: 90 JAK Dated: August 17, 2004 Received: August 17, 2004
Dear Ms. Hartman:
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 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.
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.
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Page 2
This letter 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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
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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Indications for Use
510(k) Number (if known): Device Name:
14-229 Radiation Treatment Planning (RTP) package
The use of standard CT scanners in Radiation Treatment Planning environments requires a higher geometric accuracy of anatomical data.
For the Siemens SOMATOM Emotion CT systems, a dedicated RTP package (including both For the Siements SOMA TOM Enion OF Of Systems, a carovides the following features:
- improved gantry tilt accuracy .
- reduced table top deflection .
- externally adjustable gantry laserlights .
- increased tube positioning accuracy .
- simplified horizontal positioning of the table .
- optimized field coverage using extended Field of View .
Radiation Treatment Planning (RTP) Package will be used to prepare geometric and Radiation Treatment Hamiling (NTT ) Packago The Statemal beam radiotherapy treatment planning.
(Please do not write below this line - continue on another page if needed) ( Please do not Wille befow this The - Sound-African -------------------------------------------------------------------------------------------------------------------------
Concurrence of the CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR $801.109)
Over-The-CounterUse
(Division Sign-Off)
Division of Reproductive Abdominal
Nancy C. Brogdon
ivision of Reproductive. Abo and Radiological Devices
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.