(150 days)
No
The document describes a linear accelerator system and its components for radiation therapy. While it mentions image processing and treatment planning, there is no mention of AI or ML technologies being used in the device's functionality or decision-making processes.
Yes
Explanation: The device is explicitly stated to be used for the "therapeutic treatment of cancer" by delivering X-Ray photon and electron radiation.
No
Explanation: The device is a linear accelerator system used for therapeutic treatment of cancer by delivering radiation. While it mentions the viewing, processing, filming, and archiving of medical images as part of its associated software applications and features an electronic portal imaging device (EPID) for verification, its primary stated purpose is therapeutic, not diagnostic.
No
The device description clearly states that the PreScision™ Option package is an optional feature to existing linear accelerator devices (LINACs), which are hardware. It also lists numerous hardware components required for the system to function, such as the LINAC itself, MLCs, EPID, and patient treatment couch. While software components are mentioned (syngo@workspaces), they are part of a larger hardware system for delivering radiation therapy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to "deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer." This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a linear accelerator (LINAC) system designed to deliver radiation to a patient's body. While it involves image processing for treatment planning and verification, this is in support of the therapeutic delivery of radiation, not for diagnosing a condition from a sample.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests on samples.
The mention of "viewing, processing, filming, and archiving of medical images" is related to the workflow of radiation therapy, which often involves imaging for planning and verification, but it doesn't make the entire system an IVD. The core function is therapeutic radiation delivery.
N/A
Intended Use / Indications for Use
The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
The LINAC.is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy-{IMRT}, and when used in conjunction with the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.
The syngo@workspaces includes a number of syngo@based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
Product codes
IYE
Device Description
The PreScision™ Option package is an optional feature to the existing SIEMENS ARTISTE™, ONCOR™ and PRIMUS™ family of medical linear accelerator devices [LINAC]. The basic design, safety features and function of the LINAC remain unchanged. The PreScision features upports Stereotation Therapy (SRT) and Stereotactic Radio-surgery (SRT) using the conventional linear accelerator and subsystems for the delivery of precision high dose X-Ray photon energy for treatment of lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.
The PreScision option supports the delivery of up to 2,000 (± 2%) MU / Minute X-Ray photon beam for either single-session radiosurgery or hypo-fractionated stereotactic treatment using a calibrated 6.67 MV photon energy spectrum consisting of an unflattened beam geometry, a selectable field size of 5cm x 5 cm up to 40cm x 40 cm, collimated by any validated third party stereotactic accessory such as a stereotactic cone or a Multi-leaf collimator, with or without the use of patient motion detection or physiologic gating.
The control console will support the PreScision feature with one unflattened beam energy labeled as "7UF" to differentiate from the previous 6 MV unflattened beam energy used by the predicate Stereo feature. The 7UF option replaces the existing "Stereo" option previously cleared under the PRIMUS™ (K993425) and ONCOR™ (K031764, K060226) and ARTISTE (K072585) devices.
The unflattened X-Ray photon energy spectrum is similar to the 6 MV energy spectrum as used by the PRIMUS™, ONCOR™, ARTISTE Linear Accelerator systems for the predicate Stereo option and is similar to the energy spectrum of the TomoTherapy Hi-Art system as described in Section 11, Design Description.
The SIEMENS linear accelerator product requirements for the PreScision™ option consists of the following:
A SIEMENS ARTISTE™, ONCOR™ or PRIMUS™ Family of Linear Accelerators with the minimum configuration of:
- COHERENCE™ Therapist Workspace or the syngo® Radiation Therapist (RTT) with . embedded PRIMEVIEW™ Record and Verify system or the RT Express™ system for the ONCOR™or ARTISTE™ linear accelerator systems.
- PRIMEVEIW 3i Record and Verify system used with the PRIMUS™ linear accelerator . system.
- 58 leaf multi-leaf collimator (MLC) marketed as 3D-MLC, 82 leaf MLC marketed as . OPTIFOCUS™ or the 160 Leaf MLC for:
- Stereotactic Radiotherapy 0
- Stereotactic Radiosurgery o
- Fixed fields, 0
- o Auto-sequenced,
- 0 Arc (Rotation) and
- Intensity Modulated Radiation Therapy (IMRT) treatment delivery methods, 0
- . MLC interface to support the SIEMENS ModuLeaf MLC (K030609) for precision Stereotactic or Stereotactic Radiosurgery Radiation TherapyTreatments.
- . Gating interface to support Third party, cleared, gating devices for physiologic or patient motion detection.
- . Stereotactic mode to support Third party, cleared, stereotactic hardware and patient fixation positioning devices.
- An amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID) marketed as . OPTIVUE 1000ST
- patient treatment couch; 550 TxT™ (K050422), or the ZXT™ (K910971).
Mentions image processing
The syngo@workspaces includes a number of syngo@based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072485, K060226, K993425, K061140, K060912, K052325
Reference Device(s)
K031764, K072585, K030609, K050422, K910971
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Siemens Medical Solutions USA, Inc. Oncology Care Systems
KOS2225
FEB 1 9 2009
Section 5 510(k) Summary
Submitter: Siemens Medical Solutions USA, Inc. Oncology Care Systems 4040 Nelson Avenue Concord, CA 94520 Contact: Christine Dunbar Senior Regulatory Affairs Specialist Phone: (925)602-8139 Fax: (925)602-8008 Email: christine.dunbar.ext@siemens.com Proprietary Name: PreScision™ Option Common Name: An accessory to: Accelerator, Linear, Medical Classification: 892.5050 Product Code: IYE
Substantial Equivalence Claimed To:
| PRODUCT | Clearance | Claim of Equivalence For: |
|---|---|---|
| SIEMENS ARTISTE™ | K072485 | The Stereo mode with the 160 MLC |
| SIEMENS ONCOR™ | ||
| Expression | K060226 | ONCOR™ and PRIMUS™ linear accelerator families |
| with Stereo Mode and COHERENCE Workspaces (or the | ||
| re-branded syngo® Suite for Oncology Workspaces) | ||
| and the 82 leaf MLC marketed as OPTIFOCUS. | ||
| SIEMENS PRIMUSTM | K993425 | PRIMUS™ family of linear accelerators with the Stereo |
| Mode, PRIMEVIEW 3i system, the 58 leaf MLC | ||
| Varian Trilogy™ | K061140 | Stereotactic (SRT) and Stereotactic Radio-Surgery |
| (SRS) Radiation Therapy with high dose beam rate. | ||
| TomoTherapy Hi-Art™ | K060912 | Stereotactic (SRT) and Stereotactic Radio-Surgery |
| (SRS) with unflattened beam delivery and extended | ||
| treatment field for Stereotactic Body Radiation Therapy. | ||
| Accuray Cyberknife™ | K052325 | Stereotactic (SRT) and Stereotactic Radio-Surgery |
| (SRS) robotic delivery system and increased dose rates | ||
| for reduced treatment times. |
The ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerators with the PreScision™ Option as described in this premarket notification has similar intended use and fundamental scientific technical characteristics as the devices listed above.
Description Summary:
000026
510(k) for PreScision™ Option
CONFIDENTIAL Page Sect. 5/1
1
Siemens Medical Solutions USA, Inc. Oncology Care Systems
| Market Name | Internal naming convention |
|---|---|
| ARTISTE™ | ARTISTE™ linear accelerator and ACCEL release 4+ |
| ONCOR™ Expression | ONCOR™ linear accelerator and ACCEL release 2+ |
| ONCOR™ Avant-Garde | ONCOR™ linear accelerator and ACCEL release 2+ |
| PRIMUS™ | PRIMUS™ linear accelerator and ACCEL release 2+ |
| PRIMEVIEW™ | Siemens proprietary verify and record system. The syngo® based |
| PRIMEVIEW is hosted on the COHERENCE™ Therapist | |
| Workspace. | |
| The syngo base version is marketed as PRIMEVIEW3i and is used | |
| on the PRIMUS™ linear accelerator systems. | |
| COHERENCE™ Therapist Workspace | RTT Workspace contains the SIEMENS proprietary verify and |
| record system as well as access to the Oncology Information | |
| System and directly connects to the LINAC control console. | |
| MVCB | Mega-Voltage Cone Beam - a method of obtaining 3 dimensional |
| data for portal imaging. | |
| 160 MLC™ | 160-leaf multi-leaf collimator |
| OPTIFOCUS™ | 82-leaf multi-leaf collimator |
| OPTIVUE™ | aSi flat panel electronic portal imaging device (EPID) AL7 model |
| OPTIVUE 1000ST | aSi flat panel electronic portal imaging device (EPID) AG9 model |
| SRT / SRS | Stereotactic Radiation Therapy/ Stereotactic radiosurgery ~ a |
| method of using high energy, X-Ray photon radiation for precision | |
| treatment. | |
| syngo® Therapist Workspace, RTT | |
| Express™ | RTT Workspace contains the SIEMENS proprietary verify and |
| record system as well as access to the Oncology Information | |
| System and directly connects to the LINAC control console on the | |
| ARTISTE™ linear accelerator system. | |
| syngo® Suite for Oncology | |
| Workspaces | Syngo based workstation, re-branded COHERENCE workspaces. |
| syngo® | Siemens proprietary software architecture and hosting SIEMENS |
| software applications organized by task cards on a dedicated | |
| workstation. |
Within the submission the following internal naming conventions are used:
For further definitions of the terms used in this submission, refer to the Glossary in Section 24.
Technological Characteristics:
The PreScision™ Option:
The PreScision™ Option package is an optional feature to the existing SIEMENS ARTISTE™,
ONCOR™ and PRIMUS™ family of medical linear accelerator devices [LINAC]. The basic design, safety features and function of the LINAC remain unchanged. The PreScision features upports Stereotation Therapy (SRT) and Stereotactic Radio-surgery (SRT) using the conventional linear accelerator and subsystems for the delivery of precision high dose X-Ray photon energy for treatment of lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.
The PreScision option supports the delivery of up to 2,000 (± 2%) MU / Minute X-Ray photon beam for either single-session radiosurgery or hypo-fractionated stereotactic treatment using a calibrated 6.67 MV photon energy spectrum consisting of an unflattened beam geometry, a selectable field size
2
of 5cm x 5 cm up to 40cm x 40 cm, collimated by any validated third party stereotactic accessory such as a stereotactic cone or a Multi-leaf collimator, with or without the use of patient motion detection or physiologic gating.
The control console will support the PreScision feature with one unflattened beam energy labeled as "7UF" to differentiate from the previous 6 MV unflattened beam energy used by the predicate Stereo feature. The 7UF option replaces the existing "Stereo" option previously cleared under the PRIMUS™ (K993425) and ONCOR™ (K031764, K060226) and ARTISTE (K072585) devices.
The unflattened X-Ray photon energy spectrum is similar to the 6 MV energy spectrum as used by the PRIMUS™, ONCOR™, ARTISTE Linear Accelerator systems for the predicate Stereo option and is similar to the energy spectrum of the TomoTherapy Hi-Art system as described in Section 11, Design Description.
The SIEMENS linear accelerator product requirements for the PreScision™ option consists of the following:
A SIEMENS ARTISTE™, ONCOR™ or PRIMUS™ Family of Linear Accelerators with the minimum configuration of:
- COHERENCE™ Therapist Workspace or the syngo® Radiation Therapist (RTT) with . embedded PRIMEVIEW™ Record and Verify system or the RT Express™ system for the ONCOR™or ARTISTE™ linear accelerator systems.
- PRIMEVEIW 3i Record and Verify system used with the PRIMUS™ linear accelerator . system.
- 58 leaf multi-leaf collimator (MLC) marketed as 3D-MLC, 82 leaf MLC marketed as . OPTIFOCUS™ or the 160 Leaf MLC for:
- Stereotactic Radiotherapy 0
- Stereotactic Radiosurgery o
- Fixed fields, 0
- o Auto-sequenced,
- 0 Arc (Rotation) and
- Intensity Modulated Radiation Therapy (IMRT) treatment delivery methods, 0
- . MLC interface to support the SIEMENS ModuLeaf MLC (K030609) for precision Stereotactic or Stereotactic Radiosurgery Radiation TherapyTreatments.
- . Gating interface to support Third party, cleared, gating devices for physiologic or patient motion detection.
- . Stereotactic mode to support Third party, cleared, stereotactic hardware and patient fixation positioning devices.
- An amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID) marketed as . OPTIVUE 1000ST
- patient treatment couch; 550 TxT™ (K050422), or the ZXT™ (K910971). �
Refer to Section 11 Design Description, for the Product Specification regarding these specific product features.
General Safety and Effectiveness:
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software development, verification of
3
requirements and validation testing. To minimize electrical and radiation hazards. SIEMENS adheres to recognized and established industry practice and relevant international standards.
Intended Use:
The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
The LINAC is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.
The syngo@ Suite for Oncology Workspaces:
The syngo@workspaces includes a number of syngo@based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
Summary:
In summary, it is SIEMENS' belief that the addition of the PreScision option for enhanced stereotactic radiation therapy and stereotactic radiosurgery (SRT / SRS ) does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2009
Ms. Christine Dunbar Senior Regulatory Affairs Specialist Siemens Medical Solutions, USA, Inc. Oncology Care Systems 4040 Nelson Avenue CONCORD CA 94520
Re: K082775 .
Trade/Device Name: PreScision™ Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 19, 2008 Received: September 22, 2008
Dear Ms. Dunbar:
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.
5
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 (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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 laceling 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 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppot/index.html.
Sincerely yours,
Lain B. Morris
anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Section 4
Indication For Use Statement
510(k) Number (if known): _ K082775
Device Name: PreScision™ Option
Indications for Use:
The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
The LINAC.is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy-{IMRT}, and when used in conjunction with the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.
The syngo Suite for Oncology Workspaces:
The syngo@workspaces includes a number of syngo@based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K082775 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-the-Counter Use ______ |
510(k) for PreScision™ Option