(49 days)
The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The UNIQUE is a Single Energy Linear Accelerator and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. UNIQUE is supported by the following Varian accessories: RPM Respiratory Gating (063270), PortalVision (K091209), 4D Integrated Treatment Console (K091132), Millennium Multi-Leaf Collimator (K050442).
The provided text describes a 510(k) summary for the Varian UNIQUE linear accelerator. It focuses on demonstrating substantial equivalence to a predicate device, the Varian Trilogy, rather than presenting a study with specific acceptance criteria and reported device performance metrics in the way a diagnostic AI device would.
Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a diagnostic AI device is not applicable to this submission. This is a submission for a physical medical device (linear accelerator) used for radiation therapy, not a diagnostic algorithm.
However, I can interpret the available information to address the spirit of your request as best as possible within the context of a medical device 510(k) submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a table. Instead, the "acceptance criteria" are implied by demonstrating that the UNIQUE's performance and safety characteristics are "substantially equivalent" to the predicate device (Varian Trilogy K072916) and that its design meets internal requirements. The "reported device performance" is a general statement that "the results of verification and validation activities demonstrate that the acceptance criteria have been met."
Instead of performance metrics, the document focuses on comparing device characteristics:
| Item | Acceptance Standard (Predicate Device: Trilogy - K072916) | Reported Device Characteristic (UNIQUE) |
|---|---|---|
| C-Series Software | C-Series 7.7 | C-Series 8.0 |
| Photon Energy (MV) available | 4-25 MV | 6 MV |
| Selectable Number of Photon Beams | Two | One |
| Dose Rates | 50-600 MU/min (1000 SRS rate) | 100 - 600 MU/min (No SRS rate) |
| Maximum standard treatment field size | 40cm x 40cm | 40cm x 40cm |
| Electron Treatment | Yes | No |
| Arc Treatments | Yes | Yes |
| Non-arc photon treatment mode programmable MU maximum dose | 999 MU | 1999 MU |
| Patient Support surface: Exact Couch | Yes | Yes |
| Patient support surface: Exact couch pedestal with IGRT couch top for improved MV imaging | No | Yes |
| Drive mechanism | Direct Drive | Clutch |
| Treatment Beam generation | Klystron | Magnetron |
| Support for External System Gating Interface "EXGI" | No | Yes |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A). This K101757 submission is for a physical medical device (linear accelerator) used for radiation therapy. It does not involve a "test set" of medical images or data for an AI algorithm in the typical sense. The "testing" refers to verification and validation of the hardware and software functionality to ensure it meets design specifications and safety requirements, often through engineering tests, rather than a diagnostic performance study on a patient sample.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A). As above, this device does not utilize a "ground truth" established by experts in the context of diagnostic interpretation. Ground truth for a linear accelerator would relate to its physical performance metrics (e.g., dose accuracy, beam flatness, reproducibility), which are typically verified against established physics and engineering standards, not expert consensus on medical images.
4. Adjudication method for the test set
Not Applicable (N/A). There is no mention of an adjudication method, as it doesn't involve subjective interpretations of medical data requiring such a process.
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 (N/A). This device is a treatment delivery system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). There is no mention of an "algorithm only" performance study because the device itself is a physical linear accelerator, not a standalone algorithm. Its functionality is integral to the hardware.
7. The type of ground truth used
Not Applicable (N/A) in the diagnostic sense. The "ground truth" for this type of device would be established by engineering specifications, physical measurements (e.g., dosimetry data), and regulatory standards for safety and performance of linear accelerators. The submission states, "Varian design control procedures applied to the development of the UNIQUE include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met." This implies the "ground truth" is adherence to these established design and safety requirements.
8. The sample size for the training set
Not Applicable (N/A). As this is a physical medical device and not a machine learning algorithm for diagnostic interpretation, there is no "training set."
9. How the ground truth for the training set was established
Not Applicable (N/A). No training set means no ground truth for it.
In summary: The K101757 submission for the Varian UNIQUE linear accelerator is a 510(k) summary demonstrating substantial equivalence to a predicate device. It focuses on comparing the engineering and functional characteristics of the new device to an existing one, along with stating that internal verification and validation processes confirmed its safety and performance against design requirements. It is fundamentally different from a submission for a diagnostic AI device, which would involve data sets, ground truths, and performance metrics.
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510(k) Summary
The information below is provided for the UNIQUE, following the format of 21 CFR 807.92.
AUG 1 0 2010
- Varian Medical Systems 1. Submitter: 3100 Hansen Way, M/S E110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 E-mail: vy.tran@varian.com
| 2. Name of the Device: | UNIQUE |
|---|---|
| Trade / Proprietary Names: | UNIQUE |
| Common or Usual Names: | Single Energy Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation Therapy System |
| 21 CFR §892.5050 | |
| Class II | |
| Product Code: | 90 IYE |
-
- Predicate Device: Varian Trilogy K072916
-
- Description of the Device:
,
The UNIQUE is a Single Energy Linear Accelerator and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. UNIQUE is supported by the following Varian accessories: RPM Respiratory Gating (063270), PortalVision (K091209), 4D Integrated Treatment Console (K091132), Millennium Multi-Leaf Collimator (K050442).
-
- Intended Use Statement
The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Intended Use Statement
-
- Indications for Use Statement
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Indications for Use Statement
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7. Substantial Equivalence
The UNIQUE is substantially equivalent to the predicate device, the Varian Trilogy.
The functionality of the UNIQUE is equivalent to the functionality of the Varian Trilogy in safety and effectiveness. Varian design control procedures applied to the development of the UNIQUE include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met.
Compared with the predicate device, the Varian Trilogy, the basic operation is the same. Operational differences are described in the Instructions for Use for the UNIQUE.
Substantial Equivalence Table
The table below illustrates the substantial equivalence between the UNIQUE and the predicate device, the Varian Trilogy (K072916).
The intended use for both devices is to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
| Item | Trilogy - K072916 | UNIQUE |
|---|---|---|
| C-Series Software: improvements forusability and safety, as well as support foradditional features | C-Series 7.7 | C-Series 8.0 |
| Photon Energy (MV) available | 4-25 MV | 6 MV |
| Selectable Number of Photon Beams | Two | One |
| Dose Rates | 50-600 MU/min (1000 SRS rate) | 100 - 600 MU/min (No SRS rate) |
| Maximum standard treatment field size | 40cm x 40cm | 40cm x 40cm |
| Electron Treatment | Yes | No |
| Arc Treatments: Standard and RapidArcwhere gantry rotation speed and dose rateare varied. | Yes | Yes |
| Non-arc photon treatment modeprogrammable MU maximum dose | 999 MU | 1999 MU |
| Patient Support surface: Exact Couch | Yes | Yes |
| Patient support surface: Exact couchpedestal with IGRT couch top for improvedMV imaging | No | Yes |
| Drive mechanism | Direct Drive | Clutch |
| Treatment Beam generation | Klystron | Magnetron |
| Support for External System GatingInterface "EXGI" (K072916) - export ofbeam information to external devices | No | Yes |
510(k) Summary UNIQUE - Varian Medical Systems
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 0 2010
Ms. Vy Tran Official Correspondent Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K101751
Trade/Device Name: UNIQUE Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 18, 2010 Received: June 22, 2010
Dear Ms. Tran:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CLT Allis 101 and 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
# Indications for Use
AUG 1 0 2010
510(k) Number (if known):
Device Name: UNIQUE
Indications for Use:
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The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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(Division Sign-Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K [K101751](https://510k.innolitics.com/search/K101751)
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§ 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.