(91 days)
The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
The Head Frame provides rigid immobilization of a patient's skull by attaching a rigid halo (head frame) to the patient through four invasive contact points (called screws or pins) which penetrate the patient's skin and contact the bone of the skull. The head frame is secured to either the CT table or the treatment table via a bracket which is included in the system. This ensures the patient cannot easily move during imaging or treatment. This level of immobilization is generally used for stereotactic radiosurgery.
This document is a 510(k) premarket notification for the "Varian Head Frame" system. It describes the device, its intended use, and a comparison to a predicate device, but it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like accuracy, sensitivity, or specificity.
The document discusses:
- Device Name: Varian Head Frame
- Intended Use: For immobilization during stereotactic radiosurgery or radiotherapy treatments on cranial lesions.
- Predicate Device: Optical Guidance Platform (K071360)
- Technological Characteristics: Compares features like patient fixation (four pins), materials, sterilization methods, rigid fixation mechanisms, anatomy/head/neck fixation, couch mount degrees of freedom, and positioning/localization features.
- Summary of Performance Testing: States that "Results of verification and validation testing showed conformance to applicable performance requirements specifications and assured hazard safeguards functioned properly." It also mentions biocompatibility and cleaning validation tests were met.
- Standards Conformance: Lists several ANSI/AAMI/ISO and IEC standards related to biocompatibility and medical electrical equipment.
However, the document lacks specific quantitative acceptance criteria for device performance (e.g., maximum displacement, accuracy of targeting) and details of a study proving these criteria are met. It only broadly states that "verification and validation testing showed conformance to applicable performance requirements specifications."
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.
Here's an overview of what could be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| (Missing) | (Missing) | (Missing) |
| Example: Immobilization Accuracy | e.g., < 1mm displacement | e.g., 0.5 mm displacement |
| Example: Pin Stability | e.g., No loosening for X hours | e.g., Stable for up to Y hours |
| Biocompatibility | Met ANSI/AAMI/ISO 10993-1, -5, -10, -11 | Met |
| Cleaning Validation | Met requirements | Met |
Missing Information:
- Specific quantitative acceptance criteria (e.g., for immobilization accuracy, stability).
- Quantified reported device performance values against these criteria.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not specify any test set sample size or data provenance (country of origin, retrospective/prospective) for performance evaluation. It mentions "verification and validation testing" but not the specifics of such testing in terms of patient data or sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: Not applicable, as there is no mention of a test set with ground truth established by experts. The device is a physical immobilization system, not one that generates diagnostic interpretations requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: Not applicable, as there is no mention of a test set and associated adjudication 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
Missing Information: Not applicable. This device is an immobilization system and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Missing Information: Not applicable. This device is an immobilization system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Missing Information: Not explicitly stated or applicable in the context of device performance metrics for an immobilization system. Ground truth would likely be against physical measurements (e.g., displacement measurements) rather than a diagnostic 'truth'.
8. The sample size for the training set
Missing Information: No training set is mentioned as this is a physical device, not an AI/algorithm-based system requiring training data.
9. How the ground truth for the training set was established
Missing Information: Not applicable.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that appears to be three faces in profile, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Varian Medical Systems, Inc. % Peter J. Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K142560 Trade/Device Name: Varian Head Frame Regulation Number: 21 CFR 892.5050 Regulation Name: Regulatory Class: Class II Product Code: IYE Dated: September 9, 2014 Received: September 11, 2014
Dear Peter Coronado,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
December 11, 2014
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Device Name
Head Frame System
Indications for Use (Describe)
The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Premarket Notification [510(k)] Summary Varian Head Frame
The following information is provided following the format of 21 CFR 807.92.
I. Submitter's Name: Varian Medical Systems, Inc. 3120 Hansen Way C-260 Palo Alto, CA 94304 Contact Name: Peter J. Coronado Phone: 650.424.5731 Fax: 650,842,5040 Date: September 2014 II. Trade Name: Varian Head Frame Common Name: Head Frame Classification Name: Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product Code: IYE III. Predicate Device: Optical Guidance Platform: K071360 IV. Device Description: The Head Frame provides rigid immobilization of a patient's skull by attaching a rigid halo (head frame) to the patient through four invasive contact points (called screws or pins) which penetrate the patient's skin and contact the bone of the skull. The head frame is secured to either the CT table or the treatment table via a bracket which is included in the system. This ensures the patient cannot easily move during imaging or treatment. This level of immobilization is generally used for stereotactic radiosurgery. V. Intended Use The Varian Head Frame is for use with a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery Statement: or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated. Indications for Use The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle Statement accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
VI. Technological Characteristics:
| FEATURE/SPECIFICATION | OPTICAL GUIDANCE PLATFORM510(k) ID #K071360 | HEAD FRAME V1.0 |
|---|---|---|
| Head ring patientfixation: | Four pins | Four pins |
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Premarket Notification [510(k)] Summary Varian Head Frame
| Materials: | Cranial pins: Delrin and aluminumHead ring: nickel-plated anodizedaluminum/delrin posts | Cranial pins: PEEK and aluminumHead ring: nickel-plated anodizedaluminum/delrin posts |
|---|---|---|
| Sterilization: | EtO for the cranial pins and head ringposts;Steam sterilization for the head ringassembly only | |
| Rigid fixationmechanism: | Head ring to a couch mount | |
| Anatomy/head/neckfixation (immobilization): | • Stereotactic head ring (FrameArray);• commercially available head andhead & neck restraint systems, e.g.based on the thermoplastic masksattached to couch mount or floorstand (FramelessArray) | Stereotactic head ring, head ringposts and cranial screws/pinsonly |
| Couch mount degrees offreedom: | 3 DoF couch mount | 0 axes – requires TrueBeam 6DoF couch |
| Positioning andLocalization features: | • Optical tracking of infrared markers.• Ultrasound imaging.• Active IR elements on SonArray arrayand on FrameArray headring array;• passive reflectors on FramelessArraybite block and Body Array;• optical tracking of infrared markersconnected to bite block and BodyLoc | Not Applicable - Immobilizationdevice only |
Results of verification and validation testing showed conformance to applicable VII. Summary of performance requirements specifications and assured hazard safeguards functioned properly. testing: Biocompatibilty testing requirements for irritation, sensitization, and acute systemic injection have been met. Cleaning validation test requirements have been met.
The Varian Head Frame System conforms in whole or in part with the following Standards conformance: standards:
| ANSI/AAMI/ISO 10993-1:2009 | ANSI/AAMI/ISO 10993-5:2009 |
|---|---|
| ANSI/AAMI/ISO 10993-10:2010 | ANSI/AAMI/ISO 10993-11:2010 |
| ANSI/AAMI/ISO 60601-1:2005 | IEC 60601-1-6:2005 |
| IEC 62366:2007 |
Conclusion: Based on the verification, validation and non-clinical 10993 standard testing, the Varian Head Frame is as safe, effective and performs as well as or better than the legally marketed device identified in section III above.
§ 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.