(86 days)
Positioning and repositioning of the patient's head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets
The VBH HeadFIX™ is a fixation device for cranial stereotactic radiotherapy and radiosurgery. The major parts of the system include the Vacuum Pump, Vacuum Cushion, Target Positioner Screens and Baseplate, Post Set, and Cranial Localizer.
The provided submission for K030439, concerning the VBH HeadFIX™, explicitly states that no performance data was required or requested by the Food and Drug Administration (Office of Device Evaluation) for this Class II device.
Therefore, the following information, which requires specific performance study data, cannot be extracted from the given text:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or reported performance data is provided.
- Sample sized used for the test set and the data provenance: No test set information is available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
- Adjudication method for the test set: No adjudication method is described.
- 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: No MRMC study was conducted or reported. The device is a physical fixation device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No such study was conducted or reported. The device is a physical fixation device, not an algorithm.
- The type of ground truth used: No ground truth information is available as no performance testing was required.
- The sample size for the training set: No training set information is available.
- How the ground truth for the training set was established: No ground truth establishment for a training set is described.
The submission relies on a database search for adverse effects of similar, currently marketed devices rather than prospective performance testing of the VBH HeadFIX™.
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510(k) SUMMARY
| 1. Applicant: | Medical Intelligence Medizintechnik GmbH |
|---|---|
| 2. Address: | Feyerabendstrasse 13 - 1586830 SchwabmünchenGermany |
| 3. Contact Persons: | Cornelia Damsky Tel: (203) 323-7535Christian Müller Tel: +49 (0) 8232 9692-0 |
| 4. Preparation Date: | February 7, 2003 |
| 5. Device Submitted: | VBH HeadFIX™ and accessories |
| 6. Proprietary Name: | VBH HeadFIX™ |
| 7. Common Name: | HeadFIX™ |
| 8. Classification Name: | Accelerator, Linear, Medical for positioning andrepositioning of the patient's head for stereotacticdiagnostic localization and stereotacticradiotherapy. Product Code IYE |
| 9. Substantial Equivalence: | The VBH HeadFIX™ is substantially equivalent interms of intended use to the following currentlymarketed devices: Radionics Gill-Thomas-Cosman (GTC) Relocatable Head Holder, OrfitIndustries' Raycast Immobilization SystemsHardware and Thermoplastic Materials, andBrainLAB's Brain Mask System. |
| 10. Device Description: | The VBH HeadFIX™ is a fixation device for cranialstereotactic radiotherapy and radiosurgery. Themajor parts of the system include the VacuumPump, Vacuum Cushion, Target PositionerScreens and Baseplate, Post Set, and CranialLocalizer. |
| 11. Intended Use: | The VBH HeadFIX™is intended for positioning andimmobilization of the head and neck, stereotacticdiagnostic localization and stereotacticradiotherapy of cranial targets. |
| 12. Legally-Marketed PredicatedDevice: | Radionics Gill-Thomas-Cosman (GTC)Relocatable Head Holder, Orfit Industries' RaycastImmobilization Systems Hardware andThermoplastic Materials, and BrainLAB's BrainMask System. |
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13. Performance Data:
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A database search has been performed to evaluate any adverse effects of the device that is currently marketed.
No data submitted for section 807.92 6[(b)(1)(2)(3c)].
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Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cornelia Damsky Regulatory Consultant Cornelia Damsky, Inc. 56 Westcott Road STAMFORD CT 06902 MAY - 8 2003
Re: K030439 Trade/Device Name: HeadFIX Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: February 7, 2003 Received: February 11, 2003
Dear Ms. Damsky:
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); 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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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:
| 8xxx. 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. Brogdon
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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Page_ of _____________________________________________________________________________________________________________________________________________________________________
510(k) Number (If known): K030439
Device Name: VBH HeadFIX
Indications For Use:
This product is intended for use by radiologists and surgeons for: Positioning and repositioning of the patient's head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets
(PLEASE DO NOT WRITE BEELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
イ Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices K030439
510(k) Number
§ 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.