(86 days)
Not Found
No
The device description and lack of mentions of AI/ML terms or performance studies related to algorithmic performance strongly suggest the device is a mechanical fixation system without AI/ML components.
No.
The device is described as a "fixation device" for "positioning and repositioning of the patient's head" during stereotactic diagnostic localization and radiotherapy. Its primary function is to hold the head still, rather than to treat or diagnose a disease itself.
Yes
The "Intended Use / Indications for Use" section explicitly states "Stereotactic diagnostic localization," indicating a diagnostic function for the device.
No
The device description explicitly lists multiple hardware components (Vacuum Pump, Vacuum Cushion, Target Positioner Screens and Baseplate, Post Set, and Cranial Localizer), indicating it is a physical device with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "Positioning and repositioning of the patient's head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets." These are all procedures performed on the patient, not on a sample taken from the patient.
- Device Description: The description details a physical fixation device used to hold the patient's head in place. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The information does not mention any analysis of blood, urine, tissue, or any other biological specimen. IVDs are designed to provide information about a patient's health status by examining these types of samples.
Therefore, the VBH HeadFIX™ is a medical device used for patient positioning and treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VBH HeadFIX™is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.
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
Product codes
IYE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head and neck, cranial targets
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and surgeons
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)
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)].
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Radionics Gill-Thomas-Cosman (GTC) Relocatable Head Holder, Orfit Industries' Raycast Immobilization Systems Hardware and Thermoplastic Materials, and BrainLAB's Brain Mask System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
| 1. Applicant: | Medical Intelligence Medizintechnik GmbH |
|---|---|
| 2. Address: | Feyerabendstrasse 13 - 15 |
| 86830 Schwabmünchen | |
| Germany | |
| 3. Contact Persons: | Cornelia Damsky Tel: (203) 323-7535 |
| Christian 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 and |
| repositioning of the patient's head for stereotactic | |
| diagnostic localization and stereotactic | |
| radiotherapy. Product Code IYE | |
| 9. Substantial Equivalence: | The VBH HeadFIX™ is substantially equivalent in |
| terms of intended use to the following currently | |
| marketed devices: Radionics Gill-Thomas- | |
| Cosman (GTC) Relocatable Head Holder, Orfit | |
| Industries' Raycast Immobilization Systems | |
| Hardware and Thermoplastic Materials, and | |
| BrainLAB's Brain Mask System. | |
| 10. Device Description: | 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. | |
| 11. Intended Use: | The VBH HeadFIX™is intended for positioning and |
| immobilization of the head and neck, stereotactic | |
| diagnostic localization and stereotactic | |
| radiotherapy of cranial targets. | |
| 12. Legally-Marketed Predicated | |
| Device: | Radionics Gill-Thomas-Cosman (GTC) |
| Relocatable Head Holder, Orfit Industries' Raycast | |
| Immobilization Systems Hardware and | |
| Thermoplastic Materials, and BrainLAB's Brain | |
| Mask 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)].
2
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.
3
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