(77 days)
The Extracranial Radiotherapy System is intended for stereotaxic patient positioning and localization during imaging and treatment of extracranial targets.
The Extracranial Radiotherapy System is a device consisting of a carbon fiber table, a patient support cushion and lateral support panels, stereotaxic plates and related fasteners and assembly tools. During treatment the patient lies supine on the fitted cushion. Four stereotaxic plates surround the patient during CT imaging, with one plate between the support cushion and the table, two placed laterally and one above the patient. Target positioners on the support assembly are used to align the table with the linear accelerator coordinate axes and to verify the target point for treatment.
The provided text is a 510(k) summary for the Extracranial Radiotherapy System. While it describes the device, its intended use, and substantial equivalence to predicate devices, it does not contain information about specific acceptance criteria, a detailed study proving performance, sample sizes for test/training sets, expert qualifications, or adjudication methods.
The document states that the "Extracranial Radiosurgery System, the STP Complete Module/ZD Stereotaxic Frame and the Marker System for Stereotaxic Navigation demonstrate similar treatment accuracy during testing with CT images." However, it does not elaborate on the specific acceptance criteria for "similar treatment accuracy" or the details of that testing.
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, or information about ground truth establishment based on the provided text.
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SEP 3 0 1998
510(k) Summary
| Proprietary Name: | Extracranial Radiotherapy System |
|---|---|
| Common Name: | Extracranial Radiotherapy System |
| Classification Name: | Stereotaxic Instrument |
| Reference: | 21 CFR 882.4560 |
| Proposed Regulatory Class: | II |
| Device Product Code: | HAW |
| For information contact: | Vivian KellyManager, Regulatory AffairsHoumedica Inc |
fowmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Phone: (201) 507- 7830 (201) 507-6870 Fax:
Date Prepared: July 14, 1998
Summary:
The Extracranial Radiotherapy System is a device consisting of a carbon fiber table, a patient support cushion and lateral support panels, stereotaxic plates and related fasteners and assembly tools. During treatment the patient lies supine on the fitted cushion. Four stereotaxic plates surround the patient during CT imaging, with one plate between the support cushion and the table, two placed laterally and one above the patient. Target positioners on the support assembly are used to align the table with the linear accelerator coordinate axes and to verify the target point for treatment. The Extracranial Radiotherapy System is intended for stereotaxic patient positioning and localization during imaging and treatment of extracranial targets.
The table is design to be used with Leibinger's STP Complete Module Set and Marker System (K892425) and any future Leibinger software planning systems.
The subject device is substantially equivalent to the following devices: Stereotactic Body Frame (Precision Therapy International K960338. K970291). STP Complete Module/ZD Stereotaxic Frame (Leibinger K892425/D), and Marker System for Stereotaxic Navigation (Leibinger K961120). The Extracranial Radiosurgery System and the Stereotactic Body Frame are equivalent in intended use and in design in that they both include a table or rigid frame, support cushion fitted to the patient and positioning or guide mechanism reference systems used for radiotherapy treatment with linear accelerators. The Extracranial Radiosurgery System, the STP Complete Module/ZD Stereotaxic Frame and the Marker System for Stereotaxic Navigation demonstrate similar treatment accuracy during testing with CT images.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Ms. Vivian Kelly Manager, Regulatory Affairs HOWMEDICA, Inc. 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K982463 Trade Name: Extracranial Radiotherapy System Requlatory Class: II Product Code: IYE Dated: July 14, 1998 Received: July 15, 1998
Dear Ms. Kelly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Unknown
Device Name: Extracranial Radiotherapy System
Indications for Use:
The Extracranial Radiotherapy System is intended for stereotaxic patient positioning and localization during imaging and treatment of extracranial targets.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use __________ |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K982463 |
|---|---|
| --------------- | --------- |
§ 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.