(90 days)
Not Found
No
The device description focuses on mechanical components and a reference system for physical positioning and localization using fiducials on CT/MR images. There is no mention of AI or ML in the description, intended use, or performance studies.
No
The device is described as a localization and positioning tool for diagnostic examination and treatment delivery, rather than a device that directly treats or heals a condition.
No
The Stereotactic Body Frame is a positioning and localization device used for both diagnostic and therapeutic purposes (stereotactic radiotherapy), but it does not diagnose a condition itself. It aids in localizing targets for diagnosis or treatment.
No
The device description clearly details physical components like a frame, reference indicators, a diaphragm control, an adjustable base, marker devices, an arc-ruler, and a laser. It is a hardware device used for patient positioning and localization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets." This describes a device used for patient positioning and targeting during medical procedures (diagnosis and treatment), not for examining specimens from the human body.
- Device Description: The description focuses on the physical frame, reference system, indicators for imaging, and mechanisms for patient positioning and immobilization. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: IVD devices are designed to perform tests on specimens to provide information about a patient's health status. This device does not perform any such tests.
The device is clearly a medical device used in conjunction with imaging modalities (CT or MR) and radiotherapy equipment for patient management, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.
Product codes
Not Found
Device Description
The Stereotactic Body Frame utilizes a reference system which is external to the patient's body. Using this stereotactic system, the coordinates of a target can be reproducibly localized during diagnostic examination and treatment. The Frame has built-in copper or copper sulfate solution reference indicators for CT or MR determination of target coordinates. These reference indicators, which produce fiducials on the CT or MR images, permit x, y and z coordinate determination for localization of the target. A diaphragm control attached to the Frame can be used to minimize respiratory movements. Horizontal positioning of the Frame, in the scanner or on the treatment couch, is achieved using an adjustable base on the Frame.
Marker devices are used for reproducible positioning, after fixation of the patient in a vacuum pillow. An arc-ruler is attached to the Frame and a chest marker device on the arc-ruler is used for alignment of the patient. This is based on two skin marks over the patient's sternum. Longitudinal alignment is controlled by skin marks over the tibia using a frame-mounted laser. The coordinates used for patient positioning can be easily read on the arc-ruler holding the sternum marker and on the longitudinal ruler, along which the arcruler can be moved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR
Anatomical Site
extracranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
A study was conducted to evaluate the strength and deformation of the Stereotactic Body Frame under normal use, the influence of radiation on the behavior of Frame material which has been subjected to repeated use and the radiation attenuation when irradiating different parts of the Frame was assessed. The results of this study demonstrated that the Stereotactic Body Frame is capable of safely and accurately repositioning the patient in relation to an external reference system.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SUMMARY OF SAFETY AND EFFECTIVENES SECTION 19:
APR 23 1996
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
19.1 SUBMITTER INFORMATION
| a. | Company Name: | Elekta Instrument AB |
|---|---|---|
| b. | Company Address: | St. Larsgatan 8, S-582 |
| Linkoping, Sweden | ||
| c. | Company Phone: | (011) 4613248300 |
| (011) 4613112312 | ||
| d. | Contact Person: | Sverker Glans |
| Vice President | ||
| Quality and Regulatory Affairs | ||
| Elekta Instrument AB | ||
| e. | Date Summary Prepared: | January 19, 1996 |
19.2. DEVICE IDENTIFICATION
- Stereotactic Body Frame Trade/Proprietary Name: a.
- Radiographic Head Holder Classification Name: b.
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IDENTIFICATION OF PREDICATE DEVICE 19.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Radionics | Gill-thomas-cosman (Gtc) | ||
| Relocatable Head Holder S | K934523 | 2/8/95 | |
| Med-Tec | Vac-lok Immobilization | ||
| System | K935300 | 7/18/94 |
DEVICE DESCRIPTION 19.4
The Stereotactic Body Frame utilizes a reference system which is external to the patient's body. Using this stereotactic system, the coordinates of a target can be reproducibly localized during diagnostic examination and treatment. The Frame has built-in copper or copper sulfate solution reference indicators for CT or MR determination of target coordinates. These reference indicators, which produce fiducials on the CT or MR images, permit x, y and z coordinate determination for localization of the target. A diaphragm control attached to the Frame can be used to minimize respiratory movements. Horizontal positioning of the Frame, in the scanner or on the treatment couch, is achieved using an adjustable base on the Frame.
Marker devices are used for reproducible positioning, after fixation of the patient in a vacuum pillow. An arc-ruler is attached to the Frame and a chest marker device on the arc-ruler is used for alignment of the patient. This is based on two skin marks over the patient's sternum. Longitudinal alignment is controlled by skin marks over the tibia using a frame-mounted laser. The coordinates used for patient positioning can be easily read on the arc-ruler holding the sternum marker and on the longitudinal ruler, along which the arcruler can be moved.
19.5 SUBSTANTIAL EQUIVALENCE
The Elekta Stereotactic Body Frame is substantially equivalent to other stereotactic frames currently in commercial distribution by Radionics and immobialization systems in distribution by Med-Tec in terms of the intended use of achieving a safe and accurate fixation and refixation of a patients body part for localization of targets for radiotherapy treatment with Linear accelerators.
The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison chart provided in this 510(k) submission. Differences that exist between these systems relate to physical
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appearance and materials which do not affect the relative safety or effectiveness of the device.
INTENDED USE 19.6
The Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.
TECHNOLOGICAL CHARACTERISTICS 19.7
A comparison of the technological characteristics of the predicate and legally marketed devices is provided in the following table.
PERFORMANCE DATA 19.8
A study was conducted to evaluate the strength and deformation of the Stereotactic Body Frame under normal use, the influence of radiation on the behavior of Frame material which has been subjected to repeated use and the radiation attenuation when irradiating different parts of the Frame was assessed. The results of this study demonstrated that the Stereotactic Body Frame is capable of safely and accurately repositioning the patient in relation to an external reference system.
510(K) CHECKLIST 19.9
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.