(90 days)
Not Found
No
The device description focuses on mechanical components and coordinate systems for patient positioning, with no mention of AI/ML terms or functionalities.
No.
The device is used for diagnostic localization and radiotherapy, which are procedures, not therapeutic effects produced by the device itself. The device is an accessory that assists in the accurate delivery of radiotherapy, but it does not inherently provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for stereotactic diagnostic localization."
No
The device description explicitly details physical components like a frame, laser chest pointer, arc-ruler, longitudinal ruler, pillow holder, and a quality check instrument, indicating it is a hardware-based medical device with accessories.
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 extra cranial targets." This describes a device used for positioning and treatment planning/delivery on the patient's body, not for testing samples from the body.
- Device Description: The description details a physical frame, rulers, pointers, and positioning accessories. These are all external devices used to interact with the patient's body for localization and treatment. There is no mention of reagents, samples, or analysis of biological materials.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances within those samples
- Diagnosis based on the results of such analysis
The device is clearly designed for external use in a clinical setting for diagnostic localization and therapeutic radiation delivery.
N/A
Intended Use / Indications for Use
The Accessories to the Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extra cranial targets.
Product codes
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Device Description
The Stereotactic Body Frame utilizes a reference system of coordinates that can be reproducibly localized during diagnostic examination and treatment. The Accessories to the Stereotactic Body Frame include a laser chest pointer which is mounted on an arc-ruler and is used for alignment of the patient. The coordinates used for patient positioning can be easily read on the arc-ruler holding the chest pointer and on the longitudinal ruler, along which the arc-ruler can be moved. An additional accessory to the Stereotactic Body Frame is the pillow holder, or shell. This framework is affixed to the body frame and allows for reproducible positioning of the patient within the frame. The pillow holder also allows for removal and insertion of the pillow. The pillow is available as either a vacuum bag filled with polystyrene spheres, or as a polyurethane foam-filled bag. The Stereotactic Body Frame comes equipped with a quality check instrument for verifying the accuracy of the coordinate set-up.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extra cranial targets
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
Not Found
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.
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APR 2 4 1997
के बाद में ब
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 17:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 17.1
| a. | Company Name: | Elekta Instrument AB |
|---|---|---|
| b. | Company Address: | St. Larsgatan 2, S-582 24 |
| 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 17, 1997 |
17.2. DEVICE IDENTIFICATION
| a. | Trade/Proprietary Name: | Accessories to the Stereotactic Body Frame |
|---|---|---|
| b. | Classification Name: | Medical charged-particle radiation therapy system |
IDENTIFICATION OF PREDICATE DEVICE 17.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Elekta Instrument AB | Stereotactic Body Frame | K960338 | April 23, 1996 |
DEVICE DESCRIPTION 17.4
The Stereotactic Body Frame utilizes a reference system of coordinates that can be reproducibly localized during diagnostic examination and treatment. The Accessories to
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the Stereotactic Body Frame include a laser chest pointer which is mounted on an arc-ruler and is used for alignment of the patient. The coordinates used for patient positioning can be easily read on the arc-ruler holding the chest pointer and on the longitudinal ruler, along which the arc-ruler can be moved. An additional accessory to the Stereotactic Body Frame is the pillow holder, or shell. This framework is affixed to the body frame and allows for reproducible positioning of the patient within the frame. The pillow holder also allows for removal and insertion of the pillow. The pillow is available as either a vacuum bag filled with polystyrene spheres, or as a polyurethane foam-filled bag. The Stereotactic Body Frame comes equipped with a quality check instrument for verifying the accuracy of the coordinate set-up.
17.5 SUBSTANTIAL EQUIVALENCE
The Elekta Accessories to the Stereotactic Body Frame is substantially equivalent to other stereotactic frames currently in commercial distribution by Elekta Instruments AB in terms of the intended use of achieving a safe and accurate fixation and refixation of a patients' body for localization of targets for radiotherapy treatment.
The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison chart provided in this 510(k) submission. Differences that exist between these systems is the addition of the pillow holder which aids in the accuracy of the positioning of the patient within the frame and the conversion of the chest marker to a laser pointer. The addition of these accessories does not affect the relative safety or effectiveness of the device.
17.6 INTENDED USE
The Accessories to the Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extra cranial targets.
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TECHNOLOGICAL CHARACTERISTICS 17,7
A comparison of the technological characteristics of the Accessories to the Stereotactic Body Frame and the predicate device is provided in this 510(k) submission.
510(K) CHECKLIST 17.8
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.