(90 days)
No
The summary describes a system that uses ultrasonic energy for cement removal and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is described as assisting in the removal of bone cement in a medical procedure, indicating it provides therapy.
No
The device is described as assisting in the removal of bone cement, which is a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a power module, handpiece, probes, and a cleaning system.
Based on the provided information, the OSCAR Orthosonics System for Cemented Arthroplasty Revision is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to assist in the removal of bone cement during a surgical procedure (arthroplasty revision). This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The device components (power module, handpiece, probes) are designed for direct interaction with tissue and materials within the body during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is purely therapeutic/surgical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The OSCAR system does not fit this description.
N/A
Intended Use / Indications for Use
The OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.
Product codes
Not Found
Device Description
The OSCAR Orthosonics Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, a set of cement removal probes, and an ultrasonic cleaning system for part of the reprocessing procedures for reuse of the probes. Three independent power modules are included in each device and these are mounted in a cart for ease of use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Orthosonics carried out testing to address the following issues:
- (1) temperature rise in bone during OSCAR procedures,
- (2) damage to bone from direct contact,
- (3) clinical experience,
- (4) reprocessing probes for use on the next patient,
- (5) electromagnetic compatibility,
- (6) electrical safety, and
- (7) validation of sterilization recommendations.
The results from all of these tests supported the safety and effectiveness of the Orthosonics OSCAR device and demonstrate that the Orthosonics OSCAR is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
0
AUG - 1 1996
AUG - 2 1996
510(k) Summary
OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
Common/Classification Name: Sonic surgical instrument, 21 CFR 888.4580
| Sponsor: | Orthosonics, Ltd.
Bremridge Farm
Ashburton
Devon TQ137JX
UK
+44-1364-652426
+44-1364-653589 |
|----------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Michael J. R. Young |
Prepared: May 1, 1996
LEGALLY MARKETED PREDICATE DEVICES A.
The OSCAR Orthosonics Ultrasonics Cement Removal System is substantially equivalent to the Advanced Osseous Technologies System 10 Model 100 Surgical System (K900003), and is similar to the Cooper Lasersonics CUSA System 200M (K864983).
B. DEVICE DESCRIPTION
The OSCAR Orthosonics Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, a set of cement removal probes, and an ultrasonic cleaning system for part of the reprocessing procedures for reuse of the probes. Three independent power modules are included in each device and these are mounted in a cart for ease of use.
C. INTENDED USE
The OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.
D. TECHNOLOGICAL CHARACTERISTICS
The OSCAR Orthosonics Ultrasonic Cement Removal System has the same technological characteristics as the predicate device. The energy
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1
source is ultrasonic for both, and both have probes made of the titanium allov Ti-6AI-4V.
E. TESTING
Orthosonics carried out testing to address the following issues:
- (1) temperature rise in bone during OSCAR procedures,
- (2) damage to bone from direct contact,
- (3) clinical experience,
- (4) reprocessing probes for use on the next patient,
- (5) electromagnetic compatibility,
- (6) electrical safety, and
- (7) validation of sterilization recommendations.
The results from all of these tests supported the safety and effectiveness of the Orthosonics OSCAR device and demonstrate that the Orthosonics OSCAR is substantially equivalent to the predicate devices.
F. CONCLUSIONS
The Orthosonics OSCAR device has the same intended use and target population as the predicate devices. Orthosonics has demonstrated through its performance tests on the OSCAR device and its comparison of OSCAR characteristics with those of the predicate device that the OSCAR device is substantially equivalent to the predicate device.