(87 days)
No
The summary describes a mechanical device using ultrasonic energy and reciprocating motion for bone cutting. There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is described as cutting and removing bone in orthopedic applications, which is a surgical tool function, not typically considered therapeutic in nature.
No
Explanation: The device description states its purpose is "cutting and removal of bone in orthopedic applications," which is a treatment modality, not a diagnostic one.
No
The device description explicitly states it consists of a power module, a reusable handpiece, and single-use cutting blades, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for cutting and removal of bone in orthopedic applications." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device description details a surgical tool (power module, handpiece, cutting blades) that physically interacts with bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device described is a surgical instrument used for bone resection during orthopedic procedures.
N/A
Intended Use / Indications for Use
The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.
Product codes
JDX
Device Description
The OSCAR Bone Resector consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable handpiece and a range of single use cutting blades. OSCAR Bone Resector employs longitudinal mode ultrasound in conjunction with a low frequency reciprocating motion to cut and remove bone.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Orthosonics OSCAR OE3000DB cleared by FDA as K051053, Hall Versipower Surgical Instrument System (K895198), Biomet Orthopedics Inc Ultra-Drive 3 (K031280)
Reference Device(s)
Not Found
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.
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K 083830
Section 5
MAR ஜூ 0 2009
:
510(k) Summary
:
in
Contents
| Reason for Submission | |
|---|---|
| Legally Marketed Predicate Device | |
| Device Description | |
| Intended Use | |
| Technological Characteristics | |
| Substantial Equivalence Summary | |
| Testing | |
| Conclusions | |
1
K 083830
. .
510(k) Summary
OSCAR Bone Resector
Common Name: Classification Name:
Product Code: Sponsor:
Ultrasonic Surgical Instrument Instrument, Surgical, Sonic And Accessory/Attachment JDX Orthosonics Ltd Bremridge House Ashburton Devon TQ13 7JX nk T: +44 1364 652426 F: +44 1364 653589
Contact:
Dr. Michael J.R. Young,
A. REASON FOR SUBMISSION
This 510(k) is being filed to obtain clearance to market the OSCAR Bone Resector.
B. LEGALLY MARKETED PREDICATE DEVICES
This premarket notification will demonstrate that the OSCAR Bone Resector is substantially equivalent to the Orthosonics OSCAR OE3000DB cleared by FDA as K051053, Hall Versipower Surgical Instrument System (K895198) and the Biomet Orthopedics Inc Ultra-Drive 3 (K031280).
C. DEVICE DESCRIPTION
The OSCAR Bone Resector consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable handpiece and a range of single use cutting blades. OSCAR Bone Resector employs longitudinal mode ultrasound in conjunction with a low frequency reciprocating motion to cut and remove bone.
D. INTENDED USE
The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.
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E. TECHNOLOGICAL CHARACTERISTICS
The basic technological characteristics of the OSCAR Bone Resector are the same as those of the predicate devices. Both OSCAR Bone Resector and Orthosonics OSCAR OE3000DB systems are designed to use ultrasound to cut bone during orthopedic surgery. The main difference is that the OSCAR Bone Resector system also incorporates a low frequency reciprocating action, similar to the Hall Versipower Plus Oscillator saw, making the cut quicker, more controllable and cooler than either predicate device, and particulary reducing the likelihood of soft tissue collateral damage.
F. SUBSTANTIAL EQUIVALENCE SUMMARY
OSCAR Bone Resector is a medical device, that uses ultrasound to cut bone. This is the same function as embraced by the predicate device.
OSCAR Bone Resector has the same technological characteristics as the predicate devices. However, the descriptive characteristics may not be sufficiently precise to assure substantial equivalence. Therefore, performance testing was carried out for some characteristics. The data from this testing are available and are presented in this 510(k). The data do in fact demonstrate equivalence.
G. TESTING
- Testing to FCC Part 18 will be carried out prior to marketing the device in the USA. Electrical testing to UL 60601-1 will be carried out by Underwriters Laboratories before marketing the device in the USA.
H. CONCLUSIONS
This premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the center for Devices and Radiological Health.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2009
Orthosonics, Ltd. % Michael J.R. Young, Ph.D. Managing Director Bremridge House Ashburton, Devon TQ13 7JX United Kingdom
Re: K083830
Trade/Device Name: OSCAR Bone Resector Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachment Regulatory Class: II Product Code: JDX Dated: December 18. 2008 Received: December 23, 2008
Dear Dr. Young:
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 such 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
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Page 2 - Michael J.R. Young, Ph.D.
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
O.A. m.D. for
Mark N. Moller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 1 083 830
Device Name: OSCAR Bone Resector
Indications For Use:
The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.C. Glesner
(Division Sign-Off Division of General, Restorative, and Neurological Devices
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083830 510(k) Number