(70 days)
Not Found
No
The summary describes a surgical device for cutting bone and cement, focusing on its mechanical components and power generation. There is no mention of AI, ML, image processing, or data-driven decision-making. The device is described as an integration of existing predicate devices with identical handsets and probes, further suggesting a focus on established technology rather than novel AI/ML features.
No
The device is described as being used for cutting and removal of bone and PMMA bone cement, which are surgical procedures, not therapeutic applications.
No
The device is described as being used for "cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a generator, handsets, and probes, indicating it is not a software-only medical device.
Based on the provided information, the Orthosonics OSCAR 3 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details a system for generating power and delivering it to surgical tools (handsets and probes) for cutting and removing tissue. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Orthosonics OSCAR 3's function is purely mechanical for surgical intervention.
N/A
Intended Use / Indications for Use
The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.
Product codes (comma separated list FDA assigned to the subject device)
JDX, LZV
Device Description
The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range of single use and reusable probes. The generator is effectively an integration of the OSCAR OE3000DB and OSCAR Bone Resector generators. It comprises 3 channels, 2 of which are designed to provide power to the handsets from OSCAR OE3000DB and the third channel is dedicated to provide power to the handset from the OSCAR Bone Resector. The handsets and probes are identical to those of the predicate devices.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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510(k) Summary
FEB 1 9 2010
OSCAR 3
Common Name: Ultrasonic Surgical Instrument Classification Name: Instrument, Surgical, Sonic And Accessory/Attachment Product Code: JDX and LZV Sponsor: Orthosonics Ltd Bremridge House Ashburton Devon TQ13 7JX വി 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 3.
B. LEGALLY MARKETED PREDICATE DEVICES
This premarket notification will demonstrate that the OSCAR 3 is substantially equivalent to the Orthosonics OSCAR OE3000DB cleared by FDA as K051053 and the Orthosonics OSCAR Bone Resector (K083830).
C. DEVICE DESCRIPTION
The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range of single use and reusable probes. The generator is effectively an integration of the OSCAR OE3000DB and OSCAR Bone Resector generators. It comprises 3 channels, 2 of which are designed to provide power to the handsets from OSCAR OE3000DB and the third channel is dedicated to provide power to the handset from the OSCAR Bone Resector. The handsets and probes are identical to those of the predicate devices.
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D. INTENDED USE
The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.
E. TECHNOLOGICAL CHARACTERISTICS
The basic technological characteristics of the OSCAR 3 are the same as those of the predicate devices. Both OSCAR 3 and Orthosonics OSCAR OE3000DB systems are designed to use ultrasound to cut bone and bone cement during orthopedic surgery. The main difference is that the OSCAR 3 system also incorporates the ability to drive the handset from the OSCAR Bone Resector. In addition an optional dedicated trolley can be supplied for use with the OSCAR 3.
F. SUBSTANTIAL EQUIVALENCE SUMMARY
OSCAR 3 uses the same handsets and the same probe range in the same mode as the predicate devices. It has the same intended use as the OSCAR OE3000DB.
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/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is horizontally oriented and appears to be part of a document or header. The words are capitalized and evenly spaced, suggesting a formal or official context.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB 1 9 2010
Orthosonics Ltd. % Michael J.R. Young, Ph.D. Managing Director Bremridge House Ashburton Devon TQ13 7JX, United Kingdom
Re: K093805
Trade/Device Name: OSCAR 3 Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: Class II Product Code: JDX, LZV Dated: December 07, 2009 Received: December 11, 2009
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Michael J.R. Young, Ph.D.
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
ACTING
DSORD DIR.
FOR Mark N. Melkerson
Director Division of Surgical, Orthopedic 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): K 093805
Device Name: OSCAR 3
Indications For Use:
The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and acrylic bone cement in orthopedic applications.
V Prescription Use (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)
FOR M. MELKERSON
(Div ion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K093805