(87 days)
No
The summary describes a surgical device that uses ultrasonic energy for cutting and removal. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the hardware components and intended use.
No.
The device is used for cutting and removal of bone and acrylic bone cement, which are surgical procedures, not therapeutic treatments.
No
The device is described as being used for "cutting and removal of bone and acrylic bone cement," which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of hardware components including a power module, handsets, probes, and accessories.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Orthosonics OSCAR OE3000DB is described as a device for cutting and removal of bone and acrylic bone cement in orthopedic applications. This is a surgical tool used directly on the patient's body during a procedure.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device's function is mechanical removal of tissue and material.
Therefore, based on the provided information, the Orthosonics OSCAR OE3000DB is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Orthosonics OSCAR OE3000DB is intended to be used for cutting and removal of bone and acrylic bone cement in orthopaedic applications.
Product codes
JDX, LZV
Device Description
The Orthosonics OSCAR OE3000DB consists of a power module which generates the ultrasonic energy and provides overall control of the device, 2 gefferent handsets; one for acrylic bone cement removal and the other for the cutting and removal of bone, and a variety of probes and other accessories. Three independent power modules 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing to electrical/ safety standards was successfully carried out. Biocompatibility issues were covered by the OSCAR (K961725) application. Performance testing was carried out in an animal study and the results are included in this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
JUL 2 1 2005
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string starts with the letter 'K', followed by the numbers '051053'. The characters are written in a bold, slightly irregular style, giving them a hand-drawn appearance. The background is plain white.
510(k) Summary
Orthosonics OSCAR OE3000DB
| Common: | Ultrasonic Surgical Instrument |
|---|---|
| Classification Name: | Instrument, Surgical, Sonic and |
| Accessories/Attachments (21 C.F.R. 888.4580) | |
| Sponsor: | Orthosonics Ltd |
| Bremridge | |
| Ashburton | |
| Devon TQ13 7JX | |
| T: +44 1364 652426 | |
| F: +44 1364 653589 | |
| Contact: | Dr. Michael J. R. Young |
| Prepared: | April 25, 2005 |
REASON FOR SUBMISSION A.
This 510(k) is being filed for two main reasons. Firstly, it is to cover improvements in the existing OSCAR (K961725, K021502) which includes a new digital tuning module and new single use probes. Secondly there is a change to the intended use that now includes the cutting and removal of bone via an additional, optional handset.
LEGALLY MARKETED PREDICATE DEVICES B.
The Orthosonics OSCAR OE3000DB is substantially equivalent to the Biomet Ultra-Drive® 3 (K031280), and the Orthosonics OSCAR (K961725, K021502).
DEVICE DESCRIPTION C.
The Orthosonics OSCAR OE3000DB consists of a power module which generates the ultrasonic energy and provides overall control of the device, 2 gefferent handsets; one for acrylic bone cement removal and the other for the cutting and removal of bone, and a variety of probes and other accessories. Three independent power modules are mounted in a cart for ease of use.
D. INTENDED USE
The Orthosonics OSCAR OE3000DB is intended to be used for cutting and removal of bone and acrylic bone cement in orthopaedic applications.
SUBSTANTIAL EQUIVALENCE SUMMARY E.
1
The Orthosonics OSCAR OE3000DB is a medical device, and it has the same indications for use and target population as the legally marketed predicate device.
The Orthosonics OSCAR OE3000DB has the same technological characteristics The Oredicate device. However, the descriptive characteristics may not be as the precise to assure substantial equivalence. Therefore, performance testing was carried out for some characteristics. The data from this testing was available and was presented in this 510(k).
TECHNOLOGICAL CHARACTERISTICS F.
The basic technological characteristics of the OSCAR OE3000DB device are the same as those of the predicate devices.
TESTING G.
Testing to electrical/ safety standards was successfully carried out. Biocompatibility issues were covered by the OSCAR (K961725) application. Performance testing was carried out in an animal study and the results are included in this 510(k).
CONCLUSIONS H.
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.
.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2005
Orthosonics c/o T. Whit Athey, Ph.D. Health Policy Resources Group, LLC 2305 Gold Mine Road Brookeville, Maryland 20833
Re: K051053
Trade/Device Name: OSCAR OE3000DB Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: II Product Code: JDX, and LZV Dated: April 25, 2005 Received: April 25, 2005
Dear Dr. Athey:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 rots) premium is substantially equivalent (for the indications felerenced above and nave determined in the enclicate devices marketed in interstate for use stated in the chelosure) to regally manative personal perice Americal period for to commerce prior to May 20, 1970, the enaounce with the provisions of the Federal Food, Drug, devices that have been reculire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (P You may, therefore, market the device, subject to the general controls provisions of the Act. The Y ou may, therefore, manol the Act include requirements for annual registration, listing of general controls provisions of the 1100 lines and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc aboro) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlio "Little 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouch Smo
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 Frease be advised that I DA 3 issualites our device complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that I DA has made a dolorimiation administered by other Federal agencies. You must of any reactal slatures and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 607), labeling (21 OFR Part 820); go a carrers 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
$\frac{1}{2} \cdot \frac{1}{2} = \frac{1}{4}$
3
Page 2 -- T. Whit Athey, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailier of substantial equivalence of your device to a legally premarket notheation: "The PDF mining of easification 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 If you desire specific advice for Jour 2011 5. Also, please note the regulation entitled, Comact the Office of Complanes at (21 to 21 to 21 Station" (21CFR Part 807.97). You may obtain " Misolanding by releveles to premainters in the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Conson http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Euch
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
1-051053 510(k) Number (if known):
OSCAR OE3000DB Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Orthosonics OSCAR OE3000DB is intended to be used for cutting and The Orthosomes OSCAN OES000DD is them.
removal of bone and acrylic bone cement in orthopedic applications.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eunice Chan
; E estorative
Page 1 of 1
Nu
K
000024