(143 days)
The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.
The electric drill system consists of a power console, footswitches, connection cables, irrigation / cooling tubing sets, a remote irrigation control unit, and assorted handpieces to drive various burs, blades, drills, rasps, and saw blades. The system can also function as an endoscope lens cleaning system.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) summary for an Electric Surgical Drill/Saw System, focusing on its classification, equivalence to predicate devices, and intended use for regulatory approval.
Therefore, I cannot provide the requested table or answer the specific questions about studies, sample sizes, ground truth, or adjudication methods.
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K081475 Pg 1 of
510(k) Summary
| 510(k) Owner | OCT 1 7 2008Medtronic Xomed, Inc6743 Southpoint Drive NorthJacksonville, Florida 32216-0980 USA904-296-9600904-296-2386 (FAX) |
|---|---|
| Contact Name | Antoine KouchakjySenior Regulatory Affairs SpecialistMedtronic Xomed, Inc |
| Date Summary Prepared | May 20, 2008 |
| Proprietary Name | Electric Surgical Drill / Saw System(XPS 4000 System, Midas Rex Legend Drill System,Integrated Power Console (IPC)) |
| Common Name(s) | · Instrument, Surgical, Orthopedic, AC-Powered Motorand Accessory / Attachment (HWE)· Arthroscope (HRX)· Motor, Drill, Electric (HBC)· Drills,Burrs,Trephines&Accessories(Simple,Powered)(HBE) |
| Classification Name(s) | · Surgical instrument motors and accessories/attachments(21 CFR 878.4820, Product Code HWE, Class I)· Arthroscope(21 CFR 888.1100, Product Code HRX, Class II)· Electric cranial drill motor(21 CFR 882.4360, Product Code HBC, Class II)· Powered simple cranial drills, burrs, trephines, and theiraccessories(21 CFR 882.4310, Product Code HBE, Class II) |
Marketed device claiming equivalence to
The electric drill system is equivalent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K002523).
Device Description
The electric drill system consists of a power console, footswitches, connection cables, irrigation / cooling tubing sets, a remote irrigation control unit, and assorted handpieces to drive various burs, blades, drills, rasps, and saw blades. The system can also function as an endoscope lens cleaning system.
Intended Use / Indications for use
The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2008
Medtronic Xomed, Inc. % Mr. Antoine Kouchakjy Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K081475
Trade/Device Name: Electric Drill System [XPS4000, Midas Rex EHS system, Integrated Power Console] Regulation Number: 21 CFR 882.4310 Regulation Name: Powered compound cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE, HBC, HWE, HRX Dated: September 15, 2008 Received: September 16, 2008
Dear Mr. Kouchakjy:
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 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.
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Page 2 - Mr. Antoine Kouchakjy
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 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,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Device Name.
Electric Drill System [XPS4000, Midas Rex EHS system, Integrated Power Console (IPC)]
Indications for Use:
The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Sorthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.
Prescription Use _ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Mcoyle firmin
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number K081475
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).