(188 days)
The Primado is an electrically powered surgical system for delicate bone dissection in the ear, nose and throat areas. A wide range of attachments includes a In the car, dood and chrous, straight/angle/malleable drills, and microsaws.
The Primado is an electrically powered surgical system.
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
The document is an FDA 510(k) clearance letter for the "Primado Surgical Drill," indicating that it has been found substantially equivalent to a legally marketed predicate device. It specifies the intended use of the device and regulatory information but does not contain any performance study details or acceptance criteria for demonstrating that performance.
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SEP 1 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nakanishi, Inc c/o Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. 11" Floor Washington, DC 20005
Rc: K080722
Trade/Device Name: Primado Surgical Drill Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: August 19, 2008 Received: August 20, 2008
Dear Mr. Barritt:
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 usc 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 gencral 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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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,
M. B. Egerton, m.d.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K080722 510(k) Number (if known):
Device Name: Primado
Indications For Use:
The Primado is an electrically powered surgical system for delicate bone dissection in the ear, nose and throat areas. A wide range of attachments includes a In the car, dood and chrous, straight/angle/malleable drills, and microsaws.
ਮ 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)
Analolel-
(Division Sign-Off) (Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K080722
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§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.