(79 days)
DANNORITZER manual rongeurs are designed for cutting or biting bone during surgery involving the skull or spinal column.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document is a clearance letter from the FDA for a medical device (Dan Kerrison Rongeurs), stating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and marketing permissions but does not delve into specific performance studies or acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dannoritzer Medical Instruments c/o Business Support International Dagmar S. Maser 271 Waldroup Road P. O. Box 457 Hot Springs, North Carolina 28783
Re: K023868
Trade/Device Name: Dan Kerrison Rongeurs, Models K1 & BILLY® 1 Regulation Number: 882.4840 Regulation Name: Manual rongeur Regulatory Class: Class II Product Code: HAE Dated: November 18, 2002 Received: November 20, 2002
Dear Ms. Maser:
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.
FEB 0 7 2003
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
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Page 2 - Ms. Dagmar S. Maser
(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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Neurological Surgery Devices Branch (HFZ-450)
510(k) Number
Device Name
DAN Kerrison Rongeurs
Models KI BILLY® 1
INDICATIONS FOR USE
DANNORITZER manual rongeurs are designed for cutting or biting bone during surgery involving the skull or spinal column.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluatioion (ODE)
for
Division Sign-Off)
D. on of General. Restorative
an eurological Devices
Number K023868
Division
-Off)
Division of neral, Restorative and Neurolucal Devices
510(k) Number.
| Labels | Values |
|---|---|
| Prescription Use | \checkmark |
| Over-The-Counter Use |
(Per CFR 801 109)
OR
(Optional Format 1-2-96)
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).