(28 days)
The Leksell Stereotactic System with MR post kit is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy
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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Elekta Leksell Stereotactic System, indicating that the device is substantially equivalent to a predicate device. It defines the indications for use but does not contain details of any performance studies, acceptance criteria, sample sizes, or ground truth establishment.
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Image /page/0/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the edge. Inside the circle is a stylized image of an eagle with three lines extending from its head. The image is black and white and appears to be a scan of a document.
JUL 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Löwendahl Quality and Regulatory Affairs Manager Elekta Instrument AB P.O. Box 7593 S-103 93 Stockholm SWEDEN
Re: K031999
Trade/Device Name: Leksell Stereotactic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: 84 HA W Dated: May 9, 2003 Received: June 27, 2003
Dear Mr. Löwendahl:
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 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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ELEKTA LEKSELL STEREOTACTIC SYSTEM® Special Premarket 510(k) Notification: Device Modification
Indications for Use Statement
| 510(k) Number | To be assigned by FDA K031999 |
|---|---|
| Device Name | Elekta Leksell Stereotactic System© |
Indications for Use The Leksell Stereotactic System with MR post kit is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
David A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device:
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).