(88 days)
For use as permanently-filled and -sealed artificial fiduciary markers with the head rings and localizer I brass as permanently and systems in order to facilitate localizing and documenting the precise superimposition of CT and MRI imaging data.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "MRI Line Marker Non-invasive Radiographic Skin Marker." This document approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The 510(k) clearance process in the U.S. generally focuses on demonstrating substantial equivalence to pre-existing legally marketed devices, rather than requiring new clinical trials to establish independent safety and effectiveness metrics through specific acceptance criteria and detailed study designs as might be required for a Premarket Approval (PMA).
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "U.S. Department of Health & Human Services" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body, representing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
4 2002 MAR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Zinreich Chief Executive Officer I.Z.I. Corporation 7020 Tudsbury Road BALTIMORE MD 21244 Re: K014022
Trade/Device Name: MRI Line Marker Non-invasive Radiographic Skin Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II
Product Code: 90 IYE Dated: November 29, 2001 Received: December 6, 2001
Dear Ms. Zinreich:
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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 this 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" (21 CFR 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,
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
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Page 1 of 1
1014022
<014022 510(K) Number (if known):
CT/MRI Localizer Set Tubing Kit Product Name:
Indications for Use.
For use as permanently-filled and -sealed artificial fiduciary markers with the head rings and localizer I brass as permanently and systems in order to facilitate localizing and documenting the precise superimposition of CT and MRI imaging data.
Federal (U.S.A.) law restricts this device to sale by, or on the order of a physician.
Target Population: Adult, Child, and Infant
David A. Segerson
(Division Sign-Off) Division of Reprodu and Radiological D 510(k) Num
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over the Counter Use
SK28
/ 368/ H360/
ીને દર્દ દ્વા
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.