(28 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cervical, lumbar, and thoracic regions of the spine that can be interpreted by a trained physician.
Models CTL-63 and CTL-128 Spine Array Coils
This document is an FDA 510(k) clearance letter for two spine array coils (Models CTL-63 and CTL-128). It primarily addresses the regulatory approval process and states that the devices are substantially equivalent to legally marketed predicate devices.
Crucially, this document does NOT contain a study that proves the device meets acceptance criteria, nor does it provide any of the detailed information requested in your prompt regarding performance metrics, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).
The letter confirms that the devices are intended "to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cervical, lumbar, and thoracic regions of the spine that can be interpreted by a trained physician." However, it does not specify what "diagnostic images" means in terms of image quality metrics, clinical accuracy, or any performance benchmarks.
Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The FDA 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, which may involve engineering comparisons and basic bench testing rather than extensive clinical efficacy studies with the type of detailed performance criteria you are asking for.
To answer your questions, you would need access to the actual 510(k) submission itself (which is not provided here) or a separate clinical study report for these devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol appears to be a stylized representation of a bird or a human figure with outstretched arms, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Thomas Schubert Chief Technology Officer Invivo Corporation 3545 SW 47th Avenue GAINESVILLE FL 32608
OCT 1 3 2006
Re: K062767
Trade/Device Name: Models CTL-63 and CTL-128 Spine Array Coils Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 13, 2006 Received: September 15, 2006
Dear Mr. Schubert:
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 (Premarket Approval), 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.
Image /page/0/Picture/10 description: The image shows a circular logo with the letters "FDA" in bold, stylized font. Above the letters, the years "1906-2006" are printed, indicating a centennial celebration. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by a circular border with text, and there are three stars at the bottom of the logo.
comoting Public . )
{1}------------------------------------------------
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Special 510(K) Application, Device Modification Models CTL-63 & CTL-128 Spine Array Coils, September 13, 2006
Section C - Statement of Indications for Use
Applicant: Invivo Corporation K062767 510(k) number (if known):_ Device Name: Models CTL-63 and CTL-128 Spine Array Coils
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cervical, lumbar, and thoracic regions of the spine that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use or (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.