(80 days)
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the hip, knee, ankle, chest, and pelvic regions, as an aid to diagnosis.
The design of the 1.5T and 3.0T 8-channel General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.0T/1.5T/0.5T GE Quad/Phase Array Abdominal Coil. The GP Flex Coils is designed as receive only for high resolution diagnostic imaging of regional structures of the musculoskeletal hip, knee, foot, chest, and pelvis. The GP Flex Coils are manufactured of materials that are similar to those used to manufacture the predicate device.
The provided text is a 510(k) summary for the "1.5T and 3.0T General Purpose Flex Coils". This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It does not contain specific acceptance criteria, a study that proves the device meets such criteria, or detailed information about performance metrics, sample sizes, ground truth establishment, or expert involvement in a clinical study.
Therefore, I cannot extract the requested information from the provided text.
The document states:
- "The design of the 1.5T and 3.0T 8-channel General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.0T/1.5T/0.5T GE Quad/Phase Array Abdominal Coil."
- "Substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics."
This indicates that the clearance relies on demonstrating that the new device is fundamentally similar to an already approved device, rather than providing a new performance study against specific acceptance criteria.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness 1.5T and 3.0T General Purpose Flex Coils
MAR - 5 2010
| Submitted By: | Invivo Corporation3545 SW 47TH Ave.Gainesville, FL 32608 |
|---|---|
| Date: | December 14, 2009, revised February 8, 2010 |
| Contact Person: | Elizabeth Wheeler, Regulatory Affairs EngineerTel: (352) 336-0010, ext 164 Fax: (352) 336-1410 |
| Proprietary Name: | 1.5T and 3.0T 8-channel General Purpose Flex Coils |
| Common Name: | Coil, Magnetic Resonance, Specialty |
| Classification Name and Reference: | 21 CFR 892.1000, A magnetic resonance diagnostic |
21 CFR 892.1000, A magnetic resonance diagnostic device, 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, class II.
Device Product Code and Panel Code:
MOS / Radiology / 90
Device Description:
The design of the 1.5T and 3.0T 8-channel General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.0T/1.5T/0.5T GE Quad/Phase Array Abdominal Coil. The GP Flex Coils is designed as receive only for high resolution diagnostic imaging of regional structures of the musculoskeletal hip, knee, foot, chest, and pelvis. The GP Flex Coils are manufactured of materials that are similar to those used to manufacture the predicate device.
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the hip, knee, ankle, chest, and pelvic regions, as an aid to diagnosis.
Technological Characteristics:
The fundamental scientific technology of a radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest.
The fundamental scientific technology of the subject device described in this submission has not been altered from the predicate device.
Substantial Equivalence Information:
When compared to the predicate device, 1.0T/1.5T/0.5T GE Quad/Phase Array Abdominal Coil -K954190, cleared 11/20/95, substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAR - 5 2010
Ms. Elizabeth Wheeler Regulatory Engineer Invivo Corporation 3545 SW 47th Ave GAINESVILLE FL 36208
Re: K093842
Trade/Device Name: 1.5T and 3.0T General Purpose Flex Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 8, 2010 Received: February 12, 2010
Dear Ms. Wheeler:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
{2}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Amiell J. H. B
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: 1.5T and 3.0T General Purpose Flex Coils
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the hip, knee, ankle, chest, and pelvic regions, as an aid to diagnosis.
Prescription Use ______________________ AND/OR Over-The-Counter Use __________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) -- OLUI
Page 1 of 1
(Division Sign-Off)
Division of Radiological Dev Office of In Vitro Diagnostic Device Evaluation and Safety
510K K693842
§ 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.