(191 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, foot/ankie, shoulder and elbow regions, as an aid to diagnosis.
The design of the 1.5T and 3.0T 8-channel Medium General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.5T and 3.0T 8-channel General Purpose Flex Coil. The Medium GP Flex Coils are designed as receive only for high resolution diagnostic imaging of regional structures of the musculoskeletal hip, knee, foot/ankie, shoulder, and elbow. The Medium GP Flex Coils are manufactured of materials that are similar to those used to manufacture the predicate devices.
This is a traditional 510(k) for an MRI coil, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types for AI/ML performance evaluation is not applicable and cannot be extracted from the provided text.
The document describes the device, its intended use, and its substantial equivalence to a predicate device. The review process for such a device focuses on its physical characteristics, safety, and imaging capabilities rather than AI/ML performance metrics.
Summary of available information:
- Device Name: 1.5T and 3.0T 8-Channel Medium General Purpose Flex Coils
- Manufacturer: Invivo Corporation
- Device Type: Magnetic Resonance (MR) Specialty Coil
- Indication for Use: To produce images of the hip, knee, foot/ankle, shoulder, and elbow regions, as an aid to diagnosis, in conjunction with Philips 1.5T and 3.0T MR scanners.
- Substantial Equivalence: Based on similarities in design features, overall indications for use, and technological characteristics to the predicate device (1.5T and 3.0T 8-channel General Purpose Flex Coil - K093842).
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Invivo Corporation Traditional 510(k): 1.5T and 3.0T 8-Channel Medium General Purpose Coil
June 13, 2011
510(k) Summary of Safety and Effectiveness
1.5T and 3.0T 8-Channel Medium General Purpose Flex Coils
DEC 2 3 2011
| Submitted By: | Invivo Corporation3545 SW 47TH Ave.Gainesville, FL 32608 |
|---|---|
| Date: | June 13, 2011 |
| 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 Medium General Purpose FlexCoils |
| Common Name: | Coil, Magnetic Resonance, Specialty |
| Classification Name and Reference: | 21 CFR 892.1000. A magnetic resonance diagnosticdevice, for general diagnostic use to present imageswhich reflect the spatial distribution and/or magneticresonance spectra which reflect frequency anddistribution of nuclei exhibiting nuclear magneticresonance, class II. |
| Device Product Code and Panel Code: | MOS / Radiology / 90 |
Device Description:
The design of the 1.5T and 3.0T 8-channel Medium General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.5T and 3.0T 8-channel General Purpose Flex Coil. The Medium GP Flex Coils are designed as receive only for high resolution diagnostic imaging of regional structures of the musculoskeletal hip, knee, foot/ankie, shoulder, and elbow. The Medium GP Flex Coils are manufactured of materials that are similar to those used to manufacture the predicate devices.
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, foot/ankle, shoulder and elbow 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 new devices designs are similar to the predicates with the exception of the dimensions of the housings. The fundamental scientific technology of the subject described in this submission has not been altered from the predicate devices.
Substantial Equivalence Information:
When compared to the predicate devices, 1.5T and 3.0T 8-channel General Purpose Flex Coil - K093842, cleared 3/5/10. substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics.
CONFIDENTIAL
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. 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 emblem featuring three abstract shapes resembling an eagle or a bird in flight.
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
Ms. Lisa Simpson Regulatory Engineer Invivo Corporation 3545 SW 47th Avenue GAINSVILLE FL 32608
DEC 2 3 2011
Re: K111673
Trade/Device Name: 1.5T and 3.0T 8-Channel Medium General Purpose Flex Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: December 21st, 2011 Received: December 22nd, 2011
Dear Ms. Simpson:
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
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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 vour 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 Yours,
Mary S Patil
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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December 21, 2011
Indications for Use
510(k) Number (if known): K111673
Device Name: 1.5T and 3.0T 8-Channel Medium 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, as an aid to diagnosis.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
510K 1/1/673
Page 1 of 1
§ 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.