(24 days)
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as an accessory to produce images, as an aid to diagnosis.
The SENSE MSK S 8ch 1.5T magnetic resonance coil is designed and intended for use with a Philips 1.5T Magnetic Resonance Imaging (MRI) system. The coil device has a one-piece flexible housing made of polycarbonate and polyethylene. The device works in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as receive only for high resolution diagnostic imaging of the small regional structures of the body, such as the shoulder, elbow, wrist and hand.
The provided text is a 510(k) summary for a medical device (SENSE MSK S 8ch 1.5T magnetic resonance coil). This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a clinical study with detailed acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert qualifications, and MRMC effectiveness studies is not available in the provided text. The document does not describe a performance study or clinical trial in the way the questions imply.
The text primarily focuses on:
- Device Description: What the device is and how it functions.
- Intended Use: The purpose for which the device is to be used.
- Technological Characteristics: The fundamental science behind the device.
- Substantial Equivalence: A comparison to a legally marketed predicate device to demonstrate that the new device is as safe and effective.
The provided information simply states that "substantial equivalence is based on similarities in design features, indications for use, and technological characteristics" to the predicate device (K111673). There is no mention of a performance study to demonstrate that the device meets specific acceptance criteria, as the regulatory pathway for this device is based on demonstrating equivalence, not necessarily de novo proof of meeting performance metrics through a new clinical trial.
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510(k) Summary of Safety and Effectiveness SENSE MSK S 8ch 1.5T
FEB 1 0 2012
| Submitted By: | Invivo Corporation3545 SW 47TH Ave.Gainesville, FL 32608 |
|---|---|
| Date: | January 13, 2012 |
| Contact Person: | Lisa Simpson, Regulatory Affairs EngineerTel: (352) 336-0010, ext. 164 Fax: (352) 336-1410 |
| Proprietary Name: | SENSE MSK S 8ch 1.5T |
| Common Name: | Coil, Magnetic Resonance, Specialty |
FEB 10#### Classification Name and Reference: 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 SENSE MSK S 8ch 1.5T magnetic resonance coil is designed and intended for use with a Philips 1.5T Magnetic Resonance Imaging (MRI) system. The coil device has a one-piece flexible housing made of polycarbonate and polyethylene. The device works in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as receive only for high resolution diagnostic imaging of the small regional structures of the body, such as the shoulder, elbow, wrist and hand.
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as an accessory to produce images, 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.
Substantial Equivalence Information:
When compared to the predicate device, 1.5T 8-Channel Medium General Purpose Flex Coil (K111673, cleared 12/23/11), substantial equivalence is based on similarities in design features, indications for use, and technological characteristics. The proposed device design is similar to the predicate with the exception of the dimensions of the housings, which were modified to accommodate smaller regions of the anatomy.
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Image /page/1/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
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
FEB 1 0 2012
Ms. Lisa Simpson Regulatory Engineer Invivo Corporation 3545 S. W. 47th Avenue GAINSVILLE FL 32608
Re: K120122
Trade/Device Name: SENSE MSK S 8ch 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 13, 2012 Received: January 17, 2012
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 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.htm1 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 Pastel
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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Indications for Use
510(k) Number (if known): Қудір (22
Device Name: SENSE MSK S 8ch 1.5T
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as an accessory to produce images, as an aid to diagnosis.
X Prescription 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)
Office of In Vitro Diagnostic
K 120.122
510K
Section 004 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.