(57 days)
The coil is indicated for use on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the upper and lower extremities, as an aid to diagnosis.
The design of the 1.5T and 3.0T 8-Channel Small Extremity Coils are based on design features of the predicate device Musculoskeletal Flex Coil Package: Upper Extremity Flex Coil. The Small Extremity Coils are designed as receive only for high resolution diagnostic imaging of bone, soft tissue, musculoskcletal and vascular structures in small extremity Coils are manufactured of materials that are similar to those used to manufacture the predicate device and other Invivo Corporation coils.
This document pertains to a 510(k) summary for a medical device called the "1.5T and 3.0T 8-Channel Small Extremity Coil." This device is an accessory for MR scanners, designed to produce images of the upper and lower extremities. It is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not a study showcasing device performance against specific acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them. The document focuses on:
- Device Description: Comparing the subject device's design to a predicate device.
- Indications for Use: What the device is intended for.
- Technological Characteristics: Stating that the fundamental technology has not changed from the predicate device.
- Substantial Equivalence Information: Arguing similarities in intended use and technological characteristics to the predicate device.
- FDA Clearance Letter: Confirming the FDA's determination of substantial equivalence.
Without a performance study or defined acceptance criteria within the provided text, it's impossible to populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies.
No study proving the device meets acceptance criteria is described in the provided text.
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K09/902
510(k) Summary of Safety and Effectiveness 1.5T and 3.0T 8-Channel Small Extremity Coil
AUG 21 2009
| Submitted By: | Invivo Corporation3545 SW 47th Ave.Gainesville, FL 32608 |
|---|---|
| Date: | June 23, 2009, revised August 6, 2009 |
| 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 Small Extremity Coil |
| 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 Small Extremity Coils are based on design features of the predicate device Musculoskeletal Flex Coil Package: Upper Extremity Flex Coil. The Small Extremity Coils are designed as receive only for high resolution diagnostic imaging of bone, soft tissue, musculoskcletal and vascular structures in small extremity Coils are manufactured of materials that are similar to those used to manufacture the predicate device and other Invivo Corporation coils.
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the upper and lower extremities, as an aid to diagnosis.
Technological Charactcristics:
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, Musculoskeletal Flex Coil Package: Upper Extremity Flex Coil and Lower Extremity Flex Coil-K983109, cleared 10/06/98, substantial equivalcnce is based on similarities in intended use, and technological characteristics.
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Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle emblem is composed of three curved shapes, resembling feathers or wings.
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
AUG 21 2009
Ms. Elizabeth Wheeler, MST, RAC Regulatory Engineer Invivo Corporation 3545 SW 47th Ave GAINESVILLE FL 32608
Re: K091902
Trade/Device Name: 1.5T and 3.0T 8-Channel Small Extremity Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 6, 2009 Received: August 7, 2009
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 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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/indr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lamme M. Mouch
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K091902
Device Name: 1.5T and 3.0T 8-Channel Small Extremity Coil
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the upper and lower extremities, 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)
forai h. Whaz
(Division Sign Off)
Page 1 of 1
(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.