(42 days)
Not Found
No
The description focuses on the physical design, materials, and radio frequency technology of an MRI head coil, with no mention of AI or ML for image processing or other functions.
No
The device is described as a "quadrature transmitting and receiving device used to produce magnetic resonance images," which is an imaging function, not a therapeutic one. The purpose is for radiologists to interpret images, not to treat a condition.
Yes
The device is used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist, which is a diagnostic purpose.
No
The device description clearly details a physical head coil with specific dimensions, materials, and mechanical features, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist." This describes a device used for imaging the body, not for performing tests on in vitro samples (like blood, urine, or tissue).
- Device Description: The description details a physical coil used in an MRI system to acquire images. It focuses on the physical characteristics, materials, and features related to image acquisition and patient comfort during the imaging process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a component of an imaging system used to visualize internal structures.
N/A
Intended Use / Indications for Use
The Insight Head Coil is a quadrature transmitting and receiving device used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist. This device provides a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patient's eyes, nose or mouth.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS, MOS
Device Description
The Insight Head Coil is a quadrature transmitting and receiving device for use in magnetic resonance imaging of the head regions. This device incorporates advanced radio frequency technology housed in a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patients eyes, nose or mouth. The materials of construction and components are all identical to the predicate devices.
The tubular shaped coil is 13" OD x 9.9" ID x 10" L with a section removed from the bottom that is 60° of the coil circumference and 2" deep. The coil is attached to 2 rails that allow it to slide back and away from the patient, and then to be positioned with the patients head inside the tubular device. The back and sides of the coil will be placed over the center of the ears of the patient while the cut out front edge will be placed parallel with the eye brows.
The outer surfaces of the coil are manufactured from painted plastic polymer materials. These materials have been found to be biologically inert. These materials are routinely used in medical device construction and can be cleaned using mild bleach or alcohol as the customers will be instructed to do so.
The outer surfaces of the coil are manufactured from materials that are routinely used in medical device construction and can be cleaned using mild bleach or alcohol.
Features of the Insight Head Coil:
Imaging
- . 2-channel quadrature design uses multiple elements that surround the head tissue
- . Optimized for high speed imaging applications
- . Compatible with Siemens and GE3T MRI systems
- . High SNR
Ergonomics
- . Large ID to accommodate a major percentage of patient population
- . Ergonomically designed for patient comfort to minimize motion artifact
- . Positioning accessories include an adjustable head support and retraction mechanism
- . Attachable mirror to reduce patient claustrophobic response
- . Complete lack of material in front of the patients face to reduce claustrophobic response.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head regions, head and neck tissues, head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained radiologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The Insight Head Coil provides images comparable to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
JUN 19 2006
7
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted as part of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart E and Section 807.92.
1. Identification of Submitter:
| Submitter: | Insight Neuroimaging Systems LLC |
|---|---|
| Address: | 11 Canterbury St. |
| Worcester MA 01610 | |
| Phone: | (508) 799-6464 |
| Fax: | (508) 799-6030 |
| Contact: | Patricia A. Milbank |
| Title: | Regulatory Consultant |
| Phone: | 425-894-9733 |
| Fax: | 425-822-3648 |
| Date Prepared: | May 5, 2006 |
2. Identification of Product:
| Trade Name: | Insight Head Coil |
|---|---|
| Regulatory Number: | 21 CFR 892.1000 |
| Regulation Name: | Magnetic Resonance Diagnostic Device |
| Common Name: | Coil, Magnetic Resonance Specialty |
| Regulatory Class: | Class II |
| Product Code: | 90 MOS |
| Manufacturer: | Insight Neuroimaging Systems LLC. |
| 11 Canterbury St. | |
| Worcester MA 01610 |
4. Indications for Use
The Insight Head Coil is a quadrature transmitting and receiving device used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist. This device provides a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patient's eyes, nose or mouth.
1
5. Device Description:
The Insight Head Coil is a quadrature transmitting and receiving device for use in magnetic resonance imaging of the head regions. This device incorporates advanced radio frequency technology housed in a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patients eyes, nose or mouth. The materials of construction and components are all identical to the predicate devices.
The tubular shaped coil is 13" OD x 9.9" ID x 10" L with a section removed from the bottom that is 60° of the coil circumference and 2" deep. The coil is attached to 2 rails that allow it to slide back and away from the patient, and then to be positioned with the patients head inside the tubular device. The back and sides of the coil will be placed over the center of the ears of the patient while the cut out front edge will be placed parallel with the eye brows.
The outer surfaces of the coil are manufactured from painted plastic polymer materials. These materials have been found to be biologically inert. These materials are routinely used in medical device construction and can be cleaned using mild bleach or alcohol as the customers will be instructed to do so.
The outer surfaces of the coil are manufactured from materials that are routinely used in medical device construction and can be cleaned using mild bleach or alcohol.
Features of the Insight Head Coil:
Imaging
- . 2-channel quadrature design uses multiple elements that surround the head tissue
- . Optimized for high speed imaging applications
- . Compatible with Siemens and GE3T MRI systems
- . High SNR
Ergonomics
- . Large ID to accommodate a major percentage of patient population
- . Ergonomically designed for patient comfort to minimize motion artifact
- . Positioning accessories include an adjustable head support and retraction mechanism
- . Attachable mirror to reduce patient claustrophobic response
- . Complete lack of material in front of the patients face to reduce claustrophobic response.
2
6. Comparison with Legally Marketed Devices
The Insight Head Coil is substantially equivalent to the legally marketed devices listed below:
| Model: | Magnetom Trio Head Coil |
|---|---|
| Manufacturer: | USA Instruments |
| 510 (k) Number: | K021330 |
| Model: | AIR Head Coil |
| Manufacturer: | Advanced Imaging Research |
| 510 (k) Number: | K023929 |
| Model: | TEM 3000 Head Coil |
| Manufacturer: | MR Instruments Inc. |
| 510 (k) Number: | K040937 |
All of these head coils are intended for use in conjunction with a magnetic resonance scanner to produce diagnostic images of the head and neck tissues that can be interpreted by a radiologist.
The predicate devices are designed for use with various MR scanners as is the Insight Head Coil.
The Insight Head Coil is a quadrature transmit and receive coil for imaging the tissues of the head and neck. All of these head coils have an open coil design to optimize imaging of heads of various sizes.
7. Conclusions
The Insight Head Coil is substantially equivalent to the identified legally marketed devices. The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The Insight Head Coil provides images comparable to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
JUN 19 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Patricia A. Milbank Regulatory Consultant Insight Neuroimaging Systems LLC 11 Canterbury Street WORCHESTER MA 01610
Re: K061281
Trade/Device Name: Insight Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: May 5, 2006 Received: May 9, 2006
Dear Ms. Milbank:
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/3/Picture/10 description: The image is a circular logo with the text "1906-2006 FDA Centennial" in it. The letters "FDA" are in large, bold font in the center of the logo. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text, but the text is too small to read.
Protecting and Promoting Public Health
4
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/cdrlv/industry/support/index.html.
Sincerely vours.
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
5
6
Indication(s) for Use Statement
510(k) Number:
To be assigned by FDA
Device Name:
Insight Head Coil
Indications for Use:
The Insight Head Coil is a quadrature transmitting and receiving device used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist. This device provides a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patient's eyes, nose or mouth.
Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lyson
(Division Sign-Off) Division of Reproductive. Ab and Radiological Devic 510(k) Numbe
Original 510(k) PreMarket Notification Insight Neuroimaging Systems LLC., Insight Head Coll