(61 days)
No
The description focuses on the physical design and performance characteristics of a receive-only surface coil for MRI, with no mention of AI or ML algorithms for image processing, analysis, or other functions.
No
The device is described as a diagnostic tool used to produce images and spectra for general diagnostic use, and to improve imaging of selected sections of the head and extremities. It does not mention any therapeutic capabilities or intent to treat any condition.
No
The device description indicates that the FlexiCoil is a "receive-only surface coil" that "expands the capability of the PoleStar N-10 MR Imaging System" and "improves imaging." This suggests it is an accessory that aids in image acquisition, not a device that makes a diagnosis. The device's function is to help present images ("reflect the spatial distribution and/or magnetic resonance spectra"), which are then used for diagnostic purposes by other devices or professionals.
No
The device description clearly outlines a physical hardware component (a malleable receive-only surface coil made of copper straps, Medical Foam Tape, and an electronic tuning box) used in conjunction with an MR imaging system. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The FlexiCoil is a component of a Magnetic Resonance (MR) imaging system. It is a surface coil that is placed on the patient's body (head or extremities) to improve the quality of the MR images.
- Intended Use: The intended use is for general diagnostic imaging by presenting images that reflect the spatial distribution and/or magnetic resonance spectra of nuclei within the body.
The device is used for in vivo (within the living body) imaging, not in vitro (outside the living body) testing of specimens.
N/A
Intended Use / Indications for Use
The FlexiCoil - malleable receive-only surface coil expands the capability of the PoleStar N-10 MR Imaging System (K002242). It improves imaging of selected sections of the head and extremities.
A magnetic resonance diagnostic device is intended for general diagnostic use A magnetic resonalloo alagheet the spatial distribution and/or magnetic to present infages, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance.
The FlexiCoil - malleable receive-only surface coil expands the capability of the The Flexioon - mancubio roome imaging of selected sections of the head and extremities.
Product codes
MOS
Device Description
The FlexiCoil is a malleable receive-only surface coil intended to facilitate intraoperative MR imaging of selected sections of the head and extremities. This component is a malleable circular enclosed coil that consists of copper straps covered with Medical Foam Tape and an electronic tuning box, which can be placed around the anatomy of interest for MR imaging. The malleable structure of the coil allows adjustment of size and shape by pulling/releasing the plastic holders on both sides of the coil, providing the highest possible contact between the coil and the area to be imaged.
Due to its malleability the FlexiCoil can cover a wider area than the presently used coils (K991243) resulting in better image uniformity and a better overall SNR when imaging structures near the surface of the patient's head or extremity. The improved SNR is a result of the coil being closer to the signal-emitting anatomy, and being fully tuned and matched to the signal and receive channel. In addition the coil can be easily placed near the anatomy to be imaged with little or no patient post procedure discomfort. The FlexiCoil is for single use only and is supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MR imaging)
Anatomical Site
Selected sections of the head and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Substantial equivalence was based on performance data. Sample images were provided in attachment 4 of the 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 2 4 2002
Image /page/0/Picture/1 description: The image shows the logo for Odin Medical Technologies. The logo features the word "odin" in bold, sans-serif font, with the words "Medical Technologies" in a smaller font size underneath. A stylized graphic of a circle with an orbital path around it is positioned to the right of the word "odin", adding a modern and technological feel to the logo.
K020601
510(k) Summary of Safety and Effectiveness
The following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).
807.92(a)(1) - Submitter Details:
| Submitter name: | Adi Ickowicz - Corporate Director of Regulatory Affairs, IP and Quality |
|---|---|
| Address: | P.O. Box 548, Yokneam Elit 20692, Israel |
| Phone: | +972-4-959-1010 |
| Fax: | +972-4-959-1011 |
| E-mail: | adi@odin.co.il |
| Contact Person: | Adi Ickowicz - Corporate Director of Regulatory Affairs, IP and Quality |
| Date: | February 11, 2002 |
807.92(a)(2) - Device Details:
| Trade Name and Common Name: | FlexiCoil - malleable receive-only surface coil |
|---|---|
| Classification: | 21 CFR 892.1000 Magnetic Resonance Diagnostic Device. |
| Class: | II |
| MRDD were reclassified by FDA from | |
| Class III to Class II effective July 28, 1998. | |
| Product Code: | MOS - Magnetic Resonance Specialty Coil |
| Performance Standards: | No applicable performance standards have been issued for this product code under section 514 of the Food and Drug and Cosmetic Act. |
807.92(a)(3) - Predicate Devices:
The FlexiCoil - malleable receive-only surface coil is substantially equivalent to the following legally marketed medical devices:
1
Image /page/1/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "ODIN" is in large, bold, black letters. Below the word "ODIN" is the phrase "Medical Technologies" in a smaller font. A curved line starts above the "N" in "ODIN" and wraps around the right side of the word, ending near the bottom of the "N".
| Medical Device Name | Applicant Name | 510(k)
Number | Product Code |
|------------------------------------------------------|-----------------------------------|------------------|--------------|
| NORMA 10 surface coil | Odin Medical
Technologies Ltd. | K991243 | LNH |
| Phased Array Musculo -
Skeletal Flex Coil Package | IGC-Medical
Advances, Inc. | K003366 | MOS |
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.
807.92(a)(4) - Device Description:
The FlexiCoil is a malleable receive-only surface coil intended to facilitate intraoperative MR imaging of selected sections of the head and extremities. This component is a malleable circular enclosed coil that consists of copper straps covered with Medical Foam Tape and an electronic tuning box, which can be placed around the anatomy of interest for MR imaging. The malleable structure of the coil allows adjustment of size and shape by pulling/releasing the plastic holders on both sides of the coil, providing the highest possible contact between the coil and the area to be imaged.
Due to its malleability the FlexiCoil can cover a wider area than the presently used coils (K991243) resulting in better image uniformity and a better overall SNR when imaging structures near the surface of the patient's head or extremity. The improved SNR is a result of the coil being closer to the signal-emitting anatomy, and being fully tuned and matched to the signal and receive channel. In addition the coil can be easily placed near the anatomy to be imaged with little or no patient post procedure discomfort. The FlexiCoil is for single use only and is supplied non-sterile.
807.92(a)(5) - Device Intended Use:
The FlexiCoil - malleable receive-only surface coil expands the capability of the PoleStar N-10 MR Imaging System (K002242). It improves imaging of selected sections of the head and extremities.
2
Image /page/2/Picture/0 description: The image shows the logo for Odin Medical Technologies. The logo features the word "odin" in bold, sans-serif font, with "Medical Technologies" written in a smaller font size below it. A stylized graphic resembling an orbit or a curved path with a dot at the top right of the word "odin" adds a modern touch to the logo.
807.92(a)(6) – Substantial Equivalence Comparison Table:
| Candidate Device | Predicate Devices | ||
|---|---|---|---|
| Parameter | FlexiCoil | NORMA 10 surface | |
| coil | Phased Array | ||
| Musculo -Skeletal | |||
| Flex Coil Package | |||
| Coil enclosure | |||
| material | Closed-cell | ||
| polyethylene | Polyolefin | Cotton fabric | |
| Coil design | Receive-Only Surface | ||
| Coil | Receive-Only Surface | ||
| Coil | Receive-Only or | ||
| Transmit and Receive | |||
| Coil | |||
| Decoupling | Active PIN diode | ||
| decoupling | Active PIN diode | ||
| decoupling | Active PIN diode | ||
| decoupling | |||
| Formation of | |||
| Resonant | |||
| Loops | Surface Coil | Surface Coil | Phased Array Coil |
| Potential for RF | |||
| burns | SAR substantially | ||
| below the permissible | |||
| limit | SAR substantially | ||
| below the permissible | |||
| limit | Not Available | ||
| RF absorption | Does not transmit RF | ||
| power | Does not transmit RF | ||
| power | Not Available | ||
| Intended use | 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 | 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 | 2D, 3D imaging, proton | ||
| density, Ti and T2 | |||
| weighted imaging. 2D, | |||
| 3D time of flight, phase | |||
| contrast imaging | |||
| Indications for | |||
| use | Selected sections of | ||
| the head and | |||
| extremities | Selected sections of | ||
| the head and | |||
| extremities | Cranial structures, | ||
| musculoskeletal | |||
| structures, peripheral | |||
| nerves and pediatric | |||
| applications |
3
Image /page/3/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in bold, sans-serif font, with the "o" being capitalized. Below "odin" is the phrase "Medical Technologies" in a smaller, sans-serif font. Above and to the right of the word "odin" is a curved line that resembles an orbit, with a solid circle at the top of the curve.
Performance Data:
Substantial equivalence was based on performance data. Sample images were provided in attachment 4 of the 510(k) submission.
Conclusions:
The PoleStar N-10 operated with the FlexiCoil - malleable receive-only surface coil adressed in this premarket notification, has the same intended use and technological characteristics as the same system operated with the legally marketed coil cleared in K991243 and does not affect the PoleStar N-10 system safety parameter specification. The FlexiCoil also has the the same intended use and technological characteristics as the other OEM predicate coil.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Adi Ickowicz Corporate Director of Regulatory Affairs, IP and Quality Odin Medical Technologies Ltd. P.O. Box 248 Yokneam Elit 20692 ISRAEL
APR 2 4 2002
Re: K020601
Trade/Device Name; FlexiCoil-Malleable receive-only surface coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: February 20, 2002 Received: February 22, 2002
Dear Mr. Ickowicz:
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your 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 11 you the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of receive to promation of the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): 020601
Device Name:
FlexiCoil - malleable receive-only surface coil
Indication For Use:
A magnetic resonance diagnostic device is intended for general diagnostic use A magnetic resonalloo alagheet the spatial distribution and/or magnetic to present infages, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance.
The FlexiCoil - malleable receive-only surface coil expands the capability of the The Flexioon - mancubio roome imaging of selected sections of the head and extremities.
(PLEASE DO NOT WRITE BELOW THE LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Nancy C. Brogdon
(Division Sign-Off)
Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020601