(57 days)
No
The summary describes a physical shielding device (RF Tent) to reduce electromagnetic interference for an existing MRI system. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
No
The RF Tent is designed to reduce electromagnetic interference for an MRI scanner, not to directly treat a medical condition or therapeutic purpose.
No
The device is a tent designed to reduce electromagnetic interference during MRI image acquisition. It does not acquire, process, or interpret medical images for diagnostic purposes itself.
No
The device description explicitly describes a physical "RF Tent" which is a hardware component designed to reduce electromagnetic interference. It is presented as an alternative to copper sheeting, which is also a physical material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce electromagnetic interference during image acquisition by an MRI scanner. This is a technical function related to the imaging equipment, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description focuses on providing shielding for an MRI device to improve image quality. It doesn't mention any interaction with biological samples or the analysis of such samples.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly designed to improve the performance of an imaging modality (MRI) by managing external interference. This falls under the category of medical devices that support diagnostic imaging, but not as an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
The RF Tent is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar N-10 (K002242).
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
To acquire high-quality MR images. it is necessary to isolate the MRI scanner from external sources of EMI (Electromagnetic Interference). Generally, copper sheeting is installed in the OR walls to isolate the OR from external interference. This solution is relatively expensive, and also requires the OR to be out of use during the installation process. Once the copper sheeting is installed, all procedures involving the PoleStar N-10 intraoperative MRI must be performed in the dedicated shielded room.
The RF Tent presented in this premarket notification expands the capability of the PoleStar N-10 (K002242), by providing a low cost, simple and effective alternative to the fixed copper shielding. Because it is portable, it also allows the PoleStar N-10 to be used in more than a single dedicated OR. Thereby increasing the flexibility of the use of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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. Signal to Noise results are provided in Attachment 2 of the 510(k) submission.
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
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 orbit-like graphic circles the right side of the word "odin", adding a modern and technological feel to the logo. The overall design is simple, clean, and professional, conveying a sense of innovation and expertise in the medical technology field.
AUG 2 8 2002
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: | May 30, 2002 |
807.92(a)(2) - Device Details:
| Trade Name and Common Name: | RF Tent |
|---|---|
| Classification: | 21 CFR 892.1000 Magnetic Resonance |
| Diagnostic Device. | |
| Class: | II |
| Product Code: | LNH - Magnetic Resonance Imaging |
| System | |
| 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 RF Tent is a new accessory of the PoleStar N-10 Intraoperative Magnetic Resonance Device (K002242), but it can also be considered as a modification to the presently installed copper sheeting solution to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent.
1
Image /page/1/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is written in bold, sans-serif font. Below the word "odin" is the phrase "Medical Technologies" in a smaller font. A circular graphic is to the right of the word "odin", with a small dot above the "i" in "odin".
807.92(a)(4) - Device Description:
To acquire high-quality MR images. it is necessary to isolate the MRI scanner from external sources of EMI (Electromagnetic Interference). Generally, copper sheeting is installed in the OR walls to isolate the OR from external interference. This solution is relatively expensive, and also requires the OR to be out of use during the installation process. Once the copper sheeting is installed, all procedures involving the PoleStar N-10 intraoperative MRI must be performed in the dedicated shielded room.
The RF Tent presented in this premarket notification expands the capability of the PoleStar N-10 (K002242), by providing a low cost, simple and effective alternative to the fixed copper shielding. Because it is portable, it also allows the PoleStar N-10 to be used in more than a single dedicated OR. Thereby increasing the flexibility of the use of the system.
807.92(a)(5) - Device Intended Use:
ないということでするとなってきませんですけど
The RF Tent is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar N-10 (K002242).
807.92(a)(6) - Substantial Equivalence Comparison Table:
The RF Tent and the presently implemented installed copper sheeting have the same intended use; to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by these means. Both solutions use conductive means to provide similar attenuation levels.
Odin RF Tent's intended use is similar to the presently implemented installed copper sheeting, with the following main advantages:
- . Initial Cost - The purchase and installation cost of the copper sheeting is approximately ten times more than the RF Cage.
- . Installation - Installation of copper sheeting requires the OR to be out of use for approximately three months. There is no installation required for the RF Tent.
2
Image /page/2/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is written in bold, sans-serif font, with "Medical Technologies" written in a smaller font size below it. A stylized graphic of a circle with a dot on top is to the right of the word "odin."
- Dedicated OR Because the RF is portable, the PoleStar N-10 does . not have to be used in a dedicated OR.
Performance Data:
Substantial equivalence was based on performance data. Signal to Noise results are provided in Attachment 2 of the 510(k) submission.
Conclusions:
The RF Tent adressed in this premarket notification, has the same intended use and technological basis as the presently implemented installed copper sheeting used with the legally marketed Intraoperative Magnetic Resonance Device PoleStar N-10 (K002242). Based on the analysis and tests performed by Odin Medical Technologies regarding the proper function of the RF Tent. We believe that the RF Tent can be safely and effectively used.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol representing the human form. The symbol consists of three stylized profiles facing to the right, stacked on top of each other.
. . . . . . . . . .
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
Mr. Adi Ickowicz Corporate Director of Regulatory Affairs, IP and Quality Odin Medical Technologies, Ltd. P.O. Box 548 Yokneam Elit 20692 ISRAEL
Re: K022157
Trade/Device Name: RF Tent Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: June 30, 2002 Received: July 2, 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 (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.
:
:
the first to the state of the state of the states and
4
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 contact 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 your responsibilities under 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K022157
RF Tent Device Name:
Indication For Use:
The RF Tent is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar N-10 (K002242).
(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 Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022157