(44 days)
NOT FOUND
No
The document describes a physical accessory (RF Tent) for an MRI system designed to reduce electromagnetic interference. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a magnetic resonance diagnostic device used to present images and spectra, which points to a diagnostic purpose rather than a therapeutic one. It does not treat or cure a disease.
No
The provided text describes the StarShield V3 as an accessory that reduces Electromagnetic Interference (EMI) for the PoleStar system. It does not perform any diagnostic function itself. The diagnostic device mentioned in the text is the PoleStar system, not the StarShield V3.
No
The device description clearly outlines multiple hardware components (foldable frame, cover, control unit, floor) that constitute the RF Tent, which is the core of the StarShield V3 accessory.
Based on the provided information, the StarShield V3 is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of the StarShield V3 is to reduce Electromagnetic Interference (EMI) during image acquisition by the PoleStar system. It does not perform any diagnostic testing on biological samples (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description clearly states it's an accessory to a magnetic resonance diagnostic device and its function is to create a shielded environment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The StarShield V3 is an accessory that facilitates the proper functioning of a magnetic resonance imaging system, which is a diagnostic imaging device, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The PoleStar system is a magnetic resonance diagnostic device 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.
The StarShield V3 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 system.
Product codes
LNH
Device Description
The StarShieldV3 is an accessory of Odin's PoleStar Intraoperative Magnetic Resonance system. It is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent, required Elootromagnotion The RF Tent is a portable modular structure that consist of four principal components:
- The foldable frame .
- The cover .
- The control unit .
- The floor .
The RF Tent is not connected to the PoleStar gantry or the OR table.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room
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)
Not Found
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.
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MAR 1 8 2005
Image /page/0/Picture/1 description: The image shows the logo for Odin Medical Technologies. The word "odin" is written in a bold, sans-serif font, with the "o" slightly larger than the other letters. Below "odin" is the phrase "Medical Technologies" in a smaller, italicized font. A curved line extends from the top right of the "n" in "odin" and arches over the word.
Special 510(k) Summary of Safety and Effectiveness
The Following Special 510(k) Summary of Safety and Effectiveness has been The Pollowing Special 510(k) Summary of Sales) and manes specified in 21 CFR § 807.92(a).
807.92(a)(1) - Submitter Details:
| Submitter name: | Adi Ickowicz –Quality and Regulatory Director |
|---|---|
| Address: | P.O. Box 548, Yokneam Elit 20698, Israel |
| Phone: | +972-4-959-1010 |
| Fax: | +972-4-959-1011 |
| E-mail: | adi@odin.co.il |
| Contact Person: | Adi Ickowicz –Quality and Regulatory Director |
| Date: | January 8, 2005 |
807.92(a)(2) - Device Details:
| Trade Name and Common Name: | |
|---|---|
| StarShield V3 | |
| Classification: | 21 CRF 892.1000 Magnetic Resonance |
| Diagnostic Device. | |
| Class: | II |
| MRDD were reclassified by FDA from | |
| Class III to Class II effective July 28, |
- |
| Product Code: | LNH - Magnetic Resonance Imaging
System |
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 it, in smaller letters, are the words "Medical Technologies". There is a curved line above and below the word "ODIN".
807.92(a)(3) - Predicate Devices:
The StarShield V3 is comparable to Odin's RF Tent
| Medical
Device Name | Applicant Name | 510(k)
Number | Classification |
|------------------------|---------------------------------|------------------|-----------------|
| RF Tent | Odin Medical Thechnologies Ltd. | K022157 | Class II device |
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.
807.92(a)(4) - Device Description:
The StarShieldV3 is an accessory of Odin's PoleStar Intraoperative Magnetic Resonance system. It is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent, required Elootromagnotion The RF Tent is a portable modular structure that consist of four principal components:
- The foldable frame .
- The cover .
- The control unit .
- The floor .
The RF Tent is not connected to the PoleStar gantry or the OR table.
2
Image /page/2/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. There is a partial circle around the right side of the word "ODIN".
807.92(a)(5) – Device Intended Use:
The general purpose of the device as defined in 21 CFR 892.1000:
The PoleStar system is a magnetic resonance diagnostic device 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.
The StarShield V3 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 system.
3
Image /page/3/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is written in large, bold, black letters. Below "odin" is the phrase "Medical Technologies" in a smaller font. There is a curved line above and to the right of the word "odin".
807.92(a)(6) -- Substantial Equivalence Comparison Table:
| Model | Odin | Odin |
|---|---|---|
| parameter | RF Tent (K022157) | StarShield V3 |
| Application | To create an area of substantially | |
| reduced Electromagnetic | ||
| Interference (EMI) in the area | ||
| enclosed by the RF Tent during | ||
| image acquisition by the PoleStar | ||
| system | Same | |
| Materials | ||
| Frame | Aluminum alloy AlMg Si 0.5 | Same |
| Cover | (Polyethylene Terephthalate) | |
| PET incorporating Cu+Ni, | ||
| laminated with flame-retardant | ||
| PVC. | Same | |
| Dimensions | ||
| Length (Folded) | 950 mm | Same |
| Length (Extended) | 3500 | Same |
| Width/Base | 1250 mm | Same |
| Maximum height | 1650 mm | Same |
| Clearance between the RF | ||
| tent and the operating table | ||
| Foot side (height) | 200 mm | Same |
| Width (each side) | 100 mm | Same |
| Head side (distance | ||
| from scanner) | 70 mm | Same |
| Average Attenuation | >40dB at 100 MHz | Same |
| Floor | Matte aluminum alloy sheet | |
| measuring 3.8 x 1.5 m | Same | |
| Energy used | Pneumatic | Electric |
| Where Used | Operating Room | Same |
| Biocompatibility | Does not contact patient | Same |
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Adi Ickowicz Director of Regulatory Affairs Odin Medical Technologies Ltd. Kochav Yokneam Building P.O. Box 548 Yokneam Elite, 20698 (2) ISRAEL
Re: K050237 Trade/Device Name: StarShield V3 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance imaging system Regulatory Class: II Product Code: LNH Dated: January 31, 2005
Received: February 23, 2005
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 the encessor the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1778, increating 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 do including approvince or a controls provisions of the Act. The general controls provisions of the Act include reguirements 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 n youval), it may be subject to such additional controls. Existing major regulations affecting your Apple ran 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 docs 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 rodotal barrers, 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) (2) 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 Section 510(k) I mis lotter villing of substantial equivalence of your device of your device to a legally prematice notification: "Thesults 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 rryou desire specifice of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 77/ - 1 od may 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/industry/support/index.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
KOS 0237 510(k) Number (if known):
StarShield V3 Device Name:
Indication For Use:
The PoleStar system is a magnetic resonance diagnostic device intended for general diagnostic use to present images, which reflect the spatial distribution and/or magnetic diagnostic use to presont magges, and distribution of nuclei exhibiting nuclear magnetic resonance.
The StarShield V3 is intended to create an area of substantially reduced I he Starburnd VS is interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system.
(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. Benson
(Division Sign-Division of Reproduc and Radiological Device 510(k) Number