(16 days)
No
The document describes a hardware component (an RF coil) for an MRI system and does not mention any software or processing capabilities that would involve AI or ML.
No
The device is a receive-only RF coil used for obtaining diagnostic images in MRI systems, not for treating conditions.
Yes
The device is a receive-only phased array RF coil used for obtaining diagnostic images, which inherently serves a diagnostic purpose in conjunction with an MRI system.
No
The device description clearly states it is a physical RF coil with coil elements, circuitry, and housing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Mark III Phased Array Shoulder Coil is a component of a Magnetic Resonance Imaging (MRI) system. Its purpose is to receive radiofrequency signals from the patient's body during an MRI scan to create diagnostic images.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It interacts directly with the patient's body to acquire imaging data.
Therefore, the Mark III Phased Array Shoulder Coil falls under the category of a medical device used for diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mark III Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Mark III Phased Array Coil is designed for use with the Signa EXCITE 3T MRI scanner manufactured by GE Medical Systems, Inc.
Product codes
90 MOS
Device Description
The Mark III Phased Array Coil consists of three volume RF coil elements in a phased array design. The coil elements and associated circuitry are enclosed to prevent any exposure to the patient or environment. The coil electronics are enclosed in both the rigid housing and the vinyl coated PVC foam. The coil is positioned on the patient's shoulder during imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging systems
Anatomical Site
shoulder and adjacent regions
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Special 510(k) Premarket Notification Special 510(K) Premarket 110 Shoulder Coil July 23, 2004
Image /page/0/Picture/2 description: The image shows the logo for USA Instruments, Inc. The logo consists of the company name in a simple, sans-serif font, with the letters "USA" slightly larger than "Instruments, Inc." To the left of the company name is a circular symbol with the letters "US" inside. The symbol appears to be a certification mark.
AUG 1 1 2004 SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Mark III Phased Array Shoulder Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive, |
| Aurora, Ohio 44202, USA | |
| Telephone: 330-995-8500; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been issued |
| under Section 514 of the Food, Drug and Cosmetic Act. | |
| 7. Intended Use: | The Mark III Phased Array Shoulder Coil is a receive-only phased |
| array RF coil, used for obtaining diagnostic images of the shoulder | |
| and adjacent regions in Magnetic Resonance Imaging systems. The | |
| indications for use are the same as for standard MR Imaging. The | |
| Mark III Phased Array Coil is designed for use with the Signa | |
| EXCITE 3T MRI scanner manufactured by GE Medical Systems, | |
| Inc. | |
| 8. Device Description : | The Mark III Phased Array Coil consists of three volume RF coil |
| elements in a phased array design. The coil elements and | |
| associated circuitry are enclosed to prevent any exposure to the | |
| patient or environment. The coil electronics are enclosed in both | |
| the rigid housing and the vinyl coated PVC foam. The coil is | |
| positioned on the patient's shoulder during imaging. |
1
Special 310(k) Premarket Notification Special - STU(K) Prematics - Mark III Shoulder Coil
USA Instruments - Mark III Shoulder Coil
July 23, 2004
Image /page/1/Picture/1 description: The image shows the logo for USA Instruments, Inc. The logo consists of a circular symbol with the letters "US" inside, followed by the text "USA Instruments, Inc." The text is in a simple, sans-serif font and is aligned to the right of the circular symbol. The logo is black and white.
9. Safety and Effectiveness:
| Mark III Phased Array Shoulder Coil
Product Features | Comparison to Predicate or other 510(k) cleared
products |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Shoulder imaging applications | -Similar to the Mark 9000 Shoulder Coil manufactured by
USA Instruments Inc. (K010946)
-Similar to the Phased Array Shoulder Coil manufactured
by Medical Advances Inc. (K945778) |
| Indications for Use
Identical to routine MRI imaging | -Similar to the Mark 9000 Shoulder Coil manufactured by
USA Instruments Inc. (K010946)
-Similar to the Phased Array Shoulder Coil manufactured
by Medical Advances Inc. (K945778) |
| Coil Enclosure Material
Vinyl coated PVC foam
Flame retardent Polyurethane Plastic
PVC Plastic | -Similar to the Mark 9000 Shoulder Coil manufactured by
USA Instruments Inc. (K010946)
-Similar to the Magna 5000 Phased Array CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
| Coil Design
Receive-only phased array design | -Similar to the Mark 9000 Shoulder Coil manufactured by
USA Instruments Inc. (K010946) |
| Decoupling
Switching diode decoupling | -Similar to the Mark 9000 Shoulder Coil manufactured by
USA Instruments Inc. (K010946) |
| Prevention of RF Burns
Does not transmit RF power; decoupling
isolates the coil elements from RF fields
during RF transmission; coil elements and
circuitry are enclosed in a non-conductive
housing. | -Similar to the Mark 9000 Shoulder Coil manufactured by
USA Instruments Inc. (K010946)
-Similar to the Excalibur 9000 TotalSENSE™ Quad Array-
Head Coil manufactured by USA Instruments, Inc.
(K022582) |
| Radio Frequency Absorption
Coil is a receive only coil and does not
transmit RF power; power deposition during
imaging is limited by SAR algorithm | -Similar to the Mark 9000 Shoulder Coil manufactured by
USA Instruments Inc. (K010946) |
| Formation of Resonant Loop
Decoupling isolates the coil elements from RF
fields during RF transmission; length of cable
and stiffness does not permit looping | -Similar to the Mark 9000 Shoulder Coil manufactured by
USA Instruments Inc. (K010946) |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.
od are: Dring Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2004
Mr. James Wrenn QA and Regulatory Manager USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K042009 Trade/Device Name: Mark III Phased Array Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: July 23, 2004
Received: July 26, 2004
Dear Mr. Wrenn:
We have reviewed your Section 510(k) premarket notification of intent to market the device WC nave reviewed your beceived the device is substantially equivalent (for the indications ferenced adove and nave betermile gally marketed predicate devices marketed in interstate for use stated in the enorosars) to togers the Medical Device Amendments, or to continer of pror to may 20, 2011 accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, marks 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 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that I DA has made a ceveres and regulations administered by other Federal agencies. You must comply or any I each states and intents, 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 quality by sections (Sections 531-542 of the Act), 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin harmening of substantial equivalence of your device to a legally premarket nothcation. The PDA miding or baseman 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 If you desire specific advice to: your down general with the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the prossesson Also, please note the regulation entitled, "Misbranding Other of Complianoo ut (201) 974) 974 Part 807.97) you may obtain. Other general by relected to premarket nonmanton - (r the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Selless http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Premarket Nouncation USA Instruments - Mark III Shoulder Coil July 23, 2004
Image /page/4/Picture/1 description: The image shows the logo for USA Instruments, Inc. The logo consists of a circular symbol with the letters "us" inside, along with the company name written in a simple, sans-serif font. The logo is clean and professional, suggesting a company that specializes in precision instruments. The text is black on a white background.
STATEMENT OF INTENDED USE
510(k) Number (if known): __ /