(16 days)
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.
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.
The provided text describes a Special 510(k) Premarket Notification for the Mark III Phased Array Shoulder Coil. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical or performance study data with defined acceptance criteria in the same way a new, high-risk device might. The document submitted for K042009 is a Traditional 510(k), which is typically for new devices. However, the internal title indicates 'Special 510(k)', which refers to an easier route for devices that are modifications to one's own legally marketed devices.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided document. The 510(k) submission primarily relies on comparisons to legally marketed predicate devices to establish safety and effectiveness.
Here's an analysis of what is available and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in this document as performance metrics with thresholds. | Demonstrated substantial equivalence to predicate devices for intended use, indications for use, coil enclosure material, coil design, decoupling, prevention of RF burns, radio frequency absorption, and formation of resonant loop. |
Missing Information: Specific quantitative performance metrics (e.g., signal-to-noise ratio, image resolution, specific absorption rate (SAR) limits) that the device must meet, and corresponding test results to prove these metrics are met. The document states "power deposition during imaging is limited by SAR algorithm", but doesn't specify the accepted SAR limits or the measured SAR of the device.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information: The document does not describe a "test set" in the context of clinical or performance data generation. The submission relies on a comparison to predicate devices, not independent testing on a new dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Missing Information: Not applicable. No test set requiring expert ground truth is described.
4. Adjudication Method for the Test Set
Missing Information: Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Missing Information: No MRMC study is described. The submission focuses on technical equivalence rather than clinical comparative effectiveness.
6. If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)
Missing Information: Not applicable. This device is a passive RF coil, not an algorithmic device requiring standalone performance testing in that sense. The 'performance' is implied by its design similarity to predicate devices.
7. The Type of Ground Truth Used
Missing Information: Not applicable. No new ground truth needed to be established for this submission, as it relies on the established safety and effectiveness of predicate devices.
8. The Sample Size for the Training Set
Missing Information: Not applicable. This device is a hardware component, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Missing Information: Not applicable. No training set is described.
Summary of the Study/Evidence Provided:
The "study" presented in this 510(k) notification is primarily a direct comparison of the Mark III Phased Array Shoulder Coil to legally marketed predicate devices. The manufacturer, USA Instruments, Inc., established substantial equivalence by demonstrating that their new coil has:
- Similar Intended Use: Shoulder imaging applications.
- Similar Indications for Use: Identical to routine MRI imaging.
- Similar Design Principles: Receive-only phased array design, decoupling methods (switching diode decoupling), and methods for preventing RF burns (does not transmit RF power, coil elements isolated and enclosed in non-conductive housing).
- Similar Materials: Coil enclosure materials (Vinyl coated PVC foam, Flame retardant Polyurethane Plastic, PVC Plastic).
Predicate Devices Used for Comparison:
- Mark 9000 Shoulder Coil manufactured by USA Instruments Inc. (K010946)
- Phased Array Shoulder Coil manufactured by Medical Advances Inc. (K945778)
- Magna 5000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K994345) (for enclosure materials)
- Excalibur 9000 TotalSENSE™ Quad Array-Head Coil manufactured by USA Instruments, Inc. (K022582) (for prevention of RF burns)
The safety and effectiveness argument is built upon the premise that because the Mark III Phased Array Shoulder Coil shares fundamental design characteristics, intended use, and indications for use with other legally marketed devices, it can be considered equally safe and effective. The FDA's letter concurs with this determination of substantial equivalence.
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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, USATelephone: 330-995-8500; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have been issuedunder Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The Mark III Phased Array Shoulder Coil is a receive-only phasedarray RF coil, used for obtaining diagnostic images of the shoulderand adjacent regions in Magnetic Resonance Imaging systems. Theindications for use are the same as for standard MR Imaging. TheMark III Phased Array Coil is designed for use with the SignaEXCITE 3T MRI scanner manufactured by GE Medical Systems,Inc. |
| 8. Device Description : | The Mark III Phased Array Coil consists of three volume RF coilelements in a phased array design. The coil elements andassociated circuitry are enclosed to prevent any exposure to thepatient or environment. The coil electronics are enclosed in boththe rigid housing and the vinyl coated PVC foam. The coil ispositioned on the patient's shoulder during imaging. |
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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 CoilProduct Features | Comparison to Predicate or other 510(k) clearedproducts |
|---|---|
| Intended UseShoulder imaging applications | -Similar to the Mark 9000 Shoulder Coil manufactured byUSA Instruments Inc. (K010946)-Similar to the Phased Array Shoulder Coil manufacturedby Medical Advances Inc. (K945778) |
| Indications for UseIdentical to routine MRI imaging | -Similar to the Mark 9000 Shoulder Coil manufactured byUSA Instruments Inc. (K010946)-Similar to the Phased Array Shoulder Coil manufacturedby Medical Advances Inc. (K945778) |
| Coil Enclosure MaterialVinyl coated PVC foamFlame retardent Polyurethane PlasticPVC Plastic | -Similar to the Mark 9000 Shoulder Coil manufactured byUSA Instruments Inc. (K010946)-Similar to the Magna 5000 Phased Array CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
| Coil DesignReceive-only phased array design | -Similar to the Mark 9000 Shoulder Coil manufactured byUSA Instruments Inc. (K010946) |
| DecouplingSwitching diode decoupling | -Similar to the Mark 9000 Shoulder Coil manufactured byUSA Instruments Inc. (K010946) |
| Prevention of RF BurnsDoes not transmit RF power; decouplingisolates the coil elements from RF fieldsduring RF transmission; coil elements andcircuitry are enclosed in a non-conductivehousing. | -Similar to the Mark 9000 Shoulder Coil manufactured byUSA Instruments Inc. (K010946)-Similar to the Excalibur 9000 TotalSENSE™ Quad Array-Head Coil manufactured by USA Instruments, Inc.(K022582) |
| Radio Frequency AbsorptionCoil is a receive only coil and does nottransmit RF power; power deposition duringimaging is limited by SAR algorithm | -Similar to the Mark 9000 Shoulder Coil manufactured byUSA Instruments Inc. (K010946) |
| Formation of Resonant LoopDecoupling isolates the coil elements from RFfields during RF transmission; length of cableand stiffness does not permit looping | -Similar to the Mark 9000 Shoulder Coil manufactured byUSA Instruments Inc. (K010946) |
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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.
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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
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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): __ / < 0 Y 2 ou 9
Device Name: Mark III Phased Array Shoulder Coil
Indications for Use:
The Mark III Phased Array Shoulder Coil is a receive-only PF coil, used for obtaining
The Mark III Phased Array Massactic Researce Imaging systems Th The Mark III Phased Array Shoulder Coll is a receive Resonance Imagner Imaging systems. The diagnostic images of the shoulder and adjacent regions in Nil Phased Array Coll is designed for
indications for use are the same as for standard MR Inaging. The Mark II Phase indications for use are the same as for standard First hanges
use with the Signa EXCITE 3.0T MRI scanner manufactured by GE Medical Systems, Inc
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy Brogdon
Division of Reproduct and Radiological Devi 510(k) Number
§ 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.