(10 days)
The Rapture 11000 a phased array peripheral vascular coil is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending from below the knee to the foot region, in Magnetic Resonance Imaging Systems. The Rapture 11000 Peripheral Vascular Coil is designed for use with the Signa 1.5T MRI system manufactured by GE Healthcare Technologies. The indications for use are the same as for standard MR Imaging.
The Rapture 11000 a peripheral vascular coil is a multi-element phased array receive-only coil. The coil consists of four sections: two detachable legs sections, a main base and a pre-amplifier box. The open, patient friendly design maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
This document describes the Rapture 11000 Phased Array Peripheral Vascular Coil, an MRI accessory. The submission is a Traditional 510(k) Premarket Notification from 2004.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) submission for a medical device cleared in 2004. At that time, acceptance criteria were typically demonstrated by proving substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics as might be seen for AI/ML devices today. The "acceptance criteria" here are implicitly satisfied by demonstrating the new device is as safe and effective as existing legally marketed devices.
Therefore, the table below reflects the comparison presented in the document to establish substantial equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (Rapture 11000) |
|---|---|
| Intended Use: Imaging of vasculature and soft tissue anatomy. | Intended Use: Imaging of vasculature and soft tissue anatomy extending from below the knee to the foot region. Similar to predicate devices: Flow 7000 Peripheral Vascular Coil (K982339, K010730) and Champion 5000 (K023247). |
| Indications for Use: Identical to routine MRI imaging. | Indications for Use: Identical to routine MRI imaging. Similar to predicate devices: Flow 7000 Peripheral Vascular Coil (K982339, K010730) and Champion 5000 (K023247). |
| Coil Enclosure Material: Safe and appropriate for MR environment. | Coil Enclosure Material: Flame Retardant Polyurethane, Vinyl Coated EVA Foam, Flame Retardant Polycarbonate. Similar to materials in Spirit III TotalSENSE Cardiac Coil (K031172). |
| Coil Design: Receive-only phased array coil. | Coil Design: Receive-only phased array coil. Similar to predicate devices: Flow 7000 Peripheral Vascular Coil (K982339, K010730) and Champion 5000 (K023247). |
| Decoupling: Effective isolation of RF fields. | Decoupling: Switching diode decoupling. Similar to predicate devices: Flow 7000 Peripheral Vascular Coil (K982339, K010730), Champion 5000 (K023247) and Spirit III TotalSENSE Cardiac Coil (K031172). |
| Prevention of RF Burns: No RF transmission, isolation, non-conductive housing. | Prevention of RF Burns: Does not transmit RF power; decoupling isolates elements during transmission; elements and circuitry enclosed in a non-conductive housing. Similar to predicate devices. |
| Radio Frequency Absorption: No RF power transmission. | Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power. Similar to predicate devices. |
| Formation of Resonant Loop: Decoupling and physical design prevent looping. | Formation of Resonant Loop: Decoupling isolates elements; cable length and stiffness prevent looping. Similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a specific test set or data provenance in the way an AI/ML device submission would. For a traditional medical device like an MRI coil, "testing" typically involves:
- Engineering validation and verification (e.g., electrical performance, mechanical integrity, safety tests).
- Clinical evaluation to ensure image quality and compatibility with the MRI system.
The submission does not specify a clinical study with a defined sample size for patients. The focus is on demonstrating equivalence based on design, materials, and intended use, implying that similar clinical performance is expected given the similarity to predicate devices. Therefore,
- Sample Size for Test Set: Not specified in terms of patient data.
- Data Provenance: Not applicable in the context of patient data studies for this submission type.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For a traditional MRI coil, "ground truth" would relate to the physical and functional performance of the coil itself (e.g., signal-to-noise ratio, homogeneity, artifact levels), typically assessed by engineers and MR physicists, not medical experts establishing 'ground truth' for diagnostic findings. Since no clinical studies establishing diagnostic truth are mentioned, no expert panel for ground truth is indicated.
4. Adjudication Method for the Test Set
This is not applicable to this type of device submission. Adjudication methods (like 2+1 or 3+1) are typically used in clinical trials involving subjective interpretation of diagnostic findings, often for AI/ML algorithms or new diagnostic methods where a consensus ground truth needs to be established from multiple expert readers. This submission for an MRI coil focuses on technical equivalence and safety aspects.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done or at least not reported in this summary. This type of study is common for evaluating the impact of AI on human reader performance for diagnostic tasks. For a physical device like an MRI coil, performance is generally evaluated based on image quality metrics and safety, not on how a human reader's diagnostic accuracy improves with the coil.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is an MRI hardware component, not an algorithm.
7. The Type of Ground Truth Used
For this device, the "ground truth" would primarily be established through:
- Engineering specifications and tests: Confirming electrical, mechanical, and safety parameters meet design requirements.
- Image quality metrics: Assessing signal-to-noise ratio, image homogeneity, artifact levels, and resolution achievable with the coil.
- Comparison to predicate devices: The primary ground truth for regulatory clearance here is that the new device performs at least as well as or equivalent to legally marketed predicate devices in terms of its intended function and safety.
No specific "pathology," "outcomes data," or "expert consensus" on diagnostic findings is reported as ground truth for this device's performance in the provided summary.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware component (an MRI coil), not a software algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this device is hardware and does not have a training set or associated ground truth establishment process for training.
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K04 22 07
Traditional 510(k) Premarket Notification
Pennheral Vas
AUG 2 6 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
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Magnetic Resonance Imaging Accessory 1. Device Name: Rapture 11000 2. Proprietary Name: Class II 3. Classification: 1529041 4. Establishment Registration #: USA Instruments, Inc., 5. Manufacture Facility Location: 1515 Danner Drive Aurora, Ohio 44202, USA Telephone: 330-562-1000; Fax: 330-562-1422. No applicable performance standards have been issued 6. Performance Standard: under Section 514 of the Food, Drug and Cosmetic Act. The Rapture 11000 a phased array peripheral vascular coil 7. Intended Use: is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending from below the knee to the foot region, in Magnetic Resonance Imaging Systems. The Rapture 11000 Peripheral Vascular Coil is designed for use with the Signa 1.5T MRI system manufactured by GE Healthcare Technologies. The indications for use are the same as for standard MR Imaging. The Rapture 11000 a peripheral vascular coil is a multi-8. Device Description:
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element phased array receive-only coil. The coil consists of four sections: two detachable legs sections, a main base and a pre-amplifier box. The open, patient friendly design maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
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- Safety and Effectiveness
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.
: : :
・・
| Rapture 11000 Peripheral Vascular Coil | Phased Array | Comparison to predicate device or other 510(k) cleared products |
|---|---|---|
| Intended Use: Imaging of vasculature and soft tissue anatomy extending from the torso to the foot region | -Similar to the Flow 7000 Peripheral Vascular Coil manufactured by USA Instruments, Inc. (K982339, K010730) and Champion 5000 (K023247). | |
| Indications for Use: Identical to routine MRI imaging | -Similar to the Flow 7000 Peripheral Vascular Coil manufactured by USA Instruments, Inc. (K982339, K010730) and Champion 5000 (K023247). | |
| Coil Enclosure Material:Flame Retardant PolyurethaneVinyl Coated EVA FoamFlame Retardant Polycarbonate | -Similar to materials used in Spirit III TotalSENSE Cardiac Coil (From 510(k) K031172) | |
| Coil Design: Receive-only phased array coil | -Similar to the Flow 7000 Peripheral Vascular Coil (K982339, K010730) and Champion 5000 (K023247) manufactured by USA Instruments, Inc. | |
| Decoupling: Switching diode decoupling | -Similar to the Flow 7000 Peripheral Vascular Coil (K982339, K010730), Champion 5000 (K023247) and Spirit III TotalSENSE Cardiac Coil (K031172) manufactured by USA Instruments, Inc. | |
| 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 Flow 7000 Peripheral Vascular Coil (K982339, K010730), Champion 5000 (K023247) and Spirit III TotalSENSE Cardiac Coil (K031172) manufactured by USA Instruments, Inc. | |
| Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power | -Similar to the Flow 7000 Peripheral Vascular Coil (K982339, K010730) and Champion 5000 (K023247) manufactured by USA Instruments, Inc. | |
| 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 Flow 7000 Peripheral Vascular Coil (K982339, K010730) and Champion 5000 (K023247) manufactured by USA Instruments, Inc. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2004
USA Instruments, Inc. % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K042207
Trade/Device Name: 11000 Rapture Phased Array Peripheral Vascular Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 MOS Dated: August 13, 2004 Received: August 16, 2004
Dear Mr. Lehtonen:
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 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 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I remarket notification. The FDA finding of substantial equivalence of your device to a legally promated 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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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. Brydon
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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USA Instruments 1.5T Peripheral Vascular Coil
STATEMENT OF INTENDED USE
510(k) Number (if known): __ / 0 4 22 0
Device Name: Rapture 11000
Indications for Use:
The Rapture 11000 a phased array peripheral vascular coil is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending oon, bood for obtaining that region, in Magnetic Resonance Imaging Systems. The Rapture 11000 Coil is designed for use with the Signa 1.5T MRI system manufactured by GE Healthcare Technologies.
(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 Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K042205
7
§ 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.