(10 days)
No
The summary 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 described as a coil used for obtaining diagnostic images in Magnetic Resonance Imaging Systems, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for obtaining diagnostic images".
No
The device description explicitly states it is a "multi-element phased array RF coil" with physical components like "detachable legs sections, a main base and a pre-amplifier box" enclosed in a "rigid plastic housing." This clearly indicates a hardware device, not software only.
Based on the provided information, the Rapture 11000 peripheral vascular coil is not an IVD (In Vitro Diagnostic) device.
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.
- Rapture 11000 Function: The Rapture 11000 is an RF coil used in Magnetic Resonance Imaging (MRI) systems. Its purpose is to receive signals from the body during an MRI scan to create diagnostic images. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "obtaining diagnostic images of the vasculature and soft tissue anatomy" within the body.
Therefore, the Rapture 11000 is a medical device used for in vivo (within the living body) diagnostic imaging, not in vitro diagnostics.
N/A
Intended Use / 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 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.
Product codes
MOS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
vasculature and soft tissue anatomy extending from below the knee to the foot region
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.
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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:
-
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.
-
- 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 Polyurethane | ||
| Vinyl Coated EVA Foam | ||
| Flame 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
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