← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K042207 # 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL (K042207) _Usa Instruments, Inc. · MOS · Aug 26, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K042207 ## Device Facts - **Applicant:** Usa Instruments, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Aug 26, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** 3rd-Party Reviewed ## Intended 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. ## Device Story Rapture 11000 is a multi-element phased array receive-only RF coil for MRI systems; designed for GE Signa 1.5T scanners. Input: RF signals from patient anatomy (below knee to foot). Transformation: receives signals via phased array elements; decoupling via switching diodes isolates elements during RF transmission to prevent burns. Output: diagnostic images of vasculature and soft tissue. Used in clinical MRI suites; operated by MRI technologists/radiologists. Healthcare providers use images for diagnostic decision-making. Benefits: improved image quality for peripheral vascular anatomy; patient comfort via open design. Construction: rigid plastic housing (flame retardant). ## Clinical Evidence Bench testing only. No clinical data provided. Safety and effectiveness established through design verification, material testing (flame retardant properties), and performance comparisons regarding RF decoupling, resonant loop prevention, and image quality consistency with predicate devices. ## Technological Characteristics Multi-element phased array receive-only RF coil. Materials: Flame retardant polyurethane, vinyl coated EVA foam, flame retardant polycarbonate. Decoupling: Switching diode. Energy: Passive receive-only (no RF transmission). Connectivity: Dedicated interface for GE Signa 1.5T MRI. Form factor: Rigid plastic housing with four sections (two detachable leg sections, main base, pre-amplifier box). ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - Flow 7000 Peripheral Vascular Coil ([K982339](/device/K982339.md)) - Flow 7000 Peripheral Vascular Coil ([K010730](/device/K010730.md)) - Champion 5000 ([K023247](/device/K023247.md)) ## Reference Devices - Spirit III TotalSENSE Cardiac Coil ([K031172](/device/K031172.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K04 22 07 ## Traditional 510(k) Premarket Notification Pennheral Vas AUG 2 6 2004 ## SUMMARY OF SAFETY AND EFFECTIVENESS - 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. - 9. Safety and Effectiveness {1}------------------------------------------------ . : : : ・・ | 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. | {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K042207](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K042207) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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