3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE

{0}------------------------------------------------ N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax: Image /page/0/Picture/1 description: The image shows the logo for NeoCoil, which is a black circle with a white swirl inside and the word "NeoCoil" in bold black letters. Above the logo, there is handwritten text that reads "K141832 page 1 of 3". The text is written in black ink and appears to be a document identifier or page number. JUL 3 1 2014 # 5. Traditional 510(k) Summary - 5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA - 5.2. Contact Michael Leigh Director, Regulatory/Quality 262-522-6127 (direct) 261-347-1251 (fax) Mike.leigh@neocoil.com 5.3. Preparation Date 07/03/2014 - 5.4. Name of Device - Proprietary Name: . - Common Name: . - . Classification: 3T 16ch Flex SPEEDER Coils Magnetic Resonance Specialty Coil - 21 CFR 892.1000, Product Code MOS - 5.5. Model Numbers | NeoCoil Model Number | NeoCoil Model Name | Toshiba Model Number | |----------------------|-----------------------------------|----------------------| | NC045000 | 3T 16ch Flex SPEEDER Coil, Medium | MJAJ-212A | | NC046000 | 3T 16ch Flex SPEEDER Coil, Large | MJAJ-222A | 5.6. Device Description The NeoCoil 3T 16ch Flex SPEEDER Coils are a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest. abdomen, pelvis, head, neck, and spine. The system is compatible with 2D, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. The system consists of: - Two formable, flexible and detachable antennae of different size that can be . wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes. - . Optional accessories designed for patient comfort and reduced motion artifacts. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. 5.7. Predicate Device - . 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012. | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Children<br>C | ----------------- | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>ARLE IN ARE E BELANDER AN AND AND<br>MARK | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>ANNUALIER A L C CHINA A<br>1.8 1.8 1.0 mm .<br>1 4 come of the consisted | --------------------------------------------------------------------------------------------------------------------------- | | NeoCoil, LLC {1}------------------------------------------------ N27 W23910A Paul Rd Pewaukee. WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax: Image /page/1/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a circular graphic on the left and the word "NeoCoil" on the right. The graphic is a black circle with a white crescent shape inside and a small arrow pointing to the right. The word "NeoCoil" is written in a bold, sans-serif font. ### 5.8. Comparison to Predicate The NeoCoil 3T 16ch Flex SPEEDER Coils are similar in physical, performance, design and material characteristics to the legally marketed device, the 1.5T 16ch Flex SPEEDER, K121362, as cleared on 06/15/2012. The differences introduced in this submission include: - DC and RF chains have been modified to meet the Toshiba Vantage Titan 3T Coil . Interface Description. - Additional decoupling circuit in the 3T 16ch Flex SPEEDER Large compared to the . 1.5T 16ch Flex SPEEDER Large for the purpose of improved uniformity. - . Compared to the 1.5T 16ch Flex SPEEDER, the preamplifier circuitry was moved from the antenna housing, to the cable, within a pre-amp cover located further away from the imaging volume to improve stability. The Indications for Use are consistent with the capabilities of the predicate device, the NeoCoil 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012. Clinical testing demonstrates that the differences in the devices do not affect the safety and/or the effectiveness of the device when used as labeled. - 5.9. Indications for Use To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician. #### 5.10. Intended Use Intended use of the 3T 16ch Flex SPEEDER Coils is identical to that of routine MR imaging: specifically to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine. Use of the device in conjunction with an MRI scanner is unchanged. - 5.11. Testing The following data has been submitted, referenced or relied on to demonstrate that the NeoCoil 3T 16ch Flex SPEEDER Coils are safe and effective. The devices' performance meets the requirements of pre-defined acceptance cnteria and intended uses. | Test | Pass/Fail Criteria | Result | |----------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------| | Unplugged Surface<br>Temperature | Acceptable level of risk | Pass: Surface temperature is not greater than<br>41°C when the coil is left unplugged in the MRI<br>scanner. | | Surface Temperature | Pre-defined<br>performance standards | Pass: RF and Eddy current heating is not<br>greater than 41°C. | | Blocking Network<br>Analysis | Adequate transmit<br>decoupling | Pass: Blocking network demonstrates<br>adequate active and passive transmit<br>decoupling. | ### Performance testing - Bench: {2}------------------------------------------------ Page 3 of 3 N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax: Image /page/2/Picture/2 description: The image shows the logo for NeoCoil. The logo consists of a stylized, circular graphic to the left of the word "NeoCoil". The graphic appears to be a coil shape with an arrow incorporated into the design. The text "NeoCoil" is in a bold, sans-serif font. | Test | Pass/Fail Criteria | Result | |---------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | B1 Field Distortion | Pre-defined<br>performance standards | Pass: B1 field inhomogeneity meets Toshiba<br>performance requirements and demonstrates<br>adequate active and passive transmit<br>decoupling. | | NEMA MS 6-2008 | Pre-defined<br>performance standards | Pass: SNR and Image Uniformity are<br>consistent with the requirements for indications<br>for use. | ### Published Standards testing: | Standard | Purpose | |----------------|--------------------------| | IEC 60601-1 | Electromechanical safety | | IEC 60601-1-2 | ESD | | IEC 60601-2-33 | Electromechanical safety | | ISO 10993-1 | Biocompatibility | | NEMA MS-6 | SNR and Image Uniformity | ## Performance testing - Clinical: The clinical data in this section exhibits a mix of technical factors and anatomy in the axial, sagittal and coronal planes as recommended in the FDA guidance, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 14, 1998.5 No adverse events were reported during clinical performance testing; the 3T 16ch Flex SPEEDER Coil, Large and 3T 16ch Flex SPEEDER Coil, Medium demonstrated performance adequate to support the Indications for Use. #### 5.12. Conclusion This submission demonstrates that the Indications for Use are in line with the predicate device to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine and are as safe and effective as the predicate device. As such, the 3T 16ch Flex SPEEDER Coils are equivalent to their predicate, 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012. @ 2014 NeoCoil, LLC {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 31, 2014 NEOCOIL. LLC MICHAEL LEIGH N27 W23910A PAUL RD. PEWAUKEE WI 53072 Re: K141832 Trade/Device Name: 3t 16ch Flex Speeder, Medium , 3t 16ch Flex Speeder, Large Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 3, 2014 Received: July 7, 2014 Dear Mr. Leigh: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 {4}------------------------------------------------ Page 2-Mr. Leigh or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Michael D. O'Hara Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-----------------------------------------|---------------------------------------------------------------------------------------------------| | Food and Drug Administration | | | Indications for Use | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | | 510(k) Number (if known) | k141832 | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | 3T 16ch Flex SPEEDER Coils | | Indications for Use (Describe) | To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician. | | Type of Use (Select one or both, as applicable) | | | | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------| | | <table style="display: inline-table;"><tr><td> Prescription Use (Part 21 CFR 801 Subpart D) </td><td> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) *Michael D. O'Hara* This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff *PRAStaff@fda.hhs.gov* *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* | FORM FDA 3881 (1/14) | Page 1 of 1 | | |----------------------|----------------------------------------------|-----------------| | NeoColl, LLC | 3T 16ch Flex SPEEDER Colls - 510k Submission | Page 37 of 1021 |