SPINE COIL

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for "PARAMed MEDICAL SYSTEMS". The word "PARAMed" is in large, bold, sans-serif font, with "PARAMed" in a cursive font. Below "PARAMed" is the text "MEDICAL SYSTEMS" in a smaller, sans-serif font. . . . ﺑ . . 52/109 # 8. 510(K) Summary [807.92] APR 1 0 2013 The following Special 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92. #### Manufacturer Information | Name & Address | Paramed Srl | |----------------------|----------------------------------| | | Corso Perrone 73R | | | 16152 Genova, Italy | | Submitted by: | Luca Vescovo, Authorized officer | | Establishment Reg. # | 3004994584 | 807.92(a)(1)_The submitter's name, address, telephone number, a contact person, and the date the summary was prepared; #### Submitter Information Correspondent: Contact Person Date Rim Vesan 29/11/2012 Richard Olson, Correspondent USA Paramed Medical Systems, Inc 6204 W. Oakton Street Morton Grove, IL 60053 Toll Free: 1 866 840-7565 T 1 847 470-0580nF 1 847 470-0612 Luisella De Benedetti Paramed S.r.l. Corso F.M. Perrone 73R 16152 Genova +39 010 6489 358 luisella.debenedetti@paramed.it {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for "Paramed Medical Systems". The word "Paramed" is in large, bold, sans-serif font. Below it, in a smaller font, are the words "Medical Systems". The word "Paramed" is in all caps, while the words "Medical Systems" are in small caps. 807.92(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known; | Trade Name: | SPINE COIL | |-------------------------------------|----------------------------------------------------| | Common Name: | Accessory for Magnetic resonance diagnostic system | | Classification Name(s): | System, Nuclear Magnetic Resonance Imaging | | Classification and class of device: | 21 CFR 892.1000, class II | | Classification Number: | 90MOS | | | | 807.92(a)(3) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process; #### Predicate Devices Paramed MrOpen 0.5T K101295 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Paramed Medical Systems. The word "Paramed" is in large, bold, sans-serif font. Below that, the words "Medical Systems" are in a smaller, sans-serif font. The "d" in "Paramed" has a stylized, cursive extension. 807.92(a)(4) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or noctional material for the device, including an explanation of how the promocronal macorais the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties; The proposed SPINE COIL is a surface coil aimed to the Spine district. It is characterized by the fact of being flexible. This is done to increase patient comfort. Below the pictures of the Flexible coil (code 03-2015) and the proposed SPINE COIL are shown to give an idea of the difference. Image /page/2/Picture/4 description: The image contains two separate pictures of what appears to be a CPAP machine. The picture on the left shows the machine with a white box on top of it and a tube connected to the side. The picture on the right shows the side of the machine with a tube connected to it. Figure 1: Flexible coil 03-2015 on the left and SPINE COLL 03-2016 on the right Thanks to the flexible structure the proposed and the predicate coils grant patient comfort when employed in weight bearing examinations. Both coils can be used in recumbent position just as the cleared 03-2015 coil. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for "Paramed Medical Systems". The word "Paramed" is in bold, block letters, and the words "Medical Systems" are in smaller block letters underneath. The word "Paramed" is followed by a stylized script font. The significant physical and performance characteristics of the SPINE COIL are here resumed: # Examined anatomy: Spine in all the sections ## Patient positions Recumbent Sitting or standing ### Device design Paramed S.r.l. is a company specialized in the design of NMR Tomographs since the very beginning. The company is ISO 13485 certified since year 2006 and the Quality management System is laid down to grant overall process management including design. Written procedures are the guideline for designers who are highly specialized physicists. The Quality manager performs internal audits to to grant procedures' respect. Mechanical drawings/specifications document each component being manufactured or bought. #### Materials used Paramed S.r.l. has decided to cover its devices with fire preventing ULV0 covers to minimize fire risks or damages due to external fire. Materials contacting patient or operator are Polycarbonate and Ethylene vinyl acetate copolymer foam which are the same already employed for previously cleared devices (in the specific to Paramed's K101295 MrOpen Generic Purpose 03-2010 coil. Cleaning procedures are the same as per the other receiving coils and are described in the User Manual. 55/109 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Paramed Medical Systems. The word "Paramed" is written in a bold, sans-serif font on the top line. Below that, the words "Medical Systems" are written in a smaller, sans-serif font. 807.92(a)(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph ## Device Intended Use(s) The intended use of the SPINE COIL is to enable the MrOpen K101295 systems designed by Paramed to perform MR scan of the human spine either in the conventional recumbent position or with the patient sitting or standing (weight-bearing). The SPINE COL inherits the same limitations of the Tomograph. The SPINE COIL enables the MRI System to which it is applied to acquire images of the Spine in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "Paramed Medical Systems". The word "Paramed" is in a bold, sans-serif font, with the "d" having a cursive-like extension. Below "Paramed" is the text "MEDICAL SYSTEMS" in a smaller, sans-serif font. The logo is in black and white. 807.92 (a) (6) If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device identified in paragraph (a) (3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. [omissis] #### Technological Characteristics The SPINE COIL 03-2016 is substantially equivalent to - Paramed MrOpen K101295 Flexible COIL 03-2015 . | Technological<br>Characteristic | SPINE COIL 03-2016 | Flexible coil 03-2015<br>predicate K101295 | |----------------------------------|--------------------|--------------------------------------------| | Channels | 4 | 1 | | Minimum SNR | 55 | 65 | | Minimum SNR for each<br>channels | 40 | n.a. | | Examined anatomy | Spine | Spine | - Paramed MrOpen K101295 General Purpose COL 03-2010 | Technological<br>Characteristic | SPINE COIL 03-2016 | General purpose coil 03-<br>2010 predicate K101295 | |---------------------------------|------------------------------------------|----------------------------------------------------| | Material [outer surface] | Ethylene vinyl acetate<br>copolymer foam | Ethylene vinyl acetate<br>copolymer foam | | Manufacturer | Leidel & Kracht | Leidel & Kracht | No new materials are in contact with the patient because: - · The new coil is manufactured employing the same materials as the predicate devices' coils (no new material) - · No contact with the skin is considered as normal use. The User Manual addresses the need to prevent coil contamination by minimizing contact of the coil with the patient's skin. No invasive use is intended, hence no contact with undamaged skin or body fluids. Also in the event of a foreseeable misuse there is no change in the type and duration of contact with patient between the actual and predicate devices which are aimed to perform the same examinations according to the same procedures. 52/09 {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/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 body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 10, 2013 LUISELLA DE BENEDETTI QUALITY MANAGER PARAMED S.R.L. CORSO F.M. PERRONE 73R, 16152 GENOVA ITALY Re: K123708 Trade/Device Name: Spine Coil 03-2016 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 11, 2013 Received: March 21, 2013 Dear Ms. De Benedetti: 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 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 Small Manufacturers, International and Consumer Assistance at its toll {7}------------------------------------------------ Page 2-Ms. De Benedetti free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours. Mechael Hara for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K123708 Device Name: SPINE COIL 03-2016 Indications for Use: The intended use of the SPINE COIL is to enable the MrOpen K101295 systems designed by Paramed to perform MR scan of the human spine either in the conventional recumbent position or with the patient sitting or standing (weight-bearing). The SPINE COIL inherits the same limitations of the Tomograph. The SPINE COIL enables the MRI System to which it is applied to acquire images of the Spine in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Michael FOX 'Hara (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K123708 Page 1 of 1