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.

Device Description

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.

AI/ML Overview

This document is a 510(k) K123708 Summary for a Spine Coil (03-2016) manufactured by Paramed S.r.l. It aims to demonstrate substantial equivalence to previously cleared predicate devices. The document does not describe a study to prove acceptance criteria in the typical sense of a clinical trial or performance study with diagnostic endpoints. Instead, it focuses on demonstrating technological equivalence and performance characteristics through established engineering measures.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly based on demonstrating that the new Spine Coil performs at least as well as, or is technologically equivalent to, the predicate device in terms of relevant physical and performance characteristics for an MRI coil.

Acceptance Criteria (Implicit)	Reported Device Performance (Spine Coil 03-2016)	Predicate Device Performance (Flexible coil 03-2015)
Channels	4	1
Minimum SNR (Overall)	55	65
Minimum SNR for each channel	40	n.a. (Not Applicable, as it was a single channel)
Examined Anatomy	Spine	Spine
Outer Surface Material	Ethylene vinyl acetate copolymer foam	Ethylene vinyl acetate copolymer foam
Manufacturer (Outer Surface Material)	Leidel & Kracht	Leidel & Kracht

Note on SNR: The reported "Minimum SNR" of 55 for the new device is lower than the 65 for the predicate. However, the new device has 4 channels compared to the predicate's 1 channel. In multi-channel coils, the overall SNR can be interpreted differently or combined from individual channels. The addition of "Minimum SNR for each channels" with a value of 40 for the new device suggests that individual channel performance is considered, and the multi-channel design likely contributes to overall image quality or specific functionalities not directly comparable by a single overall SNR number from a single-channel coil. The FDA's acceptance of this submission implies that this difference was sufficiently justified for substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a clinical "test set" in the context of a diagnostic performance study. The data provided focuses on the engineering specifications and performance characteristics of the coil itself, rather than diagnostic images from a patient population.

Therefore:

Sample size: Not applicable as no patient data test set is described.
Data provenance: Not applicable as it's not patient data. The information is derived from engineering specifications and testing of the device hardware.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No ground truth for a diagnostic test set is mentioned. The "ground truth" in this context would be the demonstrated physical and performance characteristics of the MRI coil itself, verified through engineering tests and measurements.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic test set or adjudication process is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a software or AI device. It is an MRI coil, a hardware accessory.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not a software or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the established engineering specifications and performance metrics of the MRI coil (e.g., number of channels, SNR values, material composition). This is established through:

Internal device testing and quality control processes by the manufacturer.
Compliance with relevant international standards for MRI equipment.
Comparison to the documented specifications of predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set is involved.

Summary of the Study (as described in the 510(k))

The "study" described in this 510(k) summary is not a clinical trial but rather a demonstration of technical and functional substantial equivalence of the new "Spine Coil 03-2016" to existing, legally marketed predicate devices (Paramed MrOpen K101295 Flexible COIL 03-2015 and Paramed MrOpen K101295 General Purpose COIL 03-2010).

The primary evidence presented focuses on:

Intended Use: The intended use of the new device is the same as the predicate devices, enabling MR scans of the human spine in various positions.
Technological Characteristics: A comparison table highlights similarities and minor differences. While the new coil has more channels (4 vs 1) and a different minimum overall SNR (55 vs 65), it also introduces a per-channel SNR (40) which is relevant for multi-channel coils. The materials in contact with the patient and the manufacturer of those materials are identical to a predicate device.
Safety: The document states that no new materials are in contact with the patient and that the coil is not intended for invasive use. Cleaning procedures are also consistent with other coils.

The FDA's letter of April 10, 2013, indicates that based on this information, the device was found to be "substantially equivalent" to the predicate devices for its stated indications for use. This means the device met the regulatory acceptance criteria for market authorization based on its engineering specifications and comparison to an established baseline, rather than through a traditional clinical performance study with patient outcome data.

Summary

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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

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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

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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.

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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.

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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.

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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 .

TechnologicalCharacteristic	SPINE COIL 03-2016	Flexible coil 03-2015predicate K101295
Channels	4	1
Minimum SNR	55	65
Minimum SNR for eachchannels	40	n.a.
Examined anatomy	Spine	Spine

Paramed MrOpen K101295 General Purpose COL 03-2010

TechnologicalCharacteristic	SPINE COIL 03-2016	General purpose coil 03-2010 predicate K101295
Material [outer surface]	Ethylene vinyl acetatecopolymer foam	Ethylene vinyl acetatecopolymer 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.

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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

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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

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Indications for Use

510(k) Number (if known): K123708

Device Name: SPINE COIL 03-2016

Indications for Use:

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

Regulation Number and Section

§ 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.