The Echostar 1.5T and Echostar Spica 1.5 T MR Systems are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body, including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluid are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis. The device is intended for prescription use only.

The Echostar Spica 1.5T MR System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI Images produced by the Echostar Spica system reflect the spatial distribution fo the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis. This device is intended for prescription use only.

Device Description

The Echostar Spica 1.5 T MR System represents a modification to the previously cleared Echostar 1.5 T (K082100); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including, a body coil, head coil, spine coil, c-spine (neck) coil, shoulder coil, knee coil, small - 4 element torso coil, large - 12 element torso coil and wrist coil.

AI/ML Overview

The provided 510(k) summary for the Alltech Echostar Spica 1.5 T MR System does not contain the detailed information requested regarding specific acceptance criteria for device performance and the study proving it meets these criteria in the context of diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Alltech EchoStar 1.5 T) based on technological characteristics and safety.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for specific pathologies) nor does it report these metrics for the device. The "performance testing" described refers to engineering and safety verifications rather than clinical diagnostic outcome measures.

Acceptance Criteria	Reported Device Performance
Not specified for diagnostic accuracy	Not specified for diagnostic accuracy
Conformance with NEMA standards and IEC 60601-2-33	Demonstrated conformance with standards; sample phantom and clinical images, and test reports presented for changes.
Safety and effectiveness similar to predicate device	Stated to have "same performance effectiveness and safety as the predicate Echostar 1.5 T."

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

No information is provided regarding a specific "test set" for evaluating diagnostic accuracy. The performance testing mentioned involves "sample phantom and clinical images." The provenance of these clinical images (e.g., country of origin, retrospective/prospective) is not disclosed, and the sample size is not specified beyond "sample" images.

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

Since no diagnostic accuracy study using a specific test set is detailed, there's no information on the number or qualifications of experts used to establish a ground truth for such a set.

4. Adjudication Method:

Given the lack of a diagnostic accuracy study, there's no mention of an adjudication method (e.g., "2+1", "3+1") for establishing ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study comparing human readers with and without AI assistance is mentioned. This device is an MRI system, not an AI-powered diagnostic tool, so such a study would not be applicable in this context.

6. Standalone (Algorithm Only) Performance:

This submission concerns an MRI system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not evaluated or reported.

7. Type of Ground Truth Used:

For the performance testing that was conducted (NEMA standards, IEC 60601-2-33), the "ground truth" would relate to quantitative measurements from phantoms and qualitative assessment of image quality from clinical images, rather than a clinical diagnostic ground truth like pathology or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. The device is an MRI scanner, and the submission does not describe a machine learning algorithm with a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above.

Summary of Device Evaluation in the 510(k):

The 510(k) submission for the Echostar Spica 1.5 T MR System focuses on demonstrating substantial equivalence to a previously cleared predicate device (Alltech EchoStar 1.5 T, K082100). The changes introduced in the Spica system (additional RF coils, removal of amplifier option, optional respiratory gating, magnet manufacturer change, software/sequence updates) are presented as minor and not impacting the fundamental scientific technology, intended use, indications for use, design principles, performance effectiveness, or safety.

The "performance testing" described in the document primarily verifies that the modified device adheres to relevant engineering and safety standards (NEMA standards and IEC 60601-2-33), and that image quality (from "sample phantom and clinical images") remains comparable to the predicate device. This is a typical approach for demonstrating substantial equivalence for modifications to existing medical imaging hardware, where direct clinical diagnostic accuracy studies are often not required if the core technology and intended use remain unchanged.

Summary

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K113.511

MAY - 2 2012

510(k) Summary

Alltech Medical Systems America 6551 Cochran Road Solon, OH 44139 Tel:1-440-424-2240 Fax:1-440-424-2255

In accordance with 21 CFR 807.92 the following summary of information is provided:

(1) Submitter

Alltech Medical Systems America, Inc. 6551 Cochran Road Solon, OH 44139 Phone: 440-424-2240 Contact: Michaeleen (Micki) Dom Date Prepared: November 23, 2011

(2) Name of the Device

Trade Name: Echostar Spica 1.5 T MR System Common name: Magnetic resonance imaging scanner Classification name: Magnetic resonance diagnostic device (21 CFR 892.1000, Product Code LNH & MOS)

(3) Marketed Device

Alltech Medical Systems America, Inc. is claiming substantial equivalence to a device that has been found to be substantially equivalent through the 510(k) premarket notification process, the Alltech EchoStar 1.5 T. The Alltech EchoStar 1.5 T. was cleared by the FDA on August 06, 2008 (K082100).

(4) Device Description

(5) Intended Use

(6a) Comparison with Predicate Device

The changes to the Echostar Spica 1.5 T MR System reflected in this 510(k) do not alter the fundamental scientific technology of the Alltech Echostar 1.5 T that was cleared by the FDA through K082100. The Echostar Spica 1.5 T MR System has the same classification information, the same intended use, the same indications for use, the same design principles, similar product design and specifications, same performance effectiveness and safety as the predicate Echostar 1.5 T. The main modifications include additional RF coils, removal of the 18KW option RF

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Image /page/1/Picture/0 description: The image shows the logo for Alltech Medical Systems America. The logo consists of the word "alltech" in a stylized font. Below the logo is the company's address, which is 6551 Cochran Road, Solon, OH 44139. The image also includes the company's telephone number, which is 1-440-424-2240, and fax number, which is 1-440-424-2255.

amplifier, optional respiratory gating, changes to the manufacturer of the magnet, changes to the software and additional sequences. These differences are slight and do not influence or raise new questions of safety and effectiveness.

(6b) Performance Testing - Summary of Test Data

Safety and performance nonclinical testing were conducted to the appropriate NEMA standards and IEC 60601-2-33 on the filing device, Echostar Spica 1.5 T MR System, that were used in the testing of Echostar 1.5 T, to verify and validate its substantial equivalence. Sample phantom and clinical images, and test reports are presented for the changes, demonstrating conformance with the standards.

(6b) Conclusion

It is the opinion of Alltech Medical Systems America, Inc. that the Echostar Spica 1.5 T MR System is substantially equivalent to the Echostar 1.5 T MRI system predicate device. The Echostar Spica 1.5 T MR System has the same technological characteristics of the predicate device, does not include any new indications for use and no new or additional safety concerns have been raised.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Michaeleen Dom Manager, Quality Systems & Regulatory Affairs AllTech Medical Systems America, Inc. 6551 Cochran Road SOLON OH 44139

Re: K113511

Trade/Device Name: Echostar Spica 1.5TMR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 21, 2012 Received: March 23, 2012

Dear Ms. Dom:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

MAY - 2 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Alltech Medical Systems America. The logo includes the company name in a bold, sans-serif font. Below the logo is the company's address, which is 6551 Cochran Road, Solon, OH 44139. The image also includes the company's telephone number, which is 1-440-424-2240, and fax number, which is 1-440-424-2255.

Indications for Use Form

510(k) Number (if known): K113511

Device Name:Echostar Spica 1.5TMR System

Indications for Use:

Prescription UseX (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use___________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Evaluation and Safety
510(k) K113511

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Regulation Number and Section

N/A