The Flex Coils are designed to produce diagnostic images of human anatomies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MR1 systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.

Device Description

The 1.5T 4CH Flex Coils are receive-only coils designed to provide images of various parts of human body. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
The 1.5T 4CH Flex coils are available in two models – 1.5T 4CH Large Flex coil and 1.5T 4CH Small Flex Coil, and are designed for use with GE 1.5T MR systems.
1.5T 4CH Flex coils are General Purpose receive only coils with 4 elements and integrated preamplifiers.
1.5T 4CH Flex coils are based on phased array technique for combining the images from 4 different channels. Coils are tuned to the proton frequency of 63.86MHz.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Healthcare 1.5T 4CH Flex Coil, structured to address your specific points:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety Standards	Compliance with IEC60601-1, IEC60601-2-33, IEC60601-1-2.	The 1.5T 4CH Flex Coil complies with these voluntary standards.
Risk Management	Compliance with ISO14971 (Risk Analysis).	Risk Analysis was applied to the development of the system.
Biocompatibility	Compliance with ISO10993-1.	The 1.5T 4CH Flex Coil complies with this voluntary standard.
Design Integrity	Requirements Reviews and Design Reviews.	Requirements Reviews and Design Reviews were applied to the development of the system.
Performance Testing	General Performance testing.	Performance testing was applied to the development of the system.
Integration Testing	System Integration testing.	Integration testing was applied to the development of the system.
Electrical Safety	Safety testing.	Safety testing was applied to the development of the system.
RF Safety (B1 Peak)	Maximum B1 Peak test - verify coil's ability to withstand maximum B1 peak fields and high B1 field energy concentrations without posing a risk to safety through arcing or voltage breakdown.	This test was performed to verify the coil's ability to withstand maximum B1 peak fields and high B1 field energy concentrations without posing a risk to safety through arcing or voltage breakdown. (Implied successful completion to support substantial equivalence).
RF Safety (Blocking Network)	Blocking Network analysis - determine the effectiveness of the blocking networks(s) for transmit decoupling to ensure safety and to minimize B1 distortion.	This test was performed to determine the effectiveness of the blocking networks for transmit decoupling to ensure safety and to minimize B1 distortion. (Implied successful completion to support substantial equivalence).
Thermal Safety	Surface temperature test under normal condition.	A surface temperature test was conducted under normal conditions. (Implied successful completion to support substantial equivalence).
Thermal Safety (Unplugged)	Surface temperature test under unplugged condition.	A surface temperature test was conducted under unplugged conditions. (Implied successful completion to support substantial equivalence).
Image Quality / Clinical	Produce diagnostic images of human anatomies, function as general purpose coils for shoulder, elbow, wrist, knee, hip, and ankle, and allow for flexible wrapping and planar imaging. Substantial equivalence to predicate device K030953 (GE 3.0T General Purpose Flex Coil).	Internal scans within GE Healthcare facility were performed to obtain sample clinical images. The device is considered as safe, as effective, and its performance is substantially equivalent to the predicate device(s) based on these internal images and the non-clinical tests. The coils are designed for the stated anatomies and use cases, producing diagnostic images.

Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical count of patients or images. The text mentions "sample clinical images" were obtained.
- Data Provenance: The study involved "Internal scans within GE Healthcare facility." This indicates the data was likely prospective and collected specifically for this filing. The country of origin is implicitly India ("Wipro GE Healthcare Pvt Ltd, Bangalore, INDIA").
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The filing focuses on technical and safety equivalence, with clinical images used internally for verification rather than a formal clinical trial with expert interpretation for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of the "internal scans" for "sample clinical images" and the absence of explicit expert review processes, it's highly probable that a formal adjudication method was not used in the context typically seen in AI device studies. The primary goal was to demonstrate image production and quality consistent with the predicate, not diagnostic accuracy against a ground truth.
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:
- No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (MRI coil), not an AI-assisted diagnostic tool. The document explicitly states: "The subject of this premarket submission, 1.5T 4CH Flex Coil did not require external clinical studies to support substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an MRI coil, which is a component of an imaging system, not a standalone algorithm or AI. Its performance is evaluated on its ability to acquire images, not to perform interpretations.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "sample clinical images" obtained from internal scans, the concept of a formal "ground truth" (e.g., pathology, expert consensus on disease presence) in the context of diagnostic accuracy is not applicable or stated. The "ground truth" for the coil's performance was likely related to the expected image quality and signal-to-noise ratio compared to engineering specifications and the predicate device, demonstrated through visual inspection of the images themselves rather than an independent diagnostic gold standard.
The sample size for the training set:
- Not applicable. This is a hardware device (MRI coil), not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. (See point 7).

Summary

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K123681 Page 1 of 3

GE Healthcare 510(k) Premarket Notification Submission

FEB 2 2 2013

510(k) Summary

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

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	26-Nov-2012
Submitter:	GE Healthcare, (Wipro GE Healthcare Pvt Ltd)122 (Part 1), John F. Welch Technology Centre,Export Promotional Industrial Park, Whitefield,Bangalore, INDIA 560066
Primary Contact Person:	Shashidhar C SRegulatory Affairs LeaderGE Healthcare, (Wipro GE Healthcare Pvt Ltd)122 (Part 1), John F. Welch Technology Centre,Export Promotional Industrial Park, Whitefield,Bangalore, INDIA 560066Telephone: +91 80 40883613Fax: +91 80 28411645
Secondary Contact Person:	Glen SabinRegulatory Affairs Director - MRGE Healthcare,(GE Medical Systems LLC)3200N Grandview Blvd., Mail Coil-W-827Waukesha, WI 53188, USAPhone: (262) 521-6848Fax: (262) 364-2785
Device:
Trade Name:	1.5T 4CH FLEX COIL
Common/Usual Name:	Coil, magnetic resonance, specialty
Classification Names:	21CFR 892.1000, Magnetic resonance diagnostic device
Product Code:	MOS
Predicate Device(s):	K030953, GE 3.0T General Purpose Flex Coil
Device Description:	The 1.5T 4CH Flex Coils are receive-only coils designedto provide images of various parts of human body. Theflexible coil is wrapped around the anatomy of interest,such as an elbow or knee or can be used for planarimaging.

The 1.5T 4CH Flex coils are available in two models –

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K123681 Page 2 of 3

GE Healthcare 510(k) Premarket Notification Submission

1.5T 4CH Large Flex coil and 1.5T 4CH Small Flex Coil, and are designed for use with GE 1.5T MR systems.

Intended Use: The Flex Coils are designed to produce diagnostic images of human anatomies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MRI systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.

Technology: 1.5T 4CH Flex Coils are flexible and can be wrapped around the anatomy of interest, which is similar to its predicate device.

1.5T 4CH Flex coils are General Purpose receive only coils with 4 elements and integrated preamplifiers.

1.5T 4CH Flex coils are based on phased array technique for combining the images from 4 different channels. Coils are tuned to the proton frequency of 63.86MHz.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

Substantial Equivalence:

The 1.5T 4CH Flex Coil complies with voluntary standards IEC60601-1, IEC60601-2-33, IEC60601-1-2, ISO14971, and ISO10993-1.

The following quality assurance measures were applied to the development of the system:

. Risk Analysis
Requirements Reviews ●
Design Reviews �
. Performance testing
Integration testing .
Safety testing .

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K123681 Page 3 of 3

GE Healthcare 510(k) Premarket Notification Submission

Maximum B1 Peak test -- This test is to verify the . coil's ability to withstand maximum B1 peak fields and high B1 field energy concentrations without posing a risk to safety through arcing or voltage breakdown
Blocking Network analysis This test determines . the effectiveness of the blocking networks(s) for transmit decoupling to ensure safety and to minimize B1 distortion
Surface temperature test under normal condition .
Surface temperature test under unplugged condition .

Summary of Clinical Tests:

Internal scans within GE Healthcare facility were performed to obtain sample clinical images. The subject of this premarket submission, 1.5T 4CH Flex Coil did not require external clinical studies to support substantial equivalence

Conclusion: GE Healthcare considers the 1.5T 4CH Flex Coil to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

Section 05

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

February 22, 2013

Shashidhar C S Regulatory Affairs Leader WIPRO GE HEALTHCARE PRIVATE, LTD. 122 (Part 1) John F Welch Trading Centre, EPIP, Whitefield Rd BANGALORE, INDIA 560066

Re: K123681

Trade/Device Name: 1.5T 4CH FLEX COIL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 26, 2012 Received: November 30, 2012

Dear Mr. Shashidhar C S:

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.

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Page 2-Mr. Shashidhar C S

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.

Michael Hara

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):

K123681

Device Name:

1.5T 4CH FLEX COIL

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Michael FDA Hara

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

Page 1 of

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.