The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems for positioning of the pediatric patient.

Device Description

The Pediatric Positioner Pad Set is a positioning device for pediatric patients used with brain, spine, and neurovascular surface coils in Magnetic Resonance Imaging. It is comprised of foam coated in Polyscan. The Pediatric Positioner Pad Set is comprised of seven components: the Base Pad, the Main Pad, the Child Head Pad, the Infant Head Pad, the two Pad Side Supports, and the Head Strap. The Base Pad rests on the MR System table. The Main Pad is then placed on top of the Base Pad. The patient is positioned on top of the Main Pad. The two Pad Side Supports are secured on either side of the patient via Velcro. Lastly, either the Child Head Pad or Infant Head Pad is used with the Head Strap to hold the patient's head in place. There are two sizes for the head pad to accommodate different patient sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Pediatric Positioner Pad Set." This device is a passive positioning aid for pediatric patients during Magnetic Resonance Imaging (MRI).

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of performance metrics (e.g., specific accuracy, sensitivity, or specificity values) for the Pediatric Positioner Pad Set. This is because the device is a passive positioning aid and not an active diagnostic or therapeutic device that produces measurable outputs requiring such criteria.

Instead, the document states the device's compliance with qualitative requirements related to its intended use and safety.

Feature/Criterion	Reported Device Performance/Compliance
Intended Use/Indications	"The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg... for positioning of the pediatric patient in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems."
Compatibility	Compatible with specified GE 1.5T and 3.0T Head, Neck, and Spine Coils and Invivo 1.5T and 3.0T 8-Channel High Resolution Brain Array Coils.
Fundamental Technology	"The Pediatric Positioner Pad Set employs the same fundamental technology as the predicate devices." (Implies it functions similarly to previously cleared devices).
Safety and Effectiveness	"GE Healthcare considers the Pediatric Positioner Pad Set to be as safe, as effective, and performance is substantially equivalent to the predicate devices." (This is the overarching conclusion of the submission, derived from compliance with regulations and the clinical study).
Voluntary Standards	"Complies with voluntary standards." (Specific standards are not listed in the provided text).
Quality System Regulations	"Designed and developed under the Quality System Regulations of 21 CFR 820 and ISO 13485."
Quality Assurance Measures	Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification). These are internal process controls to ensure the device is built to specifications and is safe.
Clinical Efficacy/Utility	A clinical study on pediatric subjects was conducted "to support substantial equivalence and to ensure the user needs are met." The clinical images obtained were included in DICOM format. (This implies that the device successfully aided in patient positioning, allowing for Diagnostic Quality images, but specific metrics like image quality scores are not provided in this summary.)

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

Sample Size for Test Set: The document states that a "clinical study on pediatric subjects" was conducted. However, it does not specify the sample size (number of subjects) used in this clinical study (which serves as the "test set" for performance evaluation).
Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a GE Healthcare submission to the FDA, it is highly probable the data was collected in the United States. The study was prospective, as it was a "clinical study on pediatric subjects" specifically conducted to support this submission.

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

The document does not mention "experts" being used to establish a formal "ground truth" in the traditional sense (e.g., for diagnostic accuracy). Since this is a positioning device, the "ground truth" would likely be the successful positioning of the patient and the acquisition of diagnostic quality MRI images.

The primary "evaluation" would have been performed by the medical staff (MR technologists, radiologists) involved in the clinical study, who would have assessed the device's ability to facilitate effective patient positioning for image acquisition. Their qualifications are not specified but would implicitly be relevant medical professionals.

4. Adjudication Method for the Test Set

No specific adjudication method (like 2+1, 3+1 consensus) is described, as the evaluation likely revolved around the usability and effectiveness of patient positioning rather than a diagnostic decision requiring such adjudication.

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

An MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human readers are assisted by AI. The Pediatric Positioner Pad Set is a passive physical device, not an AI or software-based diagnostic tool.

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

A standalone performance evaluation was not done. Again, this concept applies to algorithms or software. The Pediatric Positioner Pad Set is a physical device that functions with human interaction (positioning the patient) to achieve its intended purpose.

7. The Type of Ground Truth Used

The "ground truth" for this device would be the successful, safe, and stable positioning of pediatric patients for MRI scans, leading to the acquisition of diagnostic quality images. It is not a pathology diagnosis or an outcome measure in the typical sense. The "ground truth" is inherently tied to the practical utility in a clinical setting.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is not an AI or machine learning algorithm. Its design and development followed standard engineering and quality system processes, as indicated by the "Quality Assurance Measures" (Risk Analysis, Requirements Reviews, Design Reviews, etc.).

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

Since there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the device's design and development comes from user needs, regulatory requirements, risk analysis, and engineering specifications.

Summary

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ਸੁ

K122174

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

NOV 1 6 2012

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

Date: July 20 2012

GE Healthcare Coils (USA Instruments, Inc.) Submitter: 1515 Danner Dr. Aurora, OH 44202 USA

Establishment Registration Number: 1529041

Primary Contact Person:

Michelle Huettner Regulatory Affairs Leader, Magnetic Resonance GE Healthcare (GE Medical Systems, LLC) 3200 N. Grandview Blvd. Waukesha, WI 53188 Phone: +1 262 521 6102 Fax: +1 262 546 0902 Email: michelle.huettner(agge.com

Secondary Contact Person:

"满"

Glen Sabin

Regulatory Affairs Director, Magnetic Resonance GE Healthcare (GE Medical Systems, LLC) 3200 N. Grandview Blvd. Waukesha, WI 53188 Phone: +1 262 521 6848 Email: glen.sabin(@med.ge.com

Device: Trade Name: Pediatric Positioner Pad Set

Radiologic patient cradle Common/Usual Name:

Classification Names: 21 CFR 892.1830, Cradle, Patient, Radiologic

Product Code: KXH

K930124, Variant of Octostop and Octopaque Predicate Device(s): K030317, Model 1300GE-64 - Pediatric Positioner

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, which has a decorative, swirling pattern around the edges.

GE Healthcare 510(k) Premarket Notification Submission

Device Description: The Pediatric Positioner Pad Set is a positioning device for pediatric patients used with brain, spine, and neurovascular surface coils in Magnetic Resonance Imaging. It is comprised of foam coated in Polyscan. The Pediatric Positioner Pad Set is comprised of seven components: the Base Pad, the Main Pad, the Child Head Pad, the Infant Head Pad, the two Pad Side Supports, and the Head Strap. The Base Pad rests on the MR System table. The Main Pad is then placed on top of the Base Pad. The patient is positioned on top of the Main Pad. The two Pad Side Supports are secured on either side of the patient via Velcro. Lastly, either the Child Head Pad or Infant Head Pad is used with the Head Strap to hold the patient's head in place. There are two sizes for the head pad to accommodate different patient sizes.

The Pediatric Positioner Pad Set is compatible with the GE 1.5T Head, Neck, and Spine Coil (K052621), the Invivo 1.5T 8-Channel High Resolution Brain Array Coil (K013159), the GE 3.0T Head, Neck, and Spine Coil (K093348), and the Invivo 3.0T 8-Channel High Resolution Brain Array Coil (K024352).

The Pediatric Positioner Pad Set is indicated for use with Indications for Use: newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems for positioning of the pediatric patient.

Technology: The Pediatric Positioner Pad Set is a positioning device for pediatric patients during magnetic resonance imaging. It is used in conjunction with MR surface coils. It is a passive device, containing no electronic components or software.

The Pediatric Positioner Pad Set employs the same fundamental technology as the predicate devices.

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GE Healthcare 510(k) Premarket Notification Submission

Summary of Non-Clinical Tests: Determination of

Substantial Equivalence:

The Pediatric Positioner Pad Set complies with voluntary standards. It was designed and developed under the Quality System Regulations of 21 CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the medical device:

. Risk Analysis
. Requirements Reviews
Design Reviews .
Testing on unit level (Module verification) o
. Integration testing (System verification)
Performance testing (Verification) .
Safety testing (Verification) .

Summary of Clinical Tests:

The subject of this premarket submission, Pediatric Positioner Pad Set, required a clinical study on pediatric subjects to support substantial equivalence and to ensure the user needs are met. The clinical images obtained from that study have been included in DICOM format in this submission.

GE Healthcare considers the Pediatric Positioner Pad Set Conclusion: to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is stylized and simplified, with only a few lines used to create its form.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

NOV 1 6 2012

Ms. Michelle Huettner Regulatory Affairs Leader, Magnetic Resonance GE Healthcare Coils (USA Instruments, Inc.) 1515 Danner Drive AURORA OH 44202

Re: K122174

Trade/Device Name: Pediatric Positioner Pad Regulation Number: 21 CFR 892.1830 Regulation Name: Radiologic patient cradle Regulatory Class: I Product Code: KXH Dated: October 5, 2012 Received: October 9, 2012

Dear Ms. Huettner:

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

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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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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,

Mechal D. Offaga 14:06:42 -05'00'

Janine M. Morris 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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Indications for Use

510(k) Number (if known): K122174

Device Name: Pediatric Positioner Pad Set

Indications for Use:

Yes 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)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

2012.11.16 1 V) DA 14:08:36 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

2174 510(k)

Page 1 of

Regulation Number and Section

§ 892.1830 Radiologic patient cradle.

(a)
Identification. A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.