(116 days)
No
The device description and intended use clearly define the device as a physical positioning aid made of foam, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is a positioning device for pediatric patients during MRI scans and is not used for treating any medical condition.
No
The device is described as a "positioning device" that holds the patient in place during an MRI scan. Its purpose is patient positioning, not to diagnose medical conditions, process images for diagnostic purposes, or provide diagnostic information.
No
The device description explicitly states it is comprised of foam coated in Polyscan and lists physical components like pads and a head strap, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pediatric Positioner Pad Set is a physical device used to position pediatric patients during MRI scans. It does not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use is for positioning patients during imaging procedures, not for performing diagnostic tests on biological specimens.
The device is a positioning accessory for an imaging modality (MRI), not a diagnostic test itself.
N/A
Intended Use / Indications for Use
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.
Product codes
KXH
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
brain, spine, and neurovascular
Indicated Patient Age Range
newborn and infant patients up to 2 years of age
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K052621, K013159, K093348, K024352
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
2
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.
3
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
4
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:
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.
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)
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