(11 days)
Not Found
No
The summary describes a software package for image pasting, which is a standard image processing technique, and there is no mention of AI or ML terms or concepts.
No.
The primary function of the device is to combine and display MR images, which is an imaging and viewing utility, not a therapeutic intervention.
No
The device is described as a display option that combines multiple MR images into a single image for viewing convenience. It does not perform any analysis, interpretation, or diagnosis based on the images.
Yes
The device is described as a "software package" and its function is to combine and display existing MR images. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary function described is the display and combination of existing MR images for viewing convenience. It does not mention analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Device Description: The description reinforces that it's a "display option" for viewing combined images.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic results based on laboratory tests.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This software operates on existing medical images, which are acquired in vivo (within the body).
N/A
Intended Use / Indications for Use
The GEMS AW Pasting 1.1 software package is a display option, which combines a series of MR images acquired in multiple stations of the body into a single image. AW Pasting 1.1 provides the convenience of viewing a single image rather than several images.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The GEMS AW Pasting 1.1 software package is a display option, which provides the convenience of viewing a single image resulting from the automatic pasting of multiple images acquired in different stations of the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images
Anatomical Site
body
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY 1 3 2003
್ತ
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
Submitter Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Telephone: (262) 544-3894 Fax: (262) 548-4768 GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: April 7, 2003.
PRODUCT IDENTIFICATION
| Name: | Advantage Workstation Pasting 1.1 |
|---|---|
| Classification Name: | Accessory to Magnetic Resonance Diagnostic Device |
| Manufacturer : | General Electric Medical Systems |
| 283, rue de la Minière | |
| 78533 Buc Cedex, FRANCE | |
| Distributor: | General Electric Medical Systems, Buc, France. |
| Marketed Devices | The AW Pasting 1.1 is substantially equivalent to the devices listed below: |
| Model: | AW X-Ray Pasting (Leg'Map) |
| Manufacturer: | General Electric Medical Systems. Milwaukee. WI |
Device Description:
510(k) #:
The GEMS AW Pasting 1.1 software package is a display option, which provides the convenience of viewing a single image resulting from the automatic pasting of multiple images acquired in different stations of the body.
1
Indications for Use:
The GEMS AW Pasting 1.1 software package is a display option, which combines a series of MR images acquired in multiple stations of the body into a single image. AW Pasting 1.1 provides the convenience of viewing a single image rather than several images.
-
- 2.2
Comparison with Predicate:
The functional features of the AW Pasting 1.1 software package are substantially equivalent to that of the following device:
| Device Name | 010 A
learance Number |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| . A W Y V Y
11 BUISEA
120 H
eo
Man | 120000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 |
Adverse Effects on Health:
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.
Conclusions:
The AW Pasting does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the AW Pasting 1.1 to be equivalent to those of AW X-Ray Pasting (K973270).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2003
GE Medical Systems-Europe % Mr. Heinz-Joerg Steneberg Division Manager Medical Division TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K031396
Trade/Device Name: Pasting 1.1 Software Option for MRI Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: May 1, 2003 Received: May 2, 2003
Dear Mr. Steneberg:
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 r 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); 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.
3
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
K03 1394
Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines and flourishes, giving them a classic and recognizable appearance. The logo is in black and white.
General Electric Medical Systems
STATEMENT OF INTENDED USE
Device name: Advantage Workstation Pasting 1.1
Intended Use:
The GEMS AW Pasting 1.1 software package is a display option, which combines a series of MR images acquired in multiple stations of the body into a single image. AW Pasting 1.1 provides the convenience of viewing a single image rather than several images.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use $\surd$ 1. 1. string
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