(84 days)
The Leg'Map software is intended for use to combine a series of digital images acquired by diagnostic radiography during a table translation into a single image, such as combining a series of images of the arteries of the lower leg acquired during bolus chasing. Leg'Map provides the convenience of viewing a single image rather than several images. Also, the Leg'Map digital image meets the preference of those who want an image similar to that of the long cut film (30cm x 120cm) previously used when performing this procedure.
This optional software is run after image acquisition is completed to provide automatic pasting of multiple images acquired in bolus chasing into a single image. It has no affect on the image acquisition system. Leg'Map process its imager from strips extracted from original images and registered with correlation measurements.
The provided text describes a 510(k) summary for a medical device called Leg'Map, a software program designed to combine multiple digital X-ray images of the lower leg into a single, seamless image. However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any performance metrics, ground truth establishment, or sample sizes for testing or training.
The document focuses on:
- Identification of the product: Leg'Map software by GE Medical Systems -Europe.
- Indications for Use: To combine a series of digital images acquired during diagnostic radiography into a single image, especially for arteries of the lower leg during bolus chasing, providing convenience and a similar view to traditional long cut films.
- Device Description: Optional software that processes images after acquisition, pasting strips from original images and registering them using correlation measurements.
- Conclusions: GE Medical Systems believes Leg'Map is safe, and potential hazards (wrongly pasted images) are controlled by a risk management plan, including hazard analysis, software development process, and external evaluation by different hospitals.
Therefore, I cannot populate the requested table or provide answers to the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.
The document is a regulatory submission for 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use and safety measures, rather than detailing specific performance studies with quantitative metrics.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS August 27, 1997
This 510/k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
Contact:
Larry A. Kroger, Ph.D. Phone: 414-544-3894 Fax: 414-544-3863
NOV 2 5 1997
Identification of the product
The Leg'Map option is a software program intended to provide a high quality full leg x-ray image display of several digital acquisitions on arteries of lower limbs. It is manufactured by GE Medical Systems -Europe, 283, rue de la Miniere, 78530 BUC, France, and is distributed by GE Medical Systems, Milwaukee, WI.
Indications for Use
The Leg Map software is intended for use to combine a series of digital images acquired by diagnostic radiography during a table translation into a single image, such as combining a series of images of the arteries of the lower leg acquired during bolus chasing. Leg'Map provides the convenience of viewing a single image rather than several images. Also, the Leg'Map digital image meets the preference of those who want an image similar to that of the long cut film (30cm x 120cm) previously used when performing this procedure.
Device Description
This optional software is run after image acquisition is completed to provide automatic pasting of multiple images acquired in bolus chasing into a single image. It has no affect on the image acquisition system. Leg'Map process its imager from strips extracted from original images and registered with correlation measurements.
Conclusions
It is the opinion of GE Medical Systems that Leg'Map is safe and potential hazards (wrong pasted images) are controlled by a risk management plan including hazards analysis, software development process, and external evaluation by different hospitals ..
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure, composed of three parallel lines that curve and taper to suggest feathers or wings. Below the bird-like figure are wavy lines, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 1997
Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems, Inc. P.O. Box 414 Milwaukee, WI 53201
Re:
K973270 Advantage Paste: Angiographic Image Combiner Dated: August 29, 1997 Received: September 2, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
Dear Dr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission one not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA funding 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
W. Hiau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Leg'Map
Indications For Use:
The Leg'Map software is intended for use to combine a series of digital images acquired by diagnostic radiography during a table translation into a single image, such as combining a series of images of the arteries of the lower leg acquired during bolus chasing. Leg'Map provides the convenience of viewing a single image rather than several images. Also, the Leg'Map digital image meets the preference of those who want an image similar to that of the long cut film (30cm x 120cm) previously used when performing this procedure.
(PLESE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use_
Daniel G. Segnmen
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.