(14 days)
No
The summary describes image analysis software with productivity tools and volumetric estimation, but does not mention AI, ML, or related concepts.
No
The device is an image analysis software that aids in diagnosing and monitoring lung abnormalities rather than directly treating them. Its function is to provide information for patient management decisions, not to provide therapy.
Yes
The device is intended to measure abnormalities in the lung (nodules, lesions) from CT images and aid the physician in characterization of suspicious nodules, which are diagnostic activities.
Yes
The device is described as an "image analysis software package" that runs on a specific workstation (Advantage Windows Workstation). The description focuses solely on the software's functionality for analyzing CT images and does not mention any associated hardware components developed or included as part of the ALA-1 device itself. The workstation it runs on is listed as a reference device, not part of the ALA-1 device description.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: 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 ALA-1 software analyzes medical images (CT scans) of the lung. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it analyzes CT images to measure abnormalities and estimate volume doubling time, aiding in the characterization of suspicious nodules. This is image analysis, not in vitro testing.
Therefore, the ALA-1 device falls under the category of medical image analysis software, not an IVD.
N/A
Intended Use / Indications for Use
Advanced Lung Analysis (ALA-1) is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lessons etc.) form a set of computed Tomography (CT) images. The analysis is performed on the Advantage Windows Workstation (K913770). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. This may aid the physician in characterization of suspicious nodules and thus, patient management care decision process.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
Advanced Lung Analysis-1 (ALA-1) is an image analysis software package that provides support to the medical professional in assessing abnormalities such as lesions and nodules and changes in their growth over time. This software allows volumetric estimation of a lesion or nodule size over time. It contains productivity tools such as the book marking tool to keep a record of previously found nodules/lesions, the comparator tool to allow 'synchromized' comparison of nodule/lesion over time, database of all the nodules/lesions detected and enhanced speed and efficiency of the review process.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional
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.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular shape. The letters and the circle are in black, with some white highlights to give a sense of depth and dimension to the design. The overall design is simple, yet recognizable as the brand identity of General Electric.
GE Medical Sys
General Electric Com P O Box 414 Milwaukee, WI 53201
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 Program Manager Telephone: (262) 544-3894, FAX: (262) 544-3863 Date Prepared: August 22, 2001
PRODUCT IDENTIFICATION
| Name: | Advanced Lung Analysis-1 |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Number: | 892.1750 |
| Manufacturer : | General Electric Medical Systems |
| 283, rue de la Miniere | |
| 78533 Buc Cedex, FRANCE | |
| Distributor: | General Electric Medical Systems, Milwaukee, WI |
Marketed Devices Advanced Lung Analysis is substantially equivalent to the device listed below:
| Model: | Tissue Volume |
|---|---|
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI |
| 510(k) #: | K963345 |
Device Description:
Advanced Lung Analysis-1 (ALA-1) is an image analysis software package that provides support to the medical professional in assessing abnormalities such as lesions and nodules and changes in their growth over time. This software allows volumetric estimation of a lesion or nodule size over time. It contains productivity tools such as the book marking tool to keep a record of previously found nodules/lesions, the comparator tool to allow 'synchromized' comparison of nodule/lesion over time, database of all the nodules/lesions detected and enhanced speed and efficiency of the review process.
1
Indications for Use:
Advanced Lung Analysis (ALA-1) is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lessons etc.) form a set of computed Tomography (CT) images. The analysis is performed on the Advantage Windows Workstation (K913770). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. This may aid the physician in characterization of suspicious nodules and thus, patient management care decision process.
Comparison with Predicate:
ALA-1 is an image analysis software package that allows extraction of a suspicious lesion/nodule area found in a series of CT images from the surrounding lung tissue. The tool is laid out to give volumetric estimation of a lesion or nodule size over time. The functional features of this package are substantially equivalent to that of the following device:
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A Comments of the of
1
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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:
ALA-1 does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the ALA-1 to be equivalent to those of Tissue Volume (K963345).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
General Electric Medical Systems % Mr. Wolfram Gmelin TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K013381
OCT 2 6 2001
Trade/Device Name: Advanced Lung Analysis-1 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 8, 2001 Received: October 12, 2001
Dear Mr. Gmelin:
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 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 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 this 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" (21 CFR Part 807.97). 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. Brogdor Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Advanced Lung Analysis (ALA-I)
Indications for Use
Advanced Lung Analysis (ALA-I) is intended to provide an optimized non-invasive application to Advanced Lung Analysis (ALA-i) is ifiended to promotes, lesions etc.) from a set of computed measure abhormalities in the lung (lor examply, the Advantage Windows Workstation The software allows measurement of volume over time using a consistent (K913770). (K913770). The Somware allows theasurement of estimation of the volume doubling time.
standardized measurement protocol, thus providing and they and thus, natient standardized measurement protocol, thus providing an ostinator of the road. So and thus, patient management care decision process.
(PLEASE 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_
Nancy C brogdon
Division Sign (Off)
Division: Reproductive Abdominal,
and Radiological Devices
510(k) Number K013381