(15 days)
Not Found
No
The description focuses on retrospective gating and user selection of the optimal phase, with no mention of automated learning or decision-making processes characteristic of AI/ML.
No
The device is used to improve image quality during CT acquisitions by reducing motion artifacts, not to treat a medical condition or disease.
No
The device is described as a software/hardware option to improve clinical images by reducing motion artifacts during CT acquisition. Its purpose is to help users select the "optimum phase to perform volume imaging and post processing -quantification, contouring, segmentation," not to diagnose a disease or condition.
No
The device description explicitly states it is a "software / hardware options" and mentions a "respiratory signal coming from external device," indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device, "Smart Breath respiratory compensation option," is a software/hardware option for CT scanners. Its purpose is to improve the quality of in vivo (within the living body) images by compensating for respiratory motion during the CT scan. It processes image data acquired directly from the patient's body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the patient. The device works directly with the image data generated by the CT scanner.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics. It is a medical device used for image processing and enhancement during a diagnostic imaging procedure performed on a living patient.
N/A
Intended Use / Indications for Use
Smart Breath respiratory compensation option is a non-invasive software / hardware options that can be used to improve clinical images by reducing organ and tissue motion related to respiratory motion from patient breathing during a CT acquisition. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and then will group images by the phase selected.
Product codes
90 JAK
Device Description
Retrospective Respiratory Gating enables a patient to be scanned on a CT with normal breathing. CT data are acquired and images are reconstructed without image artifacts due to organ and tissue motion.
CT Images are synchronized with respiratory signal coming from external device and organ/tissue motion within the CT data reflecting both the organ motions and the chest motion.
The user can then visually determine the optimum phase to perform volume imaging and post processing -quantification, contouring, segmentation. The respiratory phase identification is also provided.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0.2 2919
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and connected, and the entire logo is in black against a white background.
GE Medical Systems General Electric Company 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).
Larry A. Kroger, Ph.D. Submitter Senior Regulatory Program Manager Telephone: (262) 544-3894, FAX: (262) 548-4768 Date Prepared: August 8, 2002
PRODUCT IDENTIFICATION
| Name: | Smart Breath Respiratory compensation option |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel | 892 - Radiology |
| Classification Number: | 892.1750 |
| Manufacturer : | General Electric Medical Systems |
| 283, rue de la Minière | |
| 78533 Buc Cedex, FRANCE | |
| Distributor: | General Electric Medical Systems, Milwaukee, WI |
| Marketed Devices | Smart Breath Respiratory Compensation Option is substantially equivalent to: |
| Model: | SmartScore 3.5 |
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI |
| 510(k) #: | K020929 |
Device Description:
Retrospective Respiratory Gating enables a patient to be scanned on a CT with normal breathing. CT data are acquired and images are reconstructed without image artifacts due to organ and tissue motion.
CT Images are synchronized with respiratory signal coming from external device and organ/tissue motion within the CT data reflecting both the organ motions and the chest motion.
1
The user can then visually determine the optimum phase to perform volume imaging and post processing -quantification, contouring, segmentation. The respiratory phase identification is also provided.
Indications for Use:
Smart Breath respiratory compensation option is a non-invasive software / hardware options that can be used to improve clinical images by reducing organ and tissue motion related to respiratory motion from patient breathing during a CT acquisition. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and then will group images by the phase selected.
Comparison with Predicate:
This device will use a similar technology to that already used by GE Medical Systems in our cleared device SmartScore 3.5 (K020929). Fundamentally, this device will use the same phase selection process that is used in SmartScore to group images based on cardiac phase. In SmartScore, this grouping process is the first step in developing the Cardiac calcium score. In Smart Breath, the grouping will be used primarily to look at multiple images during the same phase of the respiratory cycle which will remove tissue motion. A more detailed comparison is included in Attachment 3 of this submission.
| Device Name | FDA Clearance Number |
|---|---|
| SmartScore 3.5 | K020929 |
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:
Smart Breath Respiratory Compensation Option does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features and technology of the Smart Breath Respiratory Compensation Option to be equivalent to those of SmartScore 3.5 --K020929.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and three wavy lines below, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2002
Re: K022919
GE Medical Systems c/o Mr. Heinz Joerg Steneberg Division Manager Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Trade/Device Name: SmartBreath Respiratory Compensation Option Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: August 30, 2002 Received: September 4, 2002
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 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
Page 2
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. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INTENDED USE
510(k) Number (if known): _ 11022919
Device Name: Smart Breath respiratory compensation option
Indications For Use:
Smart Breath respiratory compensation option is a non-invasive software / hardware options that can be used to improve clinical images by reducing organ and tissue motion related to respiratory motion from patient breathing during a CT acquisition. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and then will group images by the phase selected.
(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 _________________________________________________________________________________________________________________________________________________________
David L. Lyon
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _