(182 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and there is no other language in the summary that suggests the use of AI or ML.
No
The device is an angiographic X-ray system used for generating images for diagnosis and guiding procedures, not for direct therapeutic treatment.
Yes
The "Intended Use/Indications for Use" section explicitly states that the systems are indicated for "generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures." The inclusion of "diagnostic" directly indicates its use for diagnosis.
No
The device description clearly states it is an "interventional fluoroscopic x-ray system/ x-ray angiographic system" and includes hardware components like a digital detector and gantry.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for generating images of human anatomy for diagnostic and interventional procedures, including image-guided surgical procedures. This involves imaging the patient directly.
- Device Description: The device is described as an interventional fluoroscopic x-ray system/x-ray angiographic system. This is an imaging device used on a living patient.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device operates by generating X-rays that pass through the patient's body to create images, which is fundamentally different from testing samples outside the body.
N/A
Intended Use / Indications for Use
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures.
Product codes
OWB, JAA and IZI
Device Description
The proposed device, Discovery IGS 740 is an interventional fluoroscopic x-ray system/ x-ray angiographic system with a 41 cm square digital detector.
Discovery IGS 740 is a new product model of the GE Discovery IGS interventional fluoroscopic x-ray system/ x-ray angiographic system platform with a 41cm square digital detector. GE Discovery IGS x-ray angiographic systems are based on the GE laser guided gantry. The 41cm square digital detector of the cleared predicate device Innova IGS 540 K122457 is mounted on the GE Discovery IGS gantry. This gantry is the same gantry as the Discovery IGS 730 predicate device, originally cleared with K113403.
Discovery IGS 740 is proposed in an Interventional configuration and in an OR configuration (with OR table) for the indications for use of surgery.
Discovery IGS 740 has no additional indications for use compared with the predicate device Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions K122457.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
newborn to geriatric
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)
Summary of Non-Clinical Tests:
Simulated Use Testing ensures the system conforms to user needs and intended uses through simulated clinical workflow using step-by step procedures that would be performed for representative clinical applications.
Usability validation testing is conducted to confirm that the product can be used safely and effectively. The participants for these tests are licensed and/or clinically trained healthcare providers or users. Product verification ensures the system conforms to its requirements including hazard mitigations risk management requirements. The verification tests confirm that design output meets design input requirements. Tests are executed at component, software subsystems and system levels. Dose verification, image quality verification and functional testing are part of system level verification. Performance imaging of Innova CT (CA-CBCT) has been confirmed with bench testing for uniformity, contrast and detail imaging performances. Software reliability is verified through intensive cycling of the system. The cycling tests use scenarios that simulate clinical workflow that would be performed for representative clinical applications. Safety testing is performed to confirm that the product meets the requirements of the standards listed in Table 1.
The Non-clinical Testing confirms Discovery IGS 740 meets the user requirements and its intended use and meets the design inputs requirements.
Summary of Clinical Tests:
The subject of this premarket submission, Discovery IGS 740, did not require clinical studies to support substantial equivalence. It does not introduce new indications for use. Substantial equivalence relies on clinical information that is pre-existing on the cleared predicate device (K023178).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K122457: Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions.
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
APR 2 4 2014
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 circular border. The border has decorative swirls or flourishes at three points around the circle.
Appendices
K
GE Healthcare K133278, Discovery IGS 740 Supplement
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date Summary was revised: | March 4th, 2014 |
|---|---|
| Submitter: | GE Healthcare |
| GE MEDICAL SYSTEMS, SCS | |
| 283 RUE DE LA MINIERE | |
| 78530 BUC - FRANCE | |
| T: +33-(0)1-30-70-47-41 | |
| Primary Contact Person: | Michel Genuer |
| GE Healthcare (GE MEDICAL SYSTEMS SCS) | |
| Regulatory Affairs Leader, | |
| 283 RUE DE LA MINIERE | |
| 78530 BUC - FRANCE | |
| T: +33-(0)1-30-70-47-41 | |
| Email: michel.genuer@ge.com | |
| Secondary Contact Person: | Hubert Welsch |
| Regulatory Affairs Leader, | |
| GE Healthcare | |
| 283 RUE DE LA MINIERE | |
| 78530 BUC - FRANCE | |
| T: +33-(0)1-30-70-49-51 | |
| Email: hubert.welsch@ge.com | |
| Device/Trade Name: | Discovery IGS 740 |
| Common/Usual Name: | interventional fluoroscopic x-ray system, angiographic x-ray system |
| Regulation Description: | Image-intensified fluoroscopic x-ray system. |
| Regulation number: | 892.1650 |
| Product Code: | OWB, JAA and IZI |
| Class: | II |
| Predicate Device(s): | K122457: Innova/Innova IGS/Discovery IGS/Optima angiographic, |
| fluoroscopic X-ray Systems with Cathlab Frontiers solutions. | |
| Device Description: | The proposed device, Discovery IGS 740 is an interventional |
| fluoroscopic x-ray system/ x-ray angiographic system with a 41 cm | |
| square digital detector. | |
| Discovery IGS 740 is a new product model of the GE Discovery IGS | |
| interventional fluoroscopic x-ray system/ x-ray angiographic system | |
| platform with a 41cm square digital detector. GE Discovery IGS x-ray | |
| angiographic systems are based on the GE laser guided gantry. The | |
| 41cm square digital detector of the cleared predicate device Innova | |
| IGS 540 K122457 is mounted on the GE Discovery IGS gantry. This | |
| gantry is the same gantry as the Discovery IGS 730 predicate device, | |
| originally cleared with K113403. | |
| Discovery IGS 740 is proposed in an Interventional configuration and in | |
| an OR configuration (with OR table) for the indications for use of | |
| surgery. | |
| Discovery IGS 740 has no additional indications for use compared with | |
| the predicate device Innova/Innova IGS/Discovery IGS/Optima | |
| angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers | |
| solutions K122457. | |
| Intended Use | The angiographic X-ray systems are indicated for use for patients from |
| newborn to geriatric in generating fluoroscopic and rotational images | |
| Indications for Use: | of human anatomy for cardiovascular, vascular and non-vascular, |
| diagnostic and interventional procedures. | |
| Additionally, with the OR table, the angiographic X-ray systems are | |
| indicated for use in generating fluoroscopic and rotational images of | |
| human anatomy for image-guided surgical procedures. | |
| The OR table is suitable for interventional and surgical procedures. | |
| Technology: | The proposed Discovery IGS 740 is a new combination of the laser |
| guided mobile AGV gantry of the Discovery IGS 730 (K113403) and of | |
| the 41cm solid state detector of the Innova IGS 540 (K122457). | |
| This new combination is the most important difference. It impacts the | |
| collision avoidance system which has been adapted for the 41cm | |
| detector. | |
| This adaptation does not impact the safety and effectiveness of the | |
| proposed device established with the predicate devices (K113403 & | |
| K122457). | |
| Determination of Substantial | |
| Equivalence: | Discovery IGS 740 complies with the voluntary and mandatory |
| standards listed in Table 1. | |
| Summary of Non-Clinical Tests: | |
| Simulated Use Testing ensures the system conforms to user | |
| needs and intended uses through simulated clinical workflow | |
| using step-by step procedures that would be performed for | |
| representative clinical applications. | |
| Usability validation testing is conducted to confirm that the product can be used safely and effectively. The participants for these tests are licensed and/or clinically trained healthcare providers or users. Product verification ensures the system conforms to its requirements including hazard mitigations risk management requirements. The verification tests confirm that design output meets design input requirements. Tests are executed at component, software subsystems and system levels. Dose verification, image quality verification and functional testing are part of system level verification. Performance imaging of Innova CT (CA-CBCT) has been confirmed with bench testing for uniformity, contrast and detail imaging performances. Software reliability is verified through intensive cycling of the system. The cycling tests use scenarios that simulate clinical workflow that would be performed for representative clinical applications. Safety testing is performed to confirm that the product meets the requirements of the standards listed in Table 1. | |
| The Non-clinical Testing confirms Discovery IGS 740 meets the user requirements and its intended use and meets the design inputs requirements. | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, Discovery IGS 740, did not require clinical studies to support substantial equivalence. It does not introduce new indications for use. Substantial equivalence relies on clinical information that is pre-existing on the cleared predicate device (K023178). | |
| Conclusion: | GE Healthcare considers the Discovery IGS 740 to be as safe and effective as its predicate devices, and its performances to be substantially equivalent to the predicate device(s). |
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. There are three swirls around the outside of the circle.
Appendices
K133278, Discovery IGS 740 Supplement
2
GE Healthcare
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular frame. The letters and the frame are in black, contrasting with the white background. The logo is simple, iconic, and easily recognizable.
Appendices
K133278, Discovery IGS 740 Supplement
3
Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. There are three decorative swirls equally spaced around the outside of the circle.
GE Healthcare
Appendices
K133278, Discovery IGS 740 Supplement
Table 1
: ·
| Standards N° | Standards
organization | Standards Title | Version | Date |
|----------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------|
| 21 CFR 1020.30-32 | FDA | FDA Federal Performance Standard | 2013 | 2013 |
| 60601-1 | IEC | Medical Electrical Equipment – General
requirements for basic safety and
essential performance | Ed 3 | 2005 |
| 60601-2-43 | IEC | Medical Electrical Equipment – Part 2-43:
Particular requirements for the safety of
X-ray equipment for interventional
procedures (2nd edition) | Ed 2 | 2010 |
| 60601-1-2 | IEC | Medical Electrical Equipment – Part -1-2:
General requirements for safety –
Collateral standard: Electromagnetic
Compatibility – Requirements and tests | Ed 3 | 2007 |
| 60601-1-3 | IEC | Medical Electrical Equipment – Part -1:
General requirements for safety, Section
1.3 Collateral standard: General
requirements for radiation protection in
diagnostic X-ray equipment | Ed 2 | 2008 |
| 60601-1-6 | IEC | Medical electrical equipment -Part 1-6:
General requirements for basic safety
and essential performance -Collateral
standard : Usability | Ed 3 | 2010 |
| IEC60601-2-46
(for the table) | IEC | Medical electrical equipment, Part2-46:
Particular requirements for the safety of
operating tables | Ed 2 | 2010 |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
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April 24, 2014
GE Medical Systems Scs Michel Genuer 283 Rue De La Miniere Buc, 78530 FRANCE
Re: K133278
Trade/Device Name: Discovery IGS 740 Regulation Number: 21 CFR 192.1650 Regulation Name: Interventional Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB Dated: April 14, 2014 Received: April 16, 2014
Dear Michel Genuer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - Michel Genuer
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); 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Safcty/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Smh 77)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known) K133278
Device Name Discovery IGS 740
Indications for Use (Describe)
The angiographic X-ray systems are indicated for use for patients from newborn to generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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