(182 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the GE Healthcare Discovery IGS 740, based on the provided 510(k) summary:
This device is an interventional fluoroscopic x-ray system, and the provided document indicates it is a modification of an existing device rather than a completely new AI-powered diagnostic tool. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the new configuration remains as safe and effective as the predicate devices, rather than establishing novel clinical performance metrics for a new diagnostic claim.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a modification of an existing device, the "acceptance criteria" revolve around demonstrating that the new configuration meets established safety and performance standards for such X-ray systems, and does not negatively impact existing functionalities. The document refers to compliance with voluntary and mandatory standards as acceptance criteria and summarizes non-clinical tests to confirm performance.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance / Evidence |
|---|---|---|
| Safety and Essential Performance | Compliance with IEC 60601-1 (Medical Electrical Equipment – General requirements for basic safety and essential performance) | "Safety testing is performed to confirm that the product meets the requirements of the standards listed in Table 1." (Table 1 includes IEC 60601-1). The non-clinical testing confirms the Discovery IGS 740 meets user requirements and intended use. |
| Specific Safety for Interventional X-ray Equipment | Compliance with IEC 60601-2-43 (Particular requirements for the safety of X-ray equipment for interventional procedures) | As above, confirmed through safety testing against standards in Table 1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (General requirements for safety – Collateral standard: Electromagnetic Compatibility – Requirements and tests) | As above, confirmed through safety testing against standards in Table 1. |
| Radiation Protection in Diagnostic X-ray Equipment | Compliance with IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) and FDA Federal Performance Standard (21 CFR 1020.30-32) | "Dose verification... are part of system level verification." Confirmed through safety testing against standards in Table 1. The non-clinical testing confirms the Discovery IGS 740 meets user requirements and intended use. |
| Usability | Compliance with IEC 60601-1-6 (General requirements for basic safety and essential performance - Collateral standard : Usability) | "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." The non-clinical testing confirms the Discovery IGS 740 meets user requirements and intended use. |
| Functional Equivalence & Design Input Requirements | The new combination (gantry + detector) does not negatively impact safety and effectiveness compared to predicate devices. System conforms to user needs and intended uses. Design output meets design input requirements. Performance imaging (uniformity, contrast, detail for Innova CT/CA-CBCT). Software reliability. Collision avoidance effectiveness. | "Simulated Use Testing ensures the system conforms to user needs and intended uses through simulated clinical workflow..." "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." "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..." The collision avoidance system was adapted and "does not impact the safety and effectiveness." |
| No New Indications for Use | Maintain the same indications for use as the predicate device(s). | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation relied entirely on non-clinical tests, including:
- Simulated Use Testing: Ensures conformity to user needs and intended uses through simulated clinical workflow. The number of simulated scenarios or specific "cases" is not provided.
- Usability Validation Testing: Involved licensed and/or clinically trained healthcare providers/users. The number of participants is not provided.
- Product Verification: Tests at component, software subsystems, and system levels, including dose verification, image quality verification, and functional testing.
- Bench Testing: For performance imaging of Innova CT (CA-CBCT) for uniformity, contrast, and detail.
- Software Reliability Cycling Tests: Used scenarios simulating clinical workflow.
Data Provenance: The studies are non-clinical, meaning they don't involve retrospective or prospective human patient data acquisition for this specific submission. The "clinical information" mentioned for substantial equivalence relies on pre-existing data from the cleared predicate device (K023178).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts for Usability Validation Testing: "licensed and/or clinically trained healthcare providers or users." The specific number and exact qualifications (e.g., years of experience, specialty) are not provided.
- Experts for Clinical Ground Truth: No new clinical ground truth was established by experts for this submission. The device relies on the established safety and efficacy of its predicate devices, which would have had expert involvement in their original clearances.
4. Adjudication Method for the Test Set
Since no traditional clinical "test set" with ground truth requiring adjudication was performed for this 510(k) (as it did not require clinical studies), there is no adjudication method described in the document. The evaluations were non-clinical, focusing on compliance with engineering standards, simulated use, and usability.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device itself is an X-ray imaging system, not an AI-powered diagnostic algorithm that assists human readers in lesion detection or diagnosis. This submission focuses on hardware and system changes, not reader performance.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was done in the context of an AI algorithm's diagnostic performance. The "algorithm" here refers to the system's operational software and collision avoidance system, which were verified for functionality, safety, and reliability through non-clinical testing, not for standalone diagnostic accuracy.
7. Type of Ground Truth Used
For this specific submission, the "ground truth" used was primarily engineering specifications, established safety standards, and functional requirements (e.g., image quality metrics like uniformity, contrast, detail validated by bench testing; successful operation of the collision avoidance system; adherence to usability principles). No new pathology, expert consensus on patient outcomes, or similar clinical ground truth was generated as part of this submission, as it did not involve new clinical studies.
8. Sample Size for the Training Set
Not applicable. This submission describes an X-ray imaging system, not a machine learning or AI algorithm that requires a "training set" of data for learning diagnostic patterns. The software verification involved "intensive cycling of the system" using "scenarios that simulate clinical workflow," but this is not analogous to training an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is not an AI/ML device in the sense of requiring a training set with associated ground truth for diagnostic learning.
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APR 2 4 2014
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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 HealthcareGE MEDICAL SYSTEMS, SCS283 RUE DE LA MINIERE78530 BUC - FRANCET: +33-(0)1-30-70-47-41 |
| Primary Contact Person: | Michel GenuerGE Healthcare (GE MEDICAL SYSTEMS SCS)Regulatory Affairs Leader,283 RUE DE LA MINIERE78530 BUC - FRANCET: +33-(0)1-30-70-47-41Email: michel.genuer@ge.com |
| Secondary Contact Person: | Hubert WelschRegulatory Affairs Leader,GE Healthcare283 RUE DE LA MINIERE78530 BUC - FRANCET: +33-(0)1-30-70-49-51Email: 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 interventionalfluoroscopic x-ray system/ x-ray angiographic system with a 41 cmsquare digital detector.Discovery IGS 740 is a new product model of the GE Discovery IGSinterventional fluoroscopic x-ray system/ x-ray angiographic system |
| platform with a 41cm square digital detector. GE Discovery IGS x-rayangiographic systems are based on the GE laser guided gantry. The41cm square digital detector of the cleared predicate device InnovaIGS 540 K122457 is mounted on the GE Discovery IGS gantry. Thisgantry 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 inan OR configuration (with OR table) for the indications for use ofsurgery. | |
| Discovery IGS 740 has no additional indications for use compared withthe predicate device Innova/Innova IGS/Discovery IGS/Optimaangiographic, fluoroscopic X-ray Systems with Cathlab Frontierssolutions 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 ofthe 41cm solid state detector of the Innova IGS 540 (K122457). | |
| This new combination is the most important difference. It impacts thecollision avoidance system which has been adapted for the 41cmdetector. | |
| This adaptation does not impact the safety and effectiveness of theproposed device established with the predicate devices (K113403 &K122457). | |
| Determination of SubstantialEquivalence: | Discovery IGS 740 complies with the voluntary and mandatorystandards listed in Table 1. |
| Summary of Non-Clinical Tests: | |
| Simulated Use Testing ensures the system conforms to userneeds and intended uses through simulated clinical workflowusing step-by step procedures that would be performed forrepresentative 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). |
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K133278, Discovery IGS 740 Supplement
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GE Healthcare
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Appendices
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GE Healthcare
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K133278, Discovery IGS 740 Supplement
Table 1
: ·
| Standards N° | Standardsorganization | Standards Title | Version | Date |
|---|---|---|---|---|
| 21 CFR 1020.30-32 | FDA | FDA Federal Performance Standard | 2013 | 2013 |
| 60601-1 | IEC | Medical Electrical Equipment – Generalrequirements for basic safety andessential performance | Ed 3 | 2005 |
| 60601-2-43 | IEC | Medical Electrical Equipment – Part 2-43:Particular requirements for the safety ofX-ray equipment for interventionalprocedures (2nd edition) | Ed 2 | 2010 |
| 60601-1-2 | IEC | Medical Electrical Equipment – Part -1-2:General requirements for safety –Collateral standard: ElectromagneticCompatibility – Requirements and tests | Ed 3 | 2007 |
| 60601-1-3 | IEC | Medical Electrical Equipment – Part -1:General requirements for safety, Section1.3 Collateral standard: Generalrequirements for radiation protection indiagnostic X-ray equipment | Ed 2 | 2008 |
| 60601-1-6 | IEC | Medical electrical equipment -Part 1-6:General requirements for basic safetyand essential performance -Collateralstandard : Usability | Ed 3 | 2010 |
| IEC60601-2-46(for the table) | IEC | Medical electrical equipment, Part2-46:Particular requirements for the safety ofoperating tables | Ed 2 | 2010 |
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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.
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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
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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)
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FOR FDA USE ONLY
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§ 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.