(14 days)
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications.
InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications.
The Innova 3D is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 2100''' (2100-IQ) aiready cleared under K050489), Innova 4100''' and Innova 3100'''.
The InnovaSpin is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 4100'0 and Innova 3100'9.
The Digital Fluoroscopic Imaging Systems Innova are designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition system then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-RAY system and a digital detector.
The provided text describes a 510(k) summary for GE Healthcare's Digital Fluoroscopic Imaging Systems (Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ) with optional Innova 3D or InnovaSpin. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a new device's accuracy or effectiveness.
Therefore, the document does not contain detailed acceptance criteria or a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
However, it does describe the basis for substantial equivalence, which serves as a form of "acceptance criteria" in a regulatory context, and the "study" (or rather, the data referenced) used to support this claim.
Here's a breakdown of the requested information based on the provided text, with explicit notes where the information is not present:
Acceptance Criteria and Device Performance Study for GE Innova Digital Fluoroscopic Imaging Systems
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (based on Substantial Equivalence Claim) | Reported Device Performance (based on Substantial Equivalence Claim) |
|---|---|
| Substantial Equivalence to Predicate Devices: | Claimed Substantial Equivalence to: |
| - Innova 3D option substantially equivalent to currently marketed software option Advantage 3D XR (K974715). | - Innova 3D option is substantially equivalent on Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ. |
| - InnovaSpin option substantially equivalent to currently marketed InnovaSpin option of Vascular Angiographic system Innova 2100IQ (K050489). | - InnovaSpin option is substantially equivalent on Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ. |
| - Innova 4100IQ and Innova 3100IQ devices substantially equivalent to Innova 4100 (K033244) and Innova 3100 (K031637). | - Innova 4100IQ and Innova 3100IQ devices are substantially equivalent. |
| Maintenance of Image Quality and Diagnostic Capabilities: | - "Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ and Innova 2100IQ with InnovaSpin and Innova 3D options are considered substantially equivalent to the predicates in terms of image quality and diagnostic capabilities." |
| Compliance with Regulatory Standards: | - All construction and materials compliant with UL 187 and IEC 60601-1 (existing parts), and UL 2601 and IEC 60601-1 (new parts). |
| Risk Management: | - Potential hazards controlled by a risk management plan (hazard identification, risk evaluation, software development and validation process). |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- For Innova 3D option: Clinical data was "submitted in the Advantage 3D XR 510K (K954355)." The sample size for this prior submission is not specified in the provided document.
- For InnovaSpin option: Clinical data was "submitted in the LCV+ Version 2 system 510K (K993037)." The sample size for this prior submission is not specified in the provided document.
- For Innova 2000 "Fast Spin Rotational Angiography" option (previous clearance to establish equivalence for InnovaSpin): Cleared without clinical data "based on the fact that this mode of acquisition does not address different anatomies versus LCV+ Version 2 system (K993037)."
- Data Provenance: The document states "previously submitted clinical data are applicable for this submission." The original provenance (e.g., country of origin, retrospective/prospective) of these referenced clinical datasets (K954355 and K993037) is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document as no new clinical study analyzing expert performance or ground truth establishment is described for this specific 510(k) submission. The submission relies on prior clearances.
4. Adjudication method for the test set:
- This information is not provided in the document, as no new clinical study with expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- A MRMC comparative effectiveness study is not mentioned or described in the document. The submission is focused on demonstrating substantial equivalence to existing devices and software options through technical comparison and referencing prior clinical data, not explicitly on AI assistance or reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone algorithm performance study is not described in the document. The Innova 3D and InnovaSpin are described as "software options" that "assist the physician" or "permit fast spin rotational angiography," implying they are tools used by a human, rather than standalone diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document references prior "clinical data" but does not specify the type of ground truth used in those original studies that supported the predicate devices.
8. The sample size for the training set:
- This information is not provided in the document. Since the submission relies on demonstrating substantial equivalence to already marketed devices and software, and not on developing a new AI algorithm from scratch, the concept of a "training set" in the context of machine learning is not discussed.
9. How the ground truth for the training set was established:
- This information is not provided in the document, as no training set is described for this submission.
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K0524/2
SEP 1 6 2005
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate corporation.
P.O. Box 414, W-400
GE Healthcare
Milwaukee, WI 53201 USA
1. 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).
| Identification of Submitter: | Larry A. Kroger, Ph.D.Senior Regulatory Programs ManagerGE HealthcareTel. (262) 544-3894Summary prepared: July 11, 2005 |
|---|---|
| Identification of Product:Classification Name:Manufacturer:Distributed by: | Digital Fluoroscopic Imaging SystemFluoroscopic X-ray SystemGE Medical Systems SCS.283, rue de la Minière78530 Buc Cedex, FranceGE Medical Systems, LLC, Milwaukee, WI |
| Marketed Devices: | The GE Healthcare Innova 3D option for Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices is substantially equivalent to the currently marketed software option Advantage 3D XR (K974715). |
| The GE Healthcare InnovaSpin option for Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ devices is substantially equivalent to the currently marketed InnovaSpin option of the Vascular Angiographic system Innova 2100IQ (2100-IQ) (K050489). | |
| The GE Healthcare Innova 4100IQ and Innova 3100IQ devices are substantially equivalent to the currently marketed devices Innova 4100 device cleared under K033244 and Innova 3100 device cleared under K031637. | |
| This opinion is based on the information contained in the comparison table and the product data sheets. | |
| Device Description: | The Innova 3D is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under |
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K031637), Innova 2100''' (2100-IQ) aiready cleared under
K050489), Innova 4100''' and Innova 3100'''.
The InnovaSpin is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 4100'0 and Innova 3100'9.
The Digital Fluoroscopic Imaging Systems Innova are designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition system then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-RAY system and a digital detector.
- Materials: All construction and materials are compliant with UL 187 and IEC 60601-1 for the existing parts of the product and with UL 2601 and IEC 60601-1 for the new parts.
- Design: The design is validated through Failures Modes Effects Analysis (FMEA) process, which allows managing the risks.
- Energy Source: 480 VAC 50/60Hz.
Indications for Use: For Innova 4100, Innova 410019, Innova 3100, Innova 310019, Innova 2100'9 with Innova 3D or InnovaSpin option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained
through image intensifier technology. Those devices are not intended for mammography applications.
Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
It is not intended for mammography applications.
InnovaSpin is a software option that permits fast spin rotational angiography.
It is not intended for mammography applications.
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Comparison with
The GE Healthcare Innova 3D option for Innova 4100, Innova 410010, Innova 3100, Innova 310010, Innova 210019 devices is substantially equivalent to the currently marketed software option Advantage 3D XR (K974715).
The GE Healthcare InnovaSpin option for Innova 4100, Innova 41000, Innova 3100, Innova 31000 devices is substantially equivalent to the currently marketed InnovaSpin option of the (K050489).
The GE Healthcare Innova 4100'0 and Innova 3100'0 devices are substantially equivalent to the currently marketed devices Innova 4100 device cleared under K033244 and Innova 3100 device cleared under K031637.
The indications of use for the predicative devices are given below:
-
Advantage 3D XR indications for use: The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuroangiographic cases.
-
Innova 21000 (2100-IQ) Indications for Use: The Innova 21000 (2100-1Q) system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications.
-
Innova 3100 indications for use: The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional angiography procedures. This device is not intended to mammography applications.
-
Innova 4100 indications for use: The Digital Fluoroscopic Imaging System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications.
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This opinion is based on the information contained in the comparison table and the product data sheets.
Summary of the Studies:
For the Innova 3D option: Clinical data have been submitted been submitted in the Advantage 3D XR 510K (K954355).
For the InnovaSpin option:
Clinical data have been submitted in the LCV+ Version 2 system 510K (K993037), which indications for use is cardiac angiography.
Innova 2000 "Fast Spin Rotational Angiography" option has been submitted in 2002, cleared under K022322, without clinical data based on the fact that this mode of acquisition does not address different anatomies versus LCV+ Version 2 system (K993037).
Innova 4100, Innova 41000, Innova 3100, Innova 310000 and Innova 2100'0 with InnovaSpin and Innova 3D options are considered substantially equivalent to the predicates in terms of image quality and diagnostic capabilities.
Therefore, previously submitted clinical data are applicable for this submission.
Conclusions:
GE Healthcare considers that the Innova 3D and Innova Spin options for Digital Fluoroscopic Imaging Systems Innova 4100,
Innova 41000, Innova 3100, Innova 31000 and Innova 21000 to be equivalent with the predicate devices. The potential hazards, related to the introduction of Innova 3D and InnovaSpin options are controlled by a risk management plan including:
- . A hazard identification
- A risk evaluation .
- A Software Development and Validation Process .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUL 30 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GE Healthcare % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K052412
Trade/Device Name: Digital Fluoroscopic Imaging Systems-Innova 4100, Innova 41000 Innova 3100. Innova 310010. Innova 210010 with optional Innova 3D or optional InnovaSpin
Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: August 31, 2005 Received: September 2, 2005
Dear Mr. Lehtonen:
This letter corrects our substantially equivalent letter of September 16, 2005.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/Safety/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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use 2.
510(k) Number (if known): Device Name:
K.052412
Digital Fluoroscopic Imaging Systems - Innova 4100, Innova 41000, Innova 3100, Innova 310010, Innova 210019 with optional Innova 3D or optional InnovaSpin.
Indications for Use:
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications.
InnovaSpin is a software option that permits fast spin rotational angiography.
It is not intended for mammography applications.
Over-The-Counter-Use AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broadm
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052417
Posted 13 Nov 2003
§ 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.