(20 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. These devices are not intended for mammography applications.
The Innova series digital fluoroscopy systems labeling is modified to allow the use of this device in an Operating Room environment that is suitable for this device. The device is suitable for Interventional XRAY procedures (catheter, needle, Minimally Invasive Surgery ) and can be used either in an Interventional Room (i.e. Cath Lab) or in an Operating Room Environment. The device is not suitable to do surgical procedures (ie. open surgery).
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Table of Acceptance Criteria and Reported Device Performance:
The submission does not provide a table of acceptance criteria or quantitative performance metrics for the device itself. Instead, it focuses on the device's substantial equivalence to predicate devices based on a labeling change.
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Sample Size Used for Test Set and Data Provenance:
- Sample Size: Not applicable. The submission explicitly states, "There is no clinical testing for this modification since the intended use, indications for use and other product specifications do not change."
- Data Provenance: Not applicable. No new clinical or performance data was generated for this specific modification.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No new test set requiring expert ground truth was used.
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Adjudication Method for the Test Set:
Not applicable. No new test set was adjudicated.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The submission explicitly states, "The subject of this Premarket submission, Innova in Operating room environment, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was conducted.
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Standalone (Algorithm Only) Performance Study:
No. This submission is for a medical device (digital fluoroscopy system) whose labeling was modified, not a standalone algorithm. The device's performance is considered substantially equivalent to its predicate devices, which were previously cleared.
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Type of Ground Truth Used:
Not applicable. No new ground truth was established for this submission. The ground truth for the predicate devices' initial clearance would have been established, but this information is not part of this specific submission.
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Sample Size for the Training Set:
Not applicable. This submission is for a labeling modification to an existing device, not for the development of a new algorithm or system requiring a training set.
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How the Ground Truth for the Training Set Was Established:
Not applicable. No training set was used.
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JUN 29 2009
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GE Healthcare
P. 1 of 2
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 5 june 2009 |
|---|---|
| Submitter: | GE Medical Systems, LLCDoing business with GE Healthcare3000 N. Grandview BlvdWaukesha, WI 53188 |
| Primary Contact Person: | Alan TotahRegulatory Affairs Director, Pre-marketGE HealthcareTel.: (262) -544-3424Fax.: (262) -544-3202 |
| Secondary ContactPerson: | Philip MalcaInterventional Regulatory Affairs DirectorGE Healthcare [GE Medical Systems SCS.]Tel.: 33 1 30 70 42 07Fax: 33 1 30 70 43 99 |
| Device: Trade Name: | Innova in Operating Room environment |
| Common/Usual Name: | Innova 4100IQ, 3100IQ, 2100IQ, 3131IQ, 2121IQ |
| Classification Names: | System X-Ray, Angiographic |
| Product Code: | OWB, JAA, I21 |
| Predicate Device(s): | Innova 4100IQ, 3100IQ, 2100IQ, 3131IQ, 2121IQK052412, K050489, K060259, K061163. |
Device Description: The Innova series digital fluoroscopy systems labeling is modified to allow the use of this device in an Operating Room environment that is suitable for this device. The device is suitable for Interventional XRAY procedures (catheter, needle, Minimally Invasive Surgery ) and can be used either in an Interventional Room (i.e. Cath Lab) or in an Operating Room Environment. The device is not suitable to do surgical procedures (ie. open surgery).
Intended 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
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K191658 P. 2 of 2
GE Healthcare
-510(k) Premarket Notification Submission technology. These devices are not intended for mammography applications.
Technology
Determination of Substantial Equivalence
The Innova in Operating Room environment employs the same fundamental scientific technology as its predicate devices.
The subject device is of a comparable type and substantially equivalent to the unmodified Innova. For the purpose of comparison, the modified and unmodified devices are identical except for the labeling that is modified to allow the use of this device in the Operating Room environment that is suitable for it. This labeling modification to the Operator Manual does not adversely impact safety or effectiveness of the device.
The modified and unmodified devices are identical and have the same specifications. The risk analysis done on the product in an Operating Room environment did not raise new risk other than a potential foreseeable misuse in surgery. This has resulted in a labeling change of the operator manual. No further specification and testing were required.
There is no clinical testing for this modification since the intended use, indications for use and other product specifications do not change.
The following quality assurance measures were applied to the development of the system modification:
- Risk Analysis 0
- Requirements Reviews
- Design Reviews .
- Testing on unit level (Module verification) 0
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
Summary of Clinical studies:
The subject of this Premarket submission, Innova in Operating room environment, did not require clinical studies to support substantial equivalence.
Conclusion
GE Healthcare considers the Innova in Operating Room environment to be as safe and as effective as the predicate devices Innova, and its performance is substantially equivalent to the predicate devices.
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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
Mr. Alan Totah Regulatory Affairs Director - Premarket GE Healthcare Systems 3000 N. Grandview Blvd. WAUKESHA WI 53188-1696
Re: K091658
Trade/Device Name: Innova in Operating Room Environment Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: June 5, 2009 Received: June 9, 2009
Dear Mr. Totah:
This letter corrects our substantially equivalent letter of June 29, 2009.
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 (QS) 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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GE Healthcare -510(k) Premarket Notification Submission
510(k) Number (if known): net known. K (19/165 8
Device Name: Innova in Operating Room Environment
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. These devices are not intended for mammography applications.
rescription Use X Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heils Remm
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091165
15/68
§ 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.