(27 days)
The two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.
The provided text contains information about a 510(k) submission for a Digital Fluoroscopic Imaging System with an optional Bolus Chasing feature. However, it does not include specific details about acceptance criteria, a dedicated study proving performance against defined criteria, sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth.
The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing a detailed performance study against a set of acceptance criteria.
Therefore, many parts of your request cannot be answered from the provided text.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance metrics.
- Reported Device Performance: Not explicitly stated as quantifiable performance metrics. The equivalence is based on the device's design, materials, and intended use being similar to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no specific test set or ground truth establishment process is described in the context of a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No MRMC study is mentioned. This device is an imaging system, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is an imaging system, not an algorithm being evaluated in a standalone capacity. The "Bolus Chasing option" is a feature of the imaging system itself, controlling image acquisition.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no specific performance study with ground truth is described. The basis for approval is substantial equivalence to a predicate device for its intended use.
8. The sample size for the training set
- Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of available information regarding the "study" (equivalence demonstration):
The "study" presented here is a Substantial Equivalence (SE) demonstration for the GE Healthcare Innova 4100 and Innova 3100 (with the new Bolus Chasing option).
- Predicate Device: GE Advantx LCV+ Bolus Chasing (K960575)
- Basis of Equivalence: Comparison table and product data sheets (details not provided in the text). The opinion is based on technical and functional similarity to the predicate device.
- Risk Management: The manufacturer states that potential hazards related to the new Bolus Chasing option are controlled by a risk management plan, including:
- Hazard identification
- Risk evaluation
- Software Development and Validation Process
- Testing: Materials are compliant with UL 2601 and IEC 60601-1 standards. Design controls prevent useless X-ray/contrast agent exposure during a Bolus Chasing sequence in case of failure. This implies some form of engineering testing and verification, but not a clinical performance study as typically understood for diagnostic accuracy.
In essence, the document serves as a 510(k) summary demonstrating that the new device is as safe and effective as a previously cleared device, rather than providing a new clinical performance study with defined acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are black, while the background is white. The logo is simple and recognizable, representing the well-known multinational conglomerate.
K042053
Page 2
GE Healthcare P.O. Box 414, W-400 Milwaukee, WI 53201 USA
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: 5 July 2004 |
|---|---|
| Identification of Product: | Digital Fluoroscopic Imaging System |
| Classification Name: | Fluoroscopic X-ray system - 21 CFR 892.1650 |
| Manufacturer: | GE Medical Systems Europe283, rue de la Miniere78530 Buc Cedex, France |
| Distributed by: | GE Healthcare, Milwaukee, WI |
| Marketed Devices: | The GE Healthcare Innova 4100 and Innova 3100, with thenew Bolus Chasing option for angiography of lower limbs aresubstantially equivalent to GE Advantx LCV+ (K960575). Thisopinion is based on the information contained in thecomparison table, and the product data sheets. |
| Device Description: | The new Bolus Chasing is offered as an option for Innova4100 and 3100, already cleared under K033244 andK031637. |
| Materials: | All construction and materials are compliant with UL 2601 andIEC 60601-1. |
| Design: | Controls of operation of XRAY, injection and table motion areintended to prevent from useless exposures to XRAY/contrastagent during a Bolus Chasing sequence in case of failurefrom one of these parameters (i.e., XRAY, injection and tablemotion). |
| Energy Source: | 380 - 480 VAC; 50/60Hz. |
| Indications for Use: | The Digital Fluoroscopic Imaging System with Bolus Chasingoption is indicated for use in generating fluoroscopic imagesof human anatomy for diagnostic and intervention; the optionBolus enables to perform subtraction angiography of lower |
{1}------------------------------------------------
limbs. This device is not intended for mammography applications.
K042053
Page 2 of 2
- Comparison with The GE Healthcare new Bolus Chasing option for Innova 4100, 3100 systems, is substantially equivalent to the GE Health Care Advantx LCV+ Bolus Chasing which is part of the Advantx LCV+ system (K960575).
- GE Healthcare considers that the Bolus Chasing option for Conclusions: their 41 cm and 31 cm Digital Fluoroscopic Imaging Systems Innova 4100 and Innova 3100 to be equivalent with the predicate device. The potential hazards, related to the introduction of new Bolus Chasing option, are controlled by a risk management plan including:
- · A hazard identification
- · A risk evaluation
- · A Software Development and Validation Process
{2}------------------------------------------------
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical System, Inc. P.O. Box 414, W-400 MILWAUKEE WI 53201
Re: K042053
Trade/Device Name: Innova 4100, Innova 3100 with optional Bolus Chasing Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: July 29, 2004 Received: July 30, 2004
JUL 30 2012
Dear Dr. Kroger:
This letter corrects our substantially equivalent letter of August 26, 2004.
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
{3}------------------------------------------------
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
{4}------------------------------------------------
STATEMENT OF INTENDED USE
510(k) Number (if known): ¼o42e53____________________________________________________________________________________________________________________________________________
Device Name: Digital Fluoroscopic Imaging Systems - Innova 4100, Innova 3100 with optional Bolus Chasing.
Indications for Use
The two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.
(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 | |
|---|---|---|---|
| --------------------------------------- | --- | ------------------------- | -- |
(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K042053 |
|---|---|
| --------------- | --------- |
§ 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.