The LCV+ Version 2 is indicated for use in generating fluoroscopic images of human analomy for cardiology diagnostic interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology.

Device Description

The LCV+ Version 2 is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a fiber channel link to an acquisition equipment then to a network (using DICOM) for applications such as post-processing, printing, viewing and archiving. LCV+ Version 2 consists of a cardiac monoplane positioner, a vascular table, an X-RAY system and a digital detector.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from text)	Reported Device Performance (from text)
Digital images have equivalent image capability to image-intensifier recorded images.	"Six (6) cardiologists from two (2) hospitals compared digital and Summary of Studies: image-intensifier recorded images from 31 pairs of patients, and found that the digital images had equivalent image capability."
Diagnostic capabilities of recorded fluoroscopic sequences resulting from LCV+ Version 2 are equivalent to Image Intensifier images.	"The LCV+ Version 2 provides recorded fluoroscopic sequences that result in diagnostic capabilities equivalent to Image Intensifier images."

2. Sample Size for Test Set and Data Provenance:

Sample Size: 31 pairs of patients (implying 31 cases with both digital and image-intensifier recorded images).
Data Provenance: Not explicitly stated, but the study involved "two (2) hospitals." The type of study (retrospective or prospective) is also not specified.

3. Number of Experts and Qualifications:

Number of Experts: Six (6) cardiologists.
Qualifications: "Cardiologists" from two hospitals. No further details on years of experience or specific sub-specialties are provided.

4. Adjudication Method:

The text states that the cardiologists "compared" the images. It does not describe a formal adjudication method (like 2+1 or 3+1). It seems they individually evaluated the images, and the overall finding was a consensus of "equivalent image capability." There's no mention of a tie-breaking or reconciliation process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a formal MRMC comparative effectiveness study in the sense of measuring improvement in human readers with AI vs. without AI assistance was not done.
The study described is a comparison of two imaging modalities (digital vs. image-intensifier) to establish equivalence in diagnostic capability, involving multiple readers (6 cardiologists) and multiple cases (31 pairs of patients). However, the device itself is an imaging system, not an AI assisting human readers, so this type of MRMC study would not be applicable here.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone evaluation was performed implicitly. The study assessed the diagnostic capability of the digital images produced by the LCV+ Version 2 system compared to traditional image-intensifier images. The "device" in question is the imaging system itself, and its performance (producing images with equivalent diagnostic capability) was evaluated directly.

7. Type of Ground Truth Used:

Expert Consensus/Clinical Equivalence: The ground truth was established by the subjective evaluation and comparison of the diagnostic capabilities of images by six cardiologists. It's essentially a clinical equivalence assessment based on expert opinion. There's no mention of a gold standard like pathology or long-term outcomes data to definitively determine the "true" diagnosis for each case.

8. Sample Size for the Training Set:

The document does not mention a training set. The LCV+ Version 2 is described as an X-ray imaging system with a digital detector, not a machine learning or AI-based diagnostic algorithm that would typically require a training set. The comparison study described is for validation, not training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set is mentioned for this device.

Summary

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Image /page/0/Picture/1 description: The image shows a black and white logo. The logo is circular in shape and contains the letters 'GE' in a stylized font. The letters are intertwined and appear to be handwritten. The background of the logo is solid black, while the letters are white.

・

く993037

GE Medical System

P.O. Box 414, W-709 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 Medical SystemsTel. (414) 544-3894Summary prepared: 31 August, 1999
Identification of Product:Classification Name:Manufacturer:	LCV+ Version 2Solid State X-ray Imaging SystemGE Medical Systems S.A.-Europe283, rue de la Minière78530 Buc, France
Distributed by:	GE Medical Systems, Milwaukee, WI
Marketed Devices:	The LCV+ Version 2 is substantially equivalent to the currentlymarketed LC cardiographic system (K890348), which complieswith the same or equivalent standards and has the sameintended uses. The digital sub-system, called DL; is substantiallyequivalent to the fluoroscopic digital equipment DLX (K926258and K945459).
Device Description:	The LCV+ Version 2 is designed to perform fluoroscopic x-rayexaminations. The detector is comprised of amorphous siliconwith a cesium iodide scintillator. The resulting digital image canbe sent through a fiber channel link to an acquisition equipmentthen to a network (using DICOM) for applications such as post-processing, printing, viewing and archiving. LCV+ Version 2consists of a cardiac monoplane positioner, a vascular table, anX-RAY system and a digital detector.
Materials:	All construction and materials are compliant with UL 187 for theexisting components and with UL2601, IEC 601-1 and collateralstandards for the new components.

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There are hardware and software redundancies to prevent single Design: point failures that could cause unintended motion.

Energy Source: 360V to 480V AC, 50/60Hz.

The LCV+ Version 2 is indicated for use in generating Indications for Use: for cardiology of human anatomy images fluoroscopic diagnostic/interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology: ·

It is the opinion of GE Medical Systems that the LCV+ Version 2 Comparison with is of comparable type and substantially equivalent to an Advantx Cardiography System LC (K890348). The LCV+ Version 2 presents no new safety concerns. This system will comply with the x-ray requirements of 21CFR as well as the safety requirements noted above.

Six (6) cardiologists from two (2) hospitals compared digital and Summary of Studies: image-intensifier recorded images from 31 pairs of patients, and found that the digital images had equivalent image capability.

Conclusions: GE considers the LCV+ Version 2 to be equivalent with the predicate device. The LCV+ Version 2 provides recorded fluoroscopic sequences that result in diagnostic capabilities equivalent to Image Intensifier images. The potential hazards. e.g., wrong measurements and misdiagnosis, are controlled by a risk management plan including:

· Hazard identification (Attachment 8)
· Risk evaluation (Attachment 8)
· Software Development and Validation Process (Attachment 7)
· External validations of paired sets of Image Intensifier image and digital images by two research hospitals to assess the diagnostic equivalence of the digital images.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized image of a human face in profile, with three blue lines representing the face. To the right of the seal is the word "DEPARTMENT" in blue, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JUL 30 2012

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-709 MILWAUKEE WI 53201

Re: K993037

Trade/Device Name: LCV+ Version 2 System (SSXI Fluoro Device) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: December 21, 1999 Received: December 22, 1999

Dear Dr. Kroger:

This letter corrects our substantially equivalent letter of February 14, 2000.

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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INDICATIONS FOR USE

510(k) Number (if known): _____ 9930 37

Device Name: LCV+ Version 2 System

Indications for Use

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(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 Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices x993037 510(k) Number.

Regulation Number and Section

§ 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.