The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray computed tomography applications. It can be operated in a mobile as well as a fixed site environment.

Device Description

The GE LightSpeed Plus Mobile CT Scanner System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed Plus CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.

AI/ML Overview

This 510(k) pertains to the GE LightSpeed Plus Mobile CT System, which is described as a modification of the predicate device, the GE LightSpeed Plus CT System (K000300). The submission focuses on demonstrating substantial equivalence rather than presenting a study for new performance claims. Therefore, the information requested in your prompt regarding acceptance criteria, reported performance, and a detailed study description is not present in the provided document.

Here's an breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document does not specify quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the modified device has "the same technological characteristics," "comparable in key safety and effectiveness features," "uses the same basic design, construction, and materials," and has "the same intended use" as the predicate device.
Reported Device Performance: The document does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy) for the LightSpeed Plus Mobile CT System. It broadly states that "The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards."

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the document. The submission focuses on design and safety equivalence rather than clinical performance evaluation with a test set of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the document, as there was no test set data requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not provided in the document, as there was no test set to adjudicate.

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

No MRMC comparative effectiveness study was mentioned or performed. This submission is for a modification of an existing device, focusing on substantial equivalence rather than a new clinical effectiveness claim.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No standalone performance study was performed or mentioned. This device is a CT imaging system, not an AI algorithm.

7. Type of Ground Truth Used:

This information is not applicable as there was no clinical study involving ground truth establishment for diagnostic performance. The ground truth in this context would implicitly be the established safety and performance of the predicate device.

8. Sample Size for the Training Set:

This information is not applicable as this is not an AI/machine learning device that requires a training set.

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

This information is not applicable as this is not an AI/machine learning device.

Summary of Study (as per the document):

The "Summary of Studies" section in the 510(k) states:
"The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards."

Conclusion drawn from the document:

The 510(k) is a Special 510(k), indicating a modification to an existing cleared device. The focus is on demonstrating that the changes do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate. The "study" mentioned is conformity to safety and performance standards, not a clinical trial with specific performance metrics.

Summary

{0}------------------------------------------------

Special 510(k) Premarket Notification GE Medical Systems - LightSpeed Plus Mobile CT System August 22, 2001

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white and has a vintage look.

SEP = 7 2001

KO)2836

GE Medical Systems

P.O. Box 414, NB-918 Milwaukee, WI 53201

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)

Submitter:	GE Medical SystemsPO Box 414Milwaukee, WI 53201
Contact Person:	Larry A. Kroger Ph.D.Senior Regulatory Programs ManagerTelephone: 262-544-3894; Fax: 262-544-3863
Date Prepared:	August 22, 2001
Device Name:	LightSpeed Plus Mobile Computed Tomography System.Computed Tomography X-ray System, 21 CFR 892.1750, 90-JAK
Marketed Device:	GE Medical System's LightSpeed Plus Computed Tomography System;510(k) Number K000300, currently in commercial distribution.

Device Description:

Indications for Use:

The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray computed tomography applications. It can be operated in a mobile as well as a fixed site environment.

Comparison with Predicate Device:

The GE LightSpeed Plus Mobile Computed Tomography System is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed Plus CT System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.

Summary of Studies:

The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.

Conclusion:

Intended use and fundamental scientific technology are the legally marketed GE LightSpeed Plus CT System. The design and development process of the manufacturer conforms with 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the LightSpeed Plus Mobile CT System is substantially equivalent to the currently cleared LightSpeed Plus CT System.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, with flowing lines connecting them. The symbol is positioned in the upper right quadrant of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 7 2001

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, NB-918 MILWAUKEE WI 53201

Re: K012836

LightSpeed Plus Mobil CT System (Computed Tomography X-Ray System) Dated: August 22, 2001 Received: August 23, 2001 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the interest we nave revelved your Section 10(k) notication of their to make as a legally marketed predicate devices marked in interstated in substantially equivalent (or the motions to the Medical Device Amendments, or to devices that have been reclassified in commerce probl to May 28, 1970, the clasment and of the real of the et (Act). You may, therefore, market the besigniture accordance will the provisions of the Post, 2004, 2005 and s provisions of the Act include requirements for annual registration, the general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to subject to subject to subject to subject to subject to subject to su If your device is classilied (see above) more cass II (opedia Oone of Federal Regulations, Title 21, Partical Regulario Personal additional controls. Existing major regulations articles with the Current Good Manufacturing Practice requirements, 800 to 897. A substantaly equivalian assumination assumers of man and manufacturer (21 CFR Part 820) and the children may as set form in the Quality System Regulation (QS) to Medical Derices. Failure to comply with the UMP regulation may QS Inspections, the Food alle Drig Ammisstanon (1 Dr.) Virther announcements concerning your device in the Federal Register. Please result if regulation in addition rumission submission does not affect any obligation you might have under setions 531 through nove. uns response to your premation babinessen assomes on other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of the post I fills letter will allow your device to a legally marked 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4,xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation and all a reference to premarket notification" (21 CFR 807.97). Other general Alst, please not responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C brogdon

Nancy C. Bk ogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Special 510(k) Premarket Notification Special 510(K) Premarket Notifioution
GE Medical Systems - LightSpeed Plus Mobile CT System August 22, 2001

STATEMENT OF INTENDED USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: LightSpeed Plus Mobile CT System

Indications for Use

The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray
the states and while the subservation and as answere as a fixed The LightSpeed Plus CT Scanner System is indication for house of the mobile as well as a fixed site environment.

(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)

Over-The-Counter Use_

Nancy broaden

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012836
510(k) Number.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.