General Nuclear Medicine imaging procedures for detection of radioisotope . tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.
General Head & Body computed tomography (CT) applications. ◆
Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation . correction imaging as well as functional and anatomical mapping imaging (registration and fusion).

Device Description

The "Infinia LightSpeed" system is a combination of the Infinia NM Scanner (K022960 & K991841) and the "LightSpeed" 5 CT Scanner (K030420). In addition to providing CT and NM standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the NM images and to facilitate localization of the emission activity in the patient anatomy.

AI/ML Overview

This document describes the Infinia LightSpeed system, a combination of a Nuclear Medicine (NM) scanner and a Computed Tomography (CT) scanner, primarily for performing SPECT/CT attenuation correction and functional/anatomical mapping.

Here's an analysis of the provided text regarding acceptance criteria and the study:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Standards)	Reported Device Performance
Code of Federal Regulations Title 21 Subchapter J- Radiological Health - 21CFR1020.30, 21CFR 1020.33	Implied to be met, as the device is determined substantially equivalent to legally marketed devices based on similar intended use and system performances, which would inherently include compliance with these regulations for radiological health. No specific performance metrics are provided in relation to these regulations.
NEMA NU 1-2001	Implied to be met, as the device is determined substantially equivalent to legally marketed devices based on similar intended use and system performances. No specific performance metrics are provided against NEMA NU 1-2001.
IEC60601-1 and associated collateral and particular standards	Implied to be met, as the device is determined substantially equivalent to legally marketed devices based on similar intended use and system performances. No specific performance metrics are provided against IEC60601-1.
Attenuation Correction Capability	Phantom data shows that SPECT/CT attenuation-corrected images are more uniform than NM images without attenuation correction.
Localization Capabilities	The images (from phantom data) demonstrate the localization capabilities of the SPECT/CT.

Note: The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive new clinical study data with detailed acceptance criteria and standalone performance metrics. The performance criteria listed are general regulatory and industry standards, and the "reported device performance" is a high-level summary of phantom study results.

Study Information

The provided document refers to a "Summary of Studies" that relies on phantom data. It is a submission for substantial equivalence based on modifications to existing devices, rather than a de novo submission requiring extensive new clinical trials.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The study involved "Phantom data," implying a controlled test using physical phantoms, not human subjects.
- Data Provenance: Not specified, but likely obtained in a controlled laboratory setting (prospective data from phantom experiments).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study utilized phantom data and objective measurements for uniformity and localization, which do not typically require expert consensus for ground truth establishment in the same way clinical image interpretation does.
Adjudication method for the test set:
- Not applicable. As the study used phantom data and objective measurements, there was no adjudication of expert interpretations.
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. The document describes a technical and performance evaluation using phantom data, not a multi-reader, multi-case clinical study involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "study" described is a standalone performance evaluation of the SPECT/CT system's capabilities using phantom data, focusing on image quality (uniformity) and localization. It evaluates the system's inherent ability to produce corrected and localized images.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the phantom study would be known physical properties and distributions within the phantom, along with objective measures of uniformity and spatial accuracy.
The sample size for the training set:
- Not applicable. The document describes a medical device system, not an AI algorithm that would typically have a "training set." The system's algorithms for attenuation correction and image reconstruction are based on established physics and engineering principles, not machine learning from a large training dataset as understood in AI/ML contexts.
How the ground truth for the training set was established:
- Not applicable, for the same reasons as point 7.

Summary

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DEC 2 3 2004

K043381
Page 1 of 2

510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b) 10.

Device Name
Proprietary Device Name:	Infinia LightSpeed
Establishment Name and Registration Number of Submitter
Name:	GE MEDICAL SYSTEMS F.I, HAIFA
Registration Number:	9613299
Corresponding Official:	Laurence Bigio
	GE MEDICAL SYSTEMS F.I, HAIFA
	P.O. Box 170
	Tirat Hacarmel 30200, ISRAEL
Device Classification
Classification Code:	90 KPS & 90 JAK
Panel Identification:	Radiology
Classification Name:	System Emission Computed Tomography (per21CFR 892.1200)
	System Computed Tomography(per 21CFR 892.1750)
Common Name:	Single Photon Emission Computed TomographyComputed Tomography X-Ray
Classification Class:	Class II Product

Performance standards:

Code of Federal Regulations Title 21 Subchapter J- Radiological Health -. 21CFR1020.30, 21CFR 1020.33.
NEMA NU 1-2001. ●
. IEC60601-1 and associated collateral and particular standards.

Reason for 510(k) Submission

Modifications of legally marketed devices.

Identification of Legally Marketed Equivalent Devices

GE Quasar Nuclear Medicine System ("Infinia")	K022960
"LightSpeed" 5.0 Computed Tomography System	K030420
Hawkeye Option for Dual Head Variable Angle Gamma Camera	K991841

Device Description

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K043381
Page 2 of 2

Description of Change or Modification

The Infinia Scanner (K022960) has been modified to accommodate for the CT subsystem, by including a means to align the gantries, a common table and additional software for use of CT for purposes of attenuation correction.

Intended Use of Device

The intended use of the "Infinia LightSpeed" system is to perform:

General Nuclear Medicine imaging procedures for detection of radioisotope . tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.
General Head & Body computed tomography (CT) applications. ●
Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation . correction imaging as well as functional and anatomical mapping imaging (registration and fusion).

Summary of Studies

Phantom data shows that SPECT/CT attenuation-corrected images are more uniform than NM images without attenuation correction. The images also demonstrate the localization capabilities of the SPECT/CT.

Conclusion

In the opinion of GE MEDICAL SYSTEMS F.I., HAIFA the "Infinia LightSpeed" is substantially equivalent in terms of safety and effectiveness to the legally marketed Infinia (K022960) equipped with the Hawkeye option (K991841) and to the legally marketed LightSpeed 5.0 (K030420), based upon similar intended use and system performances.

Page 25 of 28

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes across its body, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2004

GE Medical Systems F.I. HAIFA (9613299) % Mr. Alex Grob Senior Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K043381

Trade/Device Name: Infinia LightSpeed Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 KPS and JAK Dated: December 6, 2004 Received: December 9, 2004

Dear Mr. Grob:

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 reasy 2019, 11:53 am 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 do inc. require apperal 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 roderal batered and limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

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

Enclosure

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STATEMENT OF INTENDED USE

K 043381

510(k) Number (if known):

Device Name: Infinia LightSpeed

Indications for Use

The intended use of the "Infinia LightSpeed" system is to perform:

General Nuclear Medicine imaging procedures for detection of radioisotope . tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.
General Head & Body computed tomography (CT) applications. ◆
Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation . correction imaging as well as functional and anatomical mapping imaging (registration and fusion).

(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,
and Radiological Devices
510(k) Number_________________

Infinia LightSpeed 510k Nov30.doc

Page 23 of 28

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.