The Intended use of the device is to produce attenuation- corrected NM Images. The attenuation maps are also displayed with the NM images to facilitation of the NM activity in the patient anatomy.

Device Description

The "Hawkeye 4 Option" is a modification of the "Hawkeye" option (K991841). "Hawkeye 4 Option" is a Functional Anatomical Mapping and Attenuation Correction option, designed to be used on SPECT system "GE Quasar Nuclear Medicine System" (K022960 trade name "Infinia"). The X-Ray system consists of an X-ray source, High voltage power supply, collimation assembly, X-ray detection unit for 4- detectors, and data collection and processing SW. The X-ray unit is completely integrated with the Infinia (K022960) gamma camera, using the same acquisition station, patient table, and slip-ring gantry. The "Hawkeye 4 Option" provides additional features to optimize radiation dose to the patient up to 700W. The "Hawkeye 4 Option" features a multi-slice X-Ray detector, with four 5mm slices and total axial coverage of 20mm. The "Hawkeye 4 Option" also utilizes helical CT scanning to further improve the image quality, shorten the acquisition time, and enhance dose efficiency. The "Hawkeye 4 Option" provides additional features to optimize radiation dose to the patient using a range of X-ray generator power from 350W to 700W.

AI/ML Overview

The provided document, K052434, is a 510(k) summary for the "Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera". This submission asserts substantial equivalence to a predicate device, the "Hawkeye Option for Dual-Head Variable Angle Gamma Camera" (K991841), rather than demonstrating a novel performance claim requiring extensive new clinical studies and detailed acceptance criteria.

Therefore, the document does not contain the detailed information requested in the prompt, such as specific acceptance criteria for a device's performance, a study proving it meets them, sample sizes for test and training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC study results, or standalone algorithm performance.

Based on the provided text, here's what can be extracted regarding the device's evaluation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria and reported device performance in the manner typically seen for new performance claims for an AI/ML device. Instead, it states that the device was evaluated for safety and conformance to standards.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Electrical, mechanical, and radiation safety	Conforms to applicable medical device safety and performance standards.
Conformance to regulatory standards (21 CFR 820, ISO 9001 and ISO 13485)	Conforms to quality systems and applicable standards.
Substantial equivalence to predicate device (K991841)	Determined to be substantially equivalent.

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

The document does not specify any sample size used for a test set (e.g., number of images, patients, etc.) for evaluating the "Hawkeye 4 Option" beyond general safety testing. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not mention using experts to establish ground truth as would be relevant for an AI/ML diagnostic or prognostic device's performance claim. The evaluation seems to focus on engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable, as no test set requiring expert adjudication for ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study is not mentioned. The submission is a 510(k) for substantial equivalence based on technical modification and safety testing, not a new comparative effectiveness claim.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable, as this is a medical imaging system (hardware and software), not an AI algorithm being evaluated for standalone performance. The "Hawkeye 4 Option" is an integral part of a SPECT system.

7. The Type of Ground Truth Used:

The ground truth or evaluation metrics described are related to electrical, mechanical, and radiation safety standards, and conformance to quality systems (21 CFR 820, ISO 9001, ISO 13485), rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus) for a diagnostic performance claim.

8. The Sample Size for the Training Set:

The document does not refer to a "training set" as would be used in machine learning or AI development.

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

Not applicable, as no training set is mentioned in the context of an AI/ML development pipeline.

Summary of the Document's Focus:

The K052434 submission is a Special 510(k) for device modification. Its primary purpose is to demonstrate "substantial equivalence" of the "Hawkeye 4 Option" to its predicate device (K991841). The evaluation described is centered on:

Device Description: Highlighting modifications like multi-slice X-Ray detection, helical CT scanning, and optimized radiation dose (350W to 700W vs. 700W initially).
Safety and Performance Standards Conformance: Stating that the device has been evaluated for electrical, mechanical, and radiation safety and conforms to applicable medical device safety and performance standards (e.g., 21 CFR 1020.30, 21 CFR 1020.33, 21 CFR 820, ISO 9001, ISO 13485).
Intended Use: The intended use remains the same: "to produce attenuation-corrected NM Images" and "to facilitate the localization of the NM activity in the patient anatomy."
Conclusion of Substantial Equivalence: Based on similar technological characteristics, safety and effectiveness features, basic design, construction, materials, and intended use as the predicate device.

Therefore, this document does not contain the detailed, quantitative performance studies and acceptance criteria typically associated with new AI/ML device submissions, but rather focuses on demonstrating safety and equivalence for a modified imaging system component.

Summary

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K052434

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and the border are in black, set against a white background.

SEP 2 7 2005

GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

Attachment B:

Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c).

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. There are decorative swirls or flourishes around the letters, adding a stylized touch to the design.

GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

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 Systems3000 N. Grandview Blvd.Waukesha, WI 53188
Contact Person:	Laurence BigioQuality, Safety and Regulatory ManagerTelephone: +972-4-856-3663; Fax: +972-4-857-7664
Date Prepared:	August 25, 2005
Device Name:	"Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera", Radiological, 21 CFR 892.1200, 90-KPS
Marketed Device:	"Hawkeye Option for Dual-Head Variable Angle Gamma Camera" -K991841Radiological, 21 CFR 892.1200, 90-KPS

Device Description:

Code of Federal Regulations Title 21 Subchapter J- Radiological Health -21CFR1020.30, 21CFR 1020.33.

Indications for Use:

The Intended use of the device is to produce attenuation- corrected NM Images. The attenuation maps are also displayed with the NM images to facilitation of the NM activity in the patient anatomy.

Comparison with Predicate Device:

The GE "Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera" is a modification of, and is comparable and substantially equivalent to the currently marketed "Hawkeye Option for Dual-Head Variable Angle Gamma Camera" - K991841 This system has the same Special 510(k) Premarket Notification

Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. There are decorative swirls around the letters, adding a touch of elegance to the design. The logo is black and white.

GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

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 "Hawkeye" option (K991841). The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001 and ISO 13485 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 "Hawkeve 4 Option for Dual-Head Variable Angle Gamma Camera" is substantially equivalent to the currently cleared "Hawkeye Option for Dual-Head Variable Angle Gamma Camera" - K991841.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Public Health Service

SEP 2 7 2005

11 11 11 11 11

人 - 上一

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. E. Werner Safety and Regulatory Engineering GE Medical Systems F.J. Haifa 4 Hayozma St., P.O. Box 170 Tirat HaCarmel 30200 ISRAEL

Re: K052434

Trade/Device Name: Hawkeye 4 Option for Dual Head Variable Angle Gamma Camera Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 31, 2005

Received: September 6, 2005

Dear Ms. Werner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in we nave leviewed your becaon 510(tr) prohestantially equivalent (for the indications for use stated in above and nave determined the all needicate devices marketed in interstate commerce prior to the encrosure) to regally maneled production of the Medical Devices that have been May 26, 1970, the clacinent date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a premiums approvisions of the Act. The general controls provisions of the Act device, subject to the general controls proon, 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 If your device is classilled (500 above) hitional controls. Existing major regulations affecting your Apploval), it may oc subject to aderal 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 FICASC oc advised mater 221 ৳ 135amiles with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I caral statues and regulations and limited to registration and listing (21 CFR Part 807); labeling Act s requirements, modaling, but not as active requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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)
10 Jagar This letter will anow you to ocgin makemig your antial equivalence of your device to a legally premarket notification. The PDA midnig of Sacolantial equive and thus, permits your device to proceed to the market.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our lasting of 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 Also, please note the regulation entitled, "Wisotanants of the sunder the Act from the 807.97). You may obtain other general information on 50. John March Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are three decorative swirls around the letters, positioned at the top, bottom left, and bottom right of the circle.

GE Medical System, F.I. | Haifa dical System, F.i. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

STATEMENT OF INTENDED USE-

510(k) Number (if known): __ K 052434

Device Name: "Hawkeye 4 Option for Dual Head Variable Angle Gamma Camera "

Indications for Use

The Intended use of the device is to produce attenuation- corrected NM Images. The The intended use of the dovies to to proh the NM images to facilitate the localization of the NM activity in the patient anatomy.

(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 C. boydon

(Division Division of Reproductive and Rx 510k) Nu

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.