The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Description

The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide. 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and image enhancement.

AI/ML Overview

This document is a 510(k) Premarket Notification for the GE LOGIQ 9 Diagnostic Ultrasound System with IQ Filter. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to a new AI/filter feature.

Here's a breakdown of why the requested information cannot be provided from the given text:

No new AI/filter feature with performance claims: The key modification mentioned is the "IQ Filter" and "image enhancement". However, the document explicitly states in "Section b): 2. Clinical Tests: None required." This indicates that no new clinical performance claims were being made that would necessitate a study with acceptance criteria.
Focus on substantial equivalence: The core of this 510(k) is demonstrating "substantial equivalence" to a predicate device (the current GE LOGIQ 9) based on having the "same technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and basic operating modes." This means the general safety and effectiveness of ultrasound is already established, and the IQ filter is presented as an enhancement within those established parameters, not a new functional capability requiring its own detailed performance study against specific criteria.
Safety and engineering tests: The non-clinical tests focused on acoustic output, biocompatibility, cleaning, and thermal/electrical/mechanical safety—standard requirements for medical devices, not performance criteria for a specific new image processing algorithm.

Therefore, since the document states "Clinical Tests: None required," and the submission is focused on substantial equivalence based on existing device characteristics, there is no detailed information available in this text regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for the "IQ Filter" or "image enhancement" feature.

The document concludes by stating: "Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 9 BT03 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." This reinforces that the submission did not hinge on demonstrating new, quantified performance metrics for the added feature.

Summary

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K 032656

Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 9 Ultrasound BT03/IQ August 26, 2003

OCT 3 0 2003

Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

			GE Medical Systems
		General Electric CompanyP.O. Box 414, Milwaukee, WI 53201

Section a):

1. Submitter:	GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414Milwaukee, WI 53201
Contact Person:	Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
Date Prepared:	August 26, 2003
2. Device Name:	GE LOGIQ 9 Diagnostic Ultrasound System with IQ Filter,Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
3. Marketed Device:	GE LOGIQ 9 Diagnostic Ultrasound System K011188/K030934 (90-IYO/IYN)A device currently in commercial distribution.

Device Description: The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide. 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and image enhancement.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Comparison with Predicate Device: The GE LOGIQ 9 with the IQ filter is of a comparable type and substantially equivalent to the current GE LOGIQ 9. It has the same technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

2. Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 9 BT03 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

Mr. Allen Schuh Manager, Safety & Regulatory Engineering GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue MILWAUKEE WI 53219

Re: K032656

Trade/Device Name: GE LOGIQ 9 Diagnostic Ultrasound System (added: Speckle Reduction Imaging) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging syster Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN. IYO, and ITX Dated: October 1, 2003 Received: October 2, 2003

Dear Mr. Schuh:

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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Act's requirements, including, but not 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.