Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Device Description

The GE LOGIQ Twin is a compact and portable diagnostic utrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

AI/ML Overview

The provided text is a 510(k) premarket notification for the GE Vivid-i Diagnostic Ultrasound System. This type of regulatory submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. It does not typically require extensive clinical studies with specific acceptance criteria in the same way a Premarket Approval (PMA) application would for a novel device.

Based on the provided document, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of quantitative acceptance criteria for device performance or corresponding reported performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device (GE Vivid-i Ultrasound System, K033139) by highlighting comparable design, construction, materials, safety, effectiveness features, and intended uses.

The "device performance" in this context refers to the device's ability to function safely and effectively for its intended uses, which are the same as the predicate device. The performance is implied to be equivalent to the predicate.

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

No specific test set or associated sample size is mentioned for clinical performance evaluation. The document states: "2. Clinical Tests: None required." This indicates that no new clinical study was conducted to demonstrate performance in a test set. This is typical for a 510(k) submission where substantial equivalence to an already approved device is being leveraged.

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

As no clinical tests were required or performed, there is no mention of experts establishing a ground truth for a test set.

4. Adjudication Method for the Test Set

Since no clinical tests were required or performed, there is no adjudication method mentioned for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No such study was performed or mentioned in this document. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool in the sense of providing automated readings or interpretations.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to the device described. The GE Vivid-i is a diagnostic ultrasound system that produces images and data for interpretation by a qualified physician (human-in-the-loop). It is not an algorithm designed for standalone diagnostic performance.

7. The Type of Ground Truth Used

No explicit ground truth is mentioned in the context of a new clinical study for this 510(k) submission. The basis for safety and effectiveness relies on the substantial equivalence to the predicate device, which would have been established through traditional clinical practice and established methods of patient examination.

The indications for use (e.g., Fetal, Abdominal, Cardiac, etc.) are listed as "P = previously cleared by FDA" for the overall system and "E = added under Appendix E" for certain transducers, meaning their performance for those indications was previously evaluated and deemed acceptable.

8. The Sample Size for the Training Set

No training set is mentioned as this is not an AI/machine learning device that requires a training set in the typical sense for performance evaluation.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set is mentioned.

Summary of the Study (or lack thereof) Proving the Device Meets Acceptance Criteria:

The document states that "Clinical Tests: None required." and "Diagnostic ultrasound has accumulated a long history of safe and effective performance."

Instead of a new study with specific acceptance criteria, GE Healthcare demonstrated that the modified GE Vivid-i ultrasound system is substantially equivalent to a currently marketed predicate device (GE Vivid-i Ultrasound System, K033139). This equivalence is based on:

Comparable Design, Construction, and Materials: The new device shares these fundamental aspects with the predicate.
Comparable Key Safety and Effectiveness Features: Implies that the new device performs at a similar level regarding safety and clinical effectiveness as the predicate.
Same Intended Uses: The device is intended for the same clinical applications as the predicate.
Additional Software Features: These features are stated to be identical to those of other cleared GE Ultrasound systems, suggesting prior regulatory review and approval.
Non-Clinical Tests: The device underwent evaluations for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical device safety standards.
Quality Systems: The manufacturer's design and development process conforms to 21 CFR 820, ISO 9001, and ISO 13485 quality systems.

The FDA's decision to clear the device (K061525) is based on the determination of substantial equivalence to the predicate device, which implies that the device meets "acceptance criteria" effectively inherited from the predicate's established safety and effectiveness.

Summary

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Kobls25

Attachment B

Summary of Safety and Effectiveness

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

GE Healthcare General Electric Company P.O. Box 414, Milwaukee, W153201 Section a): GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 1. Submitter: PO Box 414 Milwaukee, WI 53201 Contact Person: Allen Schuh, Manager, Safety and Regulatory Engineering Telephone: 414-721-3992; Fax: 414-721-3899 June 1, 2006 Date Prepared: 2. Device Name: GE Vivid-i Diagnostic Ultrasound System Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX

Marketed Device: GE Vivid-i Ultrasound System, K033139 currently in commercial distribution.
Device Description: The GE LOGIQ Twin is a compact and portable diagnostic utrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
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); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Comparison with Predicate Device: The modified GE Vivid-i is of a comparable type and substantially equivalent to the currently marketed GE Vivid-i. It is a compact and readily portable unit having the same design, construction, and materials; is comparable in key safety and effectiveness features. It has the same intended uses as the predicate device and additional software features are identical to that of other cleared GE Ultrasound systems.

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 guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO13485 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 Twin 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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is text that reads 'U.S. Department of Health and Human Services'.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering General Electric Company GE Healthcare P.O. Box 414 MILWAUKEE WI 53201

Re: K061525 Trade Name: GE Vivid-i Regulation Number: 21 CFR 8892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR 8892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: June 1, 2006 Reccived: June 2, 2006

Dear Mr. Schuh:

We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

JUL - 3 2006

This determination of substantial equivalence applies to the following transducers intended for use with the GE Vivid-i, as described in your premarket notification:

Transducer Model Numbers

4C-RS 12L-RS 55-RS

WT 33201

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Page 2 - Mr. Allen Shuh

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 (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.

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.

Sincerely yours.

David h. Lyman
N. S. B.

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

Enclosures

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K061525

Diagnostic Ultrasound Indications for Use Form

GE Vivid-i Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P
Other[4]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative (specify)[5]	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Jainid A. Kay

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devi 510(k) Number

Prescription User (Per 21 CFR 801.109)

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K06/525

Diagnostic Ultrasound Indications for Use Form

GE Vivid-i with 4C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	E	E	E		E		E	E	E
Abdominal[1]	E	E	E		E		E	E	E
Pediatric	E	E	E		E		E	E	E
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	E	E	E		E		E	E	E
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic;

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology;

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[*] Coded Pulse is for digitally encoded harmonics and B-flow.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) this of (Nivision Sign-Off) ' Oversion of Reproductive, Abdominal ano Radiological Devices 510(k) Number _ Prescription User (Per 21 CFR 801.109)

E-3

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K061525

Diagnostic Ultrasound Indications for Use Form

GE Vivid-i with 12L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	E	E	E	E	E	E	E
Small Organ (2)	E	E	E	E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	E	E	E	E	E	E	E
Musculo-skeletal Conventional	E	E	E	E	E	E	E
Musculo-skeletal Superficial	E	E	E	E	E	E	E
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (5) (specify)	E	E	E	E	E	E	E
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [2] Small organ includes breast, testes, thyroid.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

["] Coded Pulse is for digitally encoded harmonics and B-flow.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Larson

(Division Sign-Off) Chinston of Reproductive, Abdominal, and Radiological Devices 51 Ojk) Number .

Prescription User (Per 21 CFR 801.109)

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K061525

Diagnostic Ultrasound Indications for Use Form

GE Vivid-i with 5S-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging
Ophthalmic
Fetal / Obstetrics	E	E	E	E	E	E	E	E	E
Abdominal[1]	E	E	E	E	E	E	E	E	E
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic	E	E	E	E	E	E	E	E	E
Cardiac[3]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes GYN.

[3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Erid U. Sayan

Mivision Sign-Off) Amon of Reproductive, Abdominal, - Cadiological Devices 5 Horry Number _____

Prescription User (Per 21 CFR 801.109)

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.