The iU22 system and transducer(s) function in a manner identical to all diagnostic ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The iU22 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a diagnostic ultrasound system (Philips iU22). This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended use and technical specifications.

It does not contain information about:

Specific acceptance criteria with numerical targets. The document states that "The systems have acoustic output levels below the applicable FDA limits" and "The systems are designed and manufactured to applicable electrical and physical safety standards," but it doesn't provide the specific numerical limits or performance metrics.
A study that proves the device meets acceptance criteria. The 510(k) process for this type of device relies on substantial equivalence rather than explicit performance studies with acceptance criteria for device accuracy or diagnostic capability, especially in the context of AI.
Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance. These are typically associated with performance studies for AI/CADe devices, which this ultrasound system, being from 2004, likely does not incorporate in the way modern AI devices do.
Ground truth establishment for training sets or their sample sizes. Again, this points to AI development and validation, which is not described here.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The document is for a traditional diagnostic ultrasound system seeking 510(k) clearance based on substantial equivalence to existing devices, not a study validating an AI algorithm's performance against specific metrics.

Summary

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K04254D

OC7 4 - 2004

510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92.

1) Submitter's name, address, telephone number, contact person

Philips Ultrasound 22100 Bothell Everett Highway Telephone: (425) 487-7312 Facsimile: (425) 487-8666 E-mail: Lynn.harmer@philips.com

Contact Person: Lynn Harmer

Date prepared: 21 July 2004

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name:	Diagnostic ultrasound system with accessories
Proprietary Name:	iU22 ultrasound system

Classification Name	21 CFR Section	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasonic Transducer	892.1570	90-ITX

3) Substantially Equivalent Devices

Philips Ultrasound believes that the iU22 system and transducers are substantially equivalent to the following currently marketed devices:

QLAB (K040227;) LV Analysis (K022824;) and M2424 (K022303)

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4) Device Description & Technical Comparison to Predicate Devices

The iU22 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

5) Intended Use

The iU22 system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body.

6) Conclusion

The iU22 system and transducers are substantially equivalent in safety and effectiveness to the predicate systems and transducers listed in item 3 above.

. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis.
The systems have the same gray-scale and Doppler capabilities. .
The systems use essentially the same technologies for imaging, Doppler functions and . signal processing.
. The systems have acoustic output levels below the applicable FDA limits.
The systems are manufactured of materials with materials that have been evaluated . and found to be safe for its application.
. The systems are designed and manufactured to applicable electrical and physical safety standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 4 - 2004

Phillips Ultrasound, Inc. % Ms. Michelle S. Lee Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K042540

ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Trade Name: iU22 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system 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: September 17, 2004 Received: September 20, 2004

Dear Ms. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w onate formed your booms been 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 May 20, 1910, and vith 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.

This determination of substantial equivalence applies to the following transducers intended for use with the iU22 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

X3-1 दर्श्-रि

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

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· Page 2 - Ms. Lee

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 (301) 594-4591. 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 entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours.

Daniela Logemann

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

Enclosure(s)

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System:

iU22 Ultrasound System

Intended Use:

1022 Untrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler**	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic	P	P	P	P	P	Notes 1, 3	Notes 5, 6, 8,10,12, 13
	Fetal	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10, 12, 13
	Abdominal	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10, 11, 12, 13
	Intra-operative(Abdominal, Cardiac*, Spine, Vascular)	P/N*	P/N*	P/N*	P/N*	P/N*	Notes 1, 3	Notes 5, 6, 8,10,12, 13
Fetal Imaging& Other	Intra-operative (Neuro.)	P	P	P	P	P	Notes 1, 3	Notes 3, 5, 6, 10, 12, 13
	Laparoscopic	P	P	P	P	P	Notes 1, 3	Notes 8, 10, 12, 13
	Pediatric	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8, 9, 10, 12, 13
	Small Organ (breast, thyroid, testicle)	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8, 10, 11, 12, 13
	Neonatal Cephalic	P	P	P	P	P	Notes 1, 3	Notes 5, 8, 10, 12, 13
	Adult Cephalic	P	P	P	P	P	Notes 1, 3, 4	Notes 10, 13
	Trans-rectal	P	P	P	P	P	Notes 1, 3	Notes 5,6,10,11,12, 13
	Trans-vaginal	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 7,10, 11,12, 13
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8,10, 12,13
	Musculo-skel. (Superficial)	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8, 10, 12,13
	Intra-luminal
	Other: Urology	P	P	P	P	P	Notes 1, 3	Notes 5, 10, 12
Cardiac	Cardiac Adult	P	P	P	P	P	Notes 1,2,3,4	Notes 10, 11, 12, 13
	Cardiac Pediatric	P	P	P	P	P	Notes 1,2,3,4	Notes 10, 11, 12, 13
	Trans-esophageal (Cardiac)	P	P	P	P	P	Notes 1,2,3,4	Note 10
	Other (Fetal Echo)	P	P	P	P	P	Notes 1,2,3,4	Notes 5,10, 12, 13
Peripheral	Peripheral vessel	P	P	P	P	P	Notes 1, 2, 3	Notes 2, 3, 5, 6, 7, 8, 10, 12, 13
	Cerebral Vascular	P	P	P	P	P	Notes 1, 2, 3	Notes 5, 6, 8, 10, 12, 13

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

Additional Comments:

*Addition of intraoperative (cardiac)

**Color Doppler includes Color Amplitude Doppler

Oolor Doppior instados Solor Include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 2: Combined modes include: B+Color+PWD; B+Amplitude+PWD;
Note 3: Combined modes include: B+Color+PWD; B+Amplit

Note of Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 7. Internity monitoring of follore development
Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Prescription Use (Per 21 CRF 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Lyons

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devic 510(k) Number _

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System: Transducer: Intended Use:

iU22 Ultrasound System

X3-1 XS-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	Notes 1, 3	Notes 5, 6, 8, 10,12, 13
	Abdominal	P	P	P		P	Notes 1,3	Notes 5, 6, 8, 10,12, 13
	Intra-operative (cardiac)	N	N	N		N	Notes 1,2,3	Notes 10, 11, 12, 13
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult	N	N	N	N	N	Note 1	Notes 10, 11, 12, 13
Cardiac	Cardiac Pediatric	N	N	N	N	N	Notes 1, 2, 3	Notes 10, 11, 12, 13
	Trans-esophageal (Cardiac)					P
	Fetal Echo	P	P	P		P	Notes 1, 2, 3	Notes 5, 10, 12,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

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

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Oolor Doppior Inoladoo Ocieclude: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 2: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 7. Internity monitoring of follors and of others.
Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 12: YPES

Note 13: XRES

Prescription Use (Per 21 CRF 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Syson

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

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Section 4.3

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number:
System:
Transducer:
Intended Use:

iU22 Ultrasound System

$5-1 53-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	FetalAbdominalIntra-operative (cardiac)Intra-operative (Neuro.)LaparoscopicPediatricSmall OrganNeonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Cardiac)Musculo-skel. (Conventional)Musculo-skel. (Superficial)Intra-luminal
	Other (Specify)Cardiac Adult	E	E	E	E	E	Notes 1, 2 3,4	Notes 10, 11, 13
Cardiac	Cardiac Pediatric	E	E	E	E	E	Notes 1, 2 3,4	Notes 10, 11, 13
	Trans-esophageal (Cardiac)Fetal Echo
PeripheralVessel	Peripheral vesselCerebral Vascular

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

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Solor Dopping modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 2: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note e: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 7. Infentify monitoring of follors devolusions
Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 12, OD Rings
Note 13, YDES

Note 13: XRES

Prescription Use (Per 21 CRF 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radining cal Devices 51(%) Number

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.