The iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Harmonics (Tissue and Contrast) and Elastography modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel

The clinical environments where the iU22 3.7 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

Device Description

The subject of this 510(k) notification, the iU22 ultrasound 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 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 healthcare professionals to make a diagnosis.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Philips iU22 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving efficacy or a specific performance metric against acceptance criteria through a clinical study in the way an AI/ML device submission might.

Therefore, the document does not contain information about acceptance criteria for device performance, a study to prove those criteria, sample sizes for a test set, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as typically sought for AI/ML or novel clinical device evaluations.

The "studies" referenced are primarily those that demonstrate the device meets safety and effectiveness standards comparable to the predicate devices, such as acoustic output levels, quality systems, biosafety, and electrical/physical safety standards. These are not performance studies in the sense of demonstrating a clinical outcome or a specific diagnostic accuracy.

Here's an analysis based on the information provided, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for diagnostic performance, nor does it report device performance against such criteria. The "acceptance criteria" for a 510(k) submission like this are centered on demonstrating substantial equivalence to predicate devices, focusing on:

Intended Use: The iU22 system's intended uses are comparable to predicate devices.
Operating Principles/Technology: The iU22 functions in a manner identical to diagnostic ultrasound systems.
Safety Features: Acoustic output levels are below FDA limits, equivalent quality systems are used, materials have equivalent biosafety, and the system adheres to the same electrical and physical safety standards as predicate devices.

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

No information regarding a "test set" in the context of clinical performance evaluation (like for an algorithm) is provided. This 510(k) is not based on a clinical performance study with a test set.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

Not applicable.

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

No MRMC study is mentioned. The submission is about establishing substantial equivalence, not comparative effectiveness.

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

Not applicable. The iU22 is a diagnostic ultrasound system, not an algorithm. Its performance is inherent to its hardware and software for image acquisition and display, which are always used with a human operator.

7. The Type of Ground Truth Used:

Not applicable. The "ground truth" in this context would be the established safety and effectiveness of the existing predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device with a "training set."

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

Not applicable.

Summary based on the provided document:

The Philips iU22 Diagnostic Ultrasound System's 510(k) submission (K093563) demonstrates substantial equivalence to predicate devices (Philips iU22 K042540, Siemens Acuson S2000 K072786, Philips QLAB K021966, K023877).

The criteria for this substantial equivalence are listed as:

Identical intended use: Diagnostic ultrasonic imaging and fluid flow analysis.
Same gray-scale and Doppler capabilities.
Acoustic output levels below Track 3 FDA limits.
Manufactured under equivalent quality systems.
Manufactured of materials with equivalent biosafety (evaluated and found safe).
Designed and manufactured to the same electrical and physical safety standards.

The document does not describe any specific clinical studies or performance data against numerical acceptance criteria for diagnostic accuracy, sensitivity, or specificity, as it relies on the predicate devices' established safety and effectiveness.

Summary

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510(k) Premarket Notification

FEB - 1 2010 510(k) Summary of Safety and Effectiveness iU22 Diagnostic Ultrasound System

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, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431

Contact person: Nancy Burke, Regulatory Affairs Specialist Email: Nancy.Burke@philips.com Tel: (425) 487-7371 Fax: (425) 487-8666

Date prepared: November 3, 2009

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 and transducers Proprietary name: iU22 Ultrasound System

These devices are classified as follows:

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

As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.

3. Substantially Equivalent Devices

Philips Ultrasound believes that the iU22 Ultrasound System is substantially equivalent to the following currently marketed devices:

Product	510(k)
Philips iU22	K042540
Siemens Acuson S2000	K072786
Philips QLAB	K021966, K023877

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4. Device Description and 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 healthcare professionals to make a diagnosis.

5. Intended Use

Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel

The clinical environments where the iU22 3.7 system can be used include point-ofcare areas in offices, clinical and hospital settings for diagnosis of patients.

6. Conclusion

iU22 Ultrasound System and transducers is substantially equivalent in safety and effectiveness to the predicate devices identified above:

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The systems are indicated for the diagnostic ultrasonic imaging and fluid flow ♥ analysis.
The systems have the same gray-scale and Doppler capabilities. .
The systems have acoustic output levels below the Track 3 FDA limits. .
The systems are manufactured under equivalent quality systems. .
The systems are manufactured of materials with equivalent biosafety. The . materials have been evaluated and found to be safe for this application.
The systems are designed and manufactured to the same electrical and physical . safety standards.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three birds in flight, arranged in a vertical stack. The birds are silhouetted and appear to be soaring upwards.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

FEB - 1 2010

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K093563

Trade/Device Name: iU22 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 12, 2010 Received: January 13, 2010

Dear Mr. Job:

We have reviewed your Section 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.

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

L12-5

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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Job

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/RevortaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours

signature

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Philips Ultrasound, Inc. 510(k) Premarket Notification

510(k) Number (if known):

Device Name: iU22 Diagnostic Ultrasound System

Indications for Use:

Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel

The clinical environments where the iU22 3.7 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

Prescription Use XX (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amel J. R.

(Division Sign Off) Division of Radiological Devices

510(k) Number	K093563
---------------	---------

Indications for Use Statement

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No: System: Intended Use:

iU22 Ultrasound System

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	P	P	P		P	Notes 1,3	Notes, 5,6,8,10,12,13
Fetal Imaging& Other	Fetal (includes Echo)	P	P	P		P	Notes 1,2,3	Notes,5,6,7,8,10,11,12,13
	Abdominal (includes urology)	P	P	P		P	Notes 1,2,3	Notes,5,6,7,8,9,10,11,12,13
	Intra-operative(Abdominal, cardiac, spine, Vascular)	P	P	P	E*	P	Notes1,2,3,4	Notes 5,6,8,10,12,13
	Intra-operative (Neuro.)	P	P	P		P	Notes 1, 3	Notes 3,5,6,10,12,13
	Laparoscopic	P	P	P		P	Notes 1, 3	Notes 8,10,12,13
	Pediatric	P	P	P	E*	P	Notes 1,2, 3	Notes 5,6,8,9,10,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Notes 1,2, 3	Notes5,6,8,9,10,11,12,13,15
	Neonatal Cephalic	P	P	P		P	Notes 1,3	Notes 5,8,10,12,13
	Adult Cephalic	P	P	P		P	Notes 1,3,4	Notes 10, 13
	Trans-rectal	P	P	P		P	Notes 1,3	Notes 5,6,10,11,12, 13
	Trans-vaginal	P	P	P		P	Notes 1,2,3	Notes5,6,7,10,11,12,13
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Notes 1,2,3	Notes 5,6,8,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Notes 1,2,3	Notes 5,6,8,10,12,13
	Intra-luminal
	Other: Urology	P	P	P		P	Notes 1,3	Notes 5,6,10,12
Cardiac	Cardiac Adult	P	P	P	P	P	Notes1,2,3,4	Notes 10,11,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Notes1,2,3,4	Notes 10,11,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Notes1,2,3,4	Notes 10,11,12,13
	Other (Fetal Echo)	P	P	P	P	P	Notes1,2,3,4	Notes 5,10,12,13
PeripheralVessel	Peripheral vessel	P	P	P		P	Notes1,2,3,4	Notes2,3,5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P		P	Notes 1, 2, 3	Notes 5,6,8,9,10,12,13

N= new indication; P= previously cleared (K042540); E= added under Appendix E (*9/21/2005)

Additional Comments:
*Color Doppler includes Color Amplitude Doppler	Note 8: Extended Field of View (EFOV), AKA PanoramicImaging includes SonoCT imaging
Note 1: Combined modes include: B+PWD; B+Color;B+Amplitude; B+M	Note 9: EFOV including Amplitude Doppler
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD;B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD	Note 12: 3D Imaging
Note 5: SonoCT	Note 13: XRES
Note 6: Imaging for guidance of biopsy	Note 14: TDI
Note 7: Infertility monitoring of follicle development	Note 15: Elastography

DHR

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

(Division Sign-Off) Division of Radiological Devices

510(k) Number K093563

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No:
System:
Transducer:
Intended Use:

iU22 Ultrasound System

12-5

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General	Specific	в	M	PWD	CWD	Colar	Combined*	Other
(Track I only)	(Tracks & III)					Doppler*	(Spec.)	(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)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	p		P	Notes 1, 3	Notes 5,6,8,10,12,13
	Small Organ (Breast, thyroid,	P	P	ר		p	Notes 1, 3	Notes
	testicle)							5,6,8,10,11,12,13,15
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Notes 1, 2, 3	Notes 5,6,8,10,12,13
	Musculo-skel. (Superficial)	D	P	P		P	Notes 1, 2, 3	Notes 5,6,8,10,12,13
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Fetal Echo
Perpheral	Peripheral vessel	p	P	0		P	Notes 1, 2, 3	Notes 5,6,8,9,10,12,13
Vessel	Cerebral Vascular	P	P	്		p	Notes 1, 2, 3	Notes 5,6,8,9,10,12,13

N= new indication; P= previously cleared (K030455), E= Added under appendix E.

Additional Comments:

*Color Doppler includes Color Amplitude Doppler	Note 8: Extended Field of View (EFOV), AKA PanoramicImaging includes SonoCT imaging
Note 1: Combined modes include: B+PWD; B+Color;B+Amplitude; B+M	Note 9: EFOV including Amplitude Doppler
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD;B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD	Note 12: 3D Imaging
Note 5: SonoCT	Note 13: XRES
Note 6: Imaging for guidance of biopsy	Note 14: TDI
Note 7: Infertility monitoring of follicle development	Note 15: Elastography

signature

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

(Division Sign-Off) Division of Radiological Devices

510(k) Number K093563

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.