K Number

Device Name

IU22 DIAGNOSTIC ULTRASOUND SYSTEM

Manufacturer

PHILIPS ULTRASOUND, INC.

Date Cleared

2013-06-18

(112 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

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 (including ElastPQ). 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 4.3 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 modifications to 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. ElastPQ is the Philips Ultrasound marketing name for a feature commonly referred to as shear wave elastography. The terms will be used interchangeably throughout the submission and supplemental information. The ElastPQ (shear wave) feature provides the user with tissue stiffness information. The iU22 Ultrasound system was cleared for Elastography modes per 510(k) K093563. ElastPQ is an Elastography mode on the iU22 Ultrasound Scanner where a burst of Doppler-type "push" pulses with high intensity and long pulse duration is transmitted. This mode creates waves in soft tissues and estimates the tissue stiffness by determining the speed at which these shear waves travel. This shear wave technology is similar to the ShearWave™ feature recently cleared on Aixplorer® by SuperSonic Imagine, Inc, per 510(k) K112255. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K093563, K112255

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound technology and a specific elastography feature (ElastPQ) which is based on measuring shear wave speed, not AI/ML. There are no mentions of AI, ML, training data, or performance metrics typically associated with AI/ML algorithms.

Therapeutic

No
Explanation: The device is explicitly stated as a "Diagnostic Ultrasound System" and its intended use is for "diagnostic ultrasound imaging" and "diagnosis of patients." It aids in diagnosis by providing information for healthcare professionals, rather than directly treating a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "The iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging..." and lists applications for diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly details hardware components like transducers, piezo electric arrays, and circuitry that generate and process ultrasonic waves. It is a complete ultrasound system, not just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that the iU22 Diagnostic Ultrasound System uses ultrasonic pressure waves transmitted through body tissues to create images and analyze fluid flow. It does not analyze specimens taken from the body.
Intended Use: The intended use describes diagnostic imaging of various anatomical sites within the body.
Lack of Specimen Analysis: There is no mention of analyzing biological specimens in the device description or intended use.

Therefore, the iU22 Diagnostic Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 4.3 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

Product codes (comma separated list FDA assigned to the subject device)

90IYN, 90IYO, 90ITX

Device Description

ElastPQ is the Philips Ultrasound marketing name for a feature commonly referred to as The terms will be used interchangeably throughout the shear wave elastography. submission and supplemental information.

The ElastPQ (shear wave) feature provides the user with tissue stiffness information. The iU22 Ultrasound system was cleared for Elastography modes per 510(k) K093563. ElastPQ is an Elastography mode on the iU22 Ultrasound Scanner where a burst of Doppler-type "push" pulses with high intensity and long pulse duration is transmitted. This mode creates waves in soft tissues and estimates the tissue stiffness by determining the speed at which these shear waves travel. This shear wave technology is similar to the ShearWave™ feature recently cleared on Aixplorer® by SuperSonic Imagine, Inc, per 510(k) K112255.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Intra-operative, Abdominal, Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicle), Adult and Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional, Superficial), Urology, Cardiac (Adult, Pediatric, Trans-esophageal), Fetal Echo, Peripheral Vessel, Cerebral Vascular.

Indicated Patient Age Range

Adult, Pediatric, Neonatal. Fetal patients are also included.

Intended User / Care Setting

Competent healthcare professionals.
Clinical environments where the iU22 4.3 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Shear Wave Elastography Thermal Test: Purpose was to understand the thermal implications of shear wave.
ElastPQ Measurement Report: A bench test of the iU22 ultrasound system in ElastPQ mode in order to verify precision and reproducibility.
Software Verification and Validation: Standard verification and validation testing in order to ensure the system meets specifications and user needs.

A clinical trial was not required. A usability study on ElastPQ was performed following the FDA's draft guidance on human factors (June 2011) to ensure the ElastPQ analysis package meets the usability needs of the users.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093563, K112255

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

K130499
Page 1 of 5
IU22 Ultrasound ElastPQ

JUN 1 8 2013

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

Date prepared: February 20, 2013

510(k) Premarket Notification

1. 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 iU22 Ultrasound System Proprietary name:

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 modifications to the iU22 Ultrasound System is substantially equivalent to the following currently marketed devices:

Product	510(k)
Philips iU22	K093563
SuperSonic Aixplorer	K112255

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 4.3 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.

6. Indications for Use

The 510(k) Indications for Use forms on the following 2 pages show previously cleared indications for use for the iU22 system and the new mode of operation (ElastPQ) added with this 4.3 release of iU22. The iU22 4.3 release adds a new mode of operation (ElastPQ) for the C5-1 transducer so the Indications for Use form for C5-1is also included in this submission. All other previously cleared transducers used for the iU22 remain unchanged.

7. Safety Considerations

As a track 3 ultrasound device the iU22 Ultrasound system is designed to comply with the Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA 2004).

iU22 Ultrasound complies with the referenced standard as well as the FDA ultrasound specific guidance, Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008).

The acoustic output limits for Non-Ophthalmic Applications are:

Ispta.3 ≤ 720 MW/cm² .
MI 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 Diagnostic Ultrasound System can be used include Clinical, Hospital, and point-of-care for diagnosis of patients.

These use models are within the scope of and substantially equivalent to current indications-for-use-for-the-iU22.Diagnostic.Ultrasound.System.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Smh?)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K130499 510(k)

Page 1 of

510(k) Premarket Notification

iU22 Diagnostic Ultrasound with ElastPQ

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No: System:

iU22 Ultrasound System

K130499

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	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, 16
	Intra-operative
(Abdominal, cardiac, spine,.
Vascular)	P	P	P	P	P	Notes 1,2,3,4	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	P	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	Notes
5,6,8,9,10,11,12,13,15
	Neonatal Cephalic	P	P	P		P	Notes 1,3	Notes 5,8,10,12,13
	Adult Cephalic	P	P	P	P	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	Notes 5,6,7,10,11,12,13
	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	Notes 1,2,3,4	Notes 10,11,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Notes 1,2,3,4	Notes 10,11,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Notes 1,2,3,4	Notes 10,11,12,13
	Other (Fetal Echo)	P	P	P	P	P	Notes 1,2,3,4	Notes 5,10,12,13
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Notes 1,2,3,4	Notes
2,3,5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P		P	Notes 1, 2, 3	Notes 5,6,8,9,10,12,13
N= new indication; P= previously cleared (K093563); E= added under Appendix E (*9/21/2005)
Additional Comments:
*Color Doppler includes Color Amplitude Doppler			Note 9: EFOV including Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M			Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color			Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;			Note 12: 3D Imaging

Note 4: Combined modes include: B+CWD; B+Color+CWD; Note 13: XRES B+Amplitude+CWD Note 14: TDI Note 5: SonoCT Note 6: Imaging for guidance of biopsy Note 15: Elastography Note 16: ElastPQ Note 7: Infertility monitoring of follicie development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging

includes SonoCT imaging

Page 2 of

510(k) Premarket Notification

iU22 Diagnostic Ultrasound with ElastPQ

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT ,

510(k) No:	K130499
System:	iU22 Ultrasound System
Transducer:	CS-1
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation (*includes simultaneous B-mode)
Clinical Application		B	M	PWD	CWD	Color Doppler*	Combined* (Spec.)	Other (Spec.)
General (Track I only)	Specific (Tracks I & III)
	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, 16
Fetal Imaging & Other	Intra-operative (cardiac)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Notes 1, 3	Notes 5,6,8,10,12,13
	Small Organ (Breast, thyroid, testicle)
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Fetal Echo
Peripheral Vessel	Peripheral vessel	P	P	P		P	Notes 1, 2, 3	Notes 5,6,8,9,10,12,13
	Cerebral Vascular

N= new indication; P= previously cleared (K093563), E= Added under appendix E.

Additional Comments:

*Color Doppler includes Color Amplitude Doppler	Note 9: EFOV including Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
Note 3: Combined modes include: 8+Color+PWD; B+Amplitude+PWD	Note 12: 3D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI

Note 15: Elastography

Note 16: ElastPQ

Note 6: Imaging for guidance of biopsy Note 7: Infertility monitoring of follicle development Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

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