IU22 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K130499 |
|---|---|
| Device Name | IU22 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Philips Ultrasound, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jun 18, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for 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
Device Story
iU22 Diagnostic Ultrasound System modified to include ElastPQ (shear wave elastography) feature; system generates electronic voltage pulses transmitted to piezoelectric transducer array; transducer converts pulses to ultrasonic pressure waves; system processes Doppler shift frequencies from moving targets (e.g., blood) for flow display; ElastPQ mode transmits high-intensity, long-duration 'push' pulses to create shear waves in soft tissue; system estimates tissue stiffness by measuring shear wave travel speed; used in clinical, hospital, and point-of-care settings by healthcare professionals; output provides anatomical measurements and tissue stiffness data; assists clinicians in diagnosis; benefits include non-invasive assessment of tissue stiffness.
Clinical Evidence
No clinical trial required. Evidence includes bench testing (thermal implications of shear wave, precision and reproducibility of ElastPQ measurements) and a usability study conducted per FDA human factors guidance. Device safety supported by review of field information and compliance with established electrical and acoustic output standards.
Technological Characteristics
Diagnostic ultrasound system using piezoelectric transducer arrays. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Acoustic output meets Track 3 limits (Ispta.3 ≤ 720 mW/cm², MI < 1.9, TI ≤ 6.0). ElastPQ mode utilizes high-intensity, long-duration Doppler-type 'push' pulses to induce shear waves. System supports B-mode, M-mode, Pulse/Continuous Wave Doppler, Color Doppler, Tissue Doppler, and Harmonic imaging.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients across a broad range of clinical applications including ophthalmic, fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac, and peripheral vessel assessments.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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K130499
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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
- 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 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 |
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#### 4. Device Description and Technical Comparison to Predicate Devices
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 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.
#### 5. 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
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## 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.
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### 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 < 1.9 .
- TI ≤ 6.0 .
The system and transducers are also complaint to:
- IEC 60601-1 Medical Electrical Equipment Part 1, general requirements for . safety 1988 Amendment, 1991-11, Amendment 2, 1995
- IEC 60601-1-2 Medical Electrical Equipment -- Part 1-2, General Requirements . for Safety - Collateral Standard Electromagnetic Compatibility, 2000
- IEC 60601-2-37 Medical Electrical Equipment Part 2-37: Particular . Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
### 8. Nonclinical Performance Data
Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the modified iU22 device:
- Shear Wave Elastography Thermal Test The purpose of this testing 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.
#### 9. Clinical Data
A clinical trial was not required to demonstrate safety and effectiveness of the ElastPQ Elastography mode. As part of our investigation a review of all relevant field information was performed resulting in the conclusion the technology is safe.
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#### 510(k) Premarket Notification
iU22 Diagnostic Ultrasound with E
A usability study on ElastPQ was performed following the FDA's draft guidance on human factofs (June 2011). This work was conducted to ensure the ElastPQ analysis package meets the usability needs of the users.
#### 10. Conclusion
iU22 Ultrasound System and transducers with ElastPQ is substantially equivalent in safety and effectiveness to the predicate devices identified above:
- 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.
#### 514 Performance Standards
There are no Sec. 514 performance standards for this device.
#### Prescription Status
This is a prescription device. The prescription device statement appears in the labeling.
#### Sterilization Sites
Not applicable. No components supplied sterile.
#### Track
This is a Track 3 system
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2013
Philips Ultrasound, Inc. % Ms. Jessica Stenberg Regulatory Affairs Specialist 22100 Bothell Everett Highway BOTHELL WA 98021
Re: K130499
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, ITX Dated: May 10, 2013 Received: May 24, 2013
Dear Ms. Stenberg:
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 adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
### CS-I
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.
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#### Page 2 - Ms. Stenberg
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Smh7).
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics . and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): K130499
Device Name: Philips iU22 Diagnostic Ultrasound System
Indications for 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 Liver). 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 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)
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## 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | P | P | P | | P | Notes 1,3 | Notes, 5,6,8,10,12,13 |
| Fetal Imaging<br>& Other | Fetal (includes Echo) | P | P | P | | P | Notes 1,2,3 | Notes,<br>5,6,7,8,10,11,12,13 |
| | Abdominal (includes urology) | P | P | P | | P | Notes 1,2,3 | Notes,<br>5,6,7,8,9,10,11,12,13, 16 |
| | Intra-operative<br>(Abdominal, cardiac, spine,.<br>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,<br>testicle) | P | P | P | | P | Notes 1,2, 3 | Notes<br>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<br>Vessel | Peripheral vessel | P | P | P | | P | Notes 1,2,3,4 | Notes<br>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;<br>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
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## 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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