SoftVue

K172256 · Delphinus Medical Technologies · IYO · Mar 2, 2018 · Radiology

Device Facts

• Record ID: K172256
• Device Name: SoftVue
• Applicant: Delphinus Medical Technologies
• Product Code: IYO · Radiology
• Decision Date: Mar 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

SoftVue™ is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning curvilinear array transducer. The device is not intended to be used as a replacement for screening mammography.

Device Story

SoftVue 3.0 is a B-mode ultrasonic imaging system for breast imaging. Patient lies prone on a table with breast submerged in a warm water imaging chamber. A Breast Interface Assembly uses gentle vacuum to center, shape, and stabilize the breast. An automated curvilinear array transducer (single-crystal) scans the breast to acquire ultrasound data. The system processes data into B-mode image slices, which can be stacked for volumetric visualization. It also generates colorized and grayscale relative stiffness maps and combined reflection/sound speed images for radiologist reference. A touchscreen interface allows operator control and patient data entry; DICOM worklist integration is supported. Images are transmitted to an external PACS server for review. The system includes a water conditioning unit for de-gassing and temperature control. The device aids radiologists by providing additional reference information for breast tissue assessment.

Clinical Evidence

No clinical data. Performance was established via non-clinical design verification and validation, including subsystem and full system evaluation, phantom imaging analysis, and acoustic output testing.

Technological Characteristics

B-mode ultrasonic imaging system; 3 MHz operating frequency; single-crystal curvilinear array transducer; water-based coupling medium; prone patient positioning; DICOM connectivity; touchscreen interface. Safety standards: AAMI/IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-2-37.

Indications for Use

Indicated for B-mode ultrasonic imaging of the breast in patients using an automatic scanning curvilinear array transducer. Not for use as a replacement for screening mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SoftVue™ 2.0 (K142517)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Delphinus Medical Technologies % Ms. Jillian M. Reed Regulatory and Clinical Affairs Consultant 45525 Grand River Avenue NOVI MI 48374

March 2, 2018

Re: K172256

Trade/Device Name: SoftVue Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: January 26, 2018 Received: January 31, 2018

Dear Ms. Reed:

We have reviewed vour 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.

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.

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 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| <b>Indications for Use</b> |

| Form Approved: OMB No. | 0910-0120 |
|------------------------|--------------------------|
| Expiration Date: | January 31, 2017 |
| | See PRA Statement below. |

| 510(k) Number (if known) | K172256 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SoftVue |
| Indications for Use (Describe) | SoftVue™ is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning curvilinear array transducer. The device is not intended to be used as a replacement for screening mammography. |

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| FORM FDA 3881 (1/14) | Page 1 of 1 |
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| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|----------------|--------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD<br>Doppler | Color<br>(Specify) | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & Other | Fetal<br>Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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# 1.0 Submitter Information

- 1.1 This Premarket Notification is submitted by:
Delphinus Medical Technologies, Inc. 45525 Grand River Avenue Novi, MI 48374

- 1.2 Contact Information:

| Contact Name: | Jillian M. Reed |
|-------------------|-------------------------|
| Office Telephone: | 860-238-7724 |
| E-mail: | [e-mail] |

- 1.3 Date: February 20, 2018
### Device Name 2.0

- Trade/ Proprietary Name: SoftVue 2.1
- 2.2 Common Name:
- A System, Imaging, Pulsed Echo Ultrasonic
- Transducer, Ultrasonic, Diagnostic A

### 2.3 Classification Name:

- > 21 CFR § 892.1560: Ultrasonic pulsed echo imaging system
- > 21 CFR § 892.1570: Diagnostic ultrasonic transducer

### 2.4 Product Codes

- > IYO Ultrasonic pulsed echo imaging system
- > ITX Diagnostic ultrasound transducer

### 3.0 Predicate Device

The predicate device is identified as SoftVue™ 2.0, manufactured by Delphinus Medical Technologies. SoftVue™ 2.0 received market clearance under 510(k) number K142517.

## 4.0 Device Description

SoftVue™ 3.0 is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast using a curvilinear array transducer that completely surrounds the breast. The SoftVue™ System is comprised of the following subsystems: Transducer, Table/Housing Assembly, Water Conditioning System, Computer Control System, Image Reconstruction System, Power System, and the Data Acquisition System.

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The SoftVue™ System has a built-in curvilinear transducer that is used to acquire ultrasound data. Data are acquired from a patient lying prone on the table with their breast submerged in an imaging chamber filled with warm (body temperature) water. The breast is positioned in the center of the transducer. A Breast Interface Assembly connects to the distal end of the breast using a gentle vacuum, drawing the breast downward to center, shape, and stabilize the breast for optimal imaging. Cameras located at the bottom of the imaging chamber provide a live video feed to the system operator to aid in positioning the patient's breast.

Once the scan is initiated, the transducer collects data that are processed to produce a series of B-mode ultrasound image slices that can be stacked to yield a volumetric ultrasound image of the breast. SoftVue™ also outputs colorized and grayscale relative stiffness image stacks that provide the radiologist with additional reference information.

The Water Control System is used to de-gas and warm the water that is used as the image acquisition medium. The Computer Control System controls the functionality of the other subsystems. The reconstruction engine processes the image data acquired by the transducer ring into B-mode ultrasound images.

The system includes a touchscreen display (user interface). The touchscreen display allows the user to control the system and perform an imaging procedure. Patient information is entered into the system using the QWERTY keyboard on the touchscreen display, or the user can import the patient information from a DICOM modality worklist on an externally networked RIS server. Device errors and warnings are displayed on the touchscreen display.

SoftVue™ outputs the images to an externally networked PACS server which allows the images to be stored until they are reviewed on a workstation.

# Intended Use 5.0

SoftVue™ is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning curvilinear array transducer. The device is not intended to be used as a replacement for screening mammography.

### Predicate Device Comparison 6.0

Delphinus Medical Technologies claims that the SoftVue device is substantially equivalent to the SoftVue system cleared by the FDA in K142517. Delphinus Medical Technologies claims substantial equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, physical and operational specifications as compared to the predicate device.

The SoftVue device and the predicate device utilize B-mode grayscale ultrasound images to achieve their intended use. Both the modified SoftVue device and the predicate SoftVue device are table-top systems that have automatic scanning transducers to image breast tissue.

The specific details regarding similarities and differences between the modified SoftVue 3.0 device and the predicate SoftVue 2.0 device have been identified and explained in the

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Comparison Table section of this submission. A summary of the similarities and differences between the modified SoftVue 3.0 device and the predicate SoftVue 2.0 device is included below. The differences noted between the modified SoftVue 3.0 device and the predicate SoftVue 2.0 device do not present any new issues related to safety and effectiveness.

# Similarities:

- A The modified and predicate SoftVue devices use an automated transducer to acquire stacked coronal images of a patient's breast.
- The modified and predicate SoftVue devices use broadband transducers. A
- A The modified and predicate SoftVue devices have a single operating frequency of 3 MHz.
- A Both systems acquire and process B-mode grayscale images of a patient's breast.
- A Both systems position the patient in a prone position lying on the examination table with the patient's breast in a pendulous position within an imaging chamber.
- A Both systems position the patient's breast in a fluid environment to eliminate the need for breast compression and facilitate the transmission of ultrasound waves.

# Differences:

- A The modified SoftVue device includes a Breast Interface Assembly which is used to center, stabilize, and optimize the shape of the breast. The predicate device does not have a Breast Interface Assembly.
- A The modified SoftVue device allows user access to directly view the sound speed images used to create the color relative stiffness maps. Access to these images is for additional reference information only. The predicate device does not allow user access to sound speed images.
- A The modified SoftVue device uses a single-crystal transducer. The predicate device uses a standard PZT crystal.
- A The modified SoftVue device uses a different transducer array firing pattern, as compared to the predicate device.
- >> The modified SoftVue device delivers an update transmit pulse configuration to enhance low frequency content.
- A The modified SoftVue device offers an alternative reflection imaging output that combines reflection and sound speed images, as additional reference information for radiologists. The predicate device does not output an alternative reflection image.

### 7.0 Summary of Non-Clinical Testing

- The function and performance of the modified SoftVue device has been evaluated 7.1 through non-clinical design verification and validation testing, consisting of both subsystem and full system evaluation. Testing includes system performance and image

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quality tests. The results of the evaluation tests demonstrate that the modified SoftVue device successfully meets the requirements of its intended use.

- 7.2 The SoftVue system has undergone acoustic output testing and was found to be well within industry-accepted limits.
- 7.3 The SoftVue system has been tested to applicable industry safety standards listed in Table 3, below.

| Standard # and Date | Standard Title |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/IEC 60601-1:2005;<br>Corr. 1:2006; Corr. 2:2007 | Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988;<br>Amendment 1, 1991-11, Amendment 2, 1995 |
| IEC 60601-1-2:2007 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety -<br>Collateral standard: Electromagnetic Compatibility - Requirements and Tests<br>(Edition 2:2001 with Amendment 1:2004) |
| IEC 62304:2006 | Medical device software - Software life cycle processes |
| IEC 60601-2-37:2007 | Medical electrical equipment - Part 2-37: Particular requirements for the basic<br>safety and essential performance of ultrasonic medical diagnostic and<br>monitoring equipment. |

# Table 1: Safety Testing

### 8.0 Summary of Clinical Testing

- 8.1 No clinical testing is required to be performed to assess the changes to the SoftVue System. However, a phantom imaging analysis was conducted to assess performance against established requirements. A description of the phantom testing and results are contained in this submission.
### 9.0 Conclusion

The modified SoftVue 3.0 device performs as intended and is substantially equivalent to the predicate SoftVue 2.0 device with respect to intended use, design, principles of operation, technology, materials, and performance. Any noted differences do not raise any new issues of safety and effectiveness.