Imagio Ultrasound Imaging System
Device Facts
| Record ID | K182628 |
|---|---|
| Device Name | Imagio Ultrasound Imaging System |
| Applicant | Seno Medical Instruments, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Mar 5, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
Indications for Use
The Imagio Ultrasound Imaging System is intended for the following applications: Abdominal, Small Parts, Musculoskeletal conventional, and Musculoskeletal superficial. The system also provides the ability to measure anatomical structures {abdominal, small organ, and musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Device Story
Imagio Ultrasound Imaging System is a mobile, software-controlled diagnostic ultrasound device. It acquires echo data via linear array transducers and displays images in B-Mode, Pulsed (PW) Doppler, Color Doppler, Amplitude Doppler, or harmonic imaging. Operated by clinicians in clinical settings, the system uses a control console and display to manage exams, perform measurements, and annotate images. It processes digitized ultrasound echoes to generate real-time images for diagnostic assessment. The device provides clinicians with anatomical measurements and calculation packages to be used adjunctively with other medical data. It benefits patients by enabling non-invasive visualization of internal structures and blood flow analysis. The system includes DICOM connectivity for image storage and review.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, and conformance to electrical/mechanical safety standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993).
Technological Characteristics
Mobile ultrasound system using linear array transducers (L14-5/38). Features include B-Mode, PW/Color/Amplitude Doppler, and harmonic imaging. Hardware consists of a modulo ultrasound acquisition subsystem, control console, and clinical display. Connectivity via DICOM. Conforms to IEC 60601-1, IEC 60601-2-37, and ISO 10993 standards. Software life cycle follows IEC 62304.
Indications for Use
Indicated for abdominal, small parts, and musculoskeletal (conventional and superficial) diagnostic ultrasound imaging and measurement in patients requiring such examinations.
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
- Sonix MDP Ultrasound Scanner (K080935)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows 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.
March 5, 2019
Seno Medical Instruments, Inc. % Ms. Ann Waterhouse VP Regulatory Affairs/Quality Assurance 8023 Vantage Drive. Suite 1000 SAN ANTONIO TX 78240
Re: K182628
Trade/Device Name: Imagio® Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 7, 2019 Received: February 11, 2019
Dear Ms. Waterhouse:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 vou, 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hse 2. nild
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: 06/30/2020 |
| | See PRA Statement below. |
| 510(k) Number ( <i>if known</i> ) | K182628 |
| Device Name | Imagio® Ultrasound Imaging System |
| Indications for Use (Describe) | |
| The Imagio Ultrasound Imaging System is intended for the following applications: Abdominal, Small Parts, Musculoskeletal conventional, and Musculoskeletal superficial. | |
| The system also provides the ability to measure anatomical structures {abdominal, small organ, and musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. | |
| The ultrasound platform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the wave into the human body. The system then receives echoes back from the human body, processing them to yield an image on a display. | |
| The indications for use included in the Imagio Ultrasound Imaging System comprise a subset of indications supported by the predicate device. Only one of the transducers (L14-5/38) supported by the predicate device are supported on the Imagio Ultrasound Imaging System. | |
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
| | <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> |
| | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| <b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b> | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| | Department of Health and Human Services |
| | Food and Drug Administration |
| | Office of Chief Information Officer |
| | Paperwork Reduction Act (PRA) Staff |
| | PRAStaff@fda.hhs.gov |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (7/17) | Page 1 of 1 |
| | PSC Publishing Services (301) 443-6740 |
| | EF |
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Image /page/4/Picture/0 description: The image shows the logo for Seno Medical. The logo consists of a blue swoosh shape above the word "Seno" in blue, sans-serif font. Below "Seno" is the word "MEDICAL" in a smaller, black, sans-serif font. The logo is simple and modern, with a focus on the company name.
#### K182628 510(k) Summary 5
In accordance with 21 CFR 807.92 the following summary of information is provided:
# Traditional 510(k): Imagio® Ultrasound Imaging System
| 510(k) Submitter: | Seno Medical Instruments, Inc.<br>8023 Vantage Drive, Suite 1000<br>San Antonio, TX 78240, USA<br>(210) 615-6501 phone<br>(210) 615-6508 fax |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Katherin Harris<br>Regulatory Affairs/Quality Assurance Specialist<br>Seno Medical Instruments, Inc.<br>8023 Vantage Drive, Suite 1000<br>San Antonio, TX 78240, USA<br>(210) 615-6501 phone<br>(210) 615-6508 fax<br>awaterhouse@senomedical.com |
| Date Prepared:<br>Common Name:<br>Proprietary/Trade Name: | 7 February 2019<br>Ultrasound Imaging System<br>Imagio® Ultrasound Imaging System |
## Classification Name:
Review Panel:
| Regulation Description | Device | CFR. Number | Product Code |
|------------------------------------------|------------------------------------------------|-------------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | System, Imaging, Pulsed<br>Doppler, Ultrasonic | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | System, Imaging, Pulsed<br>Echo, Ultrasonic | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | Transducer, Ultrasonic,<br>Diagnostic | 892.1570 | 90-ITX |
Radiology
# Classification: Class II
## Predicate Name(s):
| Predicate Name | 510(K) Number |
|------------------------------|---------------|
| Sonix MDP Ultrasound Scanner | K080935 |
# Clearance Request for: Imagio® Ultrasound Imaging System
K182628/S001 Additional Information
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Image /page/5/Picture/0 description: The image shows the logo for Seno Medical. The logo consists of a blue swoosh shape above the word "SENO" in blue, with the word "MEDICAL" in black below it. The font used for "MEDICAL" is a serif font.
#### 5.1 Device Description
The Imagio Ultrasound Imaging System is a multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.
The systems provide measurement capabilities for anatomical structures that provide information used for clinical diagnostic purposes. The system has a PW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.
The system is designed for use in linear scanning modes, and supports linear array probes.
The Imagio Ultrasound Imaging System is comprised of the following subsystems provided by Analogic Corporation, (previously Ultrasonix), and used in common with the predicate device:
- . Modulo - ultrasound acquisition subsystem:
- o ultrasound transmit and receive electronics;
- transducer interface connection to transducer accessory; o
- computer control, image formation, and image processing; O
- . control console;
- clinical display;
- L14-5/38 transducer;
- ultrasound imaging software;
The above subsystems from the predicate device are incorporated in the Imagio Ultrasound Imaging System together with the following Seno Medical designed components: Cart Mechanical Design
- frame;
- casters;
- wheel locking;
- adjustable height mounting arm for console and display;
- cart electrical;
- o electrical wiring and optical cables;
- o power distribution unit;
- enclosures;
- USB alpha-numeric keyboard assembly.
Note that the Analogic software has been modified to remove support for applications and transducers not needed by Seno Medical customers.
# K182628/S001 Additional Information
lmagio® breast imaging system
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Image /page/6/Picture/0 description: The image shows the logo for Seno Medical. The logo consists of the word "Seno" in a stylized, sans-serif font, with a blue swoosh above it. Below the word "Seno" is the word "MEDICAL" in a smaller, sans-serif font.
| Frequency Range | 2-15MHz |
|------------------|--------------|
| Transducer types | Linear array |
| | |
| System | Imagio System | | | | | |
|--------------------------|------------------------------------------------------------------------------------------------------------|----|-----|----|-------------------------------|------------|
| Probe | US/L-14-5 Probe | | | | | |
| Intended Use | Real-time conventional diagnostic ultrasound with color and pulsed wave<br>Doppler for fluid flow analysis | | | | | |
| Indications as follows: | | | | | | |
| Clinical<br>Application | Modes of Operation | | | | | |
| Specific<br>(Track 3) | B | M | PWD | CW | Color/Power Doppler*1 (CD/PD) | Combined*2 |
| Small Organ:<br>Breast | Yes | No | Yes | No | Yes | Yes |
| Small Organ:<br>Thyroid | Yes | No | Yes | No | Yes | Yes |
| Abdominal | Yes | No | Yes | No | Yes | Yes |
| Muskuloskeletal<br>(MSK) | Yes | No | Yes | No | Yes | Yes |
*1. Power Doppler is also referred to as Amplitude Doppler (AD) or Directional Power Doppler (DPD); Color Doppler is also referred to as color flow mapping (CFM);
# *2. B/PWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD
#### 5.2 Intended Use
The Imagio Ultrasound Imaging System is intended for the following applications: Abdominal, Small Parts, Musculoskeletal conventional, and Musculoskeletal superficial.
The system also provides the ability to measure anatomical structures {abdominal, small organ, and musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ultrasound platform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the human body. The system then receives echoes back from the human body, processing them to yield an image on a display.
The indications for use included in the Imagio Ultrasound Imaging System comprise a subset of indications supported by the predicate device. Only one of the transducers (114-5/38) supported by the predicate device are supported on the Imagio Ultrasound Imaging System.
#### K182628/S001 Additional Information
lmagio® breast imaging system
v006:p003
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Image /page/7/Picture/0 description: The image shows the logo for Seno Medical. The logo consists of a blue arc above the word "SENO" in blue, sans-serif font. Below "SENO" is the word "MEDICAL" in a smaller, black, serif font. The logo is simple and modern, with a focus on the company name.
#### Functional Use:
A clinician initiates an exam via the system user interface composed of the control console and display, by entering patient information, and selecting exam type. The clinician then connects the transducer to modulo ultrasound acquisition subsystem (if not previously connected), and selects the transducer. The user applies the transducer to the patient area of interest. The acquisition subsystem generates and applies high frequency pulsed waveforms to the transducer, which in-turn converts the electrical pulses into ultrasound acoustic pulses transmitted into the human body. The transducer then receives echoes back from the human body, and converts them into electrical signals applied to the acquisition subsystem ultrasound receivers. Each received signal is digitized and combined by the acquisition subsystem computer to generate ultrasound images. The images are presented to user on the clinical display. The clinician may adjust imaging parameters, perform measurements, annotate, and store images via the control console. All of the above mentioned subsystems, incorporated into Imagio are common to the predicate device.
This device does not include any imaging modes that were not predicate device; all of the modes and ultrasound imaging feature were provided as part of the Analogic Corporation components common to the predicate device. This includes spatial compound imaging, sound velocity, and features such as auto gain.
While the Intended Use statement for the Imagio Ultrasound Imaging System is not identical to the predicate device (Removal of application and associated transducers), the difference does not alter the intended diagnostic use of the device nor does it affect the safety and effectiveness of the device relative to the predicate.
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Image /page/8/Picture/0 description: The image shows the logo for Seno Medical. The logo consists of a blue swoosh above the word "SENO" in blue, with the word "MEDICAL" in black below it. The font used for "MEDICAL" is a serif font.
The ultrasound platform is similar to the predicate device in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves. These waves echo back from the human body, and the system processes them to yield an image/display.
Please see Section 12, Comparison between the Imagio Ultrasound Imaging System and the listed predicate device(s).
#### 5.3 Indications for Use
The Imagio Ultrasound Imaging System is intended for the following applications:
Abdominal, Small Parts, Musculoskeletal conventional, and Musculoskeletal superficial.
The system also provides the ability to measure anatomical structures {abdominal, small organ, and musculo-skeletal} and calculation packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ultrasound platform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the human body. The system then receives echoes back from the human body, processing them to yield an image on a display.
The indications for use included in the Imagio Ultrasound Imaging System comprise a subset of indications supported by the predicate device. Only one of the transducers (L14-5/38) supported by the predicate device are supported on the Imagio Ultrasound Imaging System.
#### 5.4 Comparison of Technological Characteristics with the Predicate Device
The technological characteristics are substantially similar to that of the predicate(s). The device operates identically to the predicate device(s) in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler, Continuous Wave Doppler) are the same as the predicate devices identified. Transducer patient contact materials are biocompatible.
The beam forming architecture is exact to that of the predicate device(s). The receiving and processing hardware is identical in that it is a programmable system made of 2 building blocks, which can be reconfigured to operate the system in any referenced imaging mode.
The parameters used to adjust image quality are the same as that seen in the predicates. This includes the use of TGC gain sliders, depth control, base control and angling, among others.
K182628/S001 Additional Information
lmagio® breast imaging system
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Image /page/9/Picture/0 description: The image contains the logo for Seno Medical. The logo consists of the word "Seno" in blue, with a curved line above it. Below "Seno" is the word "MEDICAL" in a smaller, serif font. The logo is simple and professional, and the blue color gives it a sense of trustworthiness.
The Imagio Ultrasound Imaging System is substantially equivalent to the predicate device(s) with regard to intended use/indications for use, and technological characteristics of the offered transducer.
#### Performance Data/Determination of Substantial Equivalence 5.5
The Imagio Ultrasound Imaging System has been evaluated for acoustic output, biocompatibility and cleaning and disinfection. The system has been found to conform with thermal, electrical, electromagnetic, and mechanical safety and has been found to conform to applicable medical device safety standards. Please see Table 1 below for a list of compliance standards.
# Table 1: Imagio and US/L-14-5 Transducer Summary of Standards
| Standard | Title |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EN ISO 10993-1 :2009 | Biological evaluation of medical devices -- Part 1: Evaluation and<br>testing within a risk management process (ISO 10993-1 :2009) |
| EN ISO 10993-5 :2009 | Biological evaluation of medical devices -- Part 5: Tests for in vitro<br>cytotoxicity (ISO 10993-5 :2009) |
| ISO 10993-10: 2010 | Biological evaluation of medical devices -- Part 10: Tests for irritation<br>and skin sensitization |
| EN ISO 14971: 2012 | Medical devices - Application of risk management to medical devices<br>(ISO 14971: 2007, Corrected version 2007-10-01) |
| ANSI/AAMI ES60601-1:2005/A1:2012 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance (IEC 60601-1:2005) |
| EN IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests (IEC 60601-<br>1-2:2007) |
| EN IEC 60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability (IEC 60601-1-6:2010) |
| IEC 60601-2-37:2007<br>+ A1:2015 | Medical electrical equipment - Part 2-37: Particular requirements for<br>the basic safety and essential performance of ultrasonic medical<br>diagnostic and monitoring equipment |
| IEC 62304:2006 + A1:2015 | Medical device software - Software life cycle processes |
| EN IEC 62366:2010 | Medical devices - Application of usability engineering to medical<br>devices (IEC 62366:2007) |
| UD2 NEMA Measurement: 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound<br>Equipment, Revision 3 |
| UD3 NEMA 3-2004: | Standard for Real-Time Display of Thermal and Mechanical Acoustic<br>Output Indices on Diagnostic Ultrasound Equipment. Revision 2 |
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Image /page/10/Picture/0 description: The image shows the logo for Seno Medical. The logo consists of the word "Seno" in blue, with a curved line above it. Below the word "Seno" is the word "Medical" in black. The logo is simple and modern, and it is likely used to represent the company's brand.
The devices acoustic output limits are:
| ISPTA (d) | 720mW/cm² |
|-----------------------|----------------------|
| TIS/TIB/TIC | 0.1 - 4.0 (Range) |
| Mechanical Index (MI) | 1.9 (Maximum) |
| ISPPA (d) | 0 - 700W/cm² (Range) |
*The limits are the same as predicate Track 3 devices
#### 5.6 Clinical Testing
Since the Imagio Ultrasound Imaging System utilizes the same technology and principles as the existing predicate device Sonix MDP Ultrasound Scanner (K080935), clinical studies were not required to support substantial equivalence.
#### 5.7 Conclusion
The intended uses and other key features are consistent with traditional clinical practice, FDA guidance's, guidelines, and established methods of patient examinations. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing manufacturer surveillance. Diagnostic ultrasound and imaging has a long history of safe and effective performance.
As such, the data herein supports this device, the Imagio Ultrasound Imaging System and the recommended transducer, US/L-14-5, as substantially equivalent with respect to safety and effectiveness to the currently cleared predicate device(s).
