(27 days)
Not Found
No
The document describes a standard diagnostic ultrasound system and mentions image processing but does not mention AI, ML, or related concepts like deep learning or neural networks. There is no information about training or test sets, which are typically associated with ML development.
No
This device is described as a "diagnostic ultrasound system" and its intended use is for "clinical examinations to evaluate differences in the echogenicity of soft tissue," which indicates its purpose is to provide images for diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "This diagnostic ultrasound system (UltraVision)..." and the "Device Description" section refers to it as a "portable Diagnostic Ultrasound System."
No
The device description explicitly states it is a "portable Diagnostic Ultrasound System" and mentions "custom probes," indicating it includes hardware components beyond just software. The performance studies also include testing related to electrical safety, EMC, and acoustic output, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the system as a "diagnostic ultrasound system" used for "clinical examinations to evaluate differences in the echogenicity of soft tissue" and for various anatomical diagnoses. This involves imaging the internal structures of the body.
- Device Description: The description details a "portable Diagnostic Ultrasound System" that uses "Ultrasonic pulsed doppler imaging" to produce images.
- Mechanism of Action: The system works by "postprocessing of received echoes to generate on-screen displays of anatomic structures of the human body." This is a physical imaging process, not a test performed on biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples) outside of the body. The system directly interacts with the patient's body to generate images.
In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens, such as blood, tissue, or urine, taken from the human body to provide information for diagnosis, monitoring, or screening. This ultrasound system does not fit that definition. It is an in vivo diagnostic imaging device.
N/A
Intended Use / Indications for Use
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and tor peripheral vessel, abdominal, and superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Product codes
IYN, IYO, ITX
Device Description
The UltraVision is a portable Diagnostic Ultrasound System, which applies the latest technologies to produce optimal images. The system facilitates a workflow from image acquisition through to archival in a standard DICOM interface to the clinics PACs system. Various image parameter adjustments, a 15 inch high resolution display and custom probes are configured to provide clear and stable images. It operates in B, M, Color Flow Doppler, PW Doppler Mode, and E mode.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Soft tissue of small parts (thyroid, breast, and testicles), peripheral vessel, abdominal, and superficial muscular skeletal.
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
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
Anatomical structures:
B mode general measurements: Distance
M mode general measurements: Distance, Time
D mode general measurements: 1
Color Flow Doppler Mode general measurements: Distance
PW Doppler Mode general measurements: Velocity
E Mode/eSie TouchTM general measurements: Provides a qualitative representation of relative tissue stiffness for the region of interest
Shear Mode/Virtual TouchTM Mode general measurements: Use Virtual Touch tissue quantification to measure tissue shear velocity (Vs) for a selected region of interest. Virtual Touch quantification uses acoustic radiation force impulse (ARFI) technology of diagnostic ultrasound to induce tissue displacement. A time-controlled sequence of "push pulses" from the transducer induces a small displacement of tissue. The ultrasound system measures shear wave velocity at the region of interest.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test: Clinical testing not required.
Non-clinical Test: Testing according to the following safety standards are conducted on the subject device:
- AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 EMC Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- Acoustic output testing as per the FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", dated September 9, 2008
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity
The UltraVision 2 system is in conformance with the standards described above which are the same or equivalent to those of the predicate device.
Biocompatibility: The patient contact materials of human body surface are evaluated under ISO 10993 and determined acceptable for the specified usage of the system. Both systems have the same acceptance level for biocompatibility.
Conclusion: Clinical studies are not required to support substantial equivalence for these conventional ultrasound systems. In addition, as discussed in the above technological comparison, the technological characteristics of the UltraVision 2 system are substantially equivalent to the referenced predicate device that has been previously cleared for USA distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2017
WinProbe Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K173265
Trade/Device Name: UltraVision 2 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: October 25, 2017 Received: October 26, 2017
Dear Mr. Job:
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.
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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use
510(k) Number (if known) K173265
Device Name
UltraVision 2 Diagnostic Ultrasound System
Indications for Use (Describe)
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and tor peripheral vessel, abdominal, and superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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 FF
3
Indications for Use Table (system)
System: UltraVision 2 Diagnostic Ultrasound System
| Clinical Application | | Mode of Operation | | | | | | Combined
(specify) | Other |
|---------------------------|--------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------------------------------------------|-----------------------|-------|
| | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | | | |
| General
(Track 1 only) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &
Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N(B+M), N(B+Color),
N (B+E), N(B+PW)
N(B+PW+color) | N¹ | |
| | Intra-operative (specify) | | | | | | | | |
| | Intra-operative (neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify)
Breast, Thyroid, Testes | P | N | N | | N | N(B+M), N(B+Color),
N (B+E), N(B+PW)
N(B+PW+color) | N¹ | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-cardiac) | | | | | | | | |
| | Musculo-skeletal (conventional) | | | | | | | | |
| | Musculo-skeletal (superficial) | P | N | N | | N | N(B+M), N(B+Color),
N (B+E), N(B+PW)
N(B+PW+color) | N¹ | |
| | Intravascular | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N(B+M), N(B+Color)
N (B+E), N(B+PW)
N(B+PW+color) | N¹ | |
| | Other (specify) | | | | | | | | |
N = new indication; P= previously cleared by FDA 510(k)150580. Notes: ¹Elastography (E-Mode)
4
Indications for Use Table (transducer)
Transducer: HL5-10EPN transducer for use with UltraVision 2
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (Track 1 only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | N | N | N | N | N(B+M), N(B+Color), | |||
| N (B+E), N(B+PW) | ||||||||
| N(B+PW+color) | N¹ | |||||||
| Intra-operative (specify) | ||||||||
| Intra-operative (neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Breast, Thyroid, Testes | P | N | N | N | N(B+M), N(B+Color), | |||
| N (B+E), N(B+PW) | ||||||||
| N(B+PW+color) | N¹ | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-cardiac) | ||||||||
| Musculo-skeletal (conventional) | ||||||||
| Musculo-skeletal (superficial) | P | N | N | N | N(B+M), N(B+Color), | |||
| N (B+E), N(B+PW) | ||||||||
| N(B+PW+color) | N¹ | |||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N(B+M), N(B+Color) | ||
| N (B+E), N(B+PW) | ||||||||
| N(B+PW+color) | N¹ | |||||||
| Other (specify) | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | N | N | N | N | N(B+M), N(B+Color), | |||
| N (B+E), N(B+PW) | ||||||||
| N(B+PW+color) | N1 | |||||||
| Intra-operative (specify) | ||||||||
| Intra-operative (neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Breast, Thyroid, Testes | N | N | N | N | N(B+M), N(B+Color), | |||
| N (B+E), N(B+PW) | ||||||||
| N(B+PW+color) | N1 | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-cardiac) | ||||||||
| Musculo-skeletal (conventional) | ||||||||
| Musculo-skeletal (superficial) | N | N | N | N | N(B+M), N(B+Color), | |||
| N (B+E), N(B+PW) | ||||||||
| N(B+PW+color) | N1 | |||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N(B+M), N(B+Color) | ||
| N (B+E), N(B+PW) | ||||||||
| N(B+PW+color) | N1 | |||||||
| Other (specify) |
N = new indication; P= previously cleared by FDA 510(k) 150580 Notes: ¹Elastography (E-Mode)
5
Indications for Use Table (transducer)
Transducer: L14-4 transducer for use with UltraVision 2
N = new indication; Notes: ¹Elastography (E-Mode)
6
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is:
Submitter
WinProbe Corporation 11770 US Highway 1, suite 302E Palm Beach Gardens, Florida 33408 Telephone: (561)626-4055 Fax: (561)624-0914 Registration #
Official Correspondent:
Guy Scott WinProbe Corp. President Email: gscott@winprobe.com Telephone: (561)626-4055 11662 Lake Shore Place North Palm Beach, Florida 33408
Or
Rose Malchow WinProbe Corp. Quality Manager Email: rmalchow@winprobe.com Telephone: (561)626-4055 11770 US Highway 1, suite 302E Palm Beach Gardens, Florida 33408
Date Prepared:
September 28th, 2017
Device Name and Classification:
Common/Usual Name:
Diagnostic Ultrasound System
Proprietary Name:
UltraVision 2 Diagnostic Ultrasound System
7
Image /page/7/Picture/0 description: The image is a coat of arms featuring a red griffin holding a spear on a white background. A banner with the word "imagine" is draped over the spear. The griffin is depicted in a dynamic pose, with one paw raised and wings spread. The shield shape is a classic heraldic form with a curved base.
| Classification Names: | FR Number | Product Code | UltraVision 2 | Acuson S2000 | UltraVision 2 (as cleared | |
|---|---|---|---|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO | by K150580) | |||
| Diagnostic Ultrasound Transducer | 892.1570 | ITX | Description | The UltraVision is a | ||
| portable Diagnostic | ||||||
| Ultrasound System, which | ||||||
| applies the latest | ||||||
| technologies to produce | ||||||
| optimal images. The | ||||||
| system facilitates a | ||||||
| workflow from image | ||||||
| acquisition through to | ||||||
| archival in a standard | ||||||
| DICOM interface to the | ||||||
| clinics PACs system. | ||||||
| Various image parameter | ||||||
| adjustments, a 15 inch | ||||||
| high resolution display and | ||||||
| custom probes are | ||||||
| configured to provide clear | ||||||
| and stable images. It | ||||||
| operates in B, M, Color | ||||||
| Flow Doppler, PW Doppler | ||||||
| Mode, and E mode. | The ultrasound systems are | |||||
| multi-purpose mobile, | ||||||
| software controlled | ||||||
| diagnostic ultrasound | ||||||
| systems with and on-screen | ||||||
| display for thermal and | ||||||
| mechanical indices related to | ||||||
| potential bio-effect | ||||||
| mechanisms. The function is | ||||||
| to acquire primary or | ||||||
| secondary harmonic | ||||||
| ultrasound echo data and | ||||||
| display it in B-Mode, M- | ||||||
| Mode, Pulsed (PW) Doppler | ||||||
| Mode, Continuous (CW) | ||||||
| Doppler Mode, Color Doppler | ||||||
| Mode, Amplitude, Doppler | ||||||
| Mode, a combination of | ||||||
| modes, or Harmonic Imaging | ||||||
| and 3D/4D Imaging on a Flat | ||||||
| Panel Display. | The UltraVision is a | |||||
| portable Diagnostic | ||||||
| Ultrasound System, which | ||||||
| applies the latest | ||||||
| technologies to produce | ||||||
| optimal images. The | ||||||
| system facilitates a | ||||||
| workflow from image | ||||||
| acquisition through to | ||||||
| archival in a standard | ||||||
| DICOM interface to the | ||||||
| clinics PACs system. | ||||||
| Various image parameter | ||||||
| adjustments, a 15 inch | ||||||
| high resolution display and | ||||||
| custom probes are | ||||||
| configured to provide clear | ||||||
| and stable images. It | ||||||
| operates in B mode. | ||||||
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN | Intended Use | This diagnostic ultrasound | ||
| system (UltraVision) and | ||||||
| its | ||||||
| transducers are | ||||||
| intended for use in clinical | ||||||
| examinations to evaluate | ||||||
| differences in the | ||||||
| echogenicity of soft tissue | ||||||
| of small parts in adult | ||||||
| patients, (thyroid, breast, | ||||||
| and testicles) and for | ||||||
| peripheral vessel, | ||||||
| abdominal, and superficial | ||||||
| muscular skeletal | ||||||
| diagnosis. | The ultrasound imaging | |||||
| systems are intended for the | ||||||
| following applications: Fetal, | ||||||
| Abdominal, Intraoperative, | ||||||
| Pediatric, Small Parts, | ||||||
| Transcranial, OB/GYN, | ||||||
| Cardiac, Pelvic, | ||||||
| Neonatal/Adult Cephalic, | ||||||
| Vascular, Musculoskeletal, | ||||||
| Superficial Musculoskeletal, | ||||||
| and Peripheral Vascular | ||||||
| applications.The system also | ||||||
| provides the ability to | ||||||
| measure anatomical | ||||||
| structures {fetal, abdominal, | ||||||
| intraoperative, pediatric, | ||||||
| small organ, neonatal | ||||||
| cephalic, adult cephalic, | This diagnostic ultrasound | |||||
| system (UltraVision) and | ||||||
| its transducers are | ||||||
| intended for use in clinical | ||||||
| examinations to evaluate | ||||||
| differences in the | ||||||
| echogenicity of soft tissue | ||||||
| of small parts in adult | ||||||
| patients, (thyroid, breast, | ||||||
| and testicles) and for | ||||||
| superficial muscular | ||||||
| skeletal diagnosis. |
Predicate Device:
Siemens Acuson S2000 Ultrasound System, K142876
Device Description:
The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode, M-Mode, Color Flow Doppler Mode, Pulsed Wave Doppler Mode, and E-Mode.
Intended Use:
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for peripheral vessel, abdominal, and superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Comparison to the predicate device:
The UltraVision 2 diagnostic ultrasound system uses the same fundamental scientific technologies as the predicate device (Siemens Acuson S2000, K142876). Table 1 compares the UltraVision 2 to the predicate device with respect to indications for use, intended use, and principles of operation for the determination of substantial equivalence. The table also compares the system to the previously cleared system.
8
9
Image /page/9/Picture/0 description: The image shows a coat of arms with a red griffin holding a spear. The griffin is standing on its hind legs and has wings. A banner with the word ".IMAGINE." is draped over the spear. The coat of arms has a white background and a black border.
| cardiac, trans-esophageal, | ||
|---|---|---|
| transrectal, transvaginal, | ||
| peripheral vessel, musculo- | ||
| skeletal (conventional), | ||
| musculo-skeletal (superficial) | ||
| and neonatal cardiac} 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 | ||
| Arterial Health Package | ||
| (AHP) software provides the | ||
| physician with the capability | ||
| to measure Intima Media | ||
| Thickness and the option to | ||
| reference normative tables | ||
| that have been validated and | ||
| published in peer-reviewed | ||
| studies. The information is | ||
| intended to provide the | ||
| physician with an easily | ||
| understood tool for | ||
| communicating with patients | ||
| regarding state of their | ||
| cardiovascular system. This | ||
| feature should be utilized | ||
| according to the "ASE | ||
| Consensus Statement; Use | ||
| of Carotid Ultrasound to | ||
| Identify Subclinical Vascular | ||
| Disease and Evaluate | ||
| Cardiovascular Disease Risk: | ||
| A Consensus Statement from | ||
| the American Association of | ||
| Echocardiography; Carotid | ||
| Intima-Media Thickness Task | ||
| Force, Endorsed by the | ||
| Society for Vascular | ||
| Imaging". The Acuson |
10
Image /page/10/Picture/0 description: The image is a coat of arms with a white background and a black border. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a red banner with the word "imagine" written on it.
| | | Acunav Ultrasound Catheter
is intended for intra-cardiac
and intra-luminal visualization
of cardiac and great vessel
anatomy and physiology, as
well as visualization of other
devices in the heart of adult
and pediatric patients | |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Power Supply | | | |
| Voltage | 90-264 V AC | 90-264 V AC | 90-264 V AC |
| Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz |
| Operation
Characteristic | | | |
| Installation and
use | a. Portable equipment
b. Mobile equipment
(when installed on
the mobile cart) | Mobile equipment | a. Portable
equipment
b. Mobile
equipment
(when
installed on
the mobile
cart) |
| Mode of operation | Continuous operation | Continuous operation | Continuous operation |
| Physical
Specifications | | | |
| Dimensions | 400 mm (W) x 50 mm (H) x
250 mm (D) | 623 mm (W) x 1300 mm
(H) x 1103 mm (D) | 400 mm (W) x 50 mm
(H) x 240 mm (D) |
| Weight | 4.5 kg | 166 kg | 4.5 kg |
| Temperature | | | |
| Operating: | 0°C to 40°C | 10°C to 40°C | 0°C to 40°C |
| Transport/Storage: | Equipment should not be
subject to excessive
temperatures during
transportation/storage | -20°C to 60°C | Equipment should not
be subject to
excessive
temperatures during |
| | | | transportation/storage |
| Relative Humidity | | | |
| Operating: | Equipment should not be
used in locations of high
humidity | 10% to 80% | Equipment should not
be used in locations
of high humidity |
| Transport/Storage: | Equipment should not be
used in locations of high
humidity | 10% to 95% | Equipment should not
be used in locations
of high humidity |
| Safety
Classifications | | | |
| Type of protection
against electric
shock | Class II | Class I | Class II |
| The degree of
protection against
electric shock | Type BF | Type BF | Type BF |
| The degree of
protection against
the harmful
ingress of liquid | IP41 for the main unit
IPX8 for the transducer | Ordinary equipment
IPX8 for the transducers | IP41 for the main unit
IPX8 for the
transducer |
| The degree of
safety of
application in the
presence of a
flammable gas | Equipment not to be used in
the presence of a flammable
gas | Equipment not to be used
in the presence of a
flammable gas | Equipment not to be
used in the presence
of a flammable gas |
| Electrical &
Mechanical Safety
& Thermal Safety
Standards | | | |
| The electrical,
mechanical, and
thermal safety
evaluation | Complies with the standard:
IEC 60601-1: 2007
IEC 60601-2-37: 2008 | Complies with the standard:
IEC 60601-1: 2007
IEC 60601-2-37: 2008 | Complies with the
standard:
IEC 60601-1: 2007
IEC 60601-2-37:
2008 |
| EMC evaluation | Complies with the standard:
IEC 60601-1-2 4th edition | Complies with the standard:
IEC 60601-1-2 | Complies with the
standard: IEC
60601-1-2 3rd edition |
| Acoustic output
evaluation | Complies with the standard:
IEC 61157 AIUM/NUMA UD-2, Acoustic Output
Measurement Standard for
Diagnostic Ultrasound | Complies with the standard:
IEC 61157 AIUM/NUMA
UD-2, Acoustic Output
Measurement Standard for
Diagnostic Ultrasound | Complies with the
standard:
IEC
61157 AIUM/NUMA
UD-2, Acoustic
Output Measurement
Standard for
Diagnostic
Ultrasound |
| Biocompatibility
evaluation | Complies with the standard:
ISO 10993-1: 2009
ISO 10993-5: 2009
ISO 10993-10: 2009 | Complies with the standard:
ISO 10993-1: 2009
ISO 10993-5: 2009
ISO 10993-10: 2009 | Complies with the
standard:
ISO 10993-1: 2009
ISO 10993-5: 2009
ISO 10993-10: 2009 |
| Disinfection | | | |
| Disinfection | Probe: .55% Ortho
Phthalaldehyde, 2.4%
Glutaraldehyde | Probe: .55% Ortho-
Phthalaldehyde 2.4%
Glutaraldehyde | Probe: .55% Ortho
Phthalaldehyde, 2.4%
Glutaraldehyde |
| Specifications | | | |
| Monitor | 15 inch display LCD flat
panel display with 2800 x
1800 pixels | 19 inch high-resolution flat
panel display | 15 inch display LCD
flat panel display with
2800 x 1800 pixels |
| General imaging
mode | B mode, M mode, E mode,
Color flow dopper mode,
shear mode | B mode, M mode, PWD
mode, Color mode, CWD
mode, eSie TouchTM
Virtual TouchTM | B mode |
| Scanning method | Linear | Linear, Rocked, Auto-
sweep, STIC (Spatial
Temporal Imaging
Correlation) | Linear |
| Focus number | Max=4 | | Max=4 |
| B mode general | Distance | Distance/Depth, Volume | Distance |
11
Image /page/11/Picture/0 description: The image is a coat of arms with a white background and a black border. In the center of the coat of arms is a red winged lion holding a spear. Above the lion is a red banner with the word "Imagine" written on it.
12
13
Image /page/13/Picture/0 description: The image shows a coat of arms with a white background and a black border. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a red banner with the word "imagine" written on it.
| measurements
M mode general
measurements | Distance, Time | and Stenosis, Area,
Volume Flow,
Circumference
Distance, Heart Rate,
Slope, Time | / |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| D mode general
measurements | 1 | Measurements on a frozen
or CINE image including
velocity/frequency, HR
(Heart Rate), S/D
(systolic/diastolic) ratio, RI
(resistive index), PI
(pulsatility index), TAMx
(time-average maximum),
TAMn (time-average
mean), Slope
(acceleration/deceleration),
volume flow, A/B ratios,
Time | |
| Color Flow
Doppler Mode
general
measurements | Distance | Measurements on a frozen
or CINE image including
velocity/frequency, HR
(heart rate), S/D
(systolic/diastolic ratio), RI
(resistive index), PI
(pulsatility index), TAMx
(time-average maximum),
TAMn (time-average
mean), Slope
(Acceleration/Deceleration),
Volume Flow, A/B ratios,
Time | |
| PW Doppler Mode
general
measurements | Velocity | Measurements on a frozen
or CINE image including
velocity/frequency, HR
(heart rate), S/D
(systolic/diastolic ratio), RI
(resistive index), PI
(pulsatility index), TAMx
(time-average maximum), | |
| | | TAMn (time-average mean), Slope (Acceleration/Deceleration), Volume Flow, A/B ratios, Time | |
| E Mode/eSie
Touch™ general
measurements | Provides a qualitative
representation of relative
tissue stiffness for the region
of interest | Provides a qualitative
representation of relative
tissue stiffness for the
region of interest | / |
| Shear
Mode/Virtual
Touch™ Mode
general
measurements | / | Use Virtual Touch tissue
quantification to measure
tissue shear velocity (Vs)
for a selected region of
interest. Virtual Touch
quantification uses acoustic
radiation force impulse
(ARFI) technology of
diagnostic ultrasound to
induce tissue displacement.
A time-controlled sequence
of "push pulses" from the
transducer induces a small
displacement of tissue. The
ultrasound system
measures shear wave
velocity at the region of
interest | / |
| Peripheral
Devices
Supported | | | |
| Printer | Sony type UPD25MD (USB)
color video printer | Black and white Mitsubishi
printer P-93DW, color Sony
printer UP-D23MD | Sony type UPD25MD
(USB) color video
printer |
| Performance | | | |
| Displayed depth | 20 mm to 300 mm | .5 cm to 30 cm | 20 mm to 300 mm |
| Gray scales | 256 | 256 | 256 |
14
Image /page/14/Picture/0 description: The image is a coat of arms featuring a red griffin holding a spear on a white background. A banner with the word "Imagine" is draped around the spear. The coat of arms has a black border. The griffin is depicted in a dynamic pose, suggesting movement and strength.
15
Image /page/15/Picture/0 description: The image is a coat of arms featuring a red griffin holding a spear on a white background. Above the griffin is a banner with the word "imagine" written on it. The shield has a black border. The griffin is depicted in a dynamic pose, with its wings spread and one leg raised.
| TGC | 8 segments | 8 segments | ||
|---|---|---|---|---|
| Image | ||||
| Adjustments | ||||
| B mode | ||||
| parameters | Gain | Gain | Gain | |
| Depth | Gray scale map | Depth | ||
| TGC | SieClear spatial | |||
| compounding | TGC | |||
| Frequency | Edge enhancement | Frequency | ||
| / | Tint/balance | / | ||
| / | Level of clarify vascular | |||
| enhancement | / | |||
| / | Gray scale or color map for | |||
| elasticity imaging | / | |||
| M mode | ||||
| parameters | Gain | Gain | / | |
| Map | Map | / | ||
| / | Tint | / | ||
| Transmit Frequency | Transmit frequency | / | ||
| Color mode & | ||||
| Power Doppler | Transmit Frequency | Transmit frequency | / | |
| mode & | ||||
| Directional Power | Gain | Gain | / | |
| mode parameters | Persistence | Persistence | / | |
| Pulsed repetition frequency | Pulsed repetition frequency | / | ||
| Smoothing | Smoothing | / | ||
| Map | Map | / | ||
| Measurement | ||||
| Accuracy | ||||
| 2D Measurement | ||||
| Depth/Distance | Range | 400 mm | 34 cm | 400 mm |
| Accuracy | 5% | 5% | 5% |
16
Image /page/16/Picture/0 description: The image is a coat of arms featuring a red griffin holding a spear on a white background. The griffin is standing upright and facing left, with its wings spread. A banner with the word "imagine" is draped above the griffin. The shield has a black border.
Table 1. Predicate Device Comparison
Intended Use:
17
The intended use and clinical applications of the UltraVision 2 system are narrowed, but still in the scope of the predicate device. Both systems are intended to be used with a conventional extracorporeal transducer. The type of transducers specified for use with the UltraVision 2 system are both linear which is also used with the predicate system. A comparison of the transducers is provided in Table 2:
| HL5-10EPN | L14-4 | 14L5 | |
|---|---|---|---|
| Type | Linear | Linear | Linear |
| Frequency Bandwidth | 5 - 12 MHz | 5-15 MHz | 5 - 14 MHz |
| Applications | • Breast | ||
| • Testes | |||
| • Thyroid | |||
| • Musculoskeletal | |||
| • Peripheral Vessel | |||
| • Abdominal | • Breast | ||
| • Testes | |||
| • Thyroid | |||
| • Musculoskeletal | |||
| • Peripheral Vessel | |||
| • Abdominal | • Breast | ||
| • Testes | |||
| • Thyroid | |||
| • Musculoskeletal | |||
| • Peripheral Vessel | |||
| • Abdominal | |||
| Number of Elements | 128 | 256 | 128 |
| Modes of Operation | B, E, M, | ||
| CFD,PWD | B, E, M, CFD, | ||
| PWD | B, C, D, M | ||
| Array Footprint | 38.1 mm | 52 mm | 39 mm |
| Acoustic output display | |||
| standard | Track 1 | Track 1 | Track 3 |
| Mechanical Index (MI) | .164 | .82 | 1.1 |
| ISPTA (mW/cm²) | 83 | 75 | 114 |
| Maximum Power (mW) | .35 | 15.3 | 27 |
| Pr (MPa) | .45 | 2.142 | 4.26 |
| Frequency (MHz) | 7.64 | 7.55 | 6 |
Table 2. Probe Comparison
Operating Principle and Design:
18
Image /page/18/Picture/0 description: The image shows a coat of arms with a white background and a black outline. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a banner with the word "Imagine" written on it. The griffin is standing on its hind legs and has wings.
Both the UltraVision 2 and the predicate system transmit ultrasonic energy into patients then postprocessing of received echoes to generate on-screen displays of anatomic structures of the human body. Both systems are designed with an LCD display screen and hand-held transducers. Both systems support the same operating modes (B, CFD, M, E, Shear, PWD) and the same measurement functions for anatomic structures. The operation characteristics (installation and use, mode of operation) and the power supply are the same in both systems.
Non-clinical Test and Safety:
Clinical Test: Clinical testing not required
Non-clinical Test:
Testing according to the following safety standards are conducted on the subject device:
-
- AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2 EMC Requirements for Medical Equipment
-
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
-
- Acoustic output testing as per the FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", dated September 9, 2008
-
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity
The UltraVision 2 system is in conformance with the standards described above which are the same or equivalent to those of the predicate device.
Biocompatibility:
The patient contact materials of human body surface are evaluated under ISO 10993 and determined acceptable for the specified usage of the system. Both systems have the same acceptance level for biocompatibility.
Conclusion:
Clinical studies are not required to support substantial equivalence for these conventional ultrasound systems. In addition, as discussed in the above technological comparison, the technological characteristics of the Ultra\lision 2 system are substantially equivalent to the referenced predicate device that has been previously cleared for USA distribution.
Substantially Equivalent Determination:
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same operational characteristics as the previously cleared predicate device, or the device has the same intended use and different operational characteristics in which substantial equivalency can be
19
Image /page/19/Picture/0 description: The image is a coat of arms with a white background and a black border. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a banner with the word ".imagine" written on it. The griffin is standing on its hind legs and has wings.
demonstrated in the device in comparison to the predicate device. In addition, the new device does not raise new questions regarding its safety and effectiveness as compared to the predicate device.
lt is shown in this 510(k) submission that the difference between the UltraVision 2 and the predicate device does not raise any questions regarding its safety and effectiveness. The UltraVision 2, as designed and produced, is determined to be substantially equivalent to the predicate device.