(27 days)
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.
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.
This document is a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It outlines the safety and effectiveness of the UltraVision 2 Diagnostic Ultrasound System by comparing it to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a performance study with specific acceptance criteria and outcome metrics for diagnostic accuracy. Substantial equivalence is determined by demonstrating that the new device has the same intended use and operational characteristics, or if different, that these differences do not raise new questions of safety or effectiveness.
Therefore, the "acceptance criteria" here are largely compliance with regulatory standards and similarity to the predicate device in terms of technical specifications and safety.
| Aspect of Acceptance Critera | Description | Reported Device Performance (UltraVision 2) |
|---|---|---|
| Intended Use | The device's intended use must be the same as or within the scope of the predicate device's intended use, and its clinical applications should not raise new safety/effectiveness concerns. | "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." This use is "narrowed, but still in the scope of the predicate device." |
| Technological Characteristics & Operational Principles | The device should use the same fundamental scientific technologies and operational characteristics as the predicate device, or any differences should not raise new safety/effectiveness concerns. | Uses "the same fundamental scientific technologies" and supports the "same operating modes (B, CFD, M, E, Shear, PWD) and the same measurement functions for anatomic structures." Operational characteristics (installation, use, power supply) are "the same." |
| Electrical & Mechanical Safety & Thermal Safety Standards | The device must comply with relevant safety standards. | Complies with IEC 60601-1: 2007, IEC 60601-2-37: 2008. |
| EMC Evaluation | The device must comply with electromagnetic compatibility standards. | Complies with IEC 60601-1-2 4th edition. |
| Acoustic Output Evaluation | The device must comply with acoustic output standards. | Complies with IEC 61157 AIUM/NUMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound. |
| Biocompatibility Evaluation | Patient contact materials must be evaluated and determined acceptable under ISO 10993. | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10. "Both systems have the same acceptance level for biocompatibility." |
| Disinfection | Disinfection methods for patient-contact parts (probes) must be specified and acceptable. | Probe: .55% Ortho Phthalaldehyde, 2.4% Glutaraldehyde (same as predicate). |
| Performance (Displayed Depth) | Range of displayed depth for imaging. | 20 mm to 300 mm (similar to predicate's .5 cm to 30 cm). |
| Performance (Gray Scales) | Number of gray scales for imaging. | 256 (same as predicate). |
| Performance (2D Measurement Accuracy - Depth/Distance) | Accuracy of distance measurements. | 5% (same as predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical Test: Clinical testing not required." This indicates that no clinical "test set" in the traditional sense of patient data was used to demonstrate the device's diagnostic performance for its 510(k) clearance. The assessment was based on non-clinical engineering and safety testing, and a comparison of technical specifications to a predicate device. Therefore, information on sample size, data provenance, or study design for diagnostic performance is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set requiring ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The UltraVision 2 Diagnostic Ultrasound System is a standalone ultrasound imaging device, not an AI-assisted diagnostic tool. No MRMC study or AI-related performance evaluation was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The UltraVision 2 is an ultrasound imaging system, not an algorithm. Its performance is evaluated as an imaging device, not as an AI or algorithmic diagnosis tool. The "E-mode" (Elastography) provides a "qualitative representation of relative tissue stiffness," but it is an imaging mode, not an automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study requiring ground truth was conducted. The "ground truth" for this submission focuses on compliance with technical and safety standards, as well as the functional equivalence of the device to its predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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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.
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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
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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
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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 | ColorDoppler | ||||
| 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)
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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 | ColorDoppler | 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 | ColorDoppler | 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)
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Indications for Use Table (transducer)
Transducer: L14-4 transducer for use with UltraVision 2
N = new indication; Notes: ¹Elastography (E-Mode)
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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
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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 aportable DiagnosticUltrasound System, whichapplies the latesttechnologies to produceoptimal images. Thesystem facilitates aworkflow from imageacquisition through toarchival in a standardDICOM interface to theclinics PACs system.Various image parameteradjustments, a 15 inchhigh resolution display andcustom probes areconfigured to provide clearand stable images. Itoperates in B, M, ColorFlow Doppler, PW DopplerMode, and E mode. | The ultrasound systems aremulti-purpose mobile,software controlleddiagnostic ultrasoundsystems with and on-screendisplay for thermal andmechanical indices related topotential bio-effectmechanisms. The function isto acquire primary orsecondary harmonicultrasound echo data anddisplay it in B-Mode, M-Mode, Pulsed (PW) DopplerMode, Continuous (CW)Doppler Mode, Color DopplerMode, Amplitude, DopplerMode, a combination ofmodes, or Harmonic Imagingand 3D/4D Imaging on a FlatPanel Display. | The UltraVision is aportable DiagnosticUltrasound System, whichapplies the latesttechnologies to produceoptimal images. Thesystem facilitates aworkflow from imageacquisition through toarchival in a standardDICOM interface to theclinics PACs system.Various image parameteradjustments, a 15 inchhigh resolution display andcustom probes areconfigured to provide clearand stable images. Itoperates in B mode. |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN | Intended Use | This diagnostic ultrasoundsystem (UltraVision) anditstransducers areintended for use in clinicalexaminations to evaluatedifferences in theechogenicity of soft tissueof small parts in adultpatients, (thyroid, breast,and testicles) and forperipheral vessel,abdominal, and superficialmuscular skeletaldiagnosis. | The ultrasound imagingsystems are intended for thefollowing applications: Fetal,Abdominal, Intraoperative,Pediatric, Small Parts,Transcranial, OB/GYN,Cardiac, Pelvic,Neonatal/Adult Cephalic,Vascular, Musculoskeletal,Superficial Musculoskeletal,and Peripheral Vascularapplications.The system alsoprovides the ability tomeasure anatomicalstructures {fetal, abdominal,intraoperative, pediatric,small organ, neonatalcephalic, adult cephalic, | This diagnostic ultrasoundsystem (UltraVision) andits transducers areintended for use in clinicalexaminations to evaluatedifferences in theechogenicity of soft tissueof small parts in adultpatients, (thyroid, breast,and testicles) and forsuperficial muscularskeletal 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.
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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 |
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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 Catheteris intended for intra-cardiacand intra-luminal visualizationof cardiac and great vesselanatomy and physiology, aswell as visualization of otherdevices in the heart of adultand 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 |
| OperationCharacteristic | |||
| Installation anduse | a. Portable equipmentb. Mobile equipment(when installed onthe mobile cart) | Mobile equipment | a. Portableequipmentb. Mobileequipment(wheninstalled onthe mobilecart) |
| Mode of operation | Continuous operation | Continuous operation | Continuous operation |
| PhysicalSpecifications | |||
| Dimensions | 400 mm (W) x 50 mm (H) x250 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 besubject to excessivetemperatures duringtransportation/storage | -20°C to 60°C | Equipment should notbe subject toexcessivetemperatures during |
| transportation/storage | |||
| Relative Humidity | |||
| Operating: | Equipment should not beused in locations of highhumidity | 10% to 80% | Equipment should notbe used in locationsof high humidity |
| Transport/Storage: | Equipment should not beused in locations of highhumidity | 10% to 95% | Equipment should notbe used in locationsof high humidity |
| SafetyClassifications | |||
| Type of protectionagainst electricshock | Class II | Class I | Class II |
| The degree ofprotection againstelectric shock | Type BF | Type BF | Type BF |
| The degree ofprotection againstthe harmfulingress of liquid | IP41 for the main unitIPX8 for the transducer | Ordinary equipmentIPX8 for the transducers | IP41 for the main unitIPX8 for thetransducer |
| The degree ofsafety ofapplication in thepresence of aflammable gas | Equipment not to be used inthe presence of a flammablegas | Equipment not to be usedin the presence of aflammable gas | Equipment not to beused in the presenceof a flammable gas |
| Electrical &Mechanical Safety& Thermal SafetyStandards | |||
| The electrical,mechanical, andthermal safetyevaluation | Complies with the standard:IEC 60601-1: 2007IEC 60601-2-37: 2008 | Complies with the standard:IEC 60601-1: 2007IEC 60601-2-37: 2008 | Complies with thestandard:IEC 60601-1: 2007IEC 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 thestandard: IEC60601-1-2 3rd edition |
| Acoustic outputevaluation | Complies with the standard:IEC 61157 AIUM/NUMA UD-2, Acoustic OutputMeasurement Standard forDiagnostic Ultrasound | Complies with the standard:IEC 61157 AIUM/NUMAUD-2, Acoustic OutputMeasurement Standard forDiagnostic Ultrasound | Complies with thestandard:IEC61157 AIUM/NUMAUD-2, AcousticOutput MeasurementStandard forDiagnosticUltrasound |
| Biocompatibilityevaluation | Complies with the standard:ISO 10993-1: 2009ISO 10993-5: 2009ISO 10993-10: 2009 | Complies with the standard:ISO 10993-1: 2009ISO 10993-5: 2009ISO 10993-10: 2009 | Complies with thestandard:ISO 10993-1: 2009ISO 10993-5: 2009ISO 10993-10: 2009 |
| Disinfection | |||
| Disinfection | Probe: .55% OrthoPhthalaldehyde, 2.4%Glutaraldehyde | Probe: .55% Ortho-Phthalaldehyde 2.4%Glutaraldehyde | Probe: .55% OrthoPhthalaldehyde, 2.4%Glutaraldehyde |
| Specifications | |||
| Monitor | 15 inch display LCD flatpanel display with 2800 x1800 pixels | 19 inch high-resolution flatpanel display | 15 inch display LCDflat panel display with2800 x 1800 pixels |
| General imagingmode | B mode, M mode, E mode,Color flow dopper mode,shear mode | B mode, M mode, PWDmode, Color mode, CWDmode, eSie TouchTMVirtual TouchTM | B mode |
| Scanning method | Linear | Linear, Rocked, Auto-sweep, STIC (SpatialTemporal ImagingCorrelation) | Linear |
| Focus number | Max=4 | Max=4 | |
| B mode general | Distance | Distance/Depth, Volume | Distance |
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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.
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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.
| measurementsM mode generalmeasurements | Distance, Time | and Stenosis, Area,Volume Flow,CircumferenceDistance, Heart Rate,Slope, Time | / |
|---|---|---|---|
| D mode generalmeasurements | 1 | Measurements on a frozenor CINE image includingvelocity/frequency, HR(Heart Rate), S/D(systolic/diastolic) ratio, RI(resistive index), PI(pulsatility index), TAMx(time-average maximum),TAMn (time-averagemean), Slope(acceleration/deceleration),volume flow, A/B ratios,Time | |
| Color FlowDoppler Modegeneralmeasurements | Distance | Measurements on a frozenor CINE image includingvelocity/frequency, HR(heart rate), S/D(systolic/diastolic ratio), RI(resistive index), PI(pulsatility index), TAMx(time-average maximum),TAMn (time-averagemean), Slope(Acceleration/Deceleration),Volume Flow, A/B ratios,Time | |
| PW Doppler Modegeneralmeasurements | Velocity | Measurements on a frozenor CINE image includingvelocity/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/eSieTouch™ generalmeasurements | Provides a qualitativerepresentation of relativetissue stiffness for the regionof interest | Provides a qualitativerepresentation of relativetissue stiffness for theregion of interest | / |
| ShearMode/VirtualTouch™ Modegeneralmeasurements | / | Use Virtual Touch tissuequantification to measuretissue shear velocity (Vs)for a selected region ofinterest. Virtual Touchquantification uses acousticradiation force impulse(ARFI) technology ofdiagnostic ultrasound toinduce tissue displacement.A time-controlled sequenceof "push pulses" from thetransducer induces a smalldisplacement of tissue. Theultrasound systemmeasures shear wavevelocity at the region ofinterest | / |
| PeripheralDevicesSupported | |||
| Printer | Sony type UPD25MD (USB)color video printer | Black and white Mitsubishiprinter P-93DW, color Sonyprinter UP-D23MD | Sony type UPD25MD(USB) color videoprinter |
| Performance | |||
| Displayed depth | 20 mm to 300 mm | .5 cm to 30 cm | 20 mm to 300 mm |
| Gray scales | 256 | 256 | 256 |
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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.
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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 | ||
|---|---|---|---|---|
| ImageAdjustments | ||||
| B modeparameters | Gain | Gain | Gain | |
| Depth | Gray scale map | Depth | ||
| TGC | SieClear spatialcompounding | TGC | ||
| Frequency | Edge enhancement | Frequency | ||
| / | Tint/balance | / | ||
| / | Level of clarify vascularenhancement | / | ||
| / | Gray scale or color map forelasticity imaging | / | ||
| M modeparameters | 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 | / | ||
| MeasurementAccuracy | ||||
| 2D Measurement | ||||
| Depth/Distance | Range | 400 mm | 34 cm | 400 mm |
| Accuracy | 5% | 5% | 5% |
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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:
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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 displaystandard | 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:
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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
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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.
§ 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.