(102 days)
The system is a general-purpose ultrasonic intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point of care for diagnosis of patients.
The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.
The BenQ Diagnostic Ultrasound System (hereinafter called "system") is an easy-to-use, portable ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical analysis. The user interface is touch screen with 13.3" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the BenQ diagnostic ultrasound:
- Compact size with 1 transducer sockets. Convertible cart-based svstem design.
- . 2D (B&M mode) with harmonic imaging
- Color Flow Imaging, Pulsed Wave Spectral Doppler, Steerable Continuous Wave Doppler, Power Doppler
- 13.3″ LCD supporting wide-viewing angle with multi-touch
- Support 64 channels, support up to 128 elements probes, and easy maintenance.
- High density transducers with frequency range from 2 to 15 MHz
- Full patient database solutions: DICOM3.0, MP4 /PNG, USB3.0, SSD, PDF report, etc.
The provided document is a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It details the device's indications for use, comparison to a predicate device, and summarization of non-clinical tests.
The document explicitly states: "The subject of this premarket submission, T3300, is not required clinical studies to support substantial equivalence." This means that the device was not evaluated through clinical studies with human subjects, and therefore, it does not contain the information requested in points 1-7 and 9 of your prompt.
The acceptance criteria mentioned in the document are primarily related to non-clinical performance and safety standards, not diagnostic accuracy derived from a test set of patient data with expert ground truth.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission and clinical studies were not required, the "acceptance criteria" are compliance with recognized safety and performance standards for medical electrical equipment and diagnostic ultrasound systems. The "reported device performance" is its demonstration of conformance to these standards.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Conformance) |
|---|---|
| Safety and Electrical Performance: | |
| IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Conforms to IEC 60601-1 (ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Consolidated Text) |
| IEC 60601-1-2 (Electromagnetic compatibility) | Conforms to IEC 60601-1-2 Edition 3: 2007-03 |
| IEC 60601-2-37 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment) | Conforms to IEC 60601-2-37 Edition 2.1 2015 |
| Biocompatibility: | |
| ISO 10993-1 (Biological evaluation of medical devices) | Patient contact materials (Housing: PC/ABS, Lens: SILICONE) comply with ISO 10993-5 and ISO 10993-10. RTV664+Ultrason S2010 silicon rubber (predicate) confirmed compliance. |
| Acoustic Output: | |
| AIUM UD2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) | Conforms to AIUM UD2-2004 (R2009) requirements for all modes of all probes. Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical Index: 1.9 Maximum. |
| Software Life Cycle Processes: | |
| IEC 62304 (Medical device software - Software life cycle processes) | Conforms to IEC 62304:2015 |
| Cleaning and Disinfection Effectiveness: | Evaluated and found to conform |
| Thermal and Mechanical Safety: | Evaluated and found to conform |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable, as no clinical test set was required or used for this 510(k) substantial equivalence determination.
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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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. This device is a diagnostic ultrasound system itself, not an AI-assisted interpretation tool. The document explicitly states, "This system in no way interprets these images or provides a medical diagnosis of the patient being examined."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (ultrasound system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The ground truth for this submission was based on engineering and safety standard compliance, not clinical diagnostic accuracy.
8. The sample size for the training set
Not applicable, as no clinical training set was used for this 510(k) submission. The "training" in this context would refer to the engineering and design validation process against specified requirements and standards.
9. How the ground truth for the training set was established
Not applicable for a clinical training set. For the non-clinical and engineering validation, "ground truth" was established based on internationally recognized standards and specifications for medical device performance and safety (e.g., IEC standards, ISO standards, AIUM guidelines). The manufacturer's design, development, and quality processes (conforming to 21 CFR 820 and ISO 13485) ensure that the device meets these established engineering and safety "ground truths."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
August 27th, 2018
Qisda Corporation % Mr. Johnson Sheu Official Correspondent No.157, Shanying Rd., Shan-Ting Li, Gueishan Dist, Taoyuan City, 333 TAIWAN
Re: K181313
Trade/Device Name: BenQ 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: July 26, 2018 Received: July 31, 2018
Dear Mr. Sheu:
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 you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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,
Jeff Balyso
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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Indications for Use
510(k) Number (if known)
K181313
Device Name BenQ Diagnostic Ultrasound System
Indications for Use (Describe)
The system is a general-purpose ultrasonic intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point of care for diagnosis of patients.
The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.
The following table provides Diagnostic Ultrasound Indications for the transducers offered with the BenQ Diagnostic Ultrasound System.
| Indications for Use | Supporting Transducers |
|---|---|
| Cardiac Adult | P42B6 |
| Obstetric | C62B |
| Urology | C62B |
| Abdomen | C62B |
| Gynecology | C62B |
| Renal | C62B |
| Musculoskeletal (Conventional) | L154BH |
| Peripheral Vessel (Carotid, Venous, Arterial) | L154BH |
| Small Parts (Breast, Thyroid) | L154BH |
| Nerve | L154BH |
| Type of Use (Select one or both, as applicable) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Diagnostic Ultrasound Indications for Use Form
T3300 Diagnostic Doppler Ultrasound System System: T3300 Diagnostic Ultrasound Pulsed Echo System T3300 Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | 2D | M | PWDoppler | CWDoppler | Color | CPA | Other*Combined | TissueHarmonicImaging |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | Fetal | N | N | N | N | N | Note 1 | N | |
| Imaging & | Abdominal | N | N | N | N | N | Note 1 | N | |
| Other | Intra-operativeSpecify | ||||||||
| Intra-operativeNeuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast,thyroid, testes) | N | N | N | N | N | Note 1 | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1 | N | ||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN,Urology, Nerve) | N | N | N | N | N | Note 1 | N | ||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | N | |
| Vessel | Other (specify) |
N = new indication; P = previously cleared by FDA E = added under this appendix Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/Color; 2D/CPA; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Indications For Use
Page 2 of 5
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BenQ Diagnostic Ultrasound System, Model T3300 510(k) Submission
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
Diagnostic Ultrasound Indications for Use Form
Transducer: C62B Curved Linear Array 2-6MHz Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | 2D | M | PWDoppler | ColorDoppler | CPA | Other*Combined | TissueHarmonicImaging |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging &Other | Fetal | N | N | N | N | N | Note1 | N |
| Abdominal | N | N | N | N | N | Note1 | N | |
| Intra-operative Specify | ||||||||
| Intra-operative Neuro | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Ob/GYN, Urology) | N | N | N | N | N | Note1 | N | |
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/CPA; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of 5
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Diagnostic Ultrasound Indications for Use Form
Transducer: L154BH Linear Array 4-15MHz Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | 2D | M | PWDoppler | Color | CPA | Other*Combined | TissueHarmonicImaging |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging &Other | Fetal | |||||||
| Abdominal | N | N | N | N | N | Note1 | N | |
| Intra-operative Specify | ||||||||
| Intra-operative Neuro | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast,thyroid, testes) | N | N | N | N | N | Note1 | N | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card) | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note1 | N | |
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Nerve) | N | N | N | N | N | Note1 | N | |
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note1 | N |
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/CPA; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 4 of 5
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Diagnostic Ultrasound Indications for Use Form
Transducer: P42B6 Phase Array 64 elements 2-4MHz Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | 2D | M | PWDoppler | CWDoppler | Color | CPA | Other*Combined | TissueHarmonicImaging |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging &Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast,thyroid, testes) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/CW Doppler;2D/Color; 2D/CPA; 2D/Color /PW Doppler; 2D/Color /CW Doppler; 2D/CPA/CW Doppler and 2D/CPA/PW Doppler
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 5 of 5
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PREMARKET NOTIFICATION [510(k)] Summary
| Company Name: | Qisda CorporationNo.157, Shanying Rd., Shan-Ting Li, Gueishan Dist.,Taoyuan City, Taiwan |
|---|---|
| Contact: | Johnson Sheu Johnson.Sheu@Qisda.com |
| Device Name: | BenQ Diagnostic Ultrasound System |
| Device Model: | T3300 |
| Common Name: | Diagnostic Ultrasound System |
| Classification Name: | Regulatory Class: IIReview Category: Tier IIClassification Panel: RadiologyRegulation Name: Ultrasonic Pulsed Doppler Imaging SystemRegulation Number: 21 CFR 892.1550 |
Primary Predicate Device :
| 510(k) Number | Product Name | Manufacturer name | Regulation Number | Product Code(s) |
|---|---|---|---|---|
| K172056 | InnoSight DiagnosticUltrasound System | Qisda Corporation | 21 CFR 892.1560 | 90-IYO90-IYN90-ITX |
Registration Number: 3010220244
Factory Location: Qisda Corporation No.159,Shanying Rd., Shan-Ting Li, Gueishan Dist., Taoyuan City,Taiwan
Product Code: IYN, IYO, ITX
Reason for Submission:
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
Predicate Device Comparison:
The InnoSight is of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device
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BenQ Diagnostic Ultrasound System, Model T3300 510(k) Submission
| Qisda | Predicate Device | Submission Device |
|---|---|---|
| Product Name | InnoSight Diagnostic Ultrasound System | BenQ Diagnostic Ultrasound System |
| 510(k) Number | K172056 | Pending |
| Indications for Use | InnoSight Diagnostic Ultrasound System is intended fordiagnostic ultrasound imaging in B (2D), M-Mode, PWDoppler, CPA, Tissue Harmonic imaging and ColorDoppler modes. It is indicated for diagnosticultrasound imaging and fluid flow analysis in thefollowing applications: Fetal, Abdominal, SmallOrgan(Breast, Thyroid, testes), trans-rectal,trans-vaginal, Other (OB/GYN, Urology, Nerve), CardiacAdult and Peripheral Vessel. The clinical environmentswhere the system can be used include clinics,hospitals, and clinical point-of-care for diagnosis ofpatients. | The system is a general-purpose ultrasonic imaginginstrument intended for use by a qualified physician forultrasound evaluation/clinical analysis etc. It can beused in non-intrusive applications, including Abdomen,Cardiology, Gynecology, Obstetric, Breast, Thyroid,Musculoskeletal, Vascular (Carotid, Venous, Arterial),Nerve, Renal, and Urology. The clinical environmentswhere the system can be used include clinics,hospitals, and clinical point of care for diagnosis ofpatients |
| Design | Based on 64 channel full digital beam former. | Based on 64 channel full digital beam former. |
| Operating Controls | Autocorrelation for color processing and FFT for pulseand CW Doppler processing.Supporting both Linear, Curve linear and Phase arrayprobes from 2 to 15 MHz. Cine play back capability andImage file archive Software upgrade with USB flashdrive. Digital Scan Converter 1366x768§ TGC 8 slider, +/- 22.5 dB | Autocorrelation for color processing and FFT for pulseand CW Doppler processing.Supporting both Linear, Curve linear and Phase arrayprobes from 2 to 15 MHz. Cine play back capability andImage file archive Software upgrade with USB flashdrive. Digital Scan Converter 1366x768§ TGC 8 slider, +/- 22.5 dB |
| § Depth Range: 1 to 28 cm | § Depth Range: 1 to 28 cm | |
| § Image sector size: 46 lines to full B (256 lines) | § Image sector size: 46 lines to full B (256 lines) | |
| § Image Sector position: Steering within full maximum | § Image Sector position: Steering within full maximum | |
| § B orientation flip: L/R key with marking on the screen | § B orientation flip: L/R key with marking on the screen | |
| § B Dynamic range control: preset 100 levels | § B Dynamic range control: preset 100 levels | |
| § Gray Scale Control: 5 levels | § Gray Scale Control: 5 levels | |
| § Focal Number: 10 focal zone setting | § Focal Number: 10 focal zone setting | |
| § B persistence: 10 levels | § B persistence: 10 levels | |
| § Image Processing: Smoothing, edge enhancement | § Image Processing: Smoothing, edge enhancement | |
| § PW sweeping speed 1,2,4,8 sec over display. | § PW sweeping speed 1,2,4,8 sec over display. | |
| § PW Wall filter setting: 20 levels | § PW Wall filter setting: 20 levels | |
| § PW sample volume: 0.23 to 20 mm | § PW sample volume: 0.23 to 20 mm | |
| § PW/B update: with UPDATE key | § PW/B update: with UPDATE key | |
| § PW cursor steering: Steer key | § PW cursor steering: Steer key | |
| § PW angle correction: - 72,0,72 degree user control | § PW angle correction: - 72,0,72 degree user control | |
| § PW spectrum dynamic range: 8 preset curve over10-80 dB§ Spectrum baseline shift and invert | § PW spectrum dynamic range: 8 preset curve over10-80 dB§ Spectrum baseline shift and invert | |
| § M Process: Peak, Mean | § M Process: Peak, Mean | |
| § Color ROI setting: Touch and drag to control size andposition§ Color steering on flat probe: +/- 15 | § Color ROI setting: Touch and drag to control size andposition§ Color steering on flat probe: +/- 15 | |
| § Color Wall Filter: Color wall filter with 20 settings | § Color Wall Filter: Color wall filter with 20 settings | |
| § Color & B priority: C-B priority Key | § Color & B priority: C-B Reject Key | |
| § Zoom factor: Up to 5x | § Zoom factor: Up to 5x | |
| § Freeze control: Touch freeze key | § Freeze control: Touch freeze key | |
| § Cine control: step, play backward, play continuously | § Cine control: step, play backward, play continuously | |
| Qisda | Predicate Device | Submission Device |
| Safety Compliance | IEC 60601-1 International Electrotechnical Comission;Medical Electrical Equipment - Part 1IEC60601-2 International Electrotechnical Comission;Electromagnetic CompatibilityIEC 60601-2-37 International ElectrotechnicalComission; Medical Electrical Equipment - Part 2-37 | IEC 60601-1 International Electrotechnical Comission;Medical Electrical Equipment - Part 1IEC60601-2 International Electrotechnical Comission;Electromagnetic CompatibilityIEC 60601-2-37 International ElectrotechnicalComission; Medical Electrical Equipment - Part 2-37 |
| Patient ContactMaterials | RTV664+Ultrason S2010 silicon rubber complies withISO10993-5and ISO10993-10 | Housing: PC/ABS Lens: SILICONE are compliance withISO 10993-5 and ISO 10993-10 |
| Operation Mode | B (2-D), M, CFM, CPA, PW,CW, Tissue Harmonic Imageand combine mode | B (2-D), M, Color(CFM), Power(CPA), PW,CW,THI(Tissue Harmonic Image) and combine mode |
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode;2-D/Pulsed Doppler and Triplex 2-D/CD/PulsedDoppler image formats; Dual B and Color in real time | Single and dual 2-D; Display of Duplex 2-D/M-mode;2-D/Pulsed Doppler and Triplex 2-D/Color/PulsedDoppler image formats; Dual B and Color in real time |
| Display Annotations | Time/date/year; transducer type; power output in %;frames per second; persistence; and compressionsettings; image depth; patient name and ID; institutionname; focal position; TGC curve display; Doppler & Mscale in sec; Doppler angle correction cursor; free formannotation anywhere on image; touch controlled;selective or global erase of the display annotations,body markers with transducer annotations | Time/date/year; transducer type; power output in %;frames per second; persistence; and compressionsettings; image depth; patient name and ID; institutionname; focal position; TGC curve display; Doppler & Mscale in sec; Doppler angle correction cursor; free formannotation anywhere on image; touch controlled;selective or global erase of the display annotations,body markers with transducer annotations |
| Display Monitor | 11.6" LCD Touch Screen | 13.3" LCD Touch Screen |
| Measurements | Distance; area; Volume; circumference; Heart Rate;calipers; velocity; PI, RI, Cardiac, OB/GYN and Vascularpackage. | Distance; area; Volume; circumference; Heart Rate;calipers; velocity; PI, RI, Cardiac, OB/GYN and Vascularpackage. |
| Transducer Types &Connectors | Convex, Phase array, and Linear array probes;Single-port connector connect 1 transducer | Convex, Phase array, and Linear array probes;Single-port connector connect 1 transducer |
| Transducer List | * C6-2* C9-4v* L12-4* S4-2 | * C62B* L154BH* P42B6 |
| System frequencyrange | 1.3 to 14.4 MHz | 1.3 to 14.4 MHz |
| Principle ofOperation | Applying high voltage burst to the Piezoelectricmaterial in the transducer and detect the reflectedecho to construct the 2-D B-mode, Doppler color, andDoppler spectrum image for diagnostic purpose. | Applying high voltage burst to the Piezoelectricmaterial in the transducer and detect the reflectedecho to construct the 2-D B-mode, Doppler color, andDoppler spectrum image for diagnostic purpose. |
| Users / Sites | Hospitals, clinics usage | Hospitals, clinics usage |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2maximum, TIS/TIB/TIC: 0.1-4.0 Range, MechanicalIndex: 1.9 Maximum, or Derated Isppa: 190 W/cm2max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2maximum, TIS/TIB/TIC:0.1-4.0 Range, MechanicalIndex: 1.9 Maximum, or Derated Isppa: 190 W/cm2max |
| Dimensions /WeightPowerRequirements | Dimension: Height 223.2 mm Width 319.6 mm Depth31.8 mm Weight: 2.46 kgPower requirements: 100~240 Volts AC, 1.7 AmpsPower Consumption: 65 watts max.Operating temperature 10-40° C; relative humidity20-85%; | Dimension: Height 238.5 mm, Width 348.2 mmDepth(Thickness): 38.5 mm. Weight: 2.6 kgPower requirements: 100~240 Volts AC, 1.6A Max.Power Consumption: 65 watts maxOperating temperature 10-40° C; relative humidity20-85%; |
| Peripherals andAccessories | LAN, USB thermal Printer, USB flash mobile drive ,HDMI video output | LAN, USB thermal Printer, USB flash mobile drive ,HDMI video output |
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BenQ Diagnostic Ultrasound System, Model T3300 510(k) Submission
General Device Description:
The BenQ Diagnostic Ultrasound System (hereinafter called "system") is an easy-to-use, portable ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical analysis. The user interface is touch screen with 13.3" display. The all-digital architecture with progressive dynamic receive focusing allows the
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BenQ Diagnostic Ultrasound System, Model T3300 510(k) Submission
system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the BenQ diagnostic ultrasound:
- Compact size with 1 transducer sockets. Convertible cart-based svstem design.
- . 2D (B&M mode) with harmonic imaging
- Color Flow Imaging, Pulsed Wave Spectral Doppler, Steerable Continuous Wave Doppler, Power Doppler
- 13.3″ LCD supporting wide-viewing angle with multi-touch
- Support 64 channels, support up to 128 elements probes, and easy maintenance.
- High density transducers with frequency range from 2 to 15 MHz
- Full patient database solutions: DICOM3.0, MP4 /PNG, USB3.0, SSD, PDF report, etc.
Indications for Use:
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Vascular (Carotid, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed.
The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.
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| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler andTriplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time. | |
|---|---|---|
| Description ofTransducers | L154BH Linear Array 4-15MHzC62B Curved Linear Array 2-6MHzP42B6 Phased Array 2-4MHz | |
| Measurements | Distance; area; Volume; circumference; Heart Rate; calipers; velocity; PI, RI,Cardiac, OB/GYN and Vascular package. | |
| Principle ofOperation | Applying high voltage burst to the Piezoelectric material in the transducerand detect the reflected echo to construct the 2-D B-mode, Doppler color,and Doppler spectrum image for diagnostic purpose. | |
| OperatingControls | TGC 8 slider Depth Range: 1 to 28 cm Image sector size: 46 lines to full B (256 lines) Image Sector position: moving within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 100 levels Gray Scale Control: 5 Settings Focal Number: up to 10 focal zone setting B persistence: 10 levels Image Processing: QScan for smoothing and edge enhancement PW sweeping speed 1x,1/2x,1/4x,1/8x over display. PW Wall filter setting: 20 settings PW sample volume: 0.2 to 20mm PW/B update: with UPDATE key PW cursor steering: Steer key PW angle correction: +/- 72 degree user control PW spectrum dynamic range: 8 preset curve Spectrum baseline shift and invert Color ROI setting: Touch and drag to control size and position Color steering on flat probe: +/- 15 Color Wall Filter: Color wall filter with 20 settings Color & B priority: C-B priority key Color Packet size: preset per Exam range up to 11 Zoom factor: Up to 5x Freeze control: Touch freeze key Cine control: step, play continuously | |
| AcousticOutput | Conform to IEC 60601-2-37 and AIUM UD2 requirements for all modes of allprobes |
Technological Characteristics:
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Summary of Non-Clinical Test:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The T3300 and its applications comply with voluntary standards.
| RecognitionNumber | Regulations No./Version | Recognition Standard |
|---|---|---|
| 19-4 | ANSIAAMI ES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text) | Medical electrical equipment - Part 1:General requirements for basic safetyand essential performance (IEC60601-1:2005, MOD). (General II(ES/EMC)) |
| 19-1 | IEC 60601-1-2 Edition 3:2007-03 | Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - Collateralstandard: Electromagnetic compatibility- Requirements and tests. (General II(ES/EMC) |
| 12-293 | IEC 60601-2-37 Edition 2.12015 | Medical electrical equipment - Part 2-37:Particular requirements for the basicsafety and essential performance ofultrasonic medical diagnostic andmonitoring equipment |
| 2-220 | ISO 10993-1 Fourth Edition2009-10-15 | Biological evaluation of medical devices -Part 1: Evaluation and testing within arisk management process [Including:Technical Corrigendum 1 (2010)] |
| 12-105 | UD 2-2004 (R2009) | Acoustic Output Measurement Standardfor Diagnostic Ultrasound EquipmentRevision 3. (Radiology) |
| 13-79 | IEC 62304:2015 | Medical device software - Software lifecycle processes |
Summary of Clinical Tests:
The subject of this premarket submission, T3300, is not required clinical studies to support substantial equivalence.
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Conclusion:
Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. It is considered that the T3300 to be as safe, as effective and performance is substantially equivalent to the predicate devices. Therefore, it is concluded that this device is safe and effective for its intended use.
§ 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.