(58 days)
The diagnostic ultrasound system (U60) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
The U60 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 15.0 inch LCD and diverse probes are configured to provide clear and stable images.
The provided text is a 510(k) premarket notification for the Edan Instruments U60 Diagnostic Ultrasound System. This type of FDA submission aims to demonstrate "substantial equivalence" to a predicate device, rather than proving safety and effectiveness from scratch through extensive clinical trials for a new, revolutionary device.
Therefore, the document does not contain detailed information about acceptance criteria and studies demonstrating that the device meets those acceptance criteria in the way one might expect for a novel AI/ML device or a device with new clinical indications. Instead, it focuses on demonstrating that the U60 is substantially equivalent to a predicate device (the U50 Diagnostic Ultrasound System) by showing similar design, intended use, indications for use, fundamental scientific technology, and performance, while complying with relevant safety standards.
Here's a breakdown of what can and cannot be extracted from the document based on your request:
Information Present in the Document:
- 1. Table of Acceptance Criteria and Reported Device Performance:
- The document presents a comparison table (within "9. Predicate Device Comparison") between the U60 (subject device) and the U50 (predicate device) across various parameters. This table effectively serves as the "acceptance criteria" for demonstrating substantial equivalence, where the acceptance criteria is generally "same" or "similar" to the predicate.
- Table of Performance (Comparison to Predicate):
| Item | U60 R1.0 Ultrasound System (Edan Instruments) Performance | U50 R2.2 Ultrasound System (Edan Instruments) Performance | Comparison Result |
|---|---|---|---|
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Same |
| Indications for Use | Applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics for abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications. | Same as U60 | Same |
| Safety Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, AIUM, NEMA UD 2, UD3 | Same | Same |
| Patient Contact Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Software life cycle processes | Complies with IEC 62304 | Complies with IEC 62304 | Same |
| Mode of Operations | Continuous operation | Continuous operation | Same |
| General Imaging mode | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW | Same |
| Measurements (B-Mode) | Distance, Area, Volume, Ratio, Histogram, Angle | Same | Same |
| Measurements (M-Mode) | Distance, Time, Slope, Heart Rate | Same | Same |
| Measurements (D-Mode) | Time, Heart Rate, Velocity, Acceleration, RI, PI, Auto (auto trace) | Same | Same |
| Scanning method | Electronic convex, Electronic linear with slant scanning | Same | Same |
| Cine loop | 1227 frames | 1227 frames | Same |
| Focus Number | Max=4 | Max=4 | Same |
| Software Packages | Abdomen, obstetric, small parts, gynecology, cardiology, urology, vascular, Pediatrics. | Same | Same |
| Principle of Operation | Applying high voltage burst to Piezoelectric material in transducer and detect reflected echo to construct diagnostic image | Same | Same |
| Acoustic Output | Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Derated ISPTA: 720 W/cm² max, Mechanic Index ≤1.9 max or Derated ISPPA 190 W/cm² max | Same | Same |
| Transducer Types | Convex Array, Linear Array, Micro Convex Array, Phased Array | Same | Same |
| Transducer Frequency | 2.0-15.0 MHz | 2.0-15.0 MHz | Same |
| Primary Display | 15inch (1024*768) | 12.1inch (1024*768) | Difference |
| Dimensions/Weight | 220 mm (W) × 370 mm (L) × 350 mm (H), 8.1kg net weight | 330 mm (W) × 320 mm (L) × 220 mm (H), 7.8kg net weight | Difference |
| Printer | B/W video thermal printer, Color video thermal printer, Graph/text laser jet printer | Same | Same |
| Storage Media | DVD, USB stick | DVD, USB stick | Same |
| Temperature (Operating) | 0°C ~40°C | 5°C ~40°C | Difference |
| Temperature (Transport/Storage) | -20~55°C | -20~55°C | Same |
| Relative humidity (Operating) | 15% ~ 95%RH (no condensation) | 25% ~ 80%RH (no condensation) | Difference |
| Relative humidity (Transport/Storage) | 15% ~ 95%RH (no condensation) | 25% ~ 93%RH (no condensation) | Difference |
| Atmospheric pressure (Operating) | 860hPa ~1060hPa | 860hPa ~1060hPa | Same |
| Atmospheric pressure (Transport/Storage) | 700hPa ~1060hPa | 700hPa ~1060hPa | Same |
| Power Requirements | AC: 100-240V 50/60Hz | AC: 100-240V 50/60Hz | Same |
| Operation System | Linux | Linux | Same |
| Safety Classifications | Class I (Type BF, main unit: IPX0, probes: IPX7, footswitch: IP68, not suitable for use in flammable gas) | Same | Same |
| Displayed depth | 20-320mm (Probe Dependent) | 20-320mm (Probe Dependent) | Same |
| Gray Scales | 256 | 256 | Same |
| Dynamic range | 150dB | 150dB | Same |
| TGC | 8 segments | 8 segments | Same |
| Zoom | Up to 400% | Up to 400% | Same |
| B-Mode Measurement Accuracy | Depth/Distance: Max 324mm, Accuracy ≤±5% Area: Max 1126 cm², Accuracy ≤±10% Angle: 0-180°, Accuracy ≤±3% Ratio: Max 1.0, Accuracy <=10% Volume: Max 999 cm³, Accuracy <=15% | Same values and accuracies listed for U50 | Same |
| M-mode Measurement Accuracy | Depth: Max 324mm, Accuracy <=5% Time: Max 13s, Accuracy <=5% Heart rate: Max 999bpm, Accuracy <=5% Slope: Max 999mm/s, Accuracy <=10% | Same values and accuracies listed for U50 | Same |
| PW mode velocity Measurement Accuracy | Range: 0.5-2.5m/s, Accuracy <=10% | Same values and accuracies listed for U50 | Same |
| CW mode velocity Measurement Accuracy | Range: 0.5-2.5m/s, Accuracy <=10% | Same values and accuracies listed for U50 | Same |
-
2. Sample sized used for the test set and the data provenance:
- The document explicitly states: "Clinical testing is not required." and "Verification and validation testing has been conducted on the U60 Ultrasound Imaging System."
- This indicates that no patient data (test set) was used in a clinical study to evaluate the device's performance against clinical endpoints. The acceptance criteria and performance data are based on bench testing and engineering verification, which demonstrate that the device performs within established technical specifications comparable to the predicate. Therefore, information about sample size or data provenance (country, retrospective/prospective) for a clinical test set is not applicable here.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI/ML device. It's a diagnostic ultrasound system. Its "performance" refers to its imaging capabilities and measurement accuracy, which are evaluated intrinsically through non-clinical (bench) testing, not through standalone algorithm performance.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (e.g., B-Mode Measurement Accuracy, M-mode Measurement Accuracy), the "ground truth" would be established by known physical standards or phantoms with precisely measured characteristics (e.g., a known distance in a test object for distance accuracy). This is standard for ultrasound system performance verification.
Information NOT Present / Not Applicable based on the Document:
- 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 expert ground truth was performed for this 510(k) submission.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, for the reason above.
- 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, as this is a diagnostic ultrasound system, not an AI-assisted device.
- 8. The sample size for the training set: Not applicable, as this is not an AI/ML device with a training set.
- 9. How the ground truth for the training set was established: Not applicable, for the reason above.
In summary:
This 510(k) submission for the Edan Instruments U60 Diagnostic Ultrasound System demonstrates substantial equivalence to a predicate (U50) primarily through non-clinical bench testing and adherence to recognized performance and safety standards. It is not an AI/ML device, nor does it present clinical study data with human-in-the-loop performance or expert-established ground truth, as is often seen with AI-based medical devices. The "acceptance criteria" discussed are a comparison of technical specifications and performance metrics to an already cleared device, asserting that the new device is "same" or "similar" and therefore equally safe and effective.
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April 13, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Edan Instruments, Inc. % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Avenue, Suite 200 SUNNYVALE CA 94089
Re: K180408
Trade/Device Name: U60 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: March 28, 2018 Received: April 2, 2018
Dear Mr. Worth:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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}------------------------------------------------
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
U60 Diagnostic Ultrasound System
Indications for Use (Describe)
The diagnostic ultrasound system (U60) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
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| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | |||
| Small Organ (Specify) * | P | P | P | P | P | P | |||
| FetalImaging& Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | P | P | P | P | P | P | |||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | |||
| Intravascular | |||||||||
| Other (Specify) ** | P | P | P | P | P | P | |||
| Adult Cardiac | P | P | P | P | P | P | P | ||
| Pediatric Cardiac | P | P | P | P | P | P | |||
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | P | P | P | P | P | P | ||
| Other (Specify) |
U60 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
| ** Other use includes Urology, Gynecology | |
|---|---|
| [1]:PDI: Power Doppler Imaging , DPDI: Directional Power Doppler Imaging , |
|---|
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{4}------------------------------------------------
| Clinical Application | Mode of Operation | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] | |
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal / Obstetrics | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) * | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) ** | P | P | P | P | P | P | |||
| Cardiac | Adult Cardiac | ||||||||
| Pediatric Cardiac | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | ||||||||
| Other (Specify) |
U60 with C352UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
| ** Other use includes Urology, Gynecology |
|---|
| [1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging | ||
|---|---|---|
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{5}------------------------------------------------
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | P | P | P | P | P | P | |
| Other (Specify) |
U60 with L1042UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{6}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] | |
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | P | P | P | P | P | P | ||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | |
| vascular | Other (Specify) |
U60 with L742UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{7}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | P | P | P | P | P | P | ||
| FetalImaging& Other | Abdominal | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | P | P | ||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | |||||||
| Other (Specify) |
U60 with E612UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
| ** Other use includes Urology, Gynecology |
|---|
| _______________ |
| [1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging | ||
|---|---|---|
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{8}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | P | P | P | P | P | P | ||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | |||||||
| Other (Specify) |
U60 with C612UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
| ** Other use includes Urology, Gynecology |
|---|
| [1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging |
|---|
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{9}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] | |
| General | Ophthalmic | |||||||
| FetalImaging& Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Cardiac | Pediatric Cardiac | P | P | P | P | P | P | P |
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | |||||||
| Other (Specify) |
U60 with C6152UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
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{10}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | P | P | P | P | P | P | P |
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
U60 with C422UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
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{11}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Specify) * | P | P | P | P | P | P | P | |
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | |
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | P | |
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Cardiac | Pediatric Cardiac | |||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | P |
| vascular | Other (Specify) |
U60 with L552UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
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{12}------------------------------------------------
U60 with C5-2b Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) * | |||||||||
| FetalImaging& Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) ** | P | P | P | P | P | P | |||
| Cardiac | Adult Cardiac | ||||||||
| Pediatric Cardiac | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
Note * Small Organ includes Thyroid, Testes, Breast
| ** Other use includes Urology, Gynecology | |
|---|---|
| [1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging | |
| [2]: Biopsy Guidance | |
| CAST THE CONSTITUTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO |
[3]: Harmonic Imaging, This feature does not use contrast agent.
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{13}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | P | P | P | P | P | P | P |
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | |||||||
| Other (Specify) |
U60 with P5-1b Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
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{14}------------------------------------------------
U60 with L15-7b Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | P | P | P | P | P | P | P | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | P | P | P | P | P | P | |
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
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{15}------------------------------------------------
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc. | ||||
|---|---|---|---|---|---|
| #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen, 518122 P.R.China. | |||||
| Tel.: (0755) 26858736 | |||||
| Fax: +1 (408) 418-4059 | |||||
| Contact Person: | Crystal Cai | ||||
| Date prepared: | February 12, 2018 | ||||
| 2. Device nameand classification: | Device Name: U60 Diagnostic Ultrasound System | ||||
| Model: U60 | |||||
| Classification Name: | |||||
| 892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN | |||||
| 892.1560 Ultrasonic, Pulsed echo, ImagingProduct code: IYO | |||||
| 892.1570 Transducer, Ultrasonic, DiagnosticProduct code: ITX | |||||
| Regulatory Class: Class II | |||||
| 3.PremarketNotification ClassIII Certificationand Summary | Not applicable, the subject device is Class II. | ||||
| 4. PredicateDevice(s): | U50 Diagnostic ultrasound system/ K173003/ Edan Instruments, Inc. | ||||
| 5. Pre-Submission,IDE | Not applicable, there is no prior submission. |
{16}------------------------------------------------
-
- Device The U60 is a portable Diagnostic Ultrasound System, which applies Description: advanced technologies. Various image parameter adjustments, 15.0 inch LCD and diverse probes are configured to provide clear and stable images.
- The diagnostic ultrasound system (U60) is applicable for adults, 7. Intended Use: pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
9. Predicate Device Comparison
Comparison to the predicate devices, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following tables:
| Item | U60 R1.0Ultrasound System(Edan Instruments) | U50 R2.2Ultrasound System(Edan Instruments) | ComparisonResult | |
|---|---|---|---|---|
| 510(k)Number | Current Submission | K173003 | ||
| Manufacturer | EDAN Instruments | EDAN Instruments | Same | |
| Intended Use | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Same | |
| Indicationsfor Use | The diagnostic ultrasound system(U60) is applicable for adults,pregnant women, pediatricpatients' ultrasound evaluation inhospitals and clinics. It isintended for use in abdominal,obstetrics, gynecology, pediatric,small parts, urology, peripheralvascular, musculoskeletal(conventional and superficial),endovaginal and cardiac clinicalapplications, by or on the orderof a physician or similarlyqualified health careprofessional. | The diagnostic ultrasound system(U50) is applicable for adults,pregnant women, pediatricpatients' ultrasound evaluation inhospitals and clinics. It isintended for use in abdominal,obstetrics, gynecology, pediatric,small parts, urology, peripheralvascular, musculoskeletal(conventional and superficial),endovaginal and cardiac clinicalapplications, by or on the orderof a physician or similarlyqualified health careprofessional. | Same | |
| Installationand Use | a. Portable Equipmentb. Mobile Equipment (when thesystem is installed on the mobiletrolley) | a. Portable Equipmentb. Mobile Equipment (when thesystem is installed on the mobiletrolley) | Same | |
| SafetyStandards | IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10AIUM, NEMA UD 2, UD3 | IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10AIUM, NEMA UD 2, UD3 | Same | |
| PatientContactMaterials | Complies with ISO 10993 | Complies with ISO 10993 | Same | |
| Software lifecycleprocesses | Complies with the standard: IEC 62304 | Complies with the standard: IEC 62304 | Same | |
| Mode ofOperations | Continuous operation | Continuous operation | Same | |
| GeneralImaging mode | B-Mode, M-Mode, Color,PDI/DPDI, PW, CW | B-Mode, M-Mode, Color,PDI/DPDI, PW, CW | Same | |
| Measurements | B-Mode: Distance, Area,Volume, Ratio, Histogram andAngle | B-Mode: Distance, Area,Volume, Ratio, Histogram andAngle | Same | |
| M-Mode: Distance, Time, Slope,and Heart Rate | M-Mode: Distance, Time, Slope,and Heart Rate | |||
| D-Mode: Time, Heart Rate,Velocity, Acceleration, RI, PI andAuto (auto trace) | D-Mode: Time, Heart Rate,Velocity, Acceleration, RI, PI andAuto (auto trace) | |||
| Scanningmethod | Electronic convexElectronic linear with slantscanning | Electronic convexElectronic linear with slantscanning | Same | |
| Cine loop | 1227 frames | 1227 frames | Same | |
| FocusNumber | Max=4 | Max=4 | Same | |
| SoftwarePackages | Abdomen, obstetric, small parts,gynecology, cardiology, urology,vascular and Pediatrics. | Abdomen, obstetric, small parts,gynecology, cardiology, urology,vascular and Pediatrics. | Same | |
| Principle ofOperation | Applying high voltage burst tothe Piezoelectric material in thetransducer and detect reflectedecho to construct diagnosticimage | Applying high voltage burst tothe Piezoelectric material in thetransducer and detect reflectedecho to construct diagnosticimage | Same | |
| AcousticOutput | Track 3: MI, TIS, TIC, TIB(TIRange 0-6.0)Derated ISPTA: 720 W/cm²maximum, Mechanic Index ≤1.9maximum or Derated ISPPA 190W/cm² max | Track 3: MI, TIS, TIC, TIB(TIRange 0-6.0)Derated ISPTA: 720 W/cm²maximum, Mechanic Index ≤1.9maximum or Derated ISPPA 190W/cm² max | Same | |
| TransducerTypes | Convex ArrayLinear ArrayMicro Convex ArrayPhased Array | Convex ArrayLinear ArrayMicro Convex ArrayPhased Array | Same | |
| TransducerFrequency | 2.0-15.0 MHz | 2.0-15.0 MHz | Same | |
| PrimaryDisplay | Primary Screen:15inch(1024*768) | Primary Screen:12.1inch(1024*768) | Difference | |
| Ports | ||||
| Dimensions/Weight | 220 mm (W) × 370 mm (L) ×350mm (H)net weight 8.1kg | 330 mm (W) × 320 mm (L) ×220 mm (H)net weight 7.8kg | Difference | |
| Printer | B/W video thermal printerColor video thermal printerGraph/text laser jet printer | B/W video thermal printerColor video thermal printerGraph/text laser jet printer | Same | |
| StorageMedia | DVD, USB stick | DVD, USB stick | Same | |
| Temperature | Operating: 0°C | Operating: 5°C | Difference | |
| Relativehumidity | Operating: 15% ~ 95%RH (nocondensation)Transport/Storage:15% ~95%RH (no condensation) | Operating: 25% ~ 80%RH (nocondensation)Transport/Storage:25% ~93%RH (no condensation) | Difference | |
| Atmosphericpressure | Operating: 860hPa ~1060hPaTransport/Storage:700hPa~1060hPa | Operating: 860hPa ~1060hPaTransport/Storage:700hPa~1060hPa | Same | |
| PowerRequirements | AC: 100-240V 50/60Hz | AC: 100-240V 50/60Hz | Same | |
| OperationSystem | Linux | Linux | Same | |
| Safety Classifications | ||||
| Typeofprotectionagainstelectric shock | Class I | Class I | Same | |
| The degree ofprotectionagainstelectric shock | Type BF. | Type BF. | Same | |
| The degree ofprotectionagainstharmfulingressofliquid | The main unit : IPX0,probes : IPX7Footswitch: IP68 | The main unit : IPX0,probes : IPX7Footswitch: IP68 | Same | |
| The degree ofsafetyofapplication inthepresenceofaflammablegas | Equipment not suitable for use inthe presence of a flammable gas | Equipment not suitable for use inthe presence of a flammable gas | Same | |
| The degree ofRF | Group 1, Class A | Group 1, Class A | Same | |
| Disinfection | ||||
| Disinfection | Probe:2.4%Glutaraldehyde,0.55%Ortho-Phthalaldehyde.Needle guide:75% medical alcohol, | Probe:2.4%Glutaraldehyde,0.55%Ortho-Phthalaldehyde.Needle guide:75% medical alcohol, | Same | |
| 2.4%Glutaraldehyde. | 2.4%Glutaraldehyde. | |||
| Performance | ||||
| Displayeddepth | 20-320mm (Probe Dependent) | 20-320mm (Probe Dependent) | Same | |
| Gray Scales | 256 | 256 | Same | |
| Dynamicrange | 150dB | 150dB | Same | |
| TGC | 8 segments | 8 segments | Same | |
| Zoom | Up to 400% | Up to 400% | Same | |
| Image Adjustments | ||||
| Image type | Image type | |||
| Gain | Gain | |||
| Depth | Depth | |||
| TGC | TGC | |||
| Freq(Frequency) | Freq(Frequency) | |||
| Gray Map | Gray Map | |||
| Dynamic Range | Dynamic Range | |||
| Rejection | Rejection | |||
| Focus Position | Focus Position | |||
| Focus Number | Focus Number | |||
| B ModeParameters | eSRI(SpackleImaging) Rejection | eSRI(SpackleImaging) Rejection | Same | |
| Pseudo color | Pseudo color | |||
| Spatial Compound | Spatial Compound | |||
| GAO(Gain Auto Optimization) | GAO(Gain Auto Optimization) | |||
| Scan Angle | Scan Angle | |||
| Scan Mode | Scan Mode | |||
| Frame Persist | Frame Persist | |||
| H Reverse(horizontal) | H Reverse(horizontal) | |||
| V Reverse(vertical) | V Reverse(vertical) | |||
| 90°Rotate | 90°Rotate | |||
| B/W Invert | B/W Invert | |||
| Freq | Freq | |||
| Sweep Speed | Sweep Speed | |||
| Display Layout | Display Layout | |||
| M ModeParameters | Gray Map | Gray Map | Same | |
| Focus Position | Focus Position | |||
| Dynamic Range | Dynamic Range | |||
| Pseudo Color | Pseudo Color | |||
| Line Average | Line Average | |||
| Flow type | Flow type | |||
| Gain | Gain | |||
| Color Mode& Power | Freq | Freq | ||
| Wallfilter | Wallfilter | |||
| DopplerMode &DirectionalPower ModeParameters | PRF(PulsedFrequency) Repetition | PRF(PulsedFrequency) Repetition | Same | |
| Base Line | Base Line | |||
| Invert | Invert | |||
| Dual Live | Dual Live | |||
| Angle Steer | Angle Steer | |||
| Packet size | Packet size | |||
| Persist | Persist | |||
| Threshold | Threshold | |||
| Smooth Filter | Smooth Filter | |||
| ROI box positionand size | ROI box positionand size | |||
| adjustment | adjustment | |||
| Flow type | Flow type | |||
| Gain | Gain | |||
| PRF | PRF | Same | ||
| Invert | Invert | |||
| Angle steer | Angle steer | |||
| Correction Angle | Correction Angle | |||
| Quick Angle | Quick Angle | |||
| PWModeParameters | Base Line | Base Line | ||
| Sample Volume | Sample Volume | Same | ||
| Wallfilter | Wallfilter | |||
| Freq | Freq | |||
| Duplex and Triplex | Duplex and Triplex | |||
| Pseudo Color | Pseudo Color | |||
| Dyn Rng | Dyn Rng | |||
| Volume | Volume | |||
| Sweep Speed | Sweep Speed | |||
| HPRF | HPRF | |||
| Flow type | Flow type | Same | ||
| Gain | Gain | |||
| PRF | PRF | |||
| Invert | Invert | |||
| Angle steer | Angle steer | |||
| CWModeParameters | Correction Angle | Correction Angle | ||
| Quick Angle | Quick Angle | |||
| Base Line | Base Line | |||
| Wallfilter | Wallfilter | |||
| Pseudo Color | Pseudo Color | |||
| Dynamic Range | Dynamic Range | |||
| Volume | Volume | |||
| Sweep Speed | Sweep Speed | |||
| B-Mode Measurement Accuracy | ||||
| RangeofDepth/Distance | Maximum 324 mm | Maximum 324 mm | Same | |
| AccuracyofDepth/Distance | ≤±5% | ≤±5% | Same | |
| Range of Area | Maximum 1126 cm² | Maximum 1126 cm² | Same | |
| AccuracyofArea | ≤±10% | ≤±10% | Same | |
| RangeofAngle | 0-180° | 0-180° | Same | |
| AccuracyofAngle | ≤±3% | ≤±3% | Same | |
| Rangeof | Maximum 1.0 | Maximum 1.0 | Same | |
| Ratio | ||||
| Accuracy of Ratio | $<=10%$ | $<=10%$ | Same | |
| Range of Volume | Maximum 999 cm³ | Maximum 999 cm³ | Same | |
| Accuracy of Volume | $<=15%$ | $<=15%$ | Same | |
| M-mode Measurement Accuracy | ||||
| Range of Depth | Maximum 324mm | Maximum 324mm | Same | |
| Accuracy of Depth | $<=5%$ | $<=5%$ | Same | |
| Range of Time | Maximum 13s | Maximum 13s | Same | |
| Accuracy of Time | $<=5%$ | $<=5%$ | Same | |
| Range of Heart rate | Maximum 999bpm | Maximum 999bpm | Same | |
| Accuracy of Heart rate | $<=5%$ | $<=5%$ | Same | |
| Range of Slope | Maximum 999mm/s | Maximum 999mm/s | Same | |
| Accuracy of Slope | $<=10%$ | $<=10%$ | Same | |
| PW mode velocity Measurement Accuracy | ||||
| Range | 0.5-2.5m/s | 0.5-2.5m/s | Same | |
| Accuracy | $<=10%$ | $<=10%$ | Same | |
| CW mode velocity Measurement Accuracy | ||||
| Range | 0.5-2.5m/s | 0.5-2.5m/s | Same | |
| Accuracy | $<=10%$ | $<=10%$ | Same |
{17}------------------------------------------------
{18}------------------------------------------------
{19}------------------------------------------------
{20}------------------------------------------------
{21}------------------------------------------------
The subject device has same intended use, similar product design, and same performance effectiveness, as the predicate device. There are no significant differences between the primary predicate. There are no new questions of safety and/or effectiveness. There are no changes to the intended use, indications for use, nor fundamental scientific technology.
10. Effectiveness and Safety Considerations:
Clinical test:
Clinical testing is not required.
Non-clinical test:
The U60 Diagnostic Ultrasound System complies with:
- (1) ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
{22}------------------------------------------------
(IEC 60601-1:2005, MOD).
(2) I IEC 60601-1-2:2014: Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
(3) IEC 60601-2-37 Edition 2.0 2007, Medical Electrical Equipment - Part 2-37: Particular Requirements for The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment.
(4) NEMA UD 3, Edition 2004 Standard for real-time display of thermal and mechanical acoustic output Indies on diagnostic ultrasound equipment.
(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
(6) NEMA, UD2, Edition 2004 for acoustic output measurement methodology.
The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010
The tests were selected to show substantial equivalence between the subject device and the predicate.
11. Substantially Equivalent Determination
Verification and validation testing has been conducted on the U60 Ultrasound Imaging System. This premarket notification submission demonstrates that U60 Ultrasound Imaging System is substantially equivalent to the predicate devices.
§ 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.