(53 days)
The diagnostic ultrasound system (U2) 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, musculosketal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
U2 is a cart based diagnostic ultrasound system. U2 has the same intended use, similar product design, same performance effectiveness as the previous cleared U50 (K142511).
This is a 510(k) premarket notification for the U2 Diagnostic Ultrasound System. It asserts that the U2 system is substantially equivalent to the previously cleared U50 Diagnostic Ultrasound System (K142511).
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance specifications of the predicate device (U50 Diagnostic Ultrasound System, K142511). The document states that the U2 has "the same performance effectiveness as the previous cleared U50 (K142511)". Therefore, the performance criteria for the U2 are identical to those of the U50.
| Feature / Parameter | Acceptance Criteria (based on predicate U50) | Reported Device Performance (U2) |
|---|---|---|
| General Imaging Mode | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW |
| Measurements (B-Mode) | ||
| - Range of Depth/Distance | Maximum 324 mm | Maximum 324 mm |
| - Accuracy of Depth/Distance | ≤±5% | ≤±5% |
| - Range of Area | Maximum 1126 cm² | Maximum 1126 cm² |
| - Accuracy of Area | ≤±10% | ≤±10% |
| - Range of Angle | 0-180° | 0-180° |
| - Accuracy of Angle | ≤±3% | ≤±3% |
| - Range of Ratio | Maximum 1.0 | Maximum 1.0 |
| - Accuracy of Ratio | ≤±10% | ≤±10% |
| - Range of Volume | Maximum 999 cm³ | Maximum 999 cm³ |
| - Accuracy of Volume | ≤±15% | ≤±15% |
| Measurements (M-Mode) | ||
| - Range of Depth | Maximum 324mm | Maximum 324mm |
| - Accuracy of Depth | ≤±5% | ≤±5% |
| - Range of Time | Maximum 13s | Maximum 13s |
| - Accuracy of Time | ≤±5% | ≤±5% |
| - Range of Heart rate | Maximum 999bpm | Maximum 999bpm |
| - Accuracy of Heart rate | ≤±5% | ≤±5% |
| - Range of Slope | Maximum 999mm/s | Maximum 999mm/s |
| - Accuracy of Slope | ≤±10% | ≤±10% |
| Measurements (PW Mode Velocity) | ||
| - Range | 0.5-2.5m/s | 0.5-2.5m/s |
| - Accuracy | ≤±10% | ≤±10% |
| Measurements (CW Mode Velocity) | ||
| - Range | 0.5-2.5m/s | 0.5-2.5m/s |
| - Accuracy | ≤±10% | ≤±10% |
| Displayed Depth | 20-320mm (Probe Dependent) | 20-320mm (Probe Dependent) |
| Gray Scales | 256 | 256 |
| Dynamic Range | 150dB | 150dB |
| TGC | 8 segments | 8 segments |
| Zoom | Up to 400% | Up to 400% |
| 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 | 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 |
| Transducer Frequency | 2.0-15.0 MHz | 2.0-15.0 MHz |
| Cine Loop | 1227 frames | 1227 frames |
| Focus Number | Max=4 | Max=4 |
| Software Packages | Abdomen, obstetric, small parts, gynecology, cardiology, urology, vascular and Pediatrics | Abdomen, obstetric, small parts, gynecology, cardiology, urology, vascular and Pediatrics |
| Principle of Operation | Applying high voltage burst to piezoelectric material in transducer and detect reflected echo to construct diagnostic image | Applying high voltage burst to piezoelectric material in transducer and detect reflected echo to construct diagnostic image |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, AIUM, NEMA UD 2, UD3 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, NEMA UD 3, NEMA UD2, Acoustic output guidelines |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a specific test set sample size or data provenance (country of origin, retrospective/prospective) for a study of the U2's diagnostic performance. The submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document explicitly states: "Clinical testing is not required." Therefore, there was no test set requiring expert ground truth establishment for diagnostic performance.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring expert ground truth or adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned or appears to have been conducted, as the basis for clearance is substantial equivalence without clinical testing. Therefore, there is no reported effect size for human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The U2 Diagnostic Ultrasound System is a medical imaging device operated by a human, not an AI algorithm performing diagnostic tasks in a standalone capacity. The claim is for the system itself, not a specific AI diagnostic feature within it.
7. Type of Ground Truth Used
As per point 3, no clinical ground truth (expert consensus, pathology, outcomes data, etc.) was explicitly established for a test set to prove diagnostic performance. The clearance relies on equivalence to a predicate and compliance with performance and safety standards.
8. Sample Size for the Training Set
This information is not applicable. The document does not describe the development or evaluation of an AI algorithm, and therefore no training set for such an algorithm is mentioned. The U2 is a diagnostic ultrasound system, not an AI-powered diagnostic tool in the sense of requiring a training set for model development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
Edan Instruments. Inc. % Mr. Doug Worth Sr. Dir. US RA/OA 1200 Crossman Avenue, Suite 200 SUNNYVALE CA 94089
Re: K172380
Trade/Device Name: U2 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: August 1, 2017 Received: August 7, 2017
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K172380
Device Name U2 Diagnostic Ultrasound System
Indications for Use (Describe)
The diagnostic ultrasound system (U2) 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, musculosketal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
{3}------------------------------------------------
U2 Diagnostic Ultrasound System
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ (Specify) * | N | N | N | N | N | N | N | |
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N | N | N | N | N | |
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | |
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | N | |
| Intravascular | ||||||||
| Other (Specify) ** | N | N | N | N | N | N | N | |
| Adult Cardiac | N | N | N | N | N | N | N | |
| Pediatric Cardiac | N | N | N | N | N | N | N | |
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | N | N | N | N | N | N | N |
| Other (Specify) |
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+PDV/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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U2 with C352UB 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 | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | |
| 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) ** | N | N | N | N | N | N | N | |
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| 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+PDV/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)
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U2 with L1042UB 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 | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | N | N | N | N | N | N | ||
| Fetal | Neonatal Cephalic | |||||||
| Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | N | N | N | N | N | N | |
| 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 * 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)
Prescription Use (Per 21 CFR 801.109)
{6}------------------------------------------------
U2 with L742UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | N | N | N | N | N | N | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | N | N | N | N | N | N | |
| 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+PDV/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)
{7}------------------------------------------------
U2 with E612UB 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 | N | N | N | N | N | N | N | |
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal | Neonatal Cephalic | |||||||
| Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N | N | N | N | N | |
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| 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+PDV/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)
{8}------------------------------------------------
U2 with C612UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] | |
| General | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ (Specify) * | ||||||||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | N | N | N | N | N | N | ||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| 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+PDV/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 |
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{9}------------------------------------------------
U2 with C6152UB 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 | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ (Specify) * | ||||||||
| Fetal | Neonatal Cephalic | |||||||
| Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | N | N | N | N | N | N | N | |
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| 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+PDV/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)
{10}------------------------------------------------
U2 with C422UB 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 | |||||||||
| Abdominal | N | N | N | N | N | N | N | ||
| 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) ** | |||||||||
| Adult Cardiac | N | N | N | N | N | N | N | ||
| Pediatric Cardiac | |||||||||
| 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+PDV/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)
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U2 with L552UB 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 | N | N | N | N | N | N | ||
| Small Organ (Specify) * | N | N | N | N | N | N | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | N | N | N | N | N | ||
| 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+PDV/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)
{12}------------------------------------------------
U2 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 | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal | Neonatal Cephalic | |||||||
| Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | N | N | N | N | N | N | N | |
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| 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+PDV/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)
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U2 with P5-1b 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) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | N | N | N | N | N | N | N |
| 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+PDV/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)
{14}------------------------------------------------
U2 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 | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | N | N | N | N | N | N | N | |
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | |
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | N | |
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | N | N | N | N | N | N | N |
| 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+PDV/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)
{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) 26856469 Fax: +1 (408) 418-4059 |
|---|---|
| Contact Person: | Alice Yang |
| Date prepared: | August 1,2017 |
| 2. Device nameandclassification: | Device Name: U2 Diagnostic Ultrasound SystemModel: U2Classification Name:892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN892.1560 Ultrasonic, Pulsed echo, ImagingProduct code: IYO892.1570 Transducer, Ultrasonic, DiagnosticProduct code: ITXRegulatory Class: Class II |
| 3.PremarketNotificationClass IIICertificationand Summary | Not applicable, the subject device is Class II. |
| 4. PredicateDevice(s): | Edan Instruments, Inc., U50 Diagnostic Ultrasound System cleared underK142511. |
| 5. Reason forSubmission | By submission of the Traditional 510(k), Edan Instruments is requestingclearance for new device U2 Diagnostic Ultrasound System. |
| 6.Pre-Submission,IDE | Not applicable, there is no prior submission. |
| 7. DeviceDescription: | U2 is a cart based diagnostic ultrasound system. U2 has the same intended use, similar product design, same performance effectiveness as the previous cleared U50 (K142511). |
| 8. Intended Use: | The diagnostic ultrasound system (U2) 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. |
{16}------------------------------------------------
9. Predicate Device Comparison
Comparison to the predicate devices, U2 has the same intended use, similar product design, same performance effectiveness as the previous cleared U50 (K142511). The primary difference between the U2 and U50 is the operating system, the form factor of the system, an extra transducer and the number of probe sockets. The operating system of the U2 has been changed to utilize Linux; the U2 is a cart based system, where as the U50 is a tabletop system, and the U2 has 4 probe socket while the U50 has 2.
| Item | U2 Diagnostic Ultrasound System(Edan Instruments) | U50 Diagnostic Ultrasound System(Edan Instruments) | ComparisonResult |
|---|---|---|---|
| 510(k)Number | Current Submission | K142511 | |
| 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 |
| Indications forUse | The diagnostic ultrasound system(U2) is applicable for adults,pregnant women, pediatric patients'ultrasound evaluation in hospitalsand clinics. It is intended for use inabdominal, obstetrics, gynecology,pediatric, small parts, urology,peripheral vascular, musculoskeletal(conventional and superficial),endovaginal and cardiac clinicalapplications, by or on the order of aphysician or similarly qualifiedhealth care professional. | The diagnostic ultrasoundsystem(U50) is applicable for adults,pregnant women, pediatric patients'ultrasound evaluation in hospitalsand clinics. It is intended for use inabdominal, obstetrics, gynecology,pediatric, small parts, urology,peripheral vascular, musculoskeletal(conventional and superficial),endovaginal and cardiac clinicalapplications, by or on the order of aphysician or similarly qualifiedhealth care professional. | Same |
| Installationand Use | Trolley Mobile Equipment | a. Portable Equipmentb. Mobile Equipment (when thesystem is installed on the mobiletrolley) | Difference |
| SafetyStandards | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Same |
| IEC 60601-2-37 | IEC 60601-2-37 | ||
| ISO 10993-1, -5, -10 | ISO 10993-1, -5, -10 | ||
| AIUM, NEMA UD 2, UD3 | |||
| PatientContactMaterials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Software lifecycleprocesses | Complies with the standard: IEC62304 | Complies with the standard: IEC62304 | Same |
| ModeofOperations | 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 and AngleM-Mode: Distance, Time, Slope, andHeart RateD-Mode: Time, Heart Rate, Velocity,Acceleration, RI, PI and Auto (autotrace) | B-Mode: Distance, Area, Volume,Ratio, Histogram and AngleM-Mode: Distance, Time, Slope, andHeart RateD-Mode: Time, Heart Rate, Velocity,Acceleration, RI, PI and Auto (autotrace) | Same |
| Scanningmethod | Electronic convexElectronic linear with slant scanning | Electronic convexElectronic linear with slant scanning | Same |
| Cine loop | 1227 frames | 1227 frames | Same |
| Focus Number | 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 |
| PrincipleofOperation | Applying high voltage burst to thePiezoelectric material in thetransducer and detect reflected echoto construct diagnostic image | Applying high voltage burst to thePiezoelectric material in thetransducer and detect reflected echoto construct diagnostic image | Same |
| AcousticOutput | Track 3: MI, TIS, TIC, TIB(TI Range0-6.0)Derated ISPTA: 720 W/cm2 maximum,Mechanic Index ≤1.9 maximum orDerated ISPPA 190 W/cm2 max | Track 3: MI, TIS, TIC, TIB(TI Range0-6.0)Derated ISPTA: 720 W/cm2 maximum,Mechanic Index ≤1.9 maximum orDerated ISPPA 190 W/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: 15 or 19inch(1024*768) | Primary Screen: 12.1inch(1024*768) | Difference |
| TransducerPorts | Multi-Transducer Port (Four) | Multi-Transducer Port (Two) | Difference |
| Dimensions/Weight | 920 mm (L) × 650 mm (W) × 1400 mm (H) (with 15 inch monitor)920 mm (L) × 650 mm (W) × 1480 mm (H) (with 19 inch monitor)net weight 60 kg | 330 mm (W) × 320 mm (L) × 220 mm (H)net weight 7.8kg | Difference |
| Printer | B/W video thermal printer | B/W video thermal printer | Same |
| Color video thermal printerGraph/text laser jet printer | Color video thermal printerGraph/text laser jet printer | ||
| Temperature | Operating: 5°C | Operating: 5°C | Same |
| Relativehumidity | Operating: 25% ~ 80%RH (no condensation)Transport/ Storage: 25% ~ 93%RH (no condensation) | Operating: 25% ~ 80%RH (no condensation)Transport/ Storage: 25% ~ 93%RH (no condensation) | Same |
| 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 | µCosII | Difference |
| Safety Classifications | |||
| Type ofprotectionagainstelectric shock | Class I | Class I | Same |
| The degree ofprotectionagainstelectric shock | Type BF. | Type BF. | Same |
| The degree ofprotectionagainstharmfulingress ofliquid | The main unit : IPX0,probes : IPX7Footswitch: IP68 | The main unit : IPX0,probes : IPX7Footswitch: IP68 | Same |
| The degree ofsafety ofapplication inthe presenceof aflammable gas | Equipment not suitable for use in thepresence of a flammable gas | Equipment not suitable for use in thepresence 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,2.4%Glutaraldehyde. | Probe:2.4%Glutaraldehyde,0.55%Ortho-Phthalaldehyde.Needle guide:75% medical alcohol,2.4%Glutaraldehyde. | Same |
| 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 | |||
| BModeParameters | Image type | Image type | Same |
| 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 | ||
| eSRI(Spackle Rejection Imaging) | eSRI(Spackle Rejection Imaging) | ||
| 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 | Same | |
| B/W Invert | B/W Invert | ||
| M ModeParameters | Freq | Freq | |
| Sweep Speed | Sweep Speed | ||
| Display Layout | Display Layout | ||
| Gray Map | Gray Map | ||
| Focus Position | Focus Position | ||
| Dynamic Range | Dynamic Range | ||
| Pseudo Color | Pseudo Color | ||
| Line Average | Line Average | ||
| Flow type | Flow type | Same | |
| Gain | Gain | ||
| Freq | Freq | ||
| Wallfilter | Wallfilter | ||
| Color Mode &PowerDoppler Mode& DirectionalPower ModeParameters | PRF(Pulsed Repetition Frequency) | PRF(Pulsed Repetition Frequency) | |
| Base Line | Base Line | ||
| Invert | Invert | ||
| Dual Live | Dual Live | ||
| Angle Steer | Angle Steer | ||
| Color Map | Color Map | ||
| Packet size | Packet size | ||
| Persist | Persist | ||
| Threshold | Threshold | ||
| Smooth Filter | Smooth Filter | ||
| ROI box position and size adjustment | ROI box position and size adjustment | ||
| PW ModeParameters | Flow type | Flow type | Same |
| Gain | Gain | ||
| PRF | PRF | ||
| Invert | Invert | ||
| Angle steer | Angle steer | ||
| Correction Angle | Correction Angle | ||
| Quick Angle | Quick Angle | ||
| Base Line | Base Line | ||
| Sample Volume | Sample Volume | ||
| 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 | ||
| Gain | Gain | ||
| PRF | PRF | ||
| Invert | Invert | ||
| Angle steer | Angle steer | ||
| Correction Angle | Correction Angle | ||
| CWModeParameters | Quick Angle | Quick Angle | Same |
| 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 |
| RangeofRatio | Maximum 1.0 | Maximum 1.0 | Same |
| AccuracyofRatio | ≤±10% | ≤±10% | Same |
| RangeofVolume | Maximum 999 cm³ | Maximum 999 cm³ | Same |
| AccuracyofVolume | ≤±15% | ≤±15% | Same |
| M-mode Measurement Accuracy | |||
| RangeofDepth | Maximum 324mm | Maximum 324mm | Same |
| AccuracyofDepth | ≤±5% | ≤±5% | Same |
| Range of Time | Maximum 13s | Maximum 13s | Same |
| Accuracy of Time | $\leq\pm5%$ | $\leq\pm5%$ | Same |
| Range of Heart rate | Maximum 999bpm | Maximum 999bpm | Same |
| Accuracy of Heart rate | $\leq\pm5%$ | $\leq\pm5%$ | Same |
| Range of Slope | Maximum 999mm/s | Maximum 999mm/s | Same |
| Accuracy of Slope | $\leq\pm10%$ | $\leq\pm10%$ | Same |
| PW mode velocity Measurement Accuracy | |||
| Range | 0.5-2.5m/s | 0.5-2.5m/s | Same |
| Accuracy | $\leq\pm10%$ | $\leq\pm10%$ | Same |
| CW mode velocity Measurement Accuracy | |||
| Range | 0.5-2.5m/s | 0.5-2.5m/s | Same |
| Accuracy | $\leq\pm10%$ | $\leq\pm10%$ | Same |
{17}------------------------------------------------
{18}------------------------------------------------
{19}------------------------------------------------
{20}------------------------------------------------
{21}------------------------------------------------
The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
10. Effectiveness and Safety Considerations:
Clinical test:
Clinical testing is not required.
Non-clinical test:
The U2 Ultrasound Imaging System complies with:
(1) IEC 60601-1:2005/A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
(2) IEC 60601-1-2 Edition 3:2007-03, 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
{22}------------------------------------------------
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 U2 Ultrasound Imaging System. This premarket notification submission demonstrates that U2 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.