(49 days)
The diagnostic ultrasound system (U50) 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 U50 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. The R2.2 version of the U50 utilizes the Linux operating system, which enables additional printer drivers and the inclusion of an USB DVD drive.
The provided document is a 510(k) summary for the Edan Instruments U50 Diagnostic Ultrasound System, dated November 15, 2017. It demonstrates substantial equivalence to a predicate device (U50 Diagnostic Ultrasound System / K142511 / Edan Instruments, Inc.) and does not describe a study involving an AI or algorithm.
Therefore, many of the requested points related to AI/algorithm studies (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) cannot be answered from this document.
The document primarily focuses on bench testing and compliance with recognized standards to demonstrate the safety and effectiveness of the ultrasound system itself, and its substantial equivalence to the previously cleared predicate device.
Here's what can be extracted from the document regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria (Performance Specifications) and Reported Device Performance:
The document provides a comparison of specifications between the subject device (U50 R2.2) and the predicate device (U50 R2.0), showing they are "Same." This implies that the predicate's performance serves as the acceptance criteria for the subject device.
| Category | Acceptance Criteria (Predicate U50 R2.0 Performance) | Reported Device Performance (Subject U50 R2.2) | Result/Comparison |
|---|---|---|---|
| B-Mode Measurement Accuracy | |||
| Range of Depth/Distance | Maximum 324 mm | Maximum 324 mm | Same |
| Accuracy of Depth/Distance | ≤ ±5% | ≤ ±5% | Same |
| Range of Area | Maximum 1126 cm² | Maximum 1126 cm² | Same |
| Accuracy of Area | ≤ ±10% | ≤ ±10% | Same |
| Range of Angle | 0-180° | 0-180° | Same |
| Accuracy of Angle | ≤ ±3% | ≤ ±3% | Same |
| Range of Ratio | Maximum 1.0 | Maximum 1.0 | Same |
| 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 324 mm | Maximum 324 mm | 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 999 bpm | Maximum 999 bpm | Same |
| Accuracy of Heart Rate | ≤ ±5% | ≤ ±5% | Same |
| Range of Slope | Maximum 999 mm/s | Maximum 999 mm/s | Same |
| Accuracy of Slope | ≤ ±10% | ≤ ±10% | Same |
| PW mode velocity Measurement Accuracy | |||
| Range | 0.5-2.5 m/s | 0.5-2.5 m/s | Same |
| Accuracy | ≤ ±10% | ≤ ±10% | Same |
| CW mode velocity Measurement Accuracy | |||
| Range | 0.5-2.5 m/s | 0.5-2.5 m/s | Same |
| Accuracy | ≤ ±10% | ≤ ±10% | Same |
| Acoustic Output | |||
| Track 3 (MI, TIS, TIC, TIB) | TI Range 0-6.0 | TI Range 0-6.0 | Same |
| Derated ISPTA | 720 W/cm² maximum | 720 W/cm² maximum | Same |
| Mechanic Index | ≤1.9 maximum | ≤1.9 maximum | Same |
| Derated ISPPA | 190 W/cm² max | 190 W/cm² max | Same |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable (N/A) for an AI/algorithm study as this document describes a traditional medical device (ultrasound system). Performance was demonstrated through engineering and manufacturing verification and validation, including compliance with international standards for safety and acoustic output.
- Data provenance: N/A. The testing involved technical evaluations rather than clinical data sets in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the context of AI/ML is not relevant here as it's a traditional ultrasound system. Performance evaluation relies on engineering specifications and standard compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for this type of device submission.
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:
- No. This is a traditional diagnostic ultrasound system, not an AI or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is an ultrasound imaging system that requires a human operator for its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this device, "ground truth" relates to the accuracy of physical measurements and compliance with established industry and regulatory standards, rather than clinical diagnostic outcomes requiring expert consensus or pathology. Performance is demonstrated against objective technical specifications.
8. The sample size for the training set:
- N/A. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. This is not an AI/ML device.
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which are effectively its technical specifications and regulatory compliance requirements) is detailed in Section 10, "Effectiveness and Safety Considerations: Non-clinical test" of the 510(k) summary (page 22).
The document states:
"Verification and validation testing has been conducted on the U50 Ultrasound Imaging System. This premarket notification submission demonstrates that U50 Ultrasound Imaging System is substantially equivalent to the predicate devices."
Specifically, the device's performance was evaluated by demonstrating compliance with various national and international standards:
- Electrical Safety: IEC 60601-1:2005/A1:2012
- Electromagnetic Compatibility (EMC): IEC 60601-1-2 Edition 3:2007-03
- Specific Requirements for Medical Diagnostic Ultrasound: IEC 60601-2-37 Edition 2.0 2007
- Acoustic Output:
- NEMA UD 3, Edition 2004 (Standard for real-time display of thermal and mechanical acoustic output Indices)
- FDA guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated September 9, 2008.
- NEMA, UD2, Edition 2004 for acoustic output measurement methodology.
- Biocompatibility: ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010
These non-clinical tests and compliance with recognized standards are the "studies" that demonstrate the device meets its acceptance criteria for safety and effectiveness, affirming its substantial equivalence to the predicate device. No clinical testing was required for this particular submission.
{0}------------------------------------------------
November 15, 2017
Image /page/0/Picture/1 description: The image contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized eagle. The second logo is the U.S. Food & Drug Administration (FDA) logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text to the right of the square.
Edan Instruments, Inc. % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave, Suite 200 SUNNYVALE CA 94089
Re: K173003
Trade/Device Name: U50 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: November 1, 2017 Received: November 6, 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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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)
K173003
Device Name
U50 Diagnostic Ultrasound System
Indications for Use (Describe)
The diagnostic ultrasound system (U50) 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.
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 (8/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
U50 Diagnostic Ultrasound System
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] | ||
| General | Specific | ||||||||
| 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 | |||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | ||
| vascular | 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{4}------------------------------------------------
U50 with C352UB 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 | 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 | ||
| 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)
{5}------------------------------------------------
U50 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) * | P | P | P | P | P | P | ||
| FetalImaging | Neonatal Cephalic | |||||||
| & Other | 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) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | |
| 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}------------------------------------------------
U50 with L742UB 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) * | 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 | |||||||||
| Pediatric Cardiac | |||||||||
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheralvascular | Peripheral vascular | P | 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+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}------------------------------------------------
U50 with E612UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| FetalImaging& Other | 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) ** | ||||||||
| 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)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
5 / 12
{8}------------------------------------------------
U50 with C612UB 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 | 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 | |
| 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+PDV/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) Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
U50 with C6152UB Transducer
{9}------------------------------------------------
| 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) |
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) Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
U50 with C422UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
{10}------------------------------------------------
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | Other | |
| (Specify) [1] | (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 | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| & Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) ** | |||||||||
| Adult Cardiac | P | P | P | P | P | P | |||
| Cardiac | Pediatric 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+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)
Diagnostic Ultrasound Indications for Use Form
U50 with L552UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationMode of Operation |
|---|
| ------------------------------------------- |
{11}------------------------------------------------
Special 510(k) Submission of U50 Diagnostic Ultrasound System
| General | Specific | B | M | PW | CW | Color | Combined | Other(Specify) [2][3] |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | (Specify) 1] | ||||||
| Fetal / Obstetrics | ||||||||
| FetalImaging& Other | Abdominal | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | b | P | P | P | P | ||
| 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) ** | ||||||||
| Adult Cardiac | ||||||||
| Cardiac | Pediatric Cardiac | |||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | |
| 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+PDV/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) Prescription Use (Per 21 CFR 801.109)
{12}------------------------------------------------
U50 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 | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | P | P | P | P | P | P | ||
| 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+PDV/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)
{13}------------------------------------------------
U50 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 | P | P | P | P | P | P | P |
| 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 * 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)
{14}------------------------------------------------
U50 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) * | P | P | P | P | P | P | ||
| Fetal | Neonatal Cephalic | |||||||
| Imaging& Other | 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) |
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)
{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) 28340011 | ||||
| Fax: +1 (408) 418-4059 | ||||
| Contact Person: | Alice Yang | |||
| Date prepared: | September 20, 2017 | |||
| 2. Device nameand classification: | Device Name: U50 Diagnostic Ultrasound System | |||
| Model: U50 | ||||
| Classification Name: | ||||
| 892.1550 | System, Imaging, Pulsed Doppler, Ultrasonic | |||
| Product code: IYN | ||||
| 892.1560 | Ultrasonic, Pulsed echo, Imaging | |||
| Product code: IYO | ||||
| 892.1570 | Transducer, Ultrasonic, Diagnostic | |||
| Product 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/ K142511/ Edan Instruments, Inc. | |||
| 5. Pre-Submission,IDE | Not applicable, there is no prior submission. |
{16}------------------------------------------------
| 6. DeviceDescription: | The U50 is a portable Diagnostic Ultrasound System, which appliesadvanced technologies. Various image parameter adjustments, 12.1 inchLCD and diverse probes are configured to provide clear and stableimages.The R2.2 version of the U50 utilizes the Linux operating system, whichenables additional printer drivers and the inclusion of an USB DVDdrive. |
|---|---|
| 7. Intended Use: | The diagnostic ultrasound system (U50) is applicable for adults,pregnant women, pediatric patients' ultrasound evaluation in hospitalsand clinics. It is intended for use in abdominal, obstetrics, gynecology,pediatric, small parts, urology, peripheral vascular, musculoskeletal(conventional and superficial), endovaginal and cardiac clinicalapplications, by or on the order of a physician or similarly qualifiedhealth 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 | U50 R2.2 DiagnosticUltrasound System(Edan Instruments) | U50 R2.0 DiagnosticUltrasound 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 | |
| Indicationsfor Use | 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. | 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 | |
| Softwarelifecycleprocesses | 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 andAngleM-Mode: Distance, Time, Slope,and Heart RateD-Mode: Time, HeartRate.Velocity, Acceleration, RI, PI andAuto (auto trace) | B-Mode:Distance,Area,Volume, Ratio, Histogram andAngleM-Mode: Distance, Time, Slope,and Heart RateD-Mode: Time,HeartRate.Velocity, Acceleration, RI, PI andAuto (auto trace) | Same | |
| Scanningmethod | Electronic convexElectroniclinearwithslantscanning | Electronic convexElectroniclinearwithslantscanning | 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 | |
| PrincipleofOperation | 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:12.1inch(1024*768) | Primary Screen:12.1inch(1024*768) | Same | |
| Ports | ||||
| Dimensions/Weight | 330 mm (W) × 320 mm (L) ×220 mm (H)net weight 7.8kg | 330 mm (W) × 320 mm (L) ×220 mm (H)net weight 7.8kg | Same | |
| 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 | USB stick | Difference | |
| Temperature | Operating: 5°C | Operating: 5°C | Same | |
| Relativehumidity | Operating: 25% ~ 80%RH (nocondensation)Transport/ Storage: 25% ~93%RH (no condensation) | Operating: 25% ~ 80%RH (nocondensation)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 | ||||
| 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 ofsafety ofapplication 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 | ||||
| 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 | |
| Image Adjustments | ||||
| 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 | |||
| B ModeParameters | eSRI(Spackle Imaging) | eSRI(Spackle Imaging) | ||
| Rejection | Rejection | |||
| 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) | Same | ||
| V Reverse(vertical) | V Reverse(vertical) | |||
| 90°Rotate | 90°Rotate | |||
| B/W Invert | B/W Invert | |||
| M ModeParameters | Freq | Freq | ||
| Sweep Speed | ||||
| Display Layout | ||||
| 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 | |||
| Color Mode& PowerDoppler Mode&DirectionalPower ModeParameters | Freq | Freq | ||
| Wallfilter | ||||
| PRF(Pulsed Frequency) | ||||
| Repetition | Repetition | |||
| Base Line | ||||
| Invert | ||||
| Dual Live | Dual Live | |||
| Angle Steer | Angle Steer | |||
| Packet size | Packet size | Same | ||
| Persist | Persist | |||
| Threshold | Threshold | |||
| Smooth Filter | Smooth Filter | |||
| ROI box position and size | ROI box position and size | |||
| adjustment | adjustment | |||
| Flow type | Flow type | |||
| 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 | |||
| PWModeParameters | Wallfilter | Wallfilter | ||
| Freq | ||||
| Duplex and Triplex | ||||
| Pseudo Color | ||||
| Dyn Rng | ||||
| 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 | ||
| Base Line | ||||
| Wallfilter | ||||
| Pseudo Color | ||||
| Dynamic Range | ||||
| Volume | ||||
| Sweep Speed | ||||
| B-Mode Measurement Accuracy | ||||
| Range ofDepth/Distance | Maximum 324 mm | Maximum 324 mm | ||
| Accuracy ofDepth/Distance | $\leq$±5% | $\leq$±5% | ||
| Range of Area | Maximum 1126 cm2 | Maximum 1126 cm2 | ||
| Accuracy ofArea | $\leq$±10% | $\leq$±10% | ||
| Range ofAngle | 0-180° | 0-180° | ||
| Accuracy ofAngle | $\leq$±3% | $\leq$±3% | Same | |
| Range of | Maximum 1.0 | Maximum 1.0 | Same | |
| Ratio | ||||
| Accuracy of Ratio | $ \leq $ ±10% | $ \leq $ ±10% | Same | |
| Range of Volume | Maximum 999 cm³ | Maximum 999 cm³ | Same | |
| Accuracy of Volume | $ \leq $ ±15% | $ \leq $ ±15% | Same | |
| M-mode Measurement Accuracy | ||||
| Range of Depth | Maximum 324mm | Maximum 324mm | Same | |
| Accuracy of Depth | $ \leq $ ±5% | $ \leq $ ±5% | Same | |
| Range of Time | Maximum 13s | Maximum 13s | Same | |
| Accuracy of Time | $ \leq $ ±5% | $ \leq $ ±5% | Same | |
| Range of Heart rate | Maximum 999bpm | Maximum 999bpm | Same | |
| Accuracy of Heart rate | $ \leq $ ±5% | $ \leq $ ±5% | Same | |
| Range of Slope | Maximum 999mm/s | Maximum 999mm/s | Same | |
| Accuracy of Slope | $ \leq $ ±10% | $ \leq $ ±10% | Same | |
| PW mode velocity Measurement Accuracy | ||||
| Range | 0.5-2.5m/s | 0.5-2.5m/s | Same | |
| Accuracy | $ \leq $ ±10% | $ \leq $ ±10% | Same | |
| CW mode velocity Measurement Accuracy | ||||
| Range | 0.5-2.5m/s | 0.5-2.5m/s | Same | |
| Accuracy | $ \leq $ ±10% | $ \leq $ ±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 U50 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
{22}------------------------------------------------
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 U50 Ultrasound Imaging System. This premarket notification submission demonstrates that U50 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.