(393 days)
The iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only. It must be operated by qualified and trained Physician or Sonographer. It can be used in following applications: General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.
The iuStar300 Medical Ultrasound Diagnostic System is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs and for medical diagnostic purposes only. It supports 2D, M Mode, CFM and Pulse and Continuous Wave Spectral Doppler, Color Doppler Energy and Directional Color Doppler Energy modes.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) summary for an ultrasound device without any AI/ML components:
Important Note: The provided text is a 510(k) Premarket Notification for a general-purpose medical ultrasound diagnostic system, the iuStar300. This document details the substantial equivalence of the device to predicate ultrasound devices, meaning it does not contain information about the performance or validation of an Artificial Intelligence (AI) or Machine Learning (ML) component. Therefore, many of the requested fields related to AI performance, ground truth establishment, expert review, and training/test sets are not applicable to this specific document.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a traditional medical device submission and not an AI/ML component, the "acceptance criteria" discussed are primarily related to safety, performance against established standards, and substantial equivalence to legally marketed predicate devices. The "reported device performance" is implicitly that it meets these standards and is equivalent to the predicates.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Must align with predicate devices and be for visualization of internal organs for medical diagnostic purposes. | The iuStar300's intended use is visualization of internal organs by ultrasound images for medical diagnostic purposes, operated by qualified personnel, across various applications (General, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts, Musculoskeletal, Superficial Musculoskeletal, Cardiology). This is deemed equivalent to predicates. |
| Technological Characteristics | Must incorporate similar operating principles, basic design, and technological characteristics as predicate devices. | The device utilizes the same operating principle (ultrasound imaging), basic design, and technological characteristics (e.g., B-Mode, M-Mode, Pulsed/CW Doppler, Color Doppler, Amplitude Doppler, 3D/4D Imaging, Tissue Harmonic Imaging) as the predicate devices. |
| Safety and EMC Compliance | Must comply with recognized international electrical, electromagnetic compatibility (EMC), and diagnostic ultrasound safety standards. | Complies with IEC 60601-1, EN 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004. |
| Biocompatibility | Patient contact materials must undergo biological evaluation as per ISO standards. | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10. |
| Software Validation | Software must be validated. | Software validation performed. |
| Bench Testing | Device performance validated through bench testing against requirements for performance, physical attributes, and environmental conditions. | Non-clinical testing performed to provide objective evidence that the device's intended use is met. Details of specific performance metrics (e.g., resolution, penetration) are not provided in this summary but are implicit in meeting relevant standards and substantial equivalence. |
| Quality System | Manufactured under a quality system. | Manufactured under a quality system. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable. This document does not describe a test set for validating an AI/ML algorithm. The evaluation is based on meeting engineering standards and comparison to predicate devices, not on a clinical test set of patient data to assess diagnostic accuracy for an AI.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication method: Not applicable.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No, this document does not describe an MRMC study.
- Effect size: Not applicable as no AI component is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No, this document does not describe a standalone AI algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable. The "ground truth" in this context refers to compliance with established medical device standards and the functionality observed during non-clinical testing, rather than a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
- Sample size for training set: Not applicable. This document describes a traditional ultrasound system, not an AI/ML algorithm, and therefore has no training set in the AI sense.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable.
Summary of the Study:
The document describes a 510(k) Premarket Notification for the iuStar300 Medical Ultrasound Diagnostic System. The "study" referenced is a non-clinical assessment and comparison study to demonstrate substantial equivalence to legally marketed predicate devices (ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM and S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM).
The study involved:
- Verification of technical specifications: Comparing the operating principles, basic design, technological characteristics, and modes of operation (B-Mode, M-Mode, CWD, PWD, Color Doppler, Power Doppler, 3D/4D Imaging, Tissue Harmonic Imaging) of the iuStar300 to those of the predicate devices.
- Compliance with recognized standards: Testing the device against international standards for medical electrical equipment safety (IEC 60601-1, EN 60601-1-2, IEC 60601-2-37), acoustic output (NEMA UD 2-2004), and biocompatibility (ISO 10993 series).
- Software validation: Confirming that the system's software has been validated.
The conclusion is that based on this non-clinical testing and comparison, the device is considered safe and effective and substantially equivalent to the predicate devices. No AI/ML components are mentioned or evaluated in this submission.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2015
United Imaging Systems (Beijing) Co., Ltd. % Mr. Jun Peng Principal Consultant P&L Scientific, Inc. 6840 SW 45th Lane, Unit 5 MIAMI FL 33155
Re: K141720
Trade/Device Name: iuStar300 Medical Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 6, 2015 Received: July 15, 2015
Dear Mr. Peng:
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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K141720
Device Name: iuStar300 Medical Ultrasound Diagnostic System
Indications for Use:
The iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only. It must be operated by qualified and trained Physician or Sonographer. It can be used in following applications: General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use: (Per 21 CFR 801.109) OR
Over-the Counter Use:
{3}------------------------------------------------
System: iuStar300 Medical Ultrasound Diagnostic System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | N | N | N | N | N | N | Note 1 | |
| Abdominal | N | N | N | N | N | N | Note 1 | ||
| Intra-operative(Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1 | ||
| Small Organ (Specify) | N | N | N | N | N | N | Note 1 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1 | ||
| Trans-vaginal | N | N | N | N | N | N | Note 1 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1 | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | Note 1 | ||
| Intravascular | |||||||||
| Other (Urology) | N | N | N | N | N | N | Note 1 | ||
| Other (OB/GYN) | N | N | N | N | N | N | Note 1 | ||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | ||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | |
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW
Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use: ✓ __ | OR | Over-the Counter Use: __ |
|---|---|---|
| (Per 21 CFR 801.109) | (Per 21 CFR 807) |
{4}------------------------------------------------
System: iuStar300 Medical Ultrasound Diagnostic System Transducer: L10-5, Linear Array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative(Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | N | N | N | N | N | Note 1 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1 | |||
| Musculo-skeletal(Superficial) | N | N | N | N | N | Note 1 | |||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note 1 | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW
Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use: ✓ OR | Over-the Counter Use: | |
|---|---|---|
| (Per 21 CFR 801.109) | (Per 21 CFR 807) |
{5}------------------------------------------------
System: iuStar300 Medical Ultrasound Diagnostic System Transducer: C5-2, Convex
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | N | N | N | N | N | N | Note 1 | |
| Abdominal | N | N | N | N | N | N | Note 1 | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1 | ||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (OB/GYN) | N | N | N | N | N | N | Note 1 | ||
| Other (Urology) | N | N | N | N | N | N | Note 1 | ||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW
Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use: _(Per 21 CFR 801.109) | OR | Over-the Counter Use: _(Per 21 CFR 807) |
|---|---|---|
| --------------------------------------------- | ---- | --------------------------------------------- |
{6}------------------------------------------------
System: iuStar300 Medical Ultrasound Diagnostic System Transducer: EV9-4, Endo cavity
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler(Amplitude) | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1 | ||
| Trans-vaginal | N | N | N | N | N | N | Note 1 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (OB/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW
Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use: _(Per 21 CFR 801.109) | OR | Over-the Counter Use: _(Per 21 CFR 807) |
|---|---|---|
| --------------------------------------------- | ---- | --------------------------------------------- |
{7}------------------------------------------------
System: iuStar300 Medical Ultrasound Diagnostic System Transducer: V5-2, Volume Probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler(Amplitude) | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | N | N | N | N | N | N | Note 1 | Note 3, 4 |
| Abdominal | N | N | N | N | N | N | Note 1 | Note 3, 4 | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (OB/GYN) | N | N | N | N | N | N | N | Note 1 | |
| Other (Urology) | N | ||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW
Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use: ✓ | OR | Over-the Counter Use: ___ |
|---|---|---|
| (Per 21 CFR 801.109) | (Per 21 CFR 807) |
{8}------------------------------------------------
System: iuStar300 Medical Ultrasound Diagnostic System Transducer: MC5-2, Micro Convex
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1 | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (OB/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | ||
| Cardiac Pediatric | N | N | N | N | N | Note 1 | |||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW
Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use: _ ✓ _(Per 21 CFR 801.109) | OR | Over-the Counter Use: ____(Per 21 CFR 807) |
|---|---|---|
| -------------------------------------------------------- | ---- | ------------------------------------------------ |
{9}------------------------------------------------
System: iuStar300 Medical Ultrasound Diagnostic System Transducer: P4-2, Phased array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (OB/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | ||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW
Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use: ✓__ | OR | Over-the Counter Use: __ |
|---|---|---|
| (Per 21 CFR 801.109) | (Per 21 CFR 807) |
{10}------------------------------------------------
510(k) Summary
510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based:
The Assigned 510(k) Number is: K141720
1. Submitter Information:
Sponsor/510(K) Owner: .
United Imaging Systems (Beijing) Co., Ltd. 109 Bldg. 8, No. 8 West Dongbeiwang Rd. Haidian District, Beijing 100193 China Phone: 86-10-82894361 Fax: 86-10-62669095
Dated: Monday, December 15, 2014
Contact Name: .
Mr. Jun Peng P&L SCIENTIFIC, INC. 6840 SW 45TH LN UNIT 5, MIAMI, FL 33155 Phone: (305) 609 4701 Fax: (305) 397 0289 Email: jpeng@plscientificinc.com
2. Device Name
Trade Name: Medical Ultrasound Diagnostic System, Models iuStar300 Common Name: iuStar300:
3. Classification:
| Classification Names | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
4. Predicate Devices:
| Name | K number | Manufacturer information |
|---|---|---|
| ACUSONDIAGNOSTICULTRASOUND SYSTEM | X300 K061946 | SIEMENS MEDICALSOLUTIONS USA INC. |
| S20 DIGITAL COLORDOPPLER ULTRASOUNDSYSTEM | K110510 | SONOSCAPE COMPANYLIMITED |
5. Description of Device
The iuStar300 Medical Ultrasound Diagnostic System is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms.
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iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs and for medical diagnostic purposes only. It supports 2D, M Mode, CFM and Pulse and Continuous Wave Spectral Doppler, Color Doppler Energy and Directional Color Doppler Energy modes.
6. Intended Use
The iustar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only. It must be operated by qualified and trained Physician or Sonographer. It can be used in following applications: General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.
| Name | Predicate device | Predicate device | Subject device |
|---|---|---|---|
| K number | K061946 | K110510 | K141720 |
| Device TradeName | ACUSON X300DIAGNOSTICULTRASOUNDSYSTEM | S20 DIGITALCOLOR DOPPLERULTRASOUNDSYSTEM | iuStar300 Medical UltrasoundDiagnostic System |
| Common Name | |||
| ClassificationName | Ultrasonic PulsedDoppler ImagingSystem | Ultrasonic PulsedDoppler ImagingSystem | Ultrasonic Pulsed Doppler ImagingSystem |
| Indications forUse | The Siemens AcusonX300 ultrasoundimaging system isintended for thefollowing applications:General Radiology,Fetal, Abdominal,Intraoperative,Pediatric, Small Pans,Neonatal/AdultCephalic, Cardiac,Transesophageal,Pelvic, Transcranial,OB/GYN, Urology,Vascular,Musculoskeletal,SuperficialMusculoskeletal, andPeripheral Vascularapplications.The system alsoprovides for the | The device is a general-purpose ultrasonicimaging instrumentintended for use bya qualified physicianfor evaluation of Fetal,Abdominal, Pediatric,Small Organ(breast, testes, thyroid),Cephalic(neonatal andadult), Trans-rectal,Trans-vaginal,Peripheral Vascular,Musculo-skeletal(Conventional andSuperficial), Cardiac(neonatal and adult),OB/Gyn and Urology. | The iuStar300 Medical UltrasoundDiagnostic System is intended forvisualization of internal organs byultrasound images for medical diagnosticpurposes only. It must be operated byqualified and trained Physician orSonographer. It can be used in followingapplications: General application,Abdominal, Vascular, OB/GYN, Urology,Breast, Small Parts (breast, thyroid, testes)Musculoskeletal, SuperficialMusculoskeletal and Cardiology. Eachapplication includes a set of exams,including the specific measurements,reports, pictograms, annotations andsystem presets. |
| measurement ofanatomical structuresand for analysispackages that provideinformation that is usedfor clinical diagnosispurposes. | |||
| Classification | |||
| Ultrasonic PulsedDoppler ImagingSystem 892.1550IYNUltrasonic Pulsed EchoImaging System892.1560IYODiagnostic UltrasoundTransducer892.1570ITX | Ultrasonic PulsedDoppler ImagingSystem 892.1550IYNUltrasonic Pulsed EchoImaging System892.1560IYODiagnostic UltrasoundTransducer892.1570ITX | Ultrasonic Pulsed Doppler ImagingSystem 892.1550IYNUltrasonic Pulsed Echo Imaging System892.1560IYODiagnostic Ultrasound Transducer892.1570ITX | |
| Probe Types | |||
| Convex probe | √ | √ | √ |
| Linear probe | √ | √ | √ |
| Micro-ConvexProbe | √ | √ | √ |
| Phase array probe | √ | √ | √ |
| 4D Volume probe | √ | √ | √ |
| Probe frequency | |||
| 2.0MHz -13.0MHz | 2.0MHz-12.0MHz | 2MHz -14MHz | |
| Modes of Operation | |||
| B-Mode | B-Mode | B-Mode | B Mode |
| M-Mode | M-Mode | M-Mode | M Mode |
| Pulsed (PW)Doppler Mode | Pulsed (PW)Doppler mode | Pulsed Doppler | Pulsed (PW) Doppler |
| Continuous (CW)Doppler Mode | Continuous wave(CW) Dopplermode | Continuous wave(CW) Dopplermode | Continuous wave (CW) Dopplermode |
| Color DopplerMode | Color DopplerMode | Color DopplerImaging (CDI) | Color Doppler Mode |
| AmplitudeDoppler Mode | Amplitude DopplerMode | Power AmplitudeDoppler Mode | Power Amplitude Doppler Mode |
| 3D Imaging orHarmonicImaging | 3D Imaging orHarmonic Imaging | 3D Imaging orTissue HarmonicImaging | 3D Imaging or Tissue HarmonicImaging |
| 4D Imaging | 4D Imaging | 4D Imaging | 4D Imaging |
| Safety & EMC Compliance | |||
| IEC 60601 1 | √ | √ | √ |
| IEC 60601-1-2 | √ | √ | |
| IEC 60601-2-37 | √ | √ | |
| NEMA UD 2-2004 | √ | √ | |
| ISO 10993-1:2009 | √ | √ | |
| ISO 10993-5:1999 | √ | √ | |
| ISO 10993-10:2002 | √ | √ | |
| Acoustic Output Display Standard | |||
| Track 3 | √ | √ | |
| Patient Contact Materials | |||
| ISO 10993-1:2009 | √ | √ | |
| Functionality |
7. Summary of Comparison in Technological Characteristics to Predicate Device
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The subject device is similar to the predicate devices:
- Has the same intended use and indications for use
- Utilizes the same operating principle
- Incorporates the same basic design ●
- Incorporates the same technological characteristics ●
- Tested to the same electrical and electromagnetic safety standards for medical ● electrical equipment
- Manufactured under a quality system ●
8. Discussion of major difference vs. predicate device
- United Imaging has no Stress Echocardiography function; Sonoscape comes with ● Stress Echocardiography, Siemens X300 comes with Stress Echocardiography;
| Siemens K061946 | SonoScape K110510 | Subject device iuStar300 | Conclusion/Discussion |
|---|---|---|---|
| Tissue harmonic imaging | High Quality Noise Filter | Tissue Harmonic Imaging | The same function. |
| Doppler Tissue Imaging | Multi-beam Parallel Processing Technology | Digital broadband beam forming | The same function. |
| Stress Echocardiography | Stress Echocardiography | N/A | iuStar300 has echocardiography function |
| Tissue harmonic imaging (Improve image contrast and spatial resolution; reduces noise) | μ-Scan | Uniview (Adaptive Speckle Reduction) | Same function used to reduce noise and speckle |
| SieClear Multi-View Spatial Compounding Option | M-tuning | UniCT (Spatial compound Imaging) | Compound imaging. |
| Real-time 3D | Real-time 3D(4D) | 3D/4D Imaging | Same 3D/4D imaging. |
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9. Assessment of Non-Clinical Testing:
Non-clinical testing of the iuStar300 Medical Ultrasound Diagnostic System has been performed against requirements for performance, physical attributes, environmental conditions, materials and safety, and to provide objective evidence that the device's intended use is met.
10. Summary Performance Data
- IEC 60601-1 ed3.0 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005-12-15
- EN 60601-1-2. (Third Edition. 2007-07-31). Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic
- IEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Edition 2.0, 2007-08-09)
- NEMA UD 2-2004: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- ISO 10993-5:1999: Biological evaluation of medical devices -- Part 5: Tests for In ● Vitro cytotoxicity
- ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
- ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and ● Testing
- Software validation ●
11. Conclusion
After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is safe and effective as the predicate device.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.