(393 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound modes.
No.
The device is clearly stated as being for "medical diagnostic purposes only" and is intended for "visualization of internal organs by ultrasound images," not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only." The "Device Description" also reiterates that it is a "diagnostic ultrasound system" and "intended for visualization of internal organs and for medical diagnostic purposes only."
No
The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducer, processing unit, display) to generate and process ultrasound images. While it is "software-controlled," it is not solely software.
Based on the provided information, the iuStar300 Medical Ultrasound Diagnostic System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body. The iuStar300 is an ultrasound system that visualizes internal organs within the body using sound waves.
- The intended use and device description clearly state it's for visualizing internal organs and medical diagnostic purposes by ultrasound images. This is a form of in vivo (within the living body) imaging, not in vitro (in glass/outside the body) testing.
- The applications listed (Abdominal, Vascular, OB/GYN, etc.) are all areas where ultrasound is used for direct imaging of internal structures.
Therefore, the iuStar300 falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal and Cardiology. The clinical applications per transducer are also listed as: Fetal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Other (Urology), Other (OB/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified and trained Physician or Sonographer.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Performance data provided includes compliance with IEC 60601-1 ed3.0, EN 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, ISO 10993-5:1999, ISO 10993-10:2002, ISO 10993-1:2009, and Software validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 | Color | ||||
| Doppler | 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 | Color | ||||
| Doppler | 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 | Color | ||||
| Doppler | 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | |||||||||
| (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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | |||||||||
| (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 | Color | ||||
| Doppler | 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 | Color | ||||
| Doppler | 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) |
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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 |
|---|---|---|
| ACUSON | ||
| DIAGNOSTIC | ||
| ULTRASOUND SYSTEM | X300 K061946 | SIEMENS MEDICAL |
| SOLUTIONS USA INC. | ||
| S20 DIGITAL COLOR | ||
| DOPPLER ULTRASOUND | ||
| SYSTEM | K110510 | SONOSCAPE COMPANY |
| LIMITED |
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 Trade | |||
| Name | ACUSON X300 | ||
| DIAGNOSTIC | |||
| ULTRASOUND | |||
| SYSTEM | S20 DIGITAL | ||
| COLOR DOPPLER | |||
| ULTRASOUND | |||
| SYSTEM | iuStar300 Medical Ultrasound | ||
| Diagnostic System | |||
| Common Name | |||
| Classification | |||
| Name | Ultrasonic Pulsed | ||
| Doppler Imaging | |||
| System | Ultrasonic Pulsed | ||
| Doppler Imaging | |||
| System | Ultrasonic Pulsed Doppler Imaging | ||
| System | |||
| Indications for | |||
| Use | The Siemens Acuson | ||
| X300 ultrasound | |||
| imaging system is | |||
| intended for the | |||
| following applications: | |||
| General Radiology, | |||
| Fetal, Abdominal, | |||
| Intraoperative, | |||
| Pediatric, Small Pans, | |||
| Neonatal/Adult | |||
| Cephalic, Cardiac, | |||
| Transesophageal, | |||
| Pelvic, Transcranial, | |||
| OB/GYN, Urology, | |||
| Vascular, | |||
| Musculoskeletal, | |||
| Superficial | |||
| Musculoskeletal, and | |||
| Peripheral Vascular | |||
| applications. | |||
| The system also | |||
| provides for the | The device is a general- | ||
| purpose ultrasonic | |||
| imaging instrument | |||
| intended for use by | |||
| a qualified physician | |||
| for evaluation of Fetal, | |||
| Abdominal, Pediatric, | |||
| Small Organ | |||
| (breast, testes, thyroid), | |||
| Cephalic(neonatal and | |||
| adult), Trans-rectal, | |||
| Trans-vaginal, | |||
| Peripheral Vascular, | |||
| Musculo-skeletal | |||
| (Conventional and | |||
| Superficial), Cardiac | |||
| (neonatal and adult), | |||
| OB/Gyn and Urology. | 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. | |||
| measurement of | |||
| anatomical structures | |||
| and for analysis | |||
| packages that provide | |||
| information that is used | |||
| for clinical diagnosis | |||
| purposes. | |||
| Classification | |||
| Ultrasonic Pulsed | |||
| Doppler Imaging | |||
| System 892.1550 | |||
| IYN | |||
| Ultrasonic Pulsed Echo | |||
| Imaging System | |||
| 892.1560 | |||
| IYO | |||
| Diagnostic Ultrasound | |||
| Transducer | |||
| 892.1570 | |||
| ITX | Ultrasonic Pulsed | ||
| Doppler Imaging | |||
| System 892.1550 | |||
| IYN | |||
| Ultrasonic Pulsed Echo | |||
| Imaging System | |||
| 892.1560 | |||
| IYO | |||
| Diagnostic Ultrasound | |||
| Transducer | |||
| 892.1570 | |||
| ITX | Ultrasonic Pulsed Doppler Imaging | ||
| System 892.1550 | |||
| IYN | |||
| Ultrasonic Pulsed Echo Imaging System | |||
| 892.1560 | |||
| IYO | |||
| Diagnostic Ultrasound Transducer | |||
| 892.1570 | |||
| ITX | |||
| Probe Types | |||
| Convex probe | √ | √ | √ |
| Linear probe | √ | √ | √ |
| Micro-Convex | |||
| Probe | √ | √ | √ |
| 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) Doppler | |||
| mode | Continuous wave | ||
| (CW) Doppler | |||
| mode | Continuous wave (CW) Doppler | ||
| mode | |||
| Color Doppler | |||
| Mode | Color Doppler | ||
| Mode | Color Doppler | ||
| Imaging (CDI) | Color Doppler Mode | ||
| Amplitude | |||
| Doppler Mode | Amplitude Doppler | ||
| Mode | Power Amplitude | ||
| Doppler Mode | Power Amplitude Doppler Mode | ||
| 3D Imaging or | |||
| Harmonic | |||
| Imaging | 3D Imaging or | ||
| Harmonic Imaging | 3D Imaging or | ||
| Tissue Harmonic | |||
| Imaging | 3D Imaging or Tissue Harmonic | ||
| Imaging | |||
| 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.