(59 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the description of the device and testing focuses on standard ultrasound technology and performance.
No
The device is described as a "Portable Ultrasound Diagnostic Scanner" intended for "ultrasound imaging and analysis." It performs digital acquisition, processing, and display, which are diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis..." This indicates its role in diagnosis. Additionally, the "Device Description" mentions it as a "portable ultrasound diagnostic device."
No
The device description explicitly lists hardware components such as a console, cart, AC adaptor, transducers, and printers, indicating it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Portable Ultrasound Diagnostic Scanner uses ultrasound waves to create images of internal structures within the body. It is a non-invasive imaging device.
- Intended Use: The intended use clearly states it is for "ultrasound imaging and analysis" of various anatomical sites within the body.
- No mention of samples: There is no mention of analyzing samples taken from the body.
Therefore, based on the provided information, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.
Product codes
IYN, IYO, ITX
Device Description
The Portable Ultrasound Diagnostic Scanner comprises of a console, a cart, an AC adaptor, and several transducers and printers. The console is a portable ultrasound diagnostic device with an integrated keyboard and LCD display. It is capable of digital acquisition, processing and display. The mobile cart with multiple socket-outlet and extension transducer connector improves the mobility by having all accessories on it.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal. Specific extended lists by probe type are also provided:
LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 1P4V probe: Ophthalmic, Fetal, Abdominal, Intra-operative (Neuro, Laparoscopic), Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Musculo-skeletal (Conventional, Superficial), Intravascular, Ob/GYN, Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 2P4V probe: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify, Neuro, Laparoscopic), Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Musculo-skeletal (Conventional, Superficial), Intravascular, Other (Ob/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.
OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 3P8V probe: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify, Neuro, Laparoscopic), Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Musculo-skeletal (Conventional, Superficial), Intravascular, Other (Ob/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 2C5V probe: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify, Neuro, Laparoscopic), Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Musculo-skeletal (Conventional, Superficial), Intravascular, Other (Ob/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 4EC9V probe: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify, Neuro, Laparoscopic), Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Musculo-skeletal (Conventional, Superficial), Intravascular, Other (Ob/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 12L5V probe: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify, Neuro, Laparoscopic), Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Musculo-skeletal (Conventional, Superficial), Intravascular, 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 physician / Not Found
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:
The proposed device has been tested to compliance to the following safety and performance standards:
AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012
IEC 60601-1-2: 2007
IEC 60601-2-37: 2007
NEMA UD 2: 2004
ISO 10993-5:2009
ISO 10993-10:2010
Results of performance and compliance testing conducted on Portable Ultrasound Diagnostic Scanner, indicates conformance to all applicable standards recognized by FDA for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Beijing East Whale Imaging Technology Co., Ltd. % Ms. June Li RA Manager B2-2 New City Industrial Park, No.9 KeChuang 2nd St. YiZhuang, Beijing 100023 CHINA
April 7, 2016
Re: K160343
Trade/Device Name: SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 3, 2016 Received: February 8, 2016
Dear Ms. Li:
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
1
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.
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,
Robert Ools
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) K160343
Device Name
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
Indications for Use (Describe)
The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.
| ☑ 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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Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
System: LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 1P4V probe Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of | |||||||||
| Interest | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Abdominal | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| 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 | Notes 2,3 | |
| Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Intravascular(Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | |||||||||
| Other (specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI
Note 4: Small Organ: breast, thyroid, testes
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)
4
System: SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 2P4V probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy/Region of
| Interest | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||
| (Amplitude) | ||||||||
| Doppler | Other* | |||||||
| Combined | Other* | |||||||
| Specify | ||||||||
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Abdominal | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Intra-operative Specify | ||||||||
| Intra-operative Neuro | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| 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 | Notes 2,3 |
| Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Intravascular(Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral vessel | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI;B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI
Note 3: TDI
Note 4: Q = "
Note 4: Small Organ: breast, thyroid, testes
(Division Sian Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
5
System: OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 3P8V probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy/Region of
Interest | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Other*
Combined | Other*
Specify |
|-------------------------------------------------------|---|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| Ophthalmic | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Fetal | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Abdominal | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Intra-operative Specify | | | | | | | | |
| Intra-operative Neuro | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Small Organ (specify) | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card) | | | | | | | | |
| Musculo-skeletal
(Conventional) | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Musculo-skeletal
(Superficial) | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Intravascular | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Other (Ob/GYN) | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Intravascular(Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-cardiac | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Other (specify) | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Other (specify) | | | | | | | | |
P = previously cleared by FDA; N = new indication; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI;B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI
Note 4: Small Organ: breast, thyroid, testes
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
6
System: SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 2C5V probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy/Region of
| Interest | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | Note 1 | Notes 2 | ||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2 | ||
| Small Organ (specify) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | N | N | N | N | N | Note 1 | Notes 2 | ||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intravascular | N | N | N | N | N | Note 1 | Notes 2 | ||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2 | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI;B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI
Note 3: TDI
Note 4: ""
Note 4: Small Organ: breast, thyroid, testes
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)
7
System: SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 4EC9V probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy/Region of
| Interest | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||
| (Amplitude) | ||||||||
| Doppler | Other* | |||||||
| Combined | Other* | |||||||
| Specify | ||||||||
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Abdominal | N | N | N | N | N | N | Note 1 | Notes 2 |
| Intra-operative Specify | ||||||||
| Intra-operative Neuro | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | Notes 2 | |
| Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2 | |
| Trans-urethral | N | N | N | N | N | Note 1 | Notes 2 | |
| Trans-esoph.(non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2 | |
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2 | |
| Other (specify) |
P = previously cleared by FDA; N = new indication; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI;B/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI
Note 4: Small Organ: breast, thyroid, testes
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
8
System: SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner with 12L5V probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy/Region of
| Interest | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||
| (Amplitude) | ||||||||
| Doppler | Other* | |||||||
| Combined | Other* | |||||||
| Specify | ||||||||
| Ophthalmic | N | N | N | N | N | Note 1 | Notes 2 | |
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2 | |
| Intra-operative Specify | ||||||||
| Intra-operative Neuro | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1 | Notes 1 |
| Small Organ (specify) | N | N | N | N | N | N | Note 1 | Notes 2,4 |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | N | N | N | N | Note 1 | Notes 2 | |
| Musculo-skeletal | ||||||||
| (Superficial) | N | N | N | N | N | Note 1 | Notes 2 | |
| Intravascular | ||||||||
| Other (Ob/GYN) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2 | |
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI;B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI
Note 4: Small Organ: breast, thyroid, testes
(Division Sian Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
9
510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Apr 6th 2016
2. Submitter's Information [21 CFR807.92 (a) (1)]
Name of Sponsor: Beijing East Whale Imaging Technology Co., Ltd.
| Address: | B2-2 New City Industrial Park, No.9 KeChuang 2nd St.,
YiZhuang, 100023, Beijing, China. |
|----------------|--------------------------------------------------------------------------------------------|
| Contact Name: | June Li |
| Telephone No.: | + 86 (10) 67892355-8968 |
| Fax No.: | + 86 (10) 67082218 |
| Email Address: | igli@whaleimaging.com |
3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Common Name: | Portable Ultrasound Diagnostic Scanner |
|---|---|
| Model: | P5/ P7/ P9 |
| Trade Name: | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound |
| Diagnostic Scanner | |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System |
| Ultrasonic Pulsed Echo Imaging System |
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Diagnostic Ultrasound Transducer
Classification Regulation: 892.1550/ 892.1560/ 892.1560
ll
| Product code: | IYN/ IYO/ ITX |
|---|---|
| Classification Panel: | Radiology |
Device Class:
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
| 510(k) Number | K102388 |
|---|---|
| Applicant | GE Healthcare [GE Medical Systems Ultrasound and |
| Primary Care Diagnostics, LLC] | |
| Device Name | Vivid i and Vivid q Diagnostic Ultrasound System |
5. Description of the Device [21 CFR 807.92(a)(4)]
The Portable Ultrasound Diagnostic Scanner comprises of a console, a cart, an AC adaptor, and several transducers and printers. The console is a portable ultrasound diagnostic device with an integrated keyboard and LCD display. It is capable of digital acquisition, processing and display. The mobile cart with multiple socket-outlet and extension transducer connector improves the mobility by having all accessories on it.
6. Intended Use [21 CFR 807.92(a)(5)]
The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
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The Portable Ultrasound Diagnostic Scanner employs the same fundamental technological characteristics as its predicate devices.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
Results of performance and compliance testing conducted on Portable Ultrasound Diagnostic Scanner, indicates conformance to all applicable standards recognized by FDA for this device.
Based on non-clinical test results, Portable Ultrasound Diagnostic Scanner is substantially equivalent to predicate devices in safety and effectiveness.
Non-clinical testing:
The proposed device has been tested to compliance to the following safety and performance standards:
AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 IEC 60601-1-2: 2007 IEC 60601-2-37: 2007 NEMA UD 2: 2004 ISO 10993-5:2009 ISO 10993-10:2010
Comparison with Predicated Device:
The proposed device is substantially equivalent in safety and effectiveness to the proposed device:
| Items | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Intended | |||
| Use | The Portable Ultrasound | ||
| Diagnostic Scanner is intended for | |||
| use by, or under the direction of, a | |||
| qualified physician for ultrasound | |||
| imaging and analysis in Abdomen; | the Vivid ilq ultrasound systems | ||
| are intended for use by, or under | |||
| the direction of, a qualified | |||
| physician for ultrasound imaging | |||
| and analysis in Abdominal/GYN; | |||
| Urology; | Note 1 |
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| | Small Parts; Obstetrics;
Gynecology; Cardiology;
Peripheral Vessels; Urology;
Pediatrics; Neonate; Trans-cranial;
Musculoskeletal; Fetal;
Intra-operative; Transvaginal. | Fetal/OB3; Small Organ (breast,
testes, thyroid); Pediatric;
Neonatal &
Adult Cephalic; Cardiac (adult &
pediatric); Peripheral Vascular;
Musculo-skeletal (conventional &
superficial); Transesophageal;
Intraoperative (abdominal,
thoracic and PV); Transvaginal
and
Transrectal, Intra-cardiac and
intra-lumninal applications. | | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Classification
Name | Ultrasonic Pulsed Doppler Imaging
System
Ultrasonic Pulsed Echo Imaging
System
Diagnostic Ultrasound Transducer | Ultrasonic Pulsed Doppler
Imaging System
Ultrasonic Pulsed Echo Imaging
System
Diagnostic Ultrasound Transducer | Same | | |
| Product
Code | IYN/ IYO/ ITX | IYN/ IYO/ ITX | Same | | |
| Regulation
n Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | Same | | |
| Panel | Radiology | Radiology | Same | | |
| Class | II | II | Same | | |
| Probe
Type | 1P4V, Phrase Array
2P4V, Phrase Array
3P8V, Phrase Array
2C5V, Convex Array
12L5V, Linear Array | 3Sc-RS, Phased Array
3S-RS, Phased Array
7S-RS, Phased Array
3C-RS, Convex Array
8L-RS, Linear Array | Same | | |
| | | 4EC9V, Intracavitary Convex
Array, 4-9MHz | | e8C-RS, Intracavitary Convex
Array, 4.0 - 11.0 MHz | |
| | Acoustic
Track | TRACK 3 | | TRACK 3 | Same |
| | Imaging
mode | 2D(B) mode, M-Mode,
AMM-Mode, Color Doppler, Power
Doppler (Angio), Tissue Velocity
Imaging (TVI) mode, PW mode,
CW mode, Tissue-Doppler
imaging (TVD) mode, TDI, and
some application functions | | 2D (B) Mode, Color
Doppler, Power Doppler (Angio),
M-Mode, Color M-Mode, PW and
CW Doppler spectra,
Tissue-Doppler imaging (TDI) and
LVO Contrast option applications | Same |
| Power
Supply | Voltage: 110-240 VAC
Frequency: 50/60 Hz | Voltage: 110-240 VAC
Frequency: 50/60 Hz | Same | | |
| Acoustic
Output | Track 3:MI,TIS,TIC,TIB
Derated ispta: 720Mw/cm² maximum.
TIS/TIB/TIC: 6.0 Maximum,
Mechanical Index: 1.9 Maximum,
or Derated Isppa: 190W/cm² max | Track 3: MI,TIS,TIC,TIB
Derated ispta: 720Mw/cm² maximum.
TIS/TIB/TIC: 6.0 Maximum,
Mechanical Index: 1.9 Maximum,
or Derated Isppa: 190W/cm² max | Same | | |
| Electrical
Safety | IEC 60601-1 | IEC 60601-1 | Same | | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same | | |
| Performa
nce | IEC 60601-2-37
NEMA UD 2: 2004 | IEC 60601-2-37
NEMA UD 2: 2004 | Same | | |
| Biocomp
atibility | ISO 10993-5,
ISO 10993-10 | ISO 10993-5,
ISO 10993-10 | Same | | |
| Level of
Concern
Of
Software | Moderate level of concern system | Moderate level of concern system | Same | | |
| Design | Console+Cart+Probe+ECG+
Printer
DICOM | Console+Cart+Probe+ECG+
Printer
DICOM | Same | | |
13
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Note 1: Intended use of proposed device is similar with predicate device. Applications of the predicate device cover all the applications of proposed device, and thus the difference will not affect safety and efficiency of device.
The proposed device has similar intended use, similar product design, similar performance effectiveness, and performance safety as the predicate device. The differences between the proposed device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the proposed device. And no new risk is raised regarding to effectiveness and safety. The proposed device is substantial with the predicated device.
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we concludes that Portable Ultrasound Diagnostic Scanner is substantially equivalent to predicate devices with regard to safety and effectiveness.