(59 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SIGMA P5/OMEGA P7/LAMBDA P9 Portable Ultrasound Diagnostic Scanner:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly state quantitative "acceptance criteria" for the device's imaging performance (e.g., specific resolution, penetration depth, or diagnostic accuracy metrics). Instead, it primarily establishes substantial equivalence to a predicate device (GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound System) by demonstrating similar technological characteristics and compliance with relevant safety and performance standards.
The "reported device performance" is implicitly that the device performs equivalently to the predicate device and meets the general safety and performance standards for diagnostic ultrasound systems.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety & Performance Standards Compliance | Complies with 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. |
| Similar Intended Use | Intended use is similar to the predicate device, covering abdominal, small parts, obstetrics, gynecology, cardiology, peripheral vessels, urology, pediatrics, neonate, trans-cranial, musculoskeletal, fetal, intra-operative, and transvaginal imaging. |
| Similar Technological Characteristics | Employs the same fundamental technological characteristics as the predicate devices (e.g., imaging modes, acoustic track, power supply, acoustic output, electrical safety, EMC, performance, biocompatibility, software level of concern, design). |
| No New Risks | Differences between the proposed and predicate device do not affect basic design principles, usage, effectiveness, or safety, and raise no new risks. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Non-clinical testing," and references "results of performance and compliance testing conducted on Portable Ultrasound Diagnostic Scanner." The testing focuses on compliance with international and national safety and performance standards (e.g., IEC 60601, NEMA UD 2, ISO 10993).
- Sample Size: Not specified in terms of patient or imaging data. The testing appears to be primarily device-centric (e.g., electrical safety, acoustic output, biocompatibility) rather than a clinical performance study using patient data.
- Data Provenance: The nature of the "non-clinical test results" suggests they are derived from laboratory and engineering tests of the device itself. There is no indication of patient data being used for the "test set" in the context of clinical performance. The manufacturer is "Beijing East Whale Imaging Technology Co., Ltd." in CHINA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided because the testing described is non-clinical and related to device compliance with engineering and safety standards, not a clinical performance study requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as the document describes non-clinical engineering and safety compliance testing, not a clinical study involving human readers and adjudicated ground truth.
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
Not applicable. The device described is an ultrasound diagnostic scanner, and the submission is for its substantial equivalence to a predicate ultrasound system based on technological similarities and compliance with standards. It is not an AI-powered diagnostic device, nor does the document mention any MRMC studies or AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. This is not an algorithm-only device. It's a complete ultrasound diagnostic scanner intended for use by a physician.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of "ground truth" for the non-clinical tests would be the established specifications and limits defined by the referenced standards (e.g., maximum acoustic output levels, electrical impedance, biocompatibility test results). There is no clinical "ground truth" (like pathology or expert consensus on diagnoses) discussed in this document.
8. The Sample Size for the Training Set
Not applicable. This device is an ultrasound scanner, not an AI/machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning model discussed in this document.
Summary of the Study (as described in the 510(k) Summary):
The study described is a non-clinical performance and compliance testing program. It aims to demonstrate that the SIGMA P5/OMEGA P7/LAMBDA P9 Portable Ultrasound Diagnostic Scanner (and its various probe configurations) is substantially equivalent to a legally marketed predicate device (GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound System).
The primary evidence presented for this substantial equivalence is:
- Compliance with recognized safety and performance standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, ISO 10993-5, and ISO 10993-10.
- Similar intended use: The indications for use broadly overlap with the predicate device across various anatomical regions and clinical applications.
- Similar technological characteristics: The document details a side-by-side comparison (table on pages 11-12) showing that the proposed device shares the same classification, product codes, regulation numbers, panel, class, probe types (though specific model names differ, the general categories are similar), acoustic track, imaging modes, power supply, acoustic output limits, electrical safety, EMC, performance standards, biocompatibility standards, software level of concern, and design with the predicate.
The conclusion is that "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." This means the "study" effectively demonstrates that the device functions within established safety parameters and has similar capabilities to an already-approved device, thus meeting the requirements for 510(k) clearance by proving substantial equivalence.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is 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
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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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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.
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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 ofInterest | B | M | PWD | CWD | ColorDoppler | 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)
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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 ApplicationAnatomy/Region ofInterest | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | 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)
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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 ApplicationAnatomy/Region ofInterest | B | M | PWD | CWD | ColorDoppler | 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 ApplicationAnatomy/Region ofInterest | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | 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 ApplicationAnatomy/Region ofInterest | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | 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
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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 ApplicationAnatomy/Region ofInterest | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | 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 UltrasoundDiagnostic Scanner |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging SystemUltrasonic Pulsed Echo Imaging System |
{10}------------------------------------------------
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 andPrimary 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 |
|---|---|---|---|
| IntendedUse | The Portable UltrasoundDiagnostic Scanner is intended foruse by, or under the direction of, aqualified physician for ultrasoundimaging and analysis in Abdomen; | the Vivid ilq ultrasound systemsare intended for use by, or underthe direction of, a qualifiedphysician for ultrasound imagingand 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); TransvaginalandTransrectal, Intra-cardiac andintra-lumninal applications. | ||||
|---|---|---|---|---|---|
| ClassificationName | Ultrasonic Pulsed Doppler ImagingSystemUltrasonic Pulsed Echo ImagingSystemDiagnostic Ultrasound Transducer | Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed Echo ImagingSystemDiagnostic Ultrasound Transducer | Same | ||
| ProductCode | IYN/ IYO/ ITX | IYN/ IYO/ ITX | Same | ||
| Regulationn Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | Same | ||
| Panel | Radiology | Radiology | Same | ||
| Class | II | II | Same | ||
| ProbeType | 1P4V, Phrase Array2P4V, Phrase Array3P8V, Phrase Array2C5V, Convex Array12L5V, Linear Array | 3Sc-RS, Phased Array3S-RS, Phased Array7S-RS, Phased Array3C-RS, Convex Array8L-RS, Linear Array | Same | ||
| 4EC9V, Intracavitary ConvexArray, 4-9MHz | e8C-RS, Intracavitary ConvexArray, 4.0 - 11.0 MHz | ||||
| AcousticTrack | TRACK 3 | TRACK 3 | Same | ||
| Imagingmode | 2D(B) mode, M-Mode,AMM-Mode, Color Doppler, PowerDoppler (Angio), Tissue VelocityImaging (TVI) mode, PW mode,CW mode, Tissue-Dopplerimaging (TVD) mode, TDI, andsome application functions | 2D (B) Mode, ColorDoppler, Power Doppler (Angio),M-Mode, Color M-Mode, PW andCW Doppler spectra,Tissue-Doppler imaging (TDI) andLVO Contrast option applications | Same | ||
| PowerSupply | Voltage: 110-240 VACFrequency: 50/60 Hz | Voltage: 110-240 VACFrequency: 50/60 Hz | Same | ||
| AcousticOutput | Track 3:MI,TIS,TIC,TIBDerated 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,TIBDerated ispta: 720Mw/cm² maximum.TIS/TIB/TIC: 6.0 Maximum,Mechanical Index: 1.9 Maximum,or Derated Isppa: 190W/cm² max | Same | ||
| ElectricalSafety | IEC 60601-1 | IEC 60601-1 | Same | ||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same | ||
| Performance | IEC 60601-2-37NEMA UD 2: 2004 | IEC 60601-2-37NEMA UD 2: 2004 | Same | ||
| Biocompatibility | ISO 10993-5,ISO 10993-10 | ISO 10993-5,ISO 10993-10 | Same | ||
| Level ofConcernOfSoftware | Moderate level of concern system | Moderate level of concern system | Same | ||
| Design | Console+Cart+Probe+ECG+PrinterDICOM | Console+Cart+Probe+ECG+PrinterDICOM | Same |
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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.
§ 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.