(15 days)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 9 product is an ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The system platform provides optimal patient diagnosis workflow with the 17" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality
The Alpinion E-CUBE 9 is an ultrasonic pulsed Doppler imaging system.
Acceptance Criteria and Device Performance:
The E-CUBE 9 utilizes the same fundamental scientific technology as its predicate device, the LOGIQ P5/A5 Diagnostic Ultrasound System (K060993). Therefore, its "acceptance criteria" are based on demonstrating substantial equivalence to this predicate device in terms of safety, effectiveness, and performance. The primary method for proving this substantial equivalence, in this case, involves non-clinical testing and comparison of intended uses.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria / Requirement | Reported Device Performance (E-CUBE 9) |
|---|---|---|
| Technology | Same fundamental scientific technology as predicate device (LOGIQ P5/A5) | Employs the same fundamental scientific technology as its predicate device. |
| Biocompatibility | Biocompatibility of transducer and patient contact materials | Transducer materials and other patient contact materials are biocompatible. |
| Acoustic Output | Conformity to applicable safety standards | Evaluated for acoustic output and found to conform to applicable medical device safety standards. |
| Thermal Safety | Conformity to applicable safety standards | Evaluated for thermal safety and found to conform to applicable medical device safety standards. |
| Electrical Safety | Conformity to applicable safety standards | Evaluated for electrical safety and found to conform to applicable medical device safety standards. |
| Electromagnetic Safety | Conformity to applicable safety standards | Evaluated for electromagnetic safety and found to conform to applicable medical device safety standards. |
| Mechanical Safety | Conformity to applicable safety standards | Evaluated for mechanical safety and found to conform to applicable medical device safety standards. |
| Compliance with Voluntary Standards | Compliance with relevant voluntary standards | Complies with voluntary standards as detailed in the premarket submission. |
| Quality Management System | Application of quality management system measures | Medical Device Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), and Design Validation were applied. |
| Intended Use & Clinical Applications | Equivalent indications for use as predicate device, including various transducers and modes | Intended for use in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac (adult), Peripheral Vascular, and Urology (including prostate) applications, with various modes (B, M, PWD, Color Doppler, Power Doppler, Tissue Harmonic Imaging, Combined, Other). Specifics are detailed for each transducer (SC1-6, C1-6, SVC1-6, VC1-6, L3-12, L3-12H, SP1-5, E3-10), all listing "P = previously cleared by FDA," indicating equivalence to previously cleared devices (including the predicate). |
Study Information:
This 510(k) summary explicitly states: "The subject of this premarket submission, E-CUBE 9, did not require clinical studies to support substantial equivalence."
Therefore, the following information regarding clinical studies or test sets is not applicable to this submission:
- Sample size used for the test set and the data provenance: Not applicable as no clinical studies were performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical studies were performed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical studies were performed.
- 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. This is a diagnostic ultrasound imaging system, and the submission does not involve AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a diagnostic ultrasound imaging system, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical studies were performed. The "ground truth" for substantial equivalence was based on meeting engineering and safety standards and having equivalent intended uses to a predicate device.
- The sample size for the training set: Not applicable as no clinical studies or AI/machine learning development requiring a "training set" were described.
- How the ground truth for the training set was established: Not applicable as no clinical studies or AI/machine learning development requiring a "training set" were described.
§ 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.