(132 days)
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.
The clinical applications and exam types including Obstetrics), Abdominal. Pediatric. Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).
Contraindications:
The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
The Cardiac Adult application is not intended for direct use on the heart.
The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic Ultrasound Scanner System with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.
The transducers are all multi-frequency transducers including:
- Linear Array
- Phased Linear Array
- Convex / Curved Array
The interaction with the patients is dependent upon the transducer type which may be:
- Surface Contact.
- Intra-operative,
- Laparoscopic, or
- Endocavity
The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.
The BK Medical ApS Ultrasound Scanner System bk2300 (K180737) did not include an AI/ML component. The provided document is a 510(k) premarket notification for an ultrasound scanner system without AI/ML functionality. Therefore, information regarding acceptance criteria and studies related to AI/ML performance (such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable.
The performance data provided focuses on the safety and effectiveness of the ultrasound system itself, including its compliance with relevant international and FDA recognized standards for medical electrical equipment, acoustic output, usability engineering, laser safety, biocompatibility, sterilization, electrical safety, electromagnetic compatibility, and software verification and validation. These are standard tests for diagnostic ultrasound systems and do not involve AI/ML.
Here's a summary of the provided performance data relevant to a non-AI/ML device:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML)
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Non-clinical/Performance - Bench Testing | Fulfilled requirements of FDA consensus standards for diagnostic ultrasound scanner systems (IEC 60601-2-37, IEC 62359, NEMA UD 2). |
| Usability Engineering | Complied with IEC 62366-1. |
| Laser Safety | Complied with IEC 60825-1. |
| Biocompatibility | Transducers are patient-contacting and comply with applicable biocompatibility standard requirements (AAMI/ANSI/ISO 10993-1). |
| Sterilization | Not sold as sterile; reprocessing methods (TIR-12, TIR-30) were tested and supported. |
| Electrical Safety | Complied with AAMI/ANSVES 60601-1 and IEC 60601-1-2. |
| Electromagnetic Compatibility (EMC) | Complied with IEC 60601-1-2. |
| Software Verification and Validation | Documentation provided per FDA guidance, considered "moderate" level of concern. Complied with EN IEC 62304. |
2. Sample Size Used for the Test Set and Data Provenance: Not applicable as this is not an AI/ML device study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not applicable as this is not an AI/ML device study.
4. Adjudication Method: Not applicable as this is not an AI/ML device study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: Not applicable as this is not an AI/ML device study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device study.
7. The type of ground truth used: Not applicable as this is not an AI/ML device study. The provided document does not mention the use of ground truth in the context of AI/ML performance evaluation.
8. The sample size for the training set: Not applicable as this is not an AI/ML device study.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device study.
§ 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.