(91 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 include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans rectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, 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 eve.
· 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 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:
- Phased Linear Array 0
- o Convex/Curved linear array.
The interaction with the patients is dependent upon the transducer type which may be:
- 0 Surface contact.
- . Intra-operative, or
- 0 contact through Endocavity
when used in locations as described by the indications for use.
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 provided documents describe a submission for the BK Medical bk2300 ultrasound system, including various transducers and clinical applications. However, the details for acceptance criteria and specific study results proving the device meets these criteria are not explicitly provided in these particular documents.
The documents are a 510(k) premarket notification letter from the FDA and several "Indications for Use" forms for the bk2300 system and its various transducers. These documents state that "design validation testing was performed to ensure that the Ultrasound Scanner System bk2300 with modifications meets design specifications" and that "Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met." However, the actual acceptance criteria values and the reported performance metrics of these tests are not included.
Therefore, I cannot provide the requested information for the following points based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The documents primarily focus on:
- FDA clearance for the device (bk2300) and its various transducers for specific indications.
- Listing of the clinical applications and exam types for which the ultrasound system is intended.
- Contraindications for the device.
- Mention of the device's technological characteristics and its similarity to predicate devices.
- A list of voluntary standards with which the system complies (e.g., IEC 60601-1, IEC 60601-2-37, IEC 62359).
To address your request fully, the actual test reports, validation studies, and performance data from BK Medical ApS would be needed, which are not present in this set of FDA clearance documents.
§ 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.