(95 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 (cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).
Contraindications:
The Ultrasound System 1300 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 System 1300 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 initial release of the 1300 system will include the BK1500 marketing configuration model.
The transducers are all multi-frequency transducers including:
- Phased Linear Array
- Convex / Curved Array .
- Linear Array. ●
The interaction with the patients is dependent upon the transducer type which may be:
- Surface Contact, ●
- Intra-operative, 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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for BK Medical Ultrasound System 1300 (K173569)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the BK Medical Ultrasound System 1300 as being substantially equivalent to its predicate device, the BK2300 Ultrasound Scanner System (K161960). Substantial equivalence means the device is as safe and effective as a legally marketed device. The acceptance criteria are therefore tied to meeting relevant standards and demonstrating comparable performance to the predicate device.
| Acceptance Criterion | Reported Device Performance (Ultrasound System 1300) |
|---|---|
| Intended Use Equivalence | The Ultrasound System 1300 has the same intended use as the predicate device: "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." |
| Clinical Application Equivalence | The clinical applications and exam types for the Ultrasound System 1300 are substantially equivalent to the predicate, including Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Intra-operative, Intra-operative Neuro, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel. Some new indications and previously cleared indications with specific transducers are detailed across pages 3-30. |
| Modes of Operation Equivalence | The Ultrasound System 1300 supports the same modes of operation as the predicate: B, M, PWD, CFM (Color Doppler and Amplitude Doppler) and combinations, Tissue Harmonic Imaging, Vector Flow Analysis, Continuous Wave Doppler (CWD), Elastography, and Contrast Imaging. Some transducers have specific new or previously cleared modes. |
| Transducer Equivalence | Modified acoustic output tables were provided for 24 transducers (9002, 9009, 9011, 9015, 9016, 9018, 9019, 9022, 9023, 9024, 9026, 9029, 9032, 9038, 9040, 9048, 9051, 9052, 9062, 9063, 9067, 9070, 9081, 9085). Three new transducers (9008, 9086, 9087) were introduced. All transducers are multi-frequency, including Phased Linear Array, Convex/Curved Array, and Linear Array. |
| Features Equivalence | The device retains the ECG (not monitoring) and Wi-Fi features present in the predicate. |
| Bio-effect Assessment | Complied with FDA guidance for Track 3 devices regarding thermal and mechanical indices (IEC 60601-2-37, IEC 62359, NEMA UD 2). |
| Biocompatibility | Patient-contacting transducers comply with applicable biocompatibility standard requirements (AAMI/ANSI/ISO 10993-1). |
| Sterilization (Reprocessing) | Reprocessing methods for transducers were tested in accordance with TIR-12 and TIR-30. The console is not patient-contacting and the device is not sold sterile. |
| Electrical Safety & EMC | Complied with AAMI/ANSI/ES 60601-1 and IEC 60601-1-2 standards. |
| Software Verification & Validation | Testing conducted as recommended by FDA guidance for "moderate" level of concern software. Complies with EN IEC 62304. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or images for evaluating the clinical performance of the device itself. The primary method for demonstrating substantial equivalence relies on bench testing against recognized standards for diagnostic ultrasound systems and transducers.
The data provenance for the non-clinical performance data is therefore from bench testing conducted by BK Medical ApS. The country of origin of this data would be Denmark, where BK Medical ApS is located. The nature of the data is retrospective in the sense that it refers to established standard tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "experts" establishing ground truth in the context of this submission is not applicable in the typical sense of evaluating AI models. Since clinical studies or evaluations using a test set of patient data were not deemed necessary for this 510(k) submission, there are no details provided about experts establishing ground truth for such a test set.
4. Adjudication Method
As there was no "test set" of clinical cases requiring expert interpretation and adjudication for this 510(k) submission, no adjudication method is mentioned or relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Clinical Studies: Not applicable - clinical studies were not required to support substantial equivalence to the predicate device." Therefore, an MRMC comparative effectiveness study was not performed, and no effect size for human readers improving with or without AI assistance is provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
No. The device is an ultrasound system with various imaging modes and functions; it is not described as an AI algorithm in the context of this submission. Its performance is evaluated as a diagnostic tool used by "qualified and trained healthcare professionals."
7. The Type of Ground Truth Used
For the purpose of this 510(k) submission, the "ground truth" for the device's performance is established by its conformance to recognized industry standards (IEC, NEMA, AAMI/ANSI/ISO) for diagnostic ultrasound systems and transducers. This includes:
- Engineering specifications and technical performance metrics related to image quality, acoustic output, electrical safety, EMC, and software functionality.
- Established safety and effectiveness profiles of the predicate device (BK2300 Ultrasound Scanner System – K161960).
There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for this submission, as clinical studies were not required.
8. The Sample Size for the Training Set
This question is not applicable. The device is a diagnostic ultrasound system, not an AI/ML algorithm that requires a training set of data in the sense typically understood for machine learning models.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no mention of a training set or AI/ML components for which ground truth would need to be established in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate ultrasound device through engineering and performance testing.
§ 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.