(111 days)
Not Found
Yes
The document explicitly mentions "Prostate Volume Assist (PVA), AI software feature" and provides details about its training and testing using deep learning validation images.
No
The device is described as a "diagnostic ultrasound imaging system" and its "Intended Use" explicitly states it is for "ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance," all of which are diagnostic functions. There is no mention of treating or preventing diseases.
Yes
The "Intended Use" explicitly states, "The system is a diagnostic ultrasound imaging system." Additionally, the "Device Description" section refers to it as a "software-controlled diagnostic ultrasound system." The "Indications for Use" further list numerous clinical applications, which are typically associated with diagnostic purposes.
No
The device description explicitly states the system consists of a "mobile console (engine)" and various hardware components like a keyboard, display monitor, and accessories. While it is software-controlled and includes an AI software feature, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance." These are all procedures performed on the patient, not on samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The description details a mobile ultrasound system with a console, display, and accessories. This is consistent with an imaging device used directly on a patient.
- Input Imaging Modality: The input modality is Ultrasound, which is a non-invasive imaging technique applied externally or internally to the body.
- Anatomical Site: The listed anatomical sites are all locations within the human body where ultrasound imaging is performed.
- Performance Studies: The performance studies focus on the technical aspects of the ultrasound system itself (safety, electromagnetic compatibility, etc.) and the accuracy of the AI feature for prostate volume measurement based on ultrasound images. There are no studies related to analyzing biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This ultrasound system does not perform such analysis on biological samples.
No
The letter does not state that a PCCP has been reviewed, approved, or cleared for this specific device. The text "Control Plan Authorized (PCCP) and relevant text: Not Found" further confirms this.
Intended Use / Indications for Use
Intended Use:
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.
Indications to Use:
The clinical applications and exam types include:
Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cramial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Transesophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).
Modes of Operation:
- 2D (B-Mode) including Tissue Harmonic Imaging
- M-Mode
- PWD Mode
- CFM Mode (C, VFI)
- Power Doppler
- Contrast Imaging
- CW Doppler
- Strain Elastography
Product codes
IYN, IYO, ITX
Device Description
The Ultrasound System 2300 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 which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications.
The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a conventional keyboard or a glass touchpad, a 19" Clinical Display Monitor (CDM). In addition, a variety of system accessories are available such as baskets, foot switch, printer start-up kit, remote control, and extra holders.
The Ultrasound System 2300 is available in the following marketing configurations:
-
- bk3000 available with a conventional keyboard configuration. The bk3000 is primarily intended for applications such as urology and general imaging
-
- bk5000 available with a conventional keyboard configuration. The bk5000 is primarily intended for surgery applications.
-
- bkActiv is a configuration available with a glass user interface (UI). bkActiv is primarily intended for surgical, anesthesiology, urology and general imaging applications.
All configurations run on the previously cleared SW platform and HW platform (engine) (K222441). The various configurations of the Ultrasound System 2300 are intended to be used for different applications as described above with various transducers and options.
The primary difference between the system configurations (also refer to Table 1) are:
- bk5000 is the premier product offering with all features and probes available.
- bk3000 is a basic product offering with only a subset of features.
- bkActiv is a configuration available with a glass user interface (UI).
The various configurations of the Ultrasound System 2300 are intended to be used with various multi-frequency transducers. The indicated uses are different and specific for each transducer listed.
- Linear Array
- Phased Linear Array
- Convex / Curved Array
The interaction with patients is dependent upon the transducer type which may include:
- Surface
- Inter-operative
- Laparoscopic
- Endocavity
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cramial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Transesophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).
Indicated Patient Age Range
Adult, Pediatric; patients scheduled for prostates biopsies (54 78 yrs) and healthy patients 30 60 yrs old.
Intended User / Care Setting
Qualified and trained healthcare professionals. Professional healthcare environment (e.g., hospitals, physician offices).
Description of the training set, sample size, data source, and annotation protocol
Patient Type: Healthy (505 images), Diseased (13447 images), Synthesized data (4104 images).
Gender: Male.
Age: patients scheduled for prostates biopsies (54 78 yrs) and healthy patients 30 60 yrs old.
Ethnicity/Country: Czech Republic, Holland. European population is representative of the US population for the PVA - workflow improvement case.
Mix of data from curved and linear arrays.
Description of the test set, sample size, data source, and annotation protocol
Patient Type: Healthy (975 images), Diseased (1461 images). Part of the test images come from the Holland dataset, which only contributed to the test set.
Gender: Male.
Age: patients scheduled for prostates biopsies (54 78 yrs) and healthy patients 30 60 yrs old.
Ethnicity/Country: Czech Republic, Holland. European population is representative of the US population for the PVA - workflow improvement case.
Mix of data from curved and linear arrays.
For the testing process, the segmentation part of the algorithm is tested using a standard metric of similarity. The test passed. The final algorithm including both segmentation and caliper placement is verified by visual evaluations by clinical experts validation testing comparing the initial caliper placement by the algorithm compared to manual placement by clinical personnel. The purpose is to compare the prostate volume calculation of PVA with volume measurement performed by clinical personnel. The clinical personnel had an average of about 15 years' experience in ultrasound. We used a freeware tool developed by the Oxford Imaging Group for manual caliper placement on given images. For testing, we use two data sets that have not been part of the training of the algorithm. Data from a clinical end-user test in the Czech Republic was being used to represent the 9018 transducer and data acquired in Amsterdam, Holland, was being used to represent the 9048 transducer. For the latter, we generated images that correspond the scanner preset, Prostate L, as the image depth is 6.5 cm, the recommended minimum depth for PVA. The human caliper setters scored the images individually. They received the following instructions; The calipers were set in pairs corresponding to a distance measurement, so calipers 1 and 2 form one distance measurement and calipers 3 and 4 form another distance measurement. The validator used 2 distance measurements (using 4 calipers) on the transverse image and one distance measurement (using 2 calipers) on the sagittal image. The volumes used for test/validation purpose are completely distinct from the ones used during training process and there is no overlap between the two.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
AI Feature Summary of Testing - Prostate Volume Assist (PVA)
Study Type: Workflow improvement and accuracy evaluation.
Sample Size (Test Images): Healthy (975), Diseased (1461).
Key Results:
Acceptance criterion: the automatic initial caliper placement shall produce a prostate volume estimate that deviates no more than 22% on average from the volume estimate based on manually placed calipers.
The automatic initial caliper placement was tested with respect to prostate volume calculation accuracy and determined for the 9018 to deviate 11% +/- 6% compared to volume calculation using manual placement. The prostate volume calculation accuracy for the 9048, using the initial placement of the calipers is expected to deviate 7% +/-15% compared to volume calculation using manual placement.
Non-clinical /Performance - Bench Testing The proposed Ultrasound System 2300 and applied transducers, have been tested and conform to the following standards:
- ANSI/AAMI/ES 60601-: 2005/ (R) 2012 and A1:2012, C1:2009/ (R) 2012 and . A2:2010/ (R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Ed. 4.0, 2014 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-2-37 - Medical Electrical Equipment - Part 2-37: Ed. 2.1, 2017 Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
- IEC 62359: Ed. 2.1. 2017 Ultrasonics Field Characterization Test Methods for . the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields
- . IEC 60825-1: Ed. 2.0, 2007 - Safety of laser products - part 1: equipment classification, and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]
- AAMI/ANSI/ISO 10993-1: 2018 Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a Risk management Process
- AAMI TIR-12:2010 and AAMI TIR-30:2011 ●
- IEC 62304: 2006/A1:2016 - Medical Device Software Life-Cycle Processes (Software / Informatics)
- NEMA PS3.1 3.20 Digital Imaging and Communications in Medicine (DICOM) ●
- ISO14971: 2019 - Application of risk management to medical devices
The following quality assurance measures are applied to the development of the system:
- · Risk Analysis
- Requirements Reviews
- Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety testing (Verification)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the date April 11, 2023. The text is written in a clear, sans-serif font. The date is formatted with the month, day, and year separated by commas.
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BK Medical Aps % Inesa Cernajute SR Regulatory Affairs Specialist Mileparken 34 Herlev, 2730 DENMARK
Re: K223830
Trade/Device Name: Ultrasound System 2300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: March 3, 2023 Received: March 3, 2023
Dear Inesa Cernajute:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph. D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223830
Device Name Ultrasound System 2300
Indications for Use (Describe)
Intended Use:
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.
Indications to Use:
The clinical applications and exam types include:
Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cramial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Transesophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).
Modes of Operation:
-
2D (B-Mode) including Tissue Harmonic Imaging
-
M-Mode
-
PWD Mode
-
CFM Mode (C, VFI)
-
Power Doppler
-
Contrast Imaging
-
CW Doppler
-
Strain Elastography
Environment:
The Ultrasound System 2300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices)
Contraindications:
The Ultrasound System 2300 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows the logo for BK Medical, a GE Healthcare company. The logo features the letters "bk" in a bold, green sans-serif font, with "medical" written below in a smaller font. Underneath "medical" is the text "a GE Healthcare company" in an even smaller font. To the right of the "bk" is a green graphic that resembles sound waves emanating from a source.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | BK Medical ApS
Mileparken 34
Herlev 2730
Denmark |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | BK Medical ApS
Mileparken 34
Herlev 2730
Denmark |
| Primary Contact Person: | Inesa Cernajute
Senior Regulatory Affairs Specialist
BK Medical
Tel: +45 42277733
E-mail: inesa.cernajute@ge.com |
| Date Prepared: | April 5, 2023 |
II. Device Names / Common Names / Classification Names:
| Trade Names: | Ultrasound System 2300 |
|---|---|
| Common Name: | Ultrasound System |
| Classification Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN (primary), IYO, ITX (secondary) |
| Class: | II |
| Regulation Number: | 21 CFR §892.1550, §892.1560, §892.1570 |
| Classification Panel: | Radiology |
5
III. Identification of Predicate or Legally Marketed Devices:
- Predicate device: Ultrasound System 2300 as cleared under 510(k) premarket notification ● No K222441.
| Trade Name: | Ultrasound System 2300 |
|---|---|
| Common Name: | Ultrasound System |
| Classification Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN (primary), IYO, ITX (secondary) |
| Class: | II |
| Regulation Number: | 21 CFR §892.1550, §892.1560, §892.1570 |
| Classification Panel: | Radiology |
IV. Device Description
The Ultrasound System 2300 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 which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications.
The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a conventional keyboard or a glass touchpad, a 19" Clinical Display Monitor (CDM). In addition, a variety of system accessories are available such as baskets, foot switch, printer start-up kit, remote control, and extra holders.
The Ultrasound System 2300 is available in the following marketing configurations:
-
- bk3000 available with a conventional keyboard configuration. The bk3000 is primarily intended for applications such as urology and general imaging
-
- bk5000 available with a conventional keyboard configuration. The bk5000 is primarily intended for surgery applications.
-
- bkActiv is a configuration available with a glass user interface (UI). bkActiv is primarily intended for surgical, anesthesiology, urology and general imaging applications.
6
All configurations run on the previously cleared SW platform and HW platform (engine) (K222441). The various configurations of the Ultrasound System 2300 are intended to be used for different applications as described above with various transducers and options.
The primary difference between the system configurations (also refer to Table 1) are:
- bk5000 is the premier product offering with all features and probes available. .
- bk3000 is a basic product offering with only a subset of features.
- bkActiv is a configuration available with a glass user interface (UI). ●
Table 1: Ultrasound System 2300 available configurations
| Catalog/
Reference
| (REF) | Model | Model Description |
|---|---|---|
| 2300 | Image: BK3000 Ultrasound System w/o Battery | BK3000 ULTRASOUND SYSTEM W/O |
| BATTERY | ||
| This configuration is primarily | ||
| intended for Urology and General | ||
| imaging applications. | ||
| 2300 | Image: BK3000 Ultrasound System w/ Battery | BK3000 ULTRASOUND SYSTEM |
| W/BATTERY | ||
| This configuration is primarily | ||
| intended for Urology and General | ||
| imaging applications. | ||
| Catalog/ | ||
| Reference | ||
| (REF) | Model | Model Description |
| 2300 | 2300-51 | |
| Image: Ultrasound system model 2300-51 | BK5000 ULTRASOUND SYSTEM W/O | |
| BATTERY |
This configuration is primarily
intended for surgical applications. |
| 2300 | 2300-61
Image: Ultrasound system model 2300-61 | BK5000 ULTRASOUND SYSTEM
W/BATTERY
This configuration is primarily
intended for surgical applications. |
| 2300 | 2300-56
Image: Ultrasound system model 2300-56 | BKACTIV ULTRASOUND SYSTEM W/O
BATTERY
This configuration is primarily
intended for surgical,
anesthesiology, urology and
general imaging applications. |
| Catalog/
Reference
(REF) | Model | Model Description |
| 2300 | 2300-66
Image: Ultrasound system | BKACTIV ULTRASOUND SYSTEM W/ BATTERY
This configuration is primarily intended for surgical, anesthesiology, urology and general imaging applications. |
7
8
The various configurations of the Ultrasound System 2300 are intended to be used with various multi-frequency transducers (see Table 2). The indicated uses are different and specific for each transducer listed.
- . Linear Array
- Phased Linear Array .
- Convex / Curved Array ●
The interaction with patients is dependent upon the transducer type which may include:
- Surface ●
- . Inter-operative
- Laparoscopic ●
- Endocavity .
9
| Transducer | bk3000 | bk5000 | bkActiv |
|---|---|---|---|
| 5Cle (9085) CURVED ARRAY TRANSDUCER | X | X | X |
| 6C2 (9040) CURVED ARRAY TRANSDUCER | X | X | X |
| 6C2s (9023) SMALL CURVED ARRAY TRANSDUCER | X | X | X |
| 9C2 (9002) CURVED ARRAY TRANSDUCER | X | X | X |
| 14L3 (9051) LINEAR ARRAY TRANSDUCER | X | X | X |
| 13L4w (9011) WIDE LINEAR ARRAY TRANSDUCER | X | X | X |
| 10L2w (9022) WIDE LINEAR ARRAY TRANSDUCER | X | X | X |
| 18L5 (9070) SMALL GIGH-FREQUENCY LINEAR ARRAY TRANSDUCER | X | X | X |
| 18L5s (9081) SMALL GIGH-FREQUENCY LINEAR ARRAY TRANSDUCER | X | X | X |
| 8L2 (9032) LINEAR ARRAY TRANSDUCER | X | X | X |
| E13C2 (9029) ENDFIRE ENDOCAVITY TRANSDUCER | X | X | X |
| E14C4t (9018) TRIPLANE ENDOCAVITY TRANSDUCER | X | X | X |
| X14CL4b (9048) BIPLANE ENDOCAVITY TRANSDUCER | X | X | X |
| E10C4 (9019) ENDOCAVITY TRANSDUCER | X | X | X |
| 20R3 (9052) ANORECTAL TRANSDUCER | X | X | X |
| N13C5 (9062) CURVED ARRAY TRANSDUCER | X | X | X |
| 5P1 (9077) PHASED ARRAY TRANSDUCER | X | X | X |
| X18L5S (9009) HOCKEY STICK TRANSDUCER | X | X | X |
| N11C5S (9063) BURR HOLE TRANSDUCER | X | X | X |
| I14C5I (9015) INTRAOPERATIVE I-SHAPE TRANSDUCER | X | X | X |
| I14C5T (9016) INTRAOPERATIVE T-SHAPE TRANSDUCER | X | X | X |
| I12C5B (9024) INTRAOPERATIVE BIPLANE TRANSDUCER | X | X | X |
| I12C5 (9034) MINI-TRANSDUCER | X | X | X |
| I12C4f (9066) LAPAROSCOPIC TRANSDUCER | X | X | X |
| X12C4 (9026) DROP-IN TRANSDUCER | X | X | X |
| X14L4 (9038) 3D ENDOCAVITY TRANSDUCER | X | X | X |
| Rob12C4 (9096) ROBOTIC TRANSDUCER | X | X | X |
| N20P6 (9007) MINIMALLY INVASIVE TRANSDUCER | X | X | X |
| I13C3f (9076) | X | X | X |
| ADVANCED LAPAROSCOPIC TRANSDUCER | |||
| T7P2m (9027) | X | X | X |
| TEE TRANSDUCER | |||
| I13C3fx (9078) | X | ||
| ADVANCED LAPAROSCOPIC TRANSDUCER WITH TRACKING |
Table 2: Transducers used with Ultrasound System 2300 configurations
V. Indications / Intended Use:
Intended Use:
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.
Indications for Use:
10
The clinical applications and exam types include:
- Fetal (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 ●
- Musculo-skeletal (Conventional and Superficial) ●
- Cardiac Adult ●
- Trans-esophageal (Cardiac) ●
- Peripheral vessel (also known as Peripheral Vascular) ●
Modes of operation:
- B-Mode (including Tissue Harmonic Imaging) -
- -M-Mode
- PWD Mode -
- CFM Mode (C, VFI) -
- Power Doppler -
- -Contrast Imaging
- CW Doppler -
- Strain Elastography -
Environment:
The Ultrasound System 2300 is intended for use in the professional healthcare environment (e.g., hospitals, physician offices).
Contraindications
The Ultrasound System 2300 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.
11
VL Comparison of Technological Characteristics with the Predicate Device
Table 3: Substantial Equivalence Table of the proposed device with its predicate devices
| Ultrasound System 2300 | Ultrasound System 2300 | ||
|---|---|---|---|
| Characteristic | Proposed device | ||
| (K223830) | Predicate | ||
| device | Comment on | ||
| Comparison | |||
| Manufacturer | BK Medical ApS | BK Medical ApS | Same |
| Common Name | Ultrasound System | Ultrasound System | Same |
| Name | |||
| (Configuration models) | bk3000 (2300-01, 2300-11) | ||
| bk5000 (2300-51, 2300-61) | |||
| bkActiv (2300-56, 2300-66) | bk3000 (2300-01, 2300-11) | ||
| bk5000 (2300-51, 2300-61) | |||
| bkActiv (2300-56, 2300-66) | Same | ||
| Mode of Operation | B, M, PW, CFM, P, THI, CI, SE, CW | ||
| Combination modes: | |||
| 2D+M, 2D+PW, 2D+C+PW, | |||
| 2D+P+PW, 2D+2D, 2D+2D | |||
| (Biplane Imaging), 2D+(2D+C), | |||
| 2D+(2D+P), 2D+THI, 2D+SE, | |||
| 2D+CI | B, M, PW, CFM, P, THI, CI, SE, CW | ||
| Combination modes: | |||
| 2D+M, 2D+PW, 2D+C+PW, | |||
| 2D+P+PW, 2D+2D, 2D+2D | |||
| (Biplane Imaging), 2D+(2D+C), | |||
| 2D+(2D+P), 2D+THI, 2D+SE, | |||
| 2D+CI | Same | ||
| Intended Use | Intended Use: | ||
| 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. | |||
| Indications for Use: | |||
| The clinical applications and exam | |||
| types include: | |||
| · Fetal (including obstetrics) | |||
| · Abdominal | |||
| · Pediatric | |||
| · Intra-operative | Intended Use: | ||
| 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. | |||
| Indications for Use: | |||
| The clinical applications and exam | |||
| types include: | |||
| · Fetal (including obstetrics) | |||
| · Abdominal | |||
| • Pediatric | |||
| · Intra-operative | Summary of changes / comparison with | ||
| predicate device | |||
| Due to the new software upgrade v. | |||
| currently cleared clinical applications | |||
| Cardiac Adult, | |||
| Fetal (including obstetrics), | |||
| Trans-rectal, | |||
| Trans-vaginal, | |||
| Small Organ and | |||
| Peripheral vessel | |||
| with transducers (9077, 9048, 9038, | |||
| 9052, 9018, 9019, 9029, 9027 and |
- previously activated on bk5000 |
| Characteristic | Ultrasound System 2300
Proposed device
(K223830) | Ultrasound System 2300
Predicate device | Comment on
Comparison |
| | • Intra-operative Neuro (also
known as Neurosurgery) | • Intra-operative Neuro (also
known as Neurosurgery) | / bk3000 configurations will now also
be enabled on bkActiv configuration. |
| | • Laparoscopic | • Laparoscopic | |
| | • Small Organ (also known as
Small Parts) | • Small Organ (also known as
Small Parts) | |
| | • Adult Cephalic (Cephalic is
also known as Adult Trans-
cranial) | • Adult Cephalic (Cephalic is
also known as Adult Trans-
cranial) | |
| | • Neonatal Cephalic | • Neonatal Cephalic | |
| | • Trans-rectal | • Trans-rectal | |
| | • Trans-vaginal | • Trans-vaginal | |
| | • Musculo-skeletal (Conventional
and Superficial) | • Musculo-skeletal (Conventional
and Superficial) | |
| | • Cardiac Adult | • Cardiac Adult | |
| | • Trans-esophageal (Cardiac) | • Trans-esophageal (Cardiac) | |
| | • Peripheral vessel (also known
as Peripheral Vascular) | • Peripheral vessel (also known
as Peripheral Vascular) | |
| | Modes of operation: | Modes of operation: | |
| | • 2 D (B-Mode) including
Tissue Harmonic Imaging | • 2 D (B-Mode) including
Tissue Harmonic Imaging | |
| | • M-Mode | • M-Mode | |
| | • PWD Mode | • PWD Mode | |
| | • CFM Mode (C, VFI) | • CFM Mode (C, VFI) | |
| | • Power Doppler | • Power Doppler | |
| | • Contrast Imaging
• CW Doppler | • Contrast Imaging
• CW Doppler | |
| | • Strain Elastography | • Strain Elastography | |
| | | | |
| | Environment: | Environment: | |
| | The Ultrasound System 2300 is
intended for use in the
professional healthcare
environment (e.g., hospitals,
physician offices). | The Ultrasound System 2300 is
intended for use in the
professional healthcare
environment (e.g., hospitals,
physician offices). | |
| | | | |
| | Ultrasound System 2300 | Ultrasound System 2300 | |
| Characteristic | Proposed device
(K223830) | Predicate
device | Comment on
Comparison |
| | Contraindications
The Ultrasound System 2300 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. | Contraindications
The Ultrasound System 2300 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. | |
| Indications/Clinical
Applications | ● Abdominal
● Intraoperative
● Intraoperative –
Neuro
(Neurosurgery)
● Pediatric
● Musculo-skeletal
Superficial &
Conventional
● Neonatal Cephalic
● Adult Cephalic (Trans-cranial)
● Laparoscopic
● Small Organ (Small Parts)
● Cardiac adult
● Transesophageal (Cardiac)
● Transrectal
● Transvaginal
● Fetal /Obstetrics
● Peripheral Vessel (Vascular) | ● Abdominal
● Intraoperative
● Intraoperative –
Neuro
(Neurosurgery)
● Pediatric
● Musculo-skeletal
Superficial &
Conventional
● Neonatal Cephalic
● Adult Cephalic (Trans-cranial)
● Laparoscopic
● Small Organ (Small Parts)
● Cardiac adult
● Transesophageal (Cardiac)
● Transrectal
● Transvaginal
● Fetal /Obstetrics
● Peripheral Vessel (Vascular) | Same |
| | | | |
| Characteristic | Ultrasound System 2300
Proposed device
(K223830) | Ultrasound System 2300
Predicate device
(K222441) | Comment on
Comparison |
| Application Environment | Professional healthcare facility environment | Professional healthcare facility environment | Same |
| Users | Qualified Professional users | Qualified Professional users | Same |
| Patient Population | Adult, Pediatric | Adult, Pediatric | Same |
| Transducer types | Surface Contact
Intra-operative
Laparoscopic
Endocavity | Surface Contact
Intra-operative
Laparoscopic
Endocavity | Same |
| System Transducers | 9002, 9007, 9009, 9011, 9015, 9016, 9018, 9019, 9022, 9023, 9024, 9026, 9027, 9029, 9032, 9034, 9038, 9040, 9048, 9051, 9052, 9062, 9063, 9066, 9070, 9076, 9077, 9081, 9085, 9096, 9078 | 9002, 9007, 9009, 9011, 9015, 9016, 9018, 9019, 9022, 9023, 9024, 9026, 9027, 9029, 9032, 9034, 9038, 9040, 9048, 9051, 9052, 9062, 9063, 9066, 9070, 9076, 9077, 9081, 9085, 9096, 9078 | Transducers 9077, 9048, 9038, 9052, 9018, 9019, 9029, 9027 and 9032 currently available with bk5000/bk3000 configurations will be enabled on bkActiv configurations to support clinical applications Cardiac Adult, Fetal (including obstetrics), Trans-rectal, Trans-vaginal, Small Organ (also known as Small Parts), Peripheral vessel (also known as Peripheral Vascular). |
| Biocompatibility | The Ultrasound System does not come
in contact with the patient. | The Ultrasound System does not come
in contact with the patient. | Same |
| Hardware | Clinical display monitor (CDM):
• 19" Optical bonded glass front.
• Can be tilted and moved sideways. | Clinical display monitor (CDM):
• 19" Optical bonded glass front.
• Can be tilted and moved sideways. | Same
No changes to hardware since last
clearance K222441. |
| | Cart:
• adjustable height and with 4
lockable wheels | Cart:
• adjustable height and with 4
lockable wheels | |
| | Keyboard:
Traditional keyboard with multiple
functionalities / specialized controls
or Glass touch UI | Keyboard:
Traditional keyboard with multiple
functionalities / specialized controls
or Glass touch UI | |
| | Scan engine:
• 4 Transducer ports
• 196 TX/RX channels
• Tracking Interface board | Scan engine:
• 4 Transducer ports
• 196 TX/RX channels
• Tracking Interface board | |
| OS Software | Windows 10 | Windows 10 | Same |
| Associated Needle
tracking accessories | UA1540 Tracking Control
Unit
UA1541 Portable EM Field
Generator (includes
field
generator and a
mounting solution)
UA1542 Clip-on needle
sensor
(CIVCO)
UA1543 Needle senor clamp
Kit (CIVCO) | UA1540 Tracking Control
Unit
UA1541 Portable EM Field
Generator (includes
field
generator and a
mounting solution)
UA1542 Clip-on needle
sensor
(CIVCO)
UA1543 Needle senor clamp
Kit (CIVCO) | Same |
| Options | | | |
| | - 3D Freehand | - 3D Freehand | - Prostate Volume Assist (PVA), AI |
| | - 3D Professional | - 3D Professional | software feature which provides a |
| | - DICOM Encrypted | - DICOM Encrypted | workflow improvement to an existing |
| | - Contrast Enhanced Ultrasound | - Contrast Enhanced Ultrasound | prostate volume measurement and |
| | - Vector Flow Imaging (VFI) | - Vector Flow Imaging (VFI) | calculation tool. It will require the |
| | - Varian Interface | - Varian Interface | same biplane/triplane transrectal |
| | - Strain Elastography | - Strain Elastography | transducers (9018, 9048) that are |
| | - Needle Enhancement (X-shine) | - Needle Enhancement (X-shine) | being used for existing prostate |
| | - BrainLab Neuro Navigation | - BrainLab Neuro Navigation | volume calculations and |
| | - bkFusion (for Urology Procedures) | - bkFusion (for Urology Procedures) | measurements. |
| | - Wi-Fi | - Wi-Fi | Comparing to the existing prostate |
| | - bkViewer (SW running on a | - bkViewer (SW running on a | measurement and calculation |
| | mac/windows pc) – not a | mac/windows pc) – not a | functionality where calipers are |
| | medical device | medical device | placed manually by the user, PVA |
| | - Lap Ablation Navigation | - Lap Ablation Navigation | allows a faster and more efficient |
| | - TP Needle Guide Supporting | | workflow. |
| | Software | | |
| | - Prostate Volume Assist (PVA) | | - In addition, proposed a new TP |
| | | | Needle Guide Supporting software |
| | | | functionality that visualizes biopsy |
| | | | lines for the TP Needle Guides |
| | | | UA1353 on the CDM (Clinical Display |
| | | | Monitor) to support the user having |
| | | | control of the needle during prostate |
| | | | biopsy procedure. |
| | | | |
| | | | |
| | | | |
| | | | |
| | Ultrasound System 2300 | Ultrasound System 2300 | |
| Characteristic | Proposed device
(TBD) | Predicate device
(K222441) | Comment on
Comparison |
| Image features | Speckle reduction, compound
imaging, tissue harmonic imaging
(thi), contrast imaging (ci), trapezoid
scanning (virtual convex) strain,
elastography (se) | Speckle reduction, compound
imaging, tissue harmonic imaging
(thi), contrast imaging (ci), trapezoid
scanning (virtual convex) strain,
elastography (se) | Same |
| UI Design | -19-inch Clinical Monitor and touch
input device
for user interaction.
-Trackball for cursor control.
-Touchpad track pad for cursor control
(Glass Touch UI)
-Full configurable interaction controls
(size/position) | -19-inch Clinical Monitor and touch
input device
for user interaction.
-Trackball for cursor control.
-Touchpad track pad for cursor control
(Glass Touch UI)
-Full configurable interaction controls
(size/position) | Same |
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VII. Performance Data
Summary of non-clinical /Performance - Bench Testing
The proposed Ultrasound System 2300 and applied transducers, have been tested and conform to the following standards:
- ANSI/AAMI/ES 60601-: 2005/ (R) 2012 and A1:2012, C1:2009/ (R) 2012 and . A2:2010/ (R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Ed. 4.0, 2014 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-2-37 - Medical Electrical Equipment - Part 2-37: Ed. 2.1, 2017 Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
- IEC 62359: Ed. 2.1. 2017 Ultrasonics Field Characterization Test Methods for . the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields
- . IEC 60825-1: Ed. 2.0, 2007 - Safety of laser products - part 1: equipment classification, and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]
- AAMI/ANSI/ISO 10993-1: 2018 Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a Risk management Process
- AAMI TIR-12:2010 and AAMI TIR-30:2011 ●
- IEC 62304: 2006/A1:2016 - Medical Device Software Life-Cycle Processes (Software / Informatics)
- NEMA PS3.1 3.20 Digital Imaging and Communications in Medicine (DICOM) ●
- ISO14971: 2019 - Application of risk management to medical devices
The following quality assurance measures are applied to the development of the system:
- · Risk Analysis
- Requirements Reviews
- Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
19
- · Performance testing (Verification)
- · Safety testing (Verification)
AI Feature Summary of Testing - Prostate Volume Assist (PVA)
Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance. The table summarizes number of datasets used for each different purpose
| Patient Type | Training
Images | Deep
Learning
Validation
images | Test
images
(Clinical
validation) | Comment |
|------------------|--------------------|------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Healthy | 505 | 190 | 975 | |
| Diseased | 13447 | 1189 | 1461 | Part of the test images
come from the Holland
dataset, which only
contributed to the test set. |
| Synthesized data | 4104 | 48 | 0 | |
- Gender: Male.
- · Age: patients scheduled for prostates biopsies (54 78 yrs) and healthy patients 30 60 yrs old; the specific age of each individual patient is not collected.
- · Ethnicity/Country: Czech Republic, Holland. Note, European population is representative of the US population for the PVA - workflow improvement case.
- · Mix of data from curved and linear arrays.
- · For the testing process, the segmentation part of the algorithm is tested using a standard metric of similarity. The test passed. The final algorithm including both segmentation and caliper placement is verified by visual evaluations by clinical experts validation testing comparing the initial caliper placement by the algorithm compared to manual placement by clinical personnel. The purpose is to compare the prostate volume calculation of PVA with volume measurement performed by clinical personnel. The clinical personnel had an average of about 15 years' experience in ultrasound. We used a freeware tool developed by the Oxford Imaging Group for manual caliper placement on given images. For testing, we use two data sets that have not been part of the training of the algorithm. Data from a clinical end-user test in the Czech Republic was being used to represent the 9018 transducer and data acquired in Amsterdam, Holland, was being used to represent the 9048 transducer. For the latter, we generated images that correspond the scanner preset, Prostate L, as the image depth is 6.5 cm, the recommended minimum depth for PVA. The human caliper setters scored the images individually. They received the following instructions; The calipers were set in pairs corresponding to a distance measurement, so calipers 1 and 2 form one distance measurement and calipers 3 and 4 form another distance
20
measurement.
The validator used 2 distance measurements (using 4 calipers) on the transverse image and one distance measurement (using 2 calipers) on the sagittal image.
Acceptance criterion: the automatic initial caliper placement shall produce a prostate volume estimate that deviates no more than 22% on average from the volume estimate based on manually placed calipers.
The automatic initial caliper placement was tested with respect to prostate volume calculation accuracy and determined for the 9018 to deviate 11% +/- 6% compared to volume calculation using manual placement. The prostate volume calculation accuracy for the 9048, using the initial placement of the calipers is expected to deviate 7% +/-15% compared to volume calculation using manual placement.
- · The volumes used for test/validation purpose are completely distinct from the ones used during training process and there is no overlap between the two.
Animal Testing
Not applicable - animal testing was not required to support substantial equivalence to the predicate device.
Clinical Studies
Not applicable - clinical studies were not required to support substantial equivalence to the predicate device.
VIII. Conclusion
BK Medical ApS considers the proposed device to be as safe, as effective and performance is substantially equivalent to the predicate device(s).