(117 days)
No
The summary describes a standard ultrasound system with various imaging modes and configurations. There is no mention of AI, ML, or any features that would typically indicate the use of such technologies for image analysis, interpretation, or workflow optimization. The performance studies focus on safety and standard performance metrics, not AI/ML model validation.
No
Explanation: The device is described as a "diagnostic ultrasound imaging system" and its intended uses and indications are all for imaging, analysis, and guidance, not for treating any condition.
Yes
The "Intended Use" section explicitly states, "The system is a diagnostic ultrasound imaging system," and the "Device Description" section further confirms it as a "software-controlled diagnostic ultrasound system."
No
The device description explicitly states that the system consists of a "mobile console (engine)" and includes hardware components like a keyboard/touchpad and a display monitor. It also mentions various system accessories. This indicates it is a hardware-based ultrasound system with software control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic ultrasound imaging system" used for "ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance." This describes a device that uses physical principles (ultrasound waves) to create images and analyze flow within the body, not a device that analyzes samples outside the body.
- Indications for Use: The listed clinical applications and exam types are all related to imaging and procedures performed directly on or within the patient's body (e.g., Fetal, Abdominal, Cardiac, Trans-rectal).
- Device Description: The description details a "mobile, software-controlled diagnostic ultrasound system" with components like a console, display, and transducers. These are characteristic of an ultrasound machine, not an IVD.
- Input Imaging Modality: The input modality is "Ultrasound," which is a non-invasive imaging technique applied to the body.
- No mention of analyzing biological samples: There is no mention of collecting or analyzing biological samples such as blood, urine, tissue, etc., which is a core function of IVD devices.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic purposes. This ultrasound system operates by sending and receiving ultrasound waves to create images of internal structures and analyze physiological processes in vivo.
N/A
Intended Use / Indications for 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-cranial), 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.
Product codes (comma separated list FDA assigned to the subject device)
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 and anesthesiology applications.
All configurations run on the previously cleared SW platform and HW platform (engine) (K180737). 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). bkActiv is primarily intended for surgical and anesthesiology applications
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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-cranial), 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
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
December 7, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
BK Medical Aps % Sandra Theodoridis SR Regulatory Affairs Specialist Mileparken 34 Herlev. 2730 DENMARK
Re: K222441
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: October 28, 2022 Received: October 28, 2022
Dear Sandra Theodoridis:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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-cranial), 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.
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3
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4
Image /page/4/Picture/0 description: The image shows the alphanumeric string "K222441" in a bold, sans-serif font. The string is horizontally oriented and centered. The characters are uniformly sized and spaced, creating a clear and legible sequence.
Image /page/4/Picture/1 description: The image is the logo for BK Medical, a GE Healthcare company. The logo features the letters "bk" in a bold, green sans-serif font stacked on top of the word "medical" in a smaller, green sans-serif font. Below "medical" is the text "a GE Healthcare company" in a smaller, lighter font. To the right of the "bk" is a stylized green graphic that resembles sound waves or a signal emanating from a source.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Submitter: | BK Medical ApS
Mileparken 34
Herlev 2730
Denmark |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | BK Medical ApS
Mileparken 34
Herlev 2730
Denmark |
| Primary Contact Person: | Sandra Theodoridis
Senior Regulatory Affairs Specialist
BK Medical
Tel: (978) 578 9353
E-mail: stheodoridis@bkmedical.com |
| Date Prepared: | August 11, 2022 |
儿 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
lll. Identification of Predicate or Legally Marketed Devices:
- . Primary predicate device: Ultrasound Scanner System bk2300 as cleared under 510(k) premarket notification No K180737.
| 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 |
- Reference predicate device: GE Logiq E10 cleared under 510(k) premarket notification No ● K211488.
| Trade Name: | GE Logiq E10 |
|---|---|
| Common Name: | GE Logiq E10 |
| Classification Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN (primary), IYO, ITX (secondary) |
| Class: | II |
| Regulation Number: | 21 CFR §892.1550 |
| 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.
6
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 and anesthesiology applications.
All configurations run on the previously cleared SW platform and HW platform (engine) (K180737). 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). bkActiv is ● primarily intended for surgical and anesthesiology applications
| Catalog/
Reference
| (REF) | Model | Model Description |
|---|---|---|
| 2300 | 2300-01 | BK3000 ULTRASOUND SYSTEM W/O |
| BATTERY | ||
| This configuration is primarily | ||
| intended for Urology and General | ||
| imaging applications. | ||
| Catalog/ | ||
| Reference | ||
| (REF) | Model | Model Description |
| 2300 | BK3000 ULTRASOUND SYSTEM | |
| W/BATTERY | ||
| This configuration is primarily | ||
| intended for Urology and General | ||
| imaging applications. | ||
| 2300 | BK5000 ULTRASOUND SYSTEM W/O | |
| BATTERY | ||
| This configuration is primarily | ||
| intended for surgical applications. | ||
| 2300 | BK5000 ULTRASOUND SYSTEM | |
| W/BATTERY | ||
| This configuration is primarily | ||
| intended for surgical applications. | ||
| Catalog/ | ||
| Reference | ||
| (REF) | Model | Model Description |
| 2300 | 2300-56 | BKACTIV ULTRASOUND SYSTEM W/O |
| BATTERY | ||
| This configuration is primarily | ||
| intended for surgical and | ||
| anesthesiology applications. | ||
| 2300 | 2300-66 | BKACTIV ULTRASOUND SYSTEM W/ |
| BATTERY | ||
| This configuration is primarily | ||
| intended for surgical and | ||
| anesthesiology applications. |
Table 1: Ultrasound Scanner System bk2300 available configurations
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 | |
| 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 | |
| E14C4t (9018) TRIPLANE ENDOCAVITY TRANSDUCER | X | X | |
| X14CL4b (9048) BIPLANE ENDOCAVITY TRANSDUCER | X | X | |
| E10C4 (9019) ENDOCAVITY TRANSDUCER | X | X | |
| 20R3 (9052) ANORECTAL TRANSDUCER | X | X | |
| N13C5 (9062) CURVED ARRAY TRANSDUCER | X | X | X |
| 5P1 (9077) PHASED ARRAY TRANSDUCER | 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 |
| 112C5 (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 | |
| Rob12C4 (9096) ROBOTIC TRANSDUCER | X | X | X |
| N20P6 (9007) MINIMALLY INVASIVE TRANSDUCER | X | X | X |
| 113C3f (9076) | X | X | X |
| ADVANCED LAPAROSCOPIC TRANSDUCER | |||
| 113C3fx (9078) | X | ||
| ADVANCED LAPAROSCOPIC TRANSDUCER WITH TRACKING |
Table 2: Transducers used with Ultrasound System 2300 configurations
> 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:
The clinical applications and exam types include:
10
- 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
| | Ultrasound System 2300 | Ultrasound Scanner
System bk2300 | Ultrasound System LOGIQ
E10 | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Proposed device
(TBD) | Primary predicate
(K180737) | (Volume Navigation/GPS
tracking option)
Reference predicate | Comment on Comparison |
| | | | (K211488) | |
| Manufacturer | BK Medical ApS | BK Medical ApS | GE Healthcare | N/A |
| Common Name | Ultrasound system | Ultrasound system | Ultrasound system | Equivalent |
| Name | bk3000 (2300-01, 2300- | bk3000 (2300-01, 2300- | LOGIQ E10 | bkActiv 2300-56 & 66 are |
| (Configuration | 11) | 11) | | configurations of the cleared |
| models) | bk5000 (2300-51, 2300- | bk5000 (2300-51, 2300- | | system K180737 |
| | 61) | 61) | | |
| | bkActiv 2300-56, 2300-66 | | | |
| Mode of Operation | B, M, PW, CFM, P, THI, | B, M, PW, CFM, P, THI, | B, M, PW Doppler, CW | Identical - Primary predicate |
| | CI, SE, CW | CI, SE, CW | Doppler, Color Doppler, | Equivalent - reference |
| | | | Color M Doppler, Power | predicate. |
| | Combination modes : | Combination modes: | Doppler, Harmonic | |
| | 2D+M, 2D+PW, | 2D+M, 2D+PW, | Imaging, Coded Pulse, | |
| | 2D+C+PW, 2D+P+PW, | 2D+C+PW, 2D+P+PW, | 3D/4D Imaging mode, | |
| | 2D+2D, 2D+2D (Biplane | 2D+2D, 2D+2D (Biplane | Elastography, Shear Wave | |
| | Imaging), 2D+(2D+C), | Imaging), 2D+(2D+C), | Elastography (Attenuation | |
| | 2D+(2D+P), 2D+THI, | 2D+(2D+P), 2D+THI, | Imaging and Combined | |
| | 2D+SE, 2D+CI | 2D+SE, 2D+CI | modes: B/M, B/Color, B/ | |
| | | | PWD, B/Color/PWD, | |
| | | | B/Power/PWD) | |
| Intended Use | Intended Use: | Intended Use: | The LOGIQ E10 is a | Identical - Primary predicate |
| | The system is a diagnostic | The system is a diagnostic | general-purpose diagnostic | Equivalent - reference |
| | ultrasound imaging system | ultrasound imaging system | ultrasound system intended | predicate. |
| | used by qualified and | used by qualified and | for use by qualified and | |
| | trained healthcare | trained healthcare | trained healthcare | |
| | professionals for | professionals for | professionals for ultrasound | |
| | ultrasound imaging, human | ultrasound imaging, | imaging, measurement, | |
| | body fluid flow analysis | human body fluid flow | | |
| Characteristic | Ultrasound System 2300
Proposed device
(TBD) | Ultrasound Scanner
System bk2300
Primary predicate
(K180737) | Ultrasound System LOGIQ
E10
(Volume Navigation/GPS
tracking option)
Reference predicate
(K211488) | Comment on Comparison |
| | and puncture and biopsy | analysis and puncture and | display and analysis of the | |
| | guidance. | biopsy guidance. | human body and fluid. | |
| | Indications for Use:
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 | Indications for Use:
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) | Vascular) | | |
| Characteristic | Ultrasound System 2300
Proposed device
(TBD) | Ultrasound Scanner
System bk2300
Primary predicate
(K180737) | Ultrasound System LOGIQ
E10
(Volume Navigation/GPS
tracking option)
Reference predicate
(K211488) | Comment on Comparison |
| | 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. | 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. | | |
| | Ultrasound System 2300 | Ultrasound Scanner
System bk2300 | Ultrasound System LOGIQ
E10
(Volume Navigation/GPS
tracking option) | |
| Characteristic | Proposed device
(TBD) | Primary predicate
(K180737) | Reference predicate
(K211488) | Comment on Comparison |
| Indications/Clinical
Applications | - Abdominal
- Intraoperative
- Intraoperative – Neuro
(Neurosurgery) - Pediatrics
- Musculo-skeletal
- Superficial &
- Conventional
- Neonatal Cephalic
- Adult Cephalic
(Transcranial) - Laparoscopic
- Cardiac adult
- Transesophageal
(Cardiac) - Transrectal
- Transvaginal
- Fetal/Obstetrics
- Small Organs (Parts)
- Peripheral Vessel
(Vascular) | - Abdominal - Intraoperative
- Intraoperative – Neuro
(Neurosurgery) - Pediatrics
- Musculo-skeletal
- Superficial &
- Conventional
- Neonatal Cephalic
- Adult Cephalic
(Transcranial) - Laparoscopic
- Cardiac adult
- Transesophageal
(Cardiac) - Transrectal
- Transvaginal
- Fetal/Obstetrics
- Small Organs (Parts)
- Peripheral Vessel
(Vascular) | - Fetal/Obstetrics - Abdominal (incl. Renal,
Gynecology/ Pelvic) - Pediatric
- Small Organ (Breast,
Testes, Thyroid) - Neonatal Cephalic
- Adult Cephalic
- Cardiac (Adult and
Pediatric) - Peripheral Vascular
- Musculo-skeletal
(Conventional and
Superficial) - Urology (incl. Prostate)
- Transrectal
- Transvaginal
- Transesophageal
- Intraoperative
(Abdominal and
Vascular) | Identical - Primary predicate.
Equivalent – reference
predicate. |
| Application
Environment | Professional healthcare
facility environment | Professional healthcare
facility environment | Professional healthcare
facility environment | Identical |
| Users | Qualified and trained
healthcare professionals | Qualified and trained
healthcare professionals | Qualified and trained
healthcare professionals | Identical |
| Patient Population | Adult, Pediatric | Adult, Pediatric | Adult, Pediatric + embryo
and fetus | Identical - Primary predicate.
Equivalent – reference
predicate. |
| Transducer types | Surface Contact
Intra-operative
Laparoscopic
Endocavity | Surface Contact
Intra-operative
Laparoscopic
Endocavity | • Sector Phased Array
• Convex Array
• Micro convex Array
• Linear Array
• Matrix Array | Identical - Primary predicate.
Equivalent – reference
predicate - Reference does
not have Laparoscopic but
has Transesophageal |
| Characteristic | Ultrasound System 2300
Proposed device
(TBD) | Ultrasound Scanner
System bk2300
Primary predicate
(K180737) | Ultrasound System LOGIQ
E10
(Volume Navigation/GPS
tracking option)
Reference predicate
(K211488) | Comment on Comparison |
| | | | • Volume probe (4D)
• Split Crystal | |
| 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, 9009, 9011, 9015,
9016, 9018, 9019, 9022,
9023, 9024, 9026, 9027,
9029, 9032, 9038, 9040,
9048, 9051, 9052, 9062,
9063, 9066, 9070, 9076,
9077, 9081, 9085, | BE9CS-D, C1-6-D
Convex, C1-6VN-D
Convex, C2-6b-D, C2-7-D
Convex, C2-7VN-D
Convex, C2-9-D
Convex, C2-9VN-D
Convex, C3-10-D Convex,
IC5-9-D Micro Convex
Intracavitary, L2-9-D
Linear, L2-9VN-D
Linear, L3-9i-D, L3-12-D,
L6-24-D
Linear Array, L8-18i-D
Linear, M5Sc-D
XDclear Active
Matrix Single
Crystal
Phased Array
Transducer, ML4-20-D
Matrix Array
Linear, ML4-20VN-D
Matrix Array
Linear, ML6-15-D
Matrix Array
Linear, RIC5-9-D 4D
Convex Volume
Intracavitary, RAB6-D 4D
Volume, 6S-D, 6Tc-RS +
RS-DLP
Transesophageal, P2D | The release of 9078 is new
and part of this submission.
The GE (VN) probes have a
similar needle tracking sensor
technology in them to the
new 9078.
9007, 9034 and 9096 were
released as per FDA's
Guidance for Industry and
FDA Staff - Marketing
Clearance of Diagnostic
Ultrasound Systems and
Transducers, issued June 27,
2019; paragraph 5.1.3.3. |
| Characteristic | Ultrasound System 2300
Proposed device
(TBD) | Ultrasound Scanner
System bk2300
Primary predicate
(K180737) | Ultrasound System LOGIQ
E10
(Volume Navigation/GPS
tracking option)
Reference predicate
(K211488) | Comment on Comparison |
| Biocompatibility | The Ultrasound system
2300 does not come in
contact with the patient. | The Ultrasound system
2300 does not come in
contact with the patient. | The Ultrasound system
2300 does not come in
contact with the patient. | Identical |
| Hardware | Clinical display monitor
(CDM):
• 19" Optical bonded glass
front.
• Can be tilted and moved
sideways.
Cart:
• Adjustable height and
with 4 lockable wheels
Keyboard:
Traditional keyboard with
multiple functionalities /
specialized controls or
Glass touch UI
Scan engine:
• 4 Transducer ports
• 196 TX/RX channels
• Tracking Interface
board | Clinical display monitor
(CDM):
• 19" Optical bonded
glass front.
• Can be tilted and moved
sideways.
Cart:
• Adjustable height and
with 4 lockable wheels
Keyboard:
Traditional keyboard with
multiple functionalities /
specialized controls
Scan engine:
• 4 Transducer ports
• 196 TX/RX channels | Clinical display monitor
(CDM):
• HDU 23.8" Wide screen
High-Resolution LED
backlight Display
• OLED 22" Wide screen
High-Resolution LED
Display
• 12-inch LCD touch screen
• Color widescreen monitor
(OLED and HDU
monitors)
Keyboard:
Full-sized, backlit
alphanumeric keyboard
with multiple
functionalities/specialized
controls
Scan engine:
• 4 Active Probe Ports
• 2 Inactive Probe Storage
Ports | Additional Glass touch UI
and new Tracking Interface
board |
| Characteristic | Ultrasound System 2300
Proposed device
(TBD) | Ultrasound Scanner
System bk2300
Primary predicate
(K180737) | Ultrasound System LOGIQ
E10
(Volume Navigation/GPS
tracking option)
Reference predicate
(K211488) | Comment on Comparison |
| | | | • VNAV Tracking Unit
(installed as HW /option) | |
| Associated Needle
tracking accessories | • Tracking control unit
• Portable EM field
generator assembly
(includes field generator
and a mounting
solution)
• Clip-on needle sensor
(CIVCO)
• Needle sensor clamp kit
(CIVCO) | N/A | • Volume Navigation
(VNAV)Option includes:
- V Nav Probe Sensor
- Volume Navigation
Stand - Virtual Tracker
Sensor | Equivalent needle tracking
HW accessories between the
proposed device and LOGIQ
E10 |
| Options | • 3D Freehand
• 3D Professional
• DICOM Encrypted
• Contrast Enhanced
Ultrasound
• Vector Flow Imaging
(VFI)
• Varian Interface
• Strain Elastography
• Needle Enhancement
(X-shine)
• BrainLab Neuro
Navigation
• bkfusion (for Urology
Procedures)
• Wi-Fi
• bkViewer (SW running
on a MAC/Windows
PC- not a medical
device) | • 3D Freehand
• 3D Professional
• DICOM Encrypted
• Contrast Enhanced
Ultrasound
• Vector Flow Imaging
(VFI)
• Varian Interface
• Strain Elastography
• Needle Enhancement
(X-shine)
• BrainLab Neuro
Navigation
• bkfusion (for Urology
Procedures)
• Wi-Fi | • Volume Navigation | Electromagnetic needle
tracking is being offered on
the proposed device as the
'LAP Ablation Navigation'
option.
The Logiq E10 includes this
feature as 'Volume
Navigation' option. |
| Characteristic | Ultrasound System 2300
Proposed device (TBD) | Ultrasound Scanner System bk2300
Primary predicate (K180737) | Ultrasound System LOGIQ E10
(Volume Navigation/GPS tracking option)
Reference predicate (K211488) | Comment on Comparison |
| - LAP Ablation
Navigation | | | | |
Table 3: Substantial Equivalence Table of the proposed device with its predicate devices
12
13
14
15
16
17
18
19
VII. Performance Data
Summary of non-clinical /Performance - Bench Testing
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Ultrasound System 2300 and its applications comply with the following voluntary 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
20
- Requirements Reviews
- Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- Performance testing (Verification)
- · Safety testing (Verification)
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).