Ultrasound System 2300
Device Facts
| Record ID | K223830 |
|---|---|
| Device Name | Ultrasound System 2300 |
| Applicant | Bk Medical Aps |
| Product Code | IYN · Radiology |
| Decision Date | Apr 11, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | AI/ML, Pediatric |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Prostate volume measurement | Deep learning segmentation and caliper placement | Prostate volume estimate deviates no more than 22% on average | 9018 transducer: 11% +/- 6%; 9048 transducer: 7% +/- 15% | Training: 505 healthy, 13447 diseased, 4104 synthesized; Validation: 190 healthy, 1189 diseased, 48 synthesized | — | Clinical validation: 975 healthy, 1461 diseased images | >1 (clinical personnel) |
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.
Device Story
Ultrasound System 2300 is a mobile, software-controlled diagnostic ultrasound system for urology, general imaging, surgical, and anesthesiology applications. It acquires, processes, and displays ultrasound signals via various transducers (linear, phased, convex, endocavity). The system features a 19-inch clinical display monitor and user interface (keyboard or glass touchpad). It includes the Prostate Volume Assist (PVA) feature, an AI-based tool that automatically segments the prostate and places calipers to calculate volume, improving workflow efficiency compared to manual caliper placement. The device is used in professional healthcare environments (hospitals, clinics) by trained healthcare professionals. Output is visualized on the monitor to guide clinical decision-making, such as puncture and biopsy procedures. Benefits include enhanced diagnostic imaging and streamlined biopsy workflows.
Clinical Evidence
No clinical studies were performed. Evidence consists of bench testing and performance verification of the Prostate Volume Assist (PVA) feature. PVA validation used 1,480 healthy and 16,097 diseased images (training/validation/test sets). Accuracy was assessed by comparing automated caliper placement to manual placement by experts (approx. 15 years experience). Results showed volume estimate deviations of 11% ± 6% (9018 transducer) and 7% ± 15% (9048 transducer), meeting the acceptance criterion of <22% average deviation.
Technological Characteristics
Mobile ultrasound console with 19-inch optical bonded glass display. Supports multiple transducers (linear, phased, convex, endocavity). Connectivity includes DICOM. Software runs on Windows 10. Features include B-mode, M-mode, PWD, CFM, Power Doppler, Contrast Imaging, CW Doppler, and Strain Elastography. AI-based Prostate Volume Assist (PVA) uses deep learning for segmentation and caliper placement. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, and ISO 10993-1.
Indications for Use
Indicated for fetal (obstetrics), abdominal, pediatric, intra-operative, intra-operative neuro (neurosurgery), laparoscopic, small organ (small parts), adult cephalic (trans-cranial), neonatal cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac adult, trans-esophageal (cardiac), and peripheral vessel (vascular) applications. Contraindicated for ophthalmic use or any use causing the acoustic beam to pass through the eye. Cardiac adult application is not intended for direct use on the heart.
Regulatory Classification
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.
Predicate Devices
- Ultrasound System 2300 (K222441)
Submission Summary (Full Text)
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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
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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
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# 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.
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K223830
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | BK Medical ApS<br>Mileparken 34<br>Herlev 2730<br>Denmark |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | BK Medical ApS<br>Mileparken 34<br>Herlev 2730<br>Denmark |
| Primary Contact Person: | Inesa Cernajute<br>Senior Regulatory Affairs Specialist<br>BK Medical<br>Tel: +45 42277733<br>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 |
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#### 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:
- 1. bk3000 available with a conventional keyboard configuration. The bk3000 is primarily intended for applications such as urology and general imaging
- 2. bk5000 available with a conventional keyboard configuration. The bk5000 is primarily intended for surgery applications.
- 3. bkActiv is a configuration available with a glass user interface (UI). bkActiv is primarily intended for surgical, anesthesiology, urology and general imaging applications.
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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/<br>Reference<br>(REF) | Model | Model Description |
|--------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2300 | Image: BK3000 Ultrasound System w/o Battery | BK3000 ULTRASOUND SYSTEM W/O<br>BATTERY<br>This configuration is primarily<br>intended for Urology and General<br>imaging applications. |
| 2300 | Image: BK3000 Ultrasound System w/ Battery | BK3000 ULTRASOUND SYSTEM<br>W/BATTERY<br>This configuration is primarily<br>intended for Urology and General<br>imaging applications. |
| Catalog/<br>Reference<br>(REF) | Model | Model Description |
| 2300 | 2300-51<br>Image: Ultrasound system model 2300-51 | BK5000 ULTRASOUND SYSTEM W/O<br>BATTERY<br><br>This configuration is primarily<br>intended for surgical applications. |
| 2300 | 2300-61<br>Image: Ultrasound system model 2300-61 | BK5000 ULTRASOUND SYSTEM<br>W/BATTERY<br><br>This configuration is primarily<br>intended for surgical applications. |
| 2300 | 2300-56<br>Image: Ultrasound system model 2300-56 | BKACTIV ULTRASOUND SYSTEM W/O<br>BATTERY<br><br>This configuration is primarily<br>intended for surgical,<br>anesthesiology, urology and<br>general imaging applications. |
| Catalog/<br>Reference<br>(REF) | Model | Model Description |
| 2300 | 2300-66<br>Image: Ultrasound system | BKACTIV ULTRASOUND SYSTEM W/ BATTERY<br><br>This configuration is primarily intended for surgical, anesthesiology, urology and general imaging applications. |
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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 .
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| 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:
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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.
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#### 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<br>(K223830) | Predicate<br>device | Comment on<br>Comparison |
| Manufacturer | BK Medical ApS | BK Medical ApS | Same |
| Common Name | Ultrasound System | Ultrasound System | Same |
| Name<br>(Configuration models) | bk3000 (2300-01, 2300-11)<br>bk5000 (2300-51, 2300-61)<br>bkActiv (2300-56, 2300-66) | bk3000 (2300-01, 2300-11)<br>bk5000 (2300-51, 2300-61)<br>bkActiv (2300-56, 2300-66) | Same |
| Mode of Operation | B, M, PW, CFM, P, THI, CI, SE, CW<br>Combination modes:<br>2D+M, 2D+PW, 2D+C+PW,<br>2D+P+PW, 2D+2D, 2D+2D<br>(Biplane Imaging), 2D+(2D+C),<br>2D+(2D+P), 2D+THI, 2D+SE,<br>2D+CI | B, M, PW, CFM, P, THI, CI, SE, CW<br>Combination modes:<br>2D+M, 2D+PW, 2D+C+PW,<br>2D+P+PW, 2D+2D, 2D+2D<br>(Biplane Imaging), 2D+(2D+C),<br>2D+(2D+P), 2D+THI, 2D+SE,<br>2D+CI | Same |
| Intended Use | Intended Use:<br>The system is a diagnostic ultrasound<br>imaging system used by qualified<br>and trained healthcare professionals<br>for ultrasound imaging, human body<br>fluid flow analysis and puncture and<br>biopsy guidance.<br>Indications for Use:<br>The clinical applications and exam<br>types include:<br>· Fetal (including obstetrics)<br>· Abdominal<br>· Pediatric<br>· Intra-operative | Intended Use:<br>The system is a diagnostic ultrasound<br>imaging system used by qualified<br>and trained healthcare professionals<br>for ultrasound imaging, human body<br>fluid flow analysis and puncture and<br>biopsy guidance.<br>Indications for Use:<br>The clinical applications and exam<br>types include:<br>· Fetal (including obstetrics)<br>· Abdominal<br>• Pediatric<br>· Intra-operative | Summary of changes / comparison with<br>predicate device<br>Due to the new software upgrade v.<br>currently cleared clinical applications<br>Cardiac Adult,<br>Fetal (including obstetrics),<br>Trans-rectal,<br>Trans-vaginal,<br>Small Organ and<br>Peripheral vessel<br>with transducers (9077, 9048, 9038,<br>9052, 9018, 9019, 9029, 9027 and<br>9032) previously activated on bk5000 |
| Characteristic | Ultrasound System 2300<br>Proposed device<br>(K223830) | Ultrasound System 2300<br>Predicate device | Comment on<br>Comparison |
| | • Intra-operative Neuro (also<br>known as Neurosurgery) | • Intra-operative Neuro (also<br>known as Neurosurgery) | / bk3000 configurations will now also<br>be enabled on bkActiv configuration. |
| | • Laparoscopic | • Laparoscopic | |
| | • Small Organ (also known as<br>Small Parts) | • Small Organ (also known as<br>Small Parts) | |
| | • Adult Cephalic (Cephalic is<br>also known as Adult Trans-<br>cranial) | • Adult Cephalic (Cephalic is<br>also known as Adult Trans-<br>cranial) | |
| | • Neonatal Cephalic | • Neonatal Cephalic | |
| | • Trans-rectal | • Trans-rectal | |
| | • Trans-vaginal | • Trans-vaginal | |
| | • Musculo-skeletal (Conventional<br>and Superficial) | • Musculo-skeletal (Conventional<br>and Superficial) | |
| | • Cardiac Adult | • Cardiac Adult | |
| | • Trans-esophageal (Cardiac) | • Trans-esophageal (Cardiac) | |
| | • Peripheral vessel (also known<br>as Peripheral Vascular) | • Peripheral vessel (also known<br>as Peripheral Vascular) | |
| | Modes of operation: | Modes of operation: | |
| | • 2 D (B-Mode) including<br>Tissue Harmonic Imaging | • 2 D (B-Mode) including<br>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<br>• CW Doppler | • Contrast Imaging<br>• CW Doppler | |
| | • Strain Elastography | • Strain Elastography | |
| | | | |
| | Environment: | Environment: | |
| | The Ultrasound System 2300 is<br>intended for use in the<br>professional healthcare<br>environment (e.g., hospitals,<br>physician offices). | The Ultrasound System 2300 is<br>intended for use in the<br>professional healthcare<br>environment (e.g., hospitals,<br>physician offices). | |
| | | | |
| | Ultrasound System 2300 | Ultrasound System 2300 | |
| Characteristic | Proposed device<br>(K223830) | Predicate<br>device | Comment on<br>Comparison |
| | Contraindications<br>The Ultrasound System 2300 is not<br>intended for ophthalmic use or any use<br>causing the acoustic beam to pass<br>through the eye.<br>The Cardiac Adult application is not<br>intended for direct use on the heart. | Contraindications<br>The Ultrasound System 2300 is not<br>intended for ophthalmic use or any use<br>causing the acoustic beam to pass<br>through the eye.<br>The Cardiac Adult application is not<br>intended for direct use on the heart. | |
| Indications/Clinical<br>Applications | ● Abdominal<br>● Intraoperative<br>● Intraoperative –<br>Neuro<br>(Neurosurgery)<br>● Pediatric<br>● Musculo-skeletal<br>Superficial &<br>Conventional<br>● Neonatal Cephalic<br>● Adult Cephalic (Trans-cranial)<br>● Laparoscopic<br>● Small Organ (Small Parts)<br>● Cardiac adult<br>● Transesophageal (Cardiac)<br>● Transrectal<br>● Transvaginal<br>● Fetal /Obstetrics<br>● Peripheral Vessel (Vascular) | ● Abdominal<br>● Intraoperative<br>● Intraoperative –<br>Neuro<br>(Neurosurgery)<br>● Pediatric<br>● Musculo-skeletal<br>Superficial &<br>Conventional<br>● Neonatal Cephalic<br>● Adult Cephalic (Trans-cranial)<br>● Laparoscopic<br>● Small Organ (Small Parts)<br>● Cardiac adult<br>● Transesophageal (Cardiac)<br>● Transrectal<br>● Transvaginal<br>● Fetal /Obstetrics<br>● Peripheral Vessel (Vascular) | Same |
| | | | |
| Characteristic | Ultrasound System 2300<br>Proposed device<br>(K223830) | Ultrasound System 2300<br>Predicate device<br>(K222441) | Comment on<br>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<br>Intra-operative<br>Laparoscopic<br>Endocavity | Surface Contact<br>Intra-operative<br>Laparoscopic<br>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<br>in contact with the patient. | The Ultrasound System does not come<br>in contact with the patient. | Same |
| Hardware | Clinical display monitor (CDM):<br>• 19" Optical bonded glass front.<br>• Can be tilted and moved sideways. | Clinical display monitor (CDM):<br>• 19" Optical bonded glass front.<br>• Can be tilted and moved sideways. | Same<br>No changes to hardware since last<br>clearance K222441. |
| | Cart:<br>• adjustable height and with 4<br>lockable wheels | Cart:<br>• adjustable height and with 4<br>lockable wheels | |
| | Keyboard:<br>Traditional keyboard with multiple<br>functionalities / specialized controls<br>or Glass touch UI | Keyboard:<br>Traditional keyboard with multiple<br>functionalities / specialized controls<br>or Glass touch UI | |
| | Scan engine:<br>• 4 Transducer ports<br>• 196 TX/RX channels<br>• Tracking Interface board | Scan engine:<br>• 4 Transducer ports<br>• 196 TX/RX channels<br>• Tracking Interface board | |
| OS Software | Windows 10…
