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).

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Prostate Volume Assist (PVA) feature, as derived from the provided document:

Acceptance Criteria and Device Performance (Prostate Volume Assist - PVA)

Acceptance Criteria	Reported Device Performance
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.	For the 9018 transducer: Deviates 11% +/- 6% compared to volume calculation using manual placement (within acceptance criteria).For the 9048 transducer: Deviates 7% +/- 15% compared to volume calculation using manual placement (within acceptance criteria).

Study Details for Prostate Volume Assist (PVA)

Sample size used for the test set and the data provenance:
- Test Images Total: 975 (Healthy) + 1461 (Diseased) = 2436 images.
- Data Provenance:
  - Czech Republic (for 9018 transducer data)
  - Amsterdam, Holland (for 9048 transducer data)
- Retrospective/Prospective: Not explicitly stated, but the description "Data from a clinical end-user test in the Czech Republic" and "data acquired in Amsterdam, Holland" suggests retrospective use of collected data for the test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified as a precise number (e.g., "3 experts"). It states "clinical experts validation testing" and "The human caliper setters scored the images individually."
- Qualifications of Experts: "The clinical personnel had an average of about 15 years' experience in ultrasound."
Adjudication method for the test set:
- The document implies individual scoring by "human caliper setters" rather than an explicit adjudication method like 2+1 or 3+1. "The human caliper setters scored the images individually." The comparison is then made against these individual manual placements.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving human readers improving with AI assistance was directly described. The study focused on validating the algorithm's performance against manual placement, indicating a standalone performance assessment of the AI. The PVA feature is described as "a workflow improvement to an existing prostate volume measurement and calculation tool" and "allows a faster and more efficient workflow," but specific effect sizes for human reader improvement with AI assistance (e.g., reduction in reading time, increase in accuracy) are not provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment of the algorithm was done. The acceptance criteria and reported device performance directly evaluate "the automatic initial caliper placement" and "the prostate volume calculation of PVA" against manual placement, implying the algorithm's performance without human input for the initial placement. The final verification involved visual evaluation by clinical experts comparing the initial algorithmic placement to manual placement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Manual Measurement: The ground truth for volume estimation was established by "manually placed calipers" by "clinical personnel" with extensive experience.
The sample size for the training set:
- Training Images Total: 505 (Healthy) + 13447 (Diseased) + 4104 (Synthesized data) = 18056 images.
How the ground truth for the training set was established:
- The document does not explicitly detail the method for establishing ground truth for the training set. It only mentions the types of images (healthy, diseased, synthesized) used for training. However, given that the validation uses expert manual measurements as ground truth, it is highly probable that the training data also utilized expert annotations or measurements, potentially with additional synthesized data to augment the dataset.

Summary

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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 ApSMileparken 34Herlev 2730Denmark
Manufacturer:	BK Medical ApSMileparken 34Herlev 2730Denmark
Primary Contact Person:	Inesa CernajuteSenior Regulatory Affairs SpecialistBK MedicalTel: +45 42277733E-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 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
1. bk5000 available with a conventional keyboard configuration. The bk5000 is primarily intended for surgery applications.
1. 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/Reference(REF)	Model	Model Description
2300	Image: BK3000 Ultrasound System w/o Battery	BK3000 ULTRASOUND SYSTEM W/OBATTERYThis configuration is primarilyintended for Urology and Generalimaging applications.
2300	Image: BK3000 Ultrasound System w/ Battery	BK3000 ULTRASOUND SYSTEMW/BATTERYThis configuration is primarilyintended for Urology and Generalimaging applications.
Catalog/Reference(REF)	Model	Model Description
2300	2300-51Image: Ultrasound system model 2300-51	BK5000 ULTRASOUND SYSTEM W/OBATTERYThis configuration is primarilyintended for surgical applications.
2300	2300-61Image: Ultrasound system model 2300-61	BK5000 ULTRASOUND SYSTEMW/BATTERYThis configuration is primarilyintended for surgical applications.
2300	2300-56Image: Ultrasound system model 2300-56	BKACTIV ULTRASOUND SYSTEM W/OBATTERYThis configuration is primarilyintended for surgical,anesthesiology, urology andgeneral imaging applications.
Catalog/Reference(REF)	Model	Model Description
2300	2300-66Image: Ultrasound system	BKACTIV ULTRASOUND SYSTEM W/ BATTERYThis 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(K223830)	Predicatedevice	Comment onComparison
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, CWCombination 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, CWCombination 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 ultrasoundimaging system used by qualifiedand trained healthcare professionalsfor ultrasound imaging, human bodyfluid flow analysis and puncture andbiopsy guidance.Indications for Use:The clinical applications and examtypes include:· Fetal (including obstetrics)· Abdominal· Pediatric· Intra-operative	Intended Use:The system is a diagnostic ultrasoundimaging system used by qualifiedand trained healthcare professionalsfor ultrasound imaging, human bodyfluid flow analysis and puncture andbiopsy guidance.Indications for Use:The clinical applications and examtypes include:· Fetal (including obstetrics)· Abdominal• Pediatric· Intra-operative	Summary of changes / comparison withpredicate deviceDue to the new software upgrade v.currently cleared clinical applicationsCardiac Adult,Fetal (including obstetrics),Trans-rectal,Trans-vaginal,Small Organ andPeripheral vesselwith transducers (9077, 9048, 9038,9052, 9018, 9019, 9029, 9027 and9032) previously activated on bk5000
Characteristic	Ultrasound System 2300Proposed device(K223830)	Ultrasound System 2300Predicate device	Comment onComparison
	• Intra-operative Neuro (alsoknown as Neurosurgery)	• Intra-operative Neuro (alsoknown as Neurosurgery)	/ bk3000 configurations will now alsobe enabled on bkActiv configuration.
	• Laparoscopic	• Laparoscopic
	• Small Organ (also known asSmall Parts)	• Small Organ (also known asSmall Parts)
	• Adult Cephalic (Cephalic isalso known as Adult Trans-cranial)	• Adult Cephalic (Cephalic isalso known as Adult Trans-cranial)
	• Neonatal Cephalic	• Neonatal Cephalic
	• Trans-rectal	• Trans-rectal
	• Trans-vaginal	• Trans-vaginal
	• Musculo-skeletal (Conventionaland Superficial)	• Musculo-skeletal (Conventionaland Superficial)
	• Cardiac Adult	• Cardiac Adult
	• Trans-esophageal (Cardiac)	• Trans-esophageal (Cardiac)
	• Peripheral vessel (also knownas Peripheral Vascular)	• Peripheral vessel (also knownas Peripheral Vascular)
	Modes of operation:	Modes of operation:
	• 2 D (B-Mode) includingTissue Harmonic Imaging	• 2 D (B-Mode) includingTissue 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 isintended for use in theprofessional healthcareenvironment (e.g., hospitals,physician offices).	The Ultrasound System 2300 isintended for use in theprofessional healthcareenvironment (e.g., hospitals,physician offices).

	Ultrasound System 2300	Ultrasound System 2300
Characteristic	Proposed device(K223830)	Predicatedevice	Comment onComparison
	ContraindicationsThe Ultrasound System 2300 is notintended for ophthalmic use or any usecausing the acoustic beam to passthrough the eye.The Cardiac Adult application is notintended for direct use on the heart.	ContraindicationsThe Ultrasound System 2300 is notintended for ophthalmic use or any usecausing the acoustic beam to passthrough the eye.The Cardiac Adult application is notintended for direct use on the heart.
Indications/ClinicalApplications	● Abdominal● Intraoperative● Intraoperative –Neuro(Neurosurgery)● Pediatric● Musculo-skeletalSuperficial &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-skeletalSuperficial &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 2300Proposed device(K223830)	Ultrasound System 2300Predicate device(K222441)	Comment onComparison
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 ContactIntra-operativeLaparoscopicEndocavity	Surface ContactIntra-operativeLaparoscopicEndocavity	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 comein contact with the patient.	The Ultrasound System does not comein 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.	SameNo changes to hardware since lastclearance K222441.
	Cart:• adjustable height and with 4lockable wheels	Cart:• adjustable height and with 4lockable wheels
	Keyboard:Traditional keyboard with multiplefunctionalities / specialized controlsor Glass touch UI	Keyboard:Traditional keyboard with multiplefunctionalities / specialized controlsor 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 Needletracking accessories	UA1540 Tracking ControlUnitUA1541 Portable EM FieldGenerator (includesfieldgenerator and amounting solution)UA1542 Clip-on needlesensor(CIVCO)UA1543 Needle senor clampKit (CIVCO)	UA1540 Tracking ControlUnitUA1541 Portable EM FieldGenerator (includesfieldgenerator and amounting solution)UA1542 Clip-on needlesensor(CIVCO)UA1543 Needle senor clampKit (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 onComparison
Image features	Speckle reduction, compoundimaging, tissue harmonic imaging(thi), contrast imaging (ci), trapezoidscanning (virtual convex) strain,elastography (se)	Speckle reduction, compoundimaging, tissue harmonic imaging(thi), contrast imaging (ci), trapezoidscanning (virtual convex) strain,elastography (se)	Same
UI Design	-19-inch Clinical Monitor and touchinput devicefor 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 touchinput devicefor 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)

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· 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	TrainingImages	DeepLearningValidationimages	Testimages(Clinicalvalidation)	Comment
Healthy	505	190	975
Diseased	13447	1189	1461	Part of the test imagescome from the Hollanddataset, which onlycontributed 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

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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).

Regulation Number and Section

§ 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.