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.

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
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 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.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) summary for an ultrasound system, focusing on its substantial equivalence to a predicate device.

Specifically, the "Performance Data" section (page 19-20) only mentions non-clinical performance (bench testing) related to safety and compliance with voluntary standards (e.g., acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety). It explicitly states:

"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."

Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, as no such study is described in this document.

Summary

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222441

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.

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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 ApSMileparken 34Herlev 2730Denmark
Manufacturer:	BK Medical ApSMileparken 34Herlev 2730Denmark
Primary Contact Person:	Sandra TheodoridisSenior Regulatory Affairs SpecialistBK MedicalTel: (978) 578 9353E-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

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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

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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 and anesthesiology applications.

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/OBATTERYThis configuration is primarilyintended for Urology and Generalimaging applications.
Catalog/Reference(REF)	Model	Model Description
2300		BK3000 ULTRASOUND SYSTEMW/BATTERYThis configuration is primarilyintended for Urology and Generalimaging applications.
2300		BK5000 ULTRASOUND SYSTEM W/OBATTERYThis configuration is primarilyintended for surgical applications.
2300		BK5000 ULTRASOUND SYSTEMW/BATTERYThis configuration is primarilyintended for surgical applications.
Catalog/Reference(REF)	Model	Model Description
2300	2300-56	BKACTIV ULTRASOUND SYSTEM W/OBATTERYThis configuration is primarilyintended for surgical andanesthesiology applications.
2300	2300-66	BKACTIV ULTRASOUND SYSTEM W/BATTERYThis configuration is primarilyintended for surgical andanesthesiology applications.

Table 1: Ultrasound Scanner System bk2300 available configurations

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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
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:

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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

	Ultrasound System 2300	Ultrasound ScannerSystem bk2300	Ultrasound System LOGIQE10
Characteristic	Proposed device(TBD)	Primary predicate(K180737)	(Volume Navigation/GPStracking 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 2300Proposed device(TBD)	Ultrasound ScannerSystem bk2300Primary predicate(K180737)	Ultrasound System LOGIQE10(Volume Navigation/GPStracking 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 applicationsand exam types include:• Fetal (includingobstetrics)• Abdominal• Pediatric• Intra-operative• Intra-operative Neuro(also known asNeurosurgery)• Laparoscopic• Small Organ (also knownas Small Parts)• Adult Cephalic (Cephalicis also known as AdultTrans-cranial)• Neonatal Cephalic• Trans-rectal• Trans-vaginal• Musculo-skeletal(Conventional andSuperficial)• Cardiac Adult• Trans-esophageal(Cardiac)• Peripheral vessel (alsoknown as Peripheral	Indications for Use:The clinical applicationsand exam types include:• Fetal (includingobstetrics)• Abdominal• Pediatric• Intra-operative• Intra-operative Neuro(also known asNeurosurgery)• Laparoscopic• Small Organ (alsoknown as Small Parts)• Adult Cephalic(Cephalic is also knownas Adult Trans-cranial)• Neonatal Cephalic• Trans-rectal• Trans-vaginal• Musculo-skeletal(Conventional andSuperficial)• Cardiac Adult• Trans-esophageal(Cardiac)• Peripheral vessel (alsoknown as Peripheral
	Vascular)	Vascular)
Characteristic	Ultrasound System 2300Proposed device(TBD)	Ultrasound ScannerSystem bk2300Primary predicate(K180737)	Ultrasound System LOGIQE10(Volume Navigation/GPStracking option)Reference predicate(K211488)	Comment on Comparison
	Modes of operation:• 2D (B-Mode) includingTissue HarmonicImaging• M-Mode• PWD Mode• CFM Mode (C, VFI)• Power Doppler• Contrast Imaging• CW Doppler• Strain ElastographyEnvironment:The Ultrasound System2300 is intended for use inthe professional healthcareenvironment (e.g.,hospitals, physicianoffices).ContraindicationsThe Ultrasound System2300 is not intended forophthalmic use or any usecausing the acoustic beamto pass through the eye.The Cardiac Adultapplication is not intendedfor direct use on the heart.	Modes of operation:• 2D (B-Mode) includingTissue HarmonicImaging• M-Mode• PWD Mode• CFM Mode (C, VFI)• Power Doppler• Contrast Imaging• CW Doppler• Strain ElastographyEnvironment:The Ultrasound System2300 is intended for use inthe professional healthcareenvironment (e.g.,hospitals, physicianoffices).ContraindicationsThe Ultrasound System2300 is not intended forophthalmic use or any usecausing the acoustic beamto pass through the eye.The Cardiac Adultapplication is not intendedfor direct use on the heart.
	Ultrasound System 2300	Ultrasound ScannerSystem bk2300	Ultrasound System LOGIQE10(Volume Navigation/GPStracking option)
Characteristic	Proposed device(TBD)	Primary predicate(K180737)	Reference predicate(K211488)	Comment on Comparison
Indications/ClinicalApplications	- 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 andPediatric)- Peripheral Vascular- Musculo-skeletal(Conventional andSuperficial)- Urology (incl. Prostate)- Transrectal- Transvaginal- Transesophageal- Intraoperative(Abdominal andVascular)	Identical - Primary predicate.Equivalent – referencepredicate.
ApplicationEnvironment	Professional healthcarefacility environment	Professional healthcarefacility environment	Professional healthcarefacility environment	Identical
Users	Qualified and trainedhealthcare professionals	Qualified and trainedhealthcare professionals	Qualified and trainedhealthcare professionals	Identical
Patient Population	Adult, Pediatric	Adult, Pediatric	Adult, Pediatric + embryoand fetus	Identical - Primary predicate.Equivalent – referencepredicate.
Transducer types	Surface ContactIntra-operativeLaparoscopicEndocavity	Surface ContactIntra-operativeLaparoscopicEndocavity	• Sector Phased Array• Convex Array• Micro convex Array• Linear Array• Matrix Array	Identical - Primary predicate.Equivalent – referencepredicate - Reference doesnot have Laparoscopic buthas Transesophageal
Characteristic	Ultrasound System 2300Proposed device(TBD)	Ultrasound ScannerSystem bk2300Primary predicate(K180737)	Ultrasound System LOGIQE10(Volume Navigation/GPStracking 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-DConvex, C1-6VN-DConvex, C2-6b-D, C2-7-DConvex, C2-7VN-DConvex, C2-9-DConvex, C2-9VN-DConvex, C3-10-D Convex,IC5-9-D Micro ConvexIntracavitary, L2-9-DLinear, L2-9VN-DLinear, L3-9i-D, L3-12-D,L6-24-DLinear Array, L8-18i-DLinear, M5Sc-DXDclear ActiveMatrix SingleCrystalPhased ArrayTransducer, ML4-20-DMatrix ArrayLinear, ML4-20VN-DMatrix ArrayLinear, ML6-15-DMatrix ArrayLinear, RIC5-9-D 4DConvex VolumeIntracavitary, RAB6-D 4DVolume, 6S-D, 6Tc-RS +RS-DLPTransesophageal, P2D	The release of 9078 is newand part of this submission.The GE (VN) probes have asimilar needle tracking sensortechnology in them to thenew 9078.9007, 9034 and 9096 werereleased as per FDA'sGuidance for Industry andFDA Staff - MarketingClearance of DiagnosticUltrasound Systems andTransducers, issued June 27,2019; paragraph 5.1.3.3.
Characteristic	Ultrasound System 2300Proposed device(TBD)	Ultrasound ScannerSystem bk2300Primary predicate(K180737)	Ultrasound System LOGIQE10(Volume Navigation/GPStracking option)Reference predicate(K211488)	Comment on Comparison
Biocompatibility	The Ultrasound system2300 does not come incontact with the patient.	The Ultrasound system2300 does not come incontact with the patient.	The Ultrasound system2300 does not come incontact with the patient.	Identical
Hardware	Clinical display monitor(CDM):• 19" Optical bonded glassfront.• Can be tilted and movedsideways.Cart:• Adjustable height andwith 4 lockable wheelsKeyboard:Traditional keyboard withmultiple functionalities /specialized controls orGlass touch UIScan engine:• 4 Transducer ports• 196 TX/RX channels• Tracking Interfaceboard	Clinical display monitor(CDM):• 19" Optical bondedglass front.• Can be tilted and movedsideways.Cart:• Adjustable height andwith 4 lockable wheelsKeyboard:Traditional keyboard withmultiple functionalities /specialized controlsScan engine:• 4 Transducer ports• 196 TX/RX channels	Clinical display monitor(CDM):• HDU 23.8" Wide screenHigh-Resolution LEDbacklight Display• OLED 22" Wide screenHigh-Resolution LEDDisplay• 12-inch LCD touch screen• Color widescreen monitor(OLED and HDUmonitors)Keyboard:Full-sized, backlitalphanumeric keyboardwith multiplefunctionalities/specializedcontrolsScan engine:• 4 Active Probe Ports• 2 Inactive Probe StoragePorts	Additional Glass touch UIand new Tracking Interfaceboard
Characteristic	Ultrasound System 2300Proposed device(TBD)	Ultrasound ScannerSystem bk2300Primary predicate(K180737)	Ultrasound System LOGIQE10(Volume Navigation/GPStracking option)Reference predicate(K211488)	Comment on Comparison
			• VNAV Tracking Unit(installed as HW /option)
Associated Needletracking accessories	• Tracking control unit• Portable EM fieldgenerator assembly(includes field generatorand a mountingsolution)• Clip-on needle sensor(CIVCO)• Needle sensor clamp kit(CIVCO)	N/A	• Volume Navigation(VNAV)Option includes:- V Nav Probe Sensor- Volume NavigationStand- Virtual TrackerSensor	Equivalent needle trackingHW accessories between theproposed device and LOGIQE10
Options	• 3D Freehand• 3D Professional• DICOM Encrypted• Contrast EnhancedUltrasound• Vector Flow Imaging(VFI)• Varian Interface• Strain Elastography• Needle Enhancement(X-shine)• BrainLab NeuroNavigation• bkfusion (for UrologyProcedures)• Wi-Fi• bkViewer (SW runningon a MAC/WindowsPC- not a medicaldevice)	• 3D Freehand• 3D Professional• DICOM Encrypted• Contrast EnhancedUltrasound• Vector Flow Imaging(VFI)• Varian Interface• Strain Elastography• Needle Enhancement(X-shine)• BrainLab NeuroNavigation• bkfusion (for UrologyProcedures)• Wi-Fi	• Volume Navigation	Electromagnetic needletracking is being offered onthe proposed device as the'LAP Ablation Navigation'option.The Logiq E10 includes thisfeature as 'VolumeNavigation' option.
Characteristic	Ultrasound System 2300Proposed device (TBD)	Ultrasound Scanner System bk2300Primary predicate (K180737)	Ultrasound System LOGIQ E10(Volume Navigation/GPS tracking option)Reference predicate (K211488)	Comment on Comparison
- LAP AblationNavigation

Table 3: Substantial Equivalence Table of the proposed device with its predicate devices

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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

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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).

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.