Ultrasound Scanner System bk2300

• K Number: K143298
• Device Name: Ultrasound Scanner System bk2300
• Manufacturer: BK MEDICAL APS
• Date Cleared: 2015-01-16 ( 60 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Applications: - Fetal (Sometimes called Obstetrics) . - Abdominal ● - Intra-operative ● - Intra-operative (Neuro) (sometimes called Neuro Surgical) ● - Pediatrics . - Small Organ (Sometimes called Small Parts) . - . Neonatal Cephalic (Cephalic is sometimes called trans-cranial) - Adult Cephalic (Cephalic is sometimes called trans-cranial) ● - Trans-rectal - . Trans-vaqinal - . Trans-urethral - Musculo-skeletal (Conventional) - Musculo-skeletal (Superficial) - Cardiac Adult - Peripheral Vessel (Sometimes called Peripheral Vascular) .

Device Description

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Predicate Devices

K140428, K043524, K100919, K130619

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound imaging techniques and signal analysis without mentioning any AI or ML components.

Therapeutic

No
The device is described as an ultrasound scanner for diagnostic imaging or fluid flow analysis, for various clinical applications and imaging modes, with capabilities for signal analysis, guidance of biopsy needles, and geometrical measurements. There is no mention of therapeutic use.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly mentions "Ultrasound scanner and transducers" and describes hardware components like "optimal 3-D unit". This indicates the device includes hardware beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to produce images and analyze physiological processes.
• Device Description: The description details an "Ultrasound scanner and transducers" and various imaging modes and analysis capabilities. These are all characteristic of an in-vivo diagnostic imaging device, not a device that analyzes samples taken from the body (in vitro).
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates by sending and receiving ultrasound waves through the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D imaqes into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Clinical Applications:

• Fetal (Sometimes called Obstetrics) .
• Abdominal ●
• Intra-operative ●
• Intra-operative (Neuro) (sometimes called Neuro Surgical) ●
• Pediatrics .
• Small Organ (Sometimes called Small Parts) .
• . Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
• Adult Cephalic (Cephalic is sometimes called trans-cranial) ●
• Trans-rectal
• . Trans-vaqinal
• . Trans-urethral
• Musculo-skeletal (Conventional)
• Musculo-skeletal (Superficial)
• Cardiac Adult
• Peripheral Vessel (Sometimes called Peripheral Vascular) .

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Pediatrics, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Peripheral Vessel

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140428, K043524, K100919, K130619

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2015

BK Medical ApS % Mrs. Randi Hauerberg Regulatory Affairs Lead Manager Mileparken 34 Herlev DK-2730 DENMARK

Re: K143298 Trade/Device Name: Ultrasound Scanner System bk2300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 11, 2014 Received: November 26, 2014

Dear Mrs. Hauerberg:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

CEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Annroved: OMB No. 0910-0120

sweck fir rember iif known

K143298

Device Name

Ultrasound Scanner System bk2300

Indications for Use (Describe)

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D imaqes into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Clinical Applications:

• Fetal (Sometimes called Obstetrics) .
• Abdominal ●
• Intra-operative ●
• Intra-operative (Neuro) (sometimes called Neuro Surgical) ●
• Pediatrics .
• Small Organ (Sometimes called Small Parts) .
• . Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
• Adult Cephalic (Cephalic is sometimes called trans-cranial) ●
• Trans-rectal
• . Trans-vaqinal
• . Trans-urethral
• Musculo-skeletal (Conventional)
• Musculo-skeletal (Superficial)
• Cardiac Adult
• Peripheral Vessel (Sometimes called Peripheral Vascular) .

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescliption Use (Part 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 801 Suppart C)

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOA USE ONLY

Concurrence of Certer for Devices and Radiclogical Health (CDRH) (Signature)

3

This section applies only to requirements of the Paperwork Recuction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response including the time to review instructions, search existing data sources, gather and maintain the dista needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burder, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Intornation Officer Paperwork Reduction Act (PRA) Staff [e-mail]

Ar agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number

4

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific
(Tracks I & III)	B	M	PWD	CWD

25. | Tissue
    Harmonic
    Imaging | Contrast
    Harmonic
    Imaging
26. | Color
    Doppler | Amplitude
    Doppler | Color
    Velocity
    Imaging | Combined
27. | Other |
    | Ophthalmic | | | | | | | | | | | |
    | Fetal 2) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Abdominal 3) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Intra-operative (Specify 4) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Intra-operative (Neuro 5) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Laparoscopic 6) | | | | | | | | | | | |
    | Pediatric 7) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Small Organ (Specify 8) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Neonatal Cephalic 9) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Adult Cephalic 10) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Trans-rectal 11) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Trans-vaginal 12) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Trans-urethral 13) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Trans-esoph. (non-Card.) 14) | | | | | | | | | | | |
    | Musculo-skel. (Conventional 15) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Musculo-skel. (Superficial 16) | P | P | P | N | P | N | P | P | P | P | N24) |
    | Intra-luminal 17) | | | | | | | | | | | |
    | Other (Specify 18) | | | | | | | | | | | |
    | Cardiac Adult 19) | P | P | P | N | P | N | P | P | P | P | |
    | Cardiac Pediatric 20) | | | | | | | | | | | |
    | Trans-esoph. (Cardiac 21) | | | | | | | | | | | |
    | Other (Specify 22) | | | | | | | | | | | |
    | Peripheral vessel 23) | P | P | P | N | P | N | P | P | P | P | N23)
    N24) |
    | Other (Specify 24) | P | P | P | | | | | | | | N |

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging. Tissue Harmonic Imaging.

The numbering in the table above refers to the comments provided below and, in case it is considered relevant, further comments and history in the Attachment 006 Instructions For Use - Attachment. Please do observe that the numbering from 1 to 24 is fixed to make the document more consistent meaning that comments are only provided in the table below if relevant.

Additional Comments:

| 1. | B+M,
B+D,
B+C,
B+D+C.
B includes Tissue Harmonic Imaging
D:PWD.
C: Color Flow mapping Doppler incl.
Amplitude(power)Doppler |
|----|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mode combinations: |

Vector Flow Imaging (VFI) 23)

24. Elastography.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

5

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9018

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Modes
Specific
(Tracks I & III)	B	M	PWD	CWD	Tissue
Harmonic
Imaging	Contrast
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)	P	P	P	P	P		P	P		P	N24)
Trans-vaginal 12)	P	P	P	P	P		P	P		P	N24)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)											N

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging. Tissue Harmonic Imaging.

The numbering in the table above refers to the comments provided below and, in case it is considered relevant, further comments and history in the Attachment 006_Instructions For Use - Attachment. Please do observe that the numbering from 1 to 24 is fixed to make the document more consistent meaning that comments are only provided in the table below if relevant.

Additional Comments:

1.
	Mode combinations:
	B+M,
	B+D,
	B+C,
	B+D+C.
	B includes Tissue Harmonic Imaging
	D:PWD.
	C: Color Flow mapping Doppler incl. Amplitude(power)Doppler

24. Elastography.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

6

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9051

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Modes
Specific
(Tracks I & III)	B	M	PWD	CWD	Tissue
Harmonic
Imaging	Contrast
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	P	P	P	P	P		P	P		P	N24)
Small Organ (Specify 8)	P	P	P	P	P		P	P		P	N24)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	P	P	P	P	P		P	P		P	N24)
Musculo-skel. (Superficial 16)	P	P	P	P	P		P	P		P	N24)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	P	P	P	P	P		P	P		P	N23)
N24)
Other (Specify 24)											N

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging. Tissue Harmonic Imaging.

The numbering in the table above refers to the comments provided below and, in case it is considered relevant, further comments and history in the Attachment 006_Instructions For Use - Attachment. Please do observe that the numbering from 1 to 24 is fixed to make the document more consistent meaning that comments are only provided in the table below if relevant.

Additional Comments:

| 1. | Mode combinations: | B+M,
B+D,
B+C,
B+D+C.
B includes Tissue Harmonic Imaging
D:PWD.
C: Color Flow mapping Doppler incl.
Amplitude(power)Doppler |

----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

Vector Flow Imaging (VFI) 23)

24. Elastography.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

7

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9062

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Modes
Specific
(Tracks I & III)	B	M	PWD	CWD

25. | Tissue
    Harmonic
    Imaging | Contrast
    Harmonic
    Imaging
26. | Color
    Doppler | Amplitude
    Doppler | Color
    Velocity
    Imaging | Combined 1) | Other |
    | Ophthalmic | | | | | | | | | | | |
    | Fetal 2) | | | | | | | | | | | |
    | Abdominal 3) | | | | | | | | | | | |
    | Intra-operative (Specify 4) | P | P | P | | P | | P | P | | P | N24) |
    | Intra-operative (Neuro 5) | P | P | P | | P | | P | P | | P | N24) |
    | Laparoscopic 6) | | | | | | | | | | | |
    | Pediatric 7) | P | P | P | | P | | P | P | | P | N24) |
    | Small Organ (Specify 8) | | | | | | | | | | | |
    | Neonatal Cephalic 9) | P | P | P | | P | | P | P | | P | N24) |
    | Adult Cephalic 10) | | | | | | | | | | | |
    | Trans-rectal 11) | | | | | | | | | | | |
    | Trans-vaginal 12) | | | | | | | | | | | |
    | Trans-urethral 13) | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) 14) | | | | | | | | | | | |
    | Musculo-skel. (Conventional 15) | | | | | | | | | | | |
    | Musculo-skel. (Superficial 16) | | | | | | | | | | | |
    | Intra-luminal 17) | | | | | | | | | | | |
    | Other (Specify 18) | | | | | | | | | | | |
    | Cardiac Adult 19) | | | | | | | | | | | |
    | Cardiac Pediatric 20) | | | | | | | | | | | |
    | Trans-esoph. (Cardiac 21) | | | | | | | | | | | |
    | Other (Specify 22) | | | | | | | | | | | |
    | Peripheral vessel 23) | | | | | | | | | | | |
    | Other (Specify 24) | | | | | | | | | | | N |

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging. Tissue Harmonic Imaging.

The numbering in the table above refers to the comments provided below and, in case it is considered relevant, further comments and history in the Attachment 006_Instructions For Use - Attachment. Please do observe that the numbering from 1 to 24 is fixed to make the document more consistent meaning that comments are only provided in the table below if relevant.

Additional Comments:

| 1. | Mode combinations: | B+M,
B+D,
B+C,
B+D+C.
B includes Tissue Harmonic Imaging
D:PWD.
C: Color Flow mapping Doppler incl.
Amplitude(power)Doppler |

----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

24. Elastography.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

8

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9077

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Modes
Specific
(Tracks I & III)	B	M	PWD	CWD

25. | Tissue
    Harmonic
    Imaging | Contrast
    Harmonic
    Imaging
26. | Color
    Doppler | Amplitude
    Doppler | Color
    Velocity
    Imaging | Combined 1) | Other |
    | Ophthalmic | | | | | | | | | | | |
    | Fetal 2) | | | | | | | | | | | |
    | Abdominal 3) | P | P | P | N | P | | P | P | | P | |
    | Intra-operative (Specify 4) | | | | | | | | | | | |
    | Intra-operative (Neuro 5) | | | | | | | | | | | |
    | Laparoscopic 6) | | | | | | | | | | | |
    | Pediatric 7) | | | | | | | | | | | |
    | Small Organ (Specify 8) | | | | | | | | | | | |
    | Neonatal Cephalic 9) | | | | | | | | | | | |
    | Adult Cephalic 10) | P | P | P | N | P | | P | P | | P | |
    | Trans-rectal 11) | | | | | | | | | | | |
    | Trans-vaginal 12) | | | | | | | | | | | |
    | Trans-urethral 13) | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) 14) | | | | | | | | | | | |
    | Musculo-skel. (Conventional 15) | | | | | | | | | | | |
    | Musculo-skel. (Superficial 16) | | | | | | | | | | | |
    | Intra-luminal 17) | | | | | | | | | | | |
    | Other (Specify 18) | | | | | | | | | | | |
    | Cardiac Adult 19) | P | P | P | N | P | | P | P | | P | |
    | Cardiac Pediatric 20) | | | | | | | | | | | |
    | Trans-esoph. (Cardiac 21) | | | | | | | | | | | |
    | Other (Specify 22) | | | | | | | | | | | |
    | Peripheral vessel 23) | | | | | | | | | | | |
    | Other (Specify 24) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging. Tissue Harmonic Imaging.

The numbering in the table above refers to the comments provided below and, in case it is considered relevant, further comments and history in the Attachment 006_Instructions For Use - Attachment. Please do observe that the numbering from 1 to 24 is fixed to make the document more consistent meaning that comments are only provided in the table below if relevant.

Additional Comments:

| 1. | Mode combinations: | B+M,
B+D,
B+C,
B+D+C.
B includes Tissue Harmonic Imaging
D:PWD.
C: Color Flow mapping Doppler incl.
Amplitude(power)Doppler |

----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

25. Continuous Wave Doppler (CWD/CW)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

9

510(k) Summary:

This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.

Submitters name: BK Medical Address: Mileparken 34, DK-2730 Herlev, Denmark Phone: [phone] Fax: [phone] Contact person: Randi Hauerberg, Regulatory Affairs Lead Manager Date prepared: November 6, 2014

Trade name: Ultrasound Scanner System bk 2300 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO, CFR 892.1560) Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1550) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570)

Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Pro Focus 2202, K043524 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919 BK Medical Ultrasound Scanner bk2300, K140428 Siemens Ultrasound Scanner System Acuson S1000, K130619

Device description:

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

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Transducers

All the transducers in this submission have previous been cleared.

Only the new modes

• Σ Elastography
• Σ Vector Flow Imaging (VFI).
• Continuous Wave Doppler (CWD/CW)

has been added to the functionality of relevant transducers as indicated in the Instructions For Use Section in VOL_004

There are no changes to the physical design of the transducers There are no changes to the patient contact materials. All patient contact materials are biocompatible.

All transducers used together with bk2300 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in the modified bk2300 is the same as the system in the predicate device Pro Focus 2202. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta [] 720 mW/cm² and MI [] 1.9 (Track 3, non ophthalmic).

The Thermal Index values are maximum 6.0, i.e. TI [] 6.0

Clinical measurement accuracy

Clinical measurements and calculations are described and accuracies are provided in the User Information.

Thermal, mechanical and electrical safety. The ultrasound scanner system bk2300 has been tested by a recognized Certified Body.

Acoustic Output Reporting

The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008"

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.

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		Summary of Technological Characteristics - Predicate Device Compared to Modified Device

| Devices and
Predicates | Predicate device
K140428,
Ultrasound
scanner bk2300 | Predicate device
K043524,
Ultrasound
scanner Pro
Focus 2202 | Predicate device
K100919,
Ultrasound
scanner Pro
Focus 2202 | Predicate device
K130619,
Ultrasound
scanner system
Acuson S1000 | Modified device
(this
application),
Ultrasound
scanner bk2300 |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Modes of
operation
Ref.: [1]
Appendix G | B | B | B | B | B |
| | THI
M,
PWD,
CFM 1)
and combinations | THI
M,
PWD,
CFM 1)
and combinations
CHI
CWD, | THI
M,
PWD,
CFM 1)
and combinations
VFI | THI
M,
PWD,
CFM 1)
and combinations
Elastography | THI
M,
PWD,
CFM 1)
and combinations
CHI
CWD,
VFI
Elastography |
| Intended Use: | Diagnostic
ultrasound
imaging or fluid
flow analysis of
the human body
as follows: | Diagnostic
ultrasound
imaging or fluid
flow analysis of
the human body
as follows: | Diagnostic
ultrasound
imaging or fluid
flow analysis of
the human body
as follows: | Diagnostic
ultrasound
imaging or fluid
flow analysis of
the human body
as follows: | Diagnostic
ultrasound
imaging or fluid
flow analysis of
the human body
as follows: |
| Indications For
Use: | Fetal (incl
Obstetrics)
Abdominal
Intraoperative
Neurosurgery | Fetal (incl
Obstetrics)
Abdominal
Intraoperative
Neurosurgery | Fetal (incl
Obstetrics)
Abdominal
Intraoperative
Neurosurgery | Fetal (incl
Obstetrics)
Abdominal
Intraoperative
Neurosurgery | Fetal (incl
Obstetrics)
Abdominal
Intraoperative
Neurosurgery |
| | Pediatrics | Pediatrics | Pediatrics | Pediatrics | Pediatrics |
| | Small Parts
(organs) | Small Parts
(organs) | Small Parts
(organs) | Small Parts
(organs) | Small Parts
(organs) |
| | Adult Cephalic | Adult Cephalic | Adult Cephalic | Adult Cephalic | Adult Cephalic |
| | Neonatal
Cephalic | | | Neonatal
Cephalic | Neonatal
Cephalic |
| | Transrectal | Transrectal | Transrectal | Transrectal | Transrectal |
| | Transvaginal | Transvaginal | Transvaginal | Transvaginal | Transvaginal |
| | Transurethral | Transurethral | Transurethral | Transurethral | Transurethral |
| | Muskulo-skeletal
(conventional and
superficial) | Muskulo-skeletal
(conventional and
superficial) | Muskulo-skeletal
(conventional and
superficial) | Muskulo-skeletal
(conventional and
superficial) | Muskulo-skeletal
(conventional and
superficial) |
| | Cardiac | Cardiac | Cardiac | Cardiac | Cardiac |
| | Peripheral Vessel | Peripheral Vessel | Peripheral Vessel | Peripheral Vessel | Peripheral Vessel |
| Features | | ECG (not
monitoring) | ECG (Not
monitoring) | | |

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1. CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.

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A brief discussion of non-clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, thermal, electrical, electromagnetic and mechanical safety, biocompatibility and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

• Σ AIUM/NEMA UD-2, Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment
• 2 AIUM/NEMA UD-3, Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• A IEC 60601-1, Medical Electrical Equipment, Part 1: General requirements for safety
• IEC 60601-1-2, General requirements for safety, Collateral Standard, Electromagnetic Compatibility - Requirements and tests
• バ IEC 60601-2-37, Particular requirements for the safety of ultrasonic diagnostic medical and monitoring equipment
• ISO 14971, Application of Risk Management of Medical Devices
• EN ISO 10993-1. Biocompatibility
• IEC 62304, Medical Device Software Software lifecycle processes
• IEC 62359, Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

Thermal, electrical, electromagnetic, mechanical and biocompatibility safety is unchanged.

Technological characteristics compared to the predicate device

The predicate devices have the same major technological characteristics as the subject device described above.

Minor differences consist with respect to the Ultrasound Scanner System: Addition of new modes.