Ultrasound Scanner System bk2300

• K Number: K152052
• Device Name: Ultrasound Scanner System bk2300
• Manufacturer: BK MEDICAL APS
• Date Cleared: 2015-09-16 ( 55 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Special
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, 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.

Device Description

Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: 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. An 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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BK Medical Ultrasound Scanner System bk2300:

Based on the provided FDA 510(k) summary (K152052), there is no specific table of acceptance criteria and reported device performance defined in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical application (e.g., detecting a disease) as would be typical for an AI/CADe device.

Instead, this submission is for a general-purpose ultrasound scanner system. The "acceptance criteria" discussed are primarily related to engineering performance, safety, and substantial equivalence to a predicate device as required for a 510(k) clearance, rather than a clinical study evaluating diagnostic performance against specific benchmarks.

Here's a breakdown of the requested information based on the document:

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1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not present "acceptance criteria" in the context of diagnostic performance metrics for a specific clinical task. The "performance" described is largely about meeting safety standards and functional capabilities.

Acceptance Criteria Category (Implied by 510(k) Process)	Stated Performance / Compliance
Functional Capabilities (Modes)	Capable of B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging, combined mode imaging, and Elastography. Signal Analysis, Guidance of biopsy needles, geometrical measurements and calculation of parameters, 3-D unit for reconstruction, Optional Vector Flow Imaging (VFI) module for axial and transverse velocity.
Acoustic Output Safety	System assures acoustic output stays below pre-amendments upper limits: Ispta < 720 mW/cm² and MI < 1.9 (Track 3, non-ophthalmic).
Thermal Index Safety	Thermal Index (TI) values are maximum 6.0 (TI < 6.0).
Clinical Measurement Accuracy	Described in the Ultrasound Scanner System bk2300 user Information. (Details not provided in this summary.)
Thermal, Mechanical, and Electrical Safety	Tested by a recognized Certified Body.
Acoustic Output Reporting	Made according to standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008".
Transducer Biocompatibility	Existing transducer patient contact materials are considered biocompatible.
Substantial Equivalence	Deemed substantially equivalent to identified predicate devices, including an optional system with an alternate power source (battery) solution.
Regulatory Compliance	Meets general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Regarding the device's conformance to clinical diagnostic acceptance criteria, the document does not provide details on studies that prove the device meets specific clinical performance benchmarks (e.g., sensitivity/specificity for detecting a condition). This is a 510(k) for a general imaging device, not a CADe/AI device with a specific diagnostic function that often requires such clinical efficacy studies.

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2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. This 510(k) summary does not describe a clinical performance study with a test set of patient data to evaluate diagnostic accuracy. The testing mentioned refers primarily to engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided. As there's no clinical performance study with a diagnostic ground truth, this information is not present.

4. Adjudication method for the test set

• Not Applicable / Not Provided.

5. 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. This device is a standalone ultrasound scanner, not an AI/CADe system designed to assist human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. The device itself is the diagnostic tool. It is not an algorithm that performs a diagnostic task independently of a human operator and interpreter. The "performance" assessment is inherent in its ability to generate images and measurements for interpretation by a clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Not Provided for diagnostic performance. The "ground truth" in this submission relates to engineering standards and regulatory requirements. For example, the "ground truth" for acoustic output is established by international and FDA-specified safety limits.

8. The sample size for the training set

• Not Applicable / Not Provided. This submission does not describe an AI/ML system that requires a "training set" of data in the common sense for diagnostic performance.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, resembling a bird in flight. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

September 16, 2015

BK Medical APS % Mr. Michael J. Doyle Global Director Regulatory & Clinical Affairs Mileparken 34 Herlev DK-2730 DENMARK

Re: K152052

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: August 28, 2015 Received: August 31, 2015

Dear Mr. Doyle:

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.

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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 Ocks

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

Enclosure

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Indications for Use

510(k) Number (if known) K152052

Device Name Ultrasound Scanner System bk2300

Indications for Use (Describe)

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, 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.

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-vaginal
• 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 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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Diagnostic Ultrasound Indications for Use Form

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	CWD25)	TissueHarmonicImaging	ContrastHarmonicImaging26)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)	P	P	P	P	P	P	P	P	P	P	P24)
Abdominal 3)	P	P	P	P	P	P	P	P	P	P	P24)
Intra-operative (Specify 4)	P	P	P	P	P	P	P	P	P	P	P24)
Intra-operative (Neuro 5)	P	P	P	P	P	P	P	P	P	P	P24)
Laparoscopic 6)
Pediatric 7)	P	P	P	P	P	P	P	P	P	P	P24)
Small Organ (Specify 8)	P	P	P	P	P	P	P	P	P	P	P24)
Neonatal Cephalic 9)	P	P	P	P	P	P	P	P	P	P	P24)
Adult Cephalic 10)	P	P	P	P	P	P	P	P	P	P	P24)
Trans-rectal 11)	P	P	P	P	P	P	P	P	P	P	P24)
Trans-vaginal 12)	P	P	P	P	P	P	P	P	P	P	P24)
Trans-urethral 13)	P	P	P	P	P	P	P	P	P	P	P24)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	P	P	P	P	P	P	P	P	P	P	P24)
Musculo-skel. (Superficial 16)	P	P	P	P	P	P	P	P	P	P	P24)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)	P	P	P	P	P	P	P	P	P	P
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	P	P	P	P	P	P	P	P	P	P	P23)P24)
Other (Specify 24)											P
Other (Specify 25)											25)

N = new indication; P = previously cleared by FDA; E = added under Appendix E. *Examples may include: Amode, 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. Note that the numbering 1 to 25 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,
Mode combinations:	B+D,
	B+C,
	B+D+C
	B includes Tissue Harmonic Imaging
	D: PWD
	C: Color Flow mapping Doppler incl. Amplitude(power)Doppler

• 23. Vector Flow Imaging (VFI)
• 24. Elastography
• 25. Battery

(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)

Prescription Use (Per 21 CFR 801.109)

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Image /page/5/Picture/0 description: The image shows the logo for BK Medical, a company that is part of the Analogic Ultrasound Group. The logo features the text "bk medical" in a green sans-serif font, with "bk" in lowercase and "medical" in lowercase. Above and to the right of the text is a green circular graphic with a white waveform design inside. Below the text is the phrase "Analogic Ultrasound Group" in a smaller, sans-serif font.

510(K) SUMMARY 8.

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR §807.92

A. Submitter's Information:

Name:	BK Medical
Address:	Mileparken 34, DK-2730 Herlev, Denmark
FDA EstablishmentOwner/Operator Number:	9680269
Contact Person:	Michael DoyleGlobal Director Regulatory & Clinical Affairs
Phone:Fax:Manufacturer:	(978) 326 - 4410(978) 977 - 6811Analogic Corporation8 Centennial DrivePeabody, MA 01960United States
FDA EstablishmentRegistration Number:	1220672
B. Device Name:
Trade/Proprietary Name:Device:	Ultrasound Scanner System bk2300System, Imaging, Pulsed Doppler, UltrasonicSystem, Imaging, Pulsed Echo, UltrasonicTransducer, Ultrasonic, Diagnostic
Regulation Description:	Ultrasonic Pulsed Doppler ImagingUltrasonic pulsed echo imaging systemDiagnostic ultrasonic transducer
Regulation MedicalSpecialty:	Radiology
Review Panel:	Radiology
Product Code:	IYOIYNITX
Submission Type:	Special 510(k)

BK Medical • Mileparken 34 • DK-2730 Herlev • Tel.: [phone] • Fax: [phone] • www.bkmed.com

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Image /page/6/Picture/0 description: The image shows the logo for BK Medical. The logo consists of the text "bk medical" in a green sans-serif font. Below the text is the phrase "Analogic Ultrasound Group" in a smaller, lighter font. To the right of the text is a green circular graphic with white lines inside.

Regulation Number:	892.1550
	892.1560
	892.1570
Device Class:	2

C. Substantial Equivalence:

The proposed Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is substantially equivalent to the identified predicates. .

D. Device Description/Indications for Use:

Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: 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. An 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.

Transducers

All the transducers in this submission have been previously cleared. There are no changes to the physical design of the transducers or the patient contact materials. Existing transducer patient contact materials are considered biocompatible. All transducers used together with Ultrasound Scanner System bk2300 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in the Ultrasound Scanner System bk2300 is the same as the predicate devices. 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, calculations, and accuracies are described in the Ultrasound Scanner System bk2300 user Information.

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Image /page/7/Picture/0 description: The image contains the logo for BK Medical, an Analogic Ultrasound Group. The logo features the text "bk medical" in a sans-serif font, colored in green. Below the text is the phrase "Analogic Ultrasound Group" in a smaller, sans-serif font. To the right of the text is a circular graphic with a green outline and a white interior, featuring a curved line design.

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".

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.