Ultrasound System 1300

• K Number: K173569
• Device Name: Ultrasound System 1300
• Manufacturer: BK Medical ApS
• Date Cleared: 2018-02-23 ( 95 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Abbreviated
• Panel: Radiology
• Reference & Predicate Devices: K161960
• Predicate For: K231764

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.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

The Ultrasound System 1300 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 1300 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.

The initial release of the 1300 system will include the BK1500 marketing configuration model.

The transducers are all multi-frequency transducers including:

• Phased Linear Array
• Convex / Curved Array .
• Linear Array. ●

The interaction with the patients is dependent upon the transducer type which may be:

• Surface Contact, ●
• Intra-operative, or ●
• Endocavity .

The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for BK Medical Ultrasound System 1300 (K173569)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the BK Medical Ultrasound System 1300 as being substantially equivalent to its predicate device, the BK2300 Ultrasound Scanner System (K161960). Substantial equivalence means the device is as safe and effective as a legally marketed device. The acceptance criteria are therefore tied to meeting relevant standards and demonstrating comparable performance to the predicate device.

Acceptance Criterion	Reported Device Performance (Ultrasound System 1300)
Intended Use Equivalence	The Ultrasound System 1300 has the same intended use as the predicate device: "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."
Clinical Application Equivalence	The clinical applications and exam types for the Ultrasound System 1300 are substantially equivalent to the predicate, including Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Intra-operative, Intra-operative Neuro, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel. Some new indications and previously cleared indications with specific transducers are detailed across pages 3-30.
Modes of Operation Equivalence	The Ultrasound System 1300 supports the same modes of operation as the predicate: B, M, PWD, CFM (Color Doppler and Amplitude Doppler) and combinations, Tissue Harmonic Imaging, Vector Flow Analysis, Continuous Wave Doppler (CWD), Elastography, and Contrast Imaging. Some transducers have specific new or previously cleared modes.
Transducer Equivalence	Modified acoustic output tables were provided for 24 transducers (9002, 9009, 9011, 9015, 9016, 9018, 9019, 9022, 9023, 9024, 9026, 9029, 9032, 9038, 9040, 9048, 9051, 9052, 9062, 9063, 9067, 9070, 9081, 9085). Three new transducers (9008, 9086, 9087) were introduced. All transducers are multi-frequency, including Phased Linear Array, Convex/Curved Array, and Linear Array.
Features Equivalence	The device retains the ECG (not monitoring) and Wi-Fi features present in the predicate.
Bio-effect Assessment	Complied with FDA guidance for Track 3 devices regarding thermal and mechanical indices (IEC 60601-2-37, IEC 62359, NEMA UD 2).
Biocompatibility	Patient-contacting transducers comply with applicable biocompatibility standard requirements (AAMI/ANSI/ISO 10993-1).
Sterilization (Reprocessing)	Reprocessing methods for transducers were tested in accordance with TIR-12 and TIR-30. The console is not patient-contacting and the device is not sold sterile.
Electrical Safety & EMC	Complied with AAMI/ANSI/ES 60601-1 and IEC 60601-1-2 standards.
Software Verification & Validation	Testing conducted as recommended by FDA guidance for "moderate" level of concern software. Complies with EN IEC 62304.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in terms of patient data or images for evaluating the clinical performance of the device itself. The primary method for demonstrating substantial equivalence relies on bench testing against recognized standards for diagnostic ultrasound systems and transducers.

The data provenance for the non-clinical performance data is therefore from bench testing conducted by BK Medical ApS. The country of origin of this data would be Denmark, where BK Medical ApS is located. The nature of the data is retrospective in the sense that it refers to established standard tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The concept of "experts" establishing ground truth in the context of this submission is not applicable in the typical sense of evaluating AI models. Since clinical studies or evaluations using a test set of patient data were not deemed necessary for this 510(k) submission, there are no details provided about experts establishing ground truth for such a test set.

4. Adjudication Method

As there was no "test set" of clinical cases requiring expert interpretation and adjudication for this 510(k) submission, no adjudication method is mentioned or relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical Studies: Not applicable - clinical studies were not required to support substantial equivalence to the predicate device." Therefore, an MRMC comparative effectiveness study was not performed, and no effect size for human readers improving with or without AI assistance is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

No. The device is an ultrasound system with various imaging modes and functions; it is not described as an AI algorithm in the context of this submission. Its performance is evaluated as a diagnostic tool used by "qualified and trained healthcare professionals."

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" for the device's performance is established by its conformance to recognized industry standards (IEC, NEMA, AAMI/ANSI/ISO) for diagnostic ultrasound systems and transducers. This includes:

• Engineering specifications and technical performance metrics related to image quality, acoustic output, electrical safety, EMC, and software functionality.
• Established safety and effectiveness profiles of the predicate device (BK2300 Ultrasound Scanner System – K161960).

There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for this submission, as clinical studies were not required.

8. The Sample Size for the Training Set

This question is not applicable. The device is a diagnostic ultrasound system, not an AI/ML algorithm that requires a training set of data in the sense typically understood for machine learning models.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no mention of a training set or AI/ML components for which ground truth would need to be established in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate ultrasound device through engineering and performance testing.

Summary

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February 23, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

BK Medical ApS % Ms. Karen Provencher Sr. Regulatory Affairs Specialist Mileparken 34 HERLEV. 2730 DENMARK

Re: K173569

Trade/Device Name: Ultrasound System 1300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 29, 2018 Received: January 30, 2018

Dear Ms. Provencher:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

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) K173569

Device Name Ultrasound System 1300

Indications for Use (Describe)

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.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

The Ultrasound System 1300 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the word "ultrasound" is the text "powered by analogic" in a smaller font, followed by a gray circle with a white design inside.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE

Ultrasound System: 1300

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 4)	TissueHarmonicImaging	CHI 5)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal	N	N	N		N	N	N	N	N	N	N 3)
Abdominal	N	N	N	N	N	N	N	N	N	N	N 3)
Intra-operative (Specify)	N	N	N		N	N	N	N	N	N	N 3)
Intra-operative (Neuro)	N	N	N		N	N	N	N	N	N	N 3)
Laparoscopic
Pediatric	N	N	N		N	N	N	N	N	N	N 3)
Small Organ (Specify)	N	N	N		N	N	N	N	N	N	N 3)
Neonatal Cephalic	N	N	N		N	N	N	N	N	N	N 3)
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	N 3)
Trans-rectal	N	N	N		N	N	N	N	N	N	N 3)
Trans-vaginal	N	N	N		N	N	N	N	N	N	N 3)
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal.(Conventional)	N	N	N		N	N	N	N	N	N	N 3)
Musculoskeletal. (Superficial)	N	N	N		N	N	N	N	N	N	N 3)
Intra-luminal
Cardiac Adult	N	N	N	N	N	N	N	N	N	N
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel	N	N	N		N	N	N	N	N	N	N 2)N 3)
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Vector Flow Imaging (VFI)

• 3. Elastography

4. Continuous Wave Doppler (CWD/CW)

5. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

6. Intra-operative: carotids, central blood vessels, aorta, vena cava, liver, biliary, pancreas, spleen, gallbladder, kidney, stomach, breast

7. Small organ: testicles, thyroid, breast, penis, parathyroid, salivary glands, lymph nodes, superficial anatomy

(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)

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Image /page/4/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green sphere with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9002 (9C2)

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	TissueHarmonicImaging	CHI	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal	P	P	P		P		P	P		P	P 2)
Abdominal	P	P	P		P		P	P		P	P 2)
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P		P	P		P	P 2)
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)	P	P	P		P		P	P		P	P 2)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P		P		P	P		P	P 2)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. 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)

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Image /page/5/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the green letters "bk" and the word "ultrasound" in green. Below the word "ultrasound" is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9008 (E11C3b)

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	TissueHarmonicImaging	CHI	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N	N	N		N		N	N		N
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

(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)

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Image /page/6/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font size.

System: 1300

Transducer: 9009 (X18L5s)

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	TissueHarmonicImaging	CHI	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify) 3)	P	P	P				P	P		P	P 2)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) 4)	P	P	P				P	P		P	P 2)
Neonatal Cephalic)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)	P	P	P				P	P		P	P 2)
Musculoskeletal. (Superficial)	P	P	P				P	P		P	P 2)
Intra-luminal
Other (Specify)
Cardiac Adult)
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P				P	P		P	P 2)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Elastography
• 3. Intra-operative: carotids, central blood vessels, aorta, vena cava
• 4. Small Organ: testicles

(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)

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Image /page/7/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the word "ultrasound" is the text "powered by analogic" in a smaller font.

System: 1300

Transducer: 9011 (13L4w)

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

Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P		P	P 3)
Small Organ (Specify) 2)	P	P	P	P	P	P		P	P 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)	P	P	P	P	P	P		P	P 3)
Musculo-skel. (Superficial)	P	P	P	P	P	P		P	P 3)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P	P	P	P		P	P 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Small Organ: thyroid, breast, testes, penis, parathyroid, salivary glands, lymph nodes.

3. 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)

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Image /page/8/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9015 (I14C5I)

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	TissueHarmonicImaging	CHI 4)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify) 3)	P	P	P		P	P	P	P		P	P 2)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P		P	P 2)
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Elastography
• 3. Intra-operative: Liver, Biliary, Pancreas, Spleen, Gallbladder, Kidney, Stomach, Breast
• 4. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(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)

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Image /page/9/Picture/0 description: The image shows the logo for BK Ultrasound. The logo features a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller, gray font, accompanied by a gray circular logo.

System: BK1300

Transducer: 9016 (I14C5T)

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	TissueHarmonicImaging	CHI 4)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	P		P	P2)
Intra-operative Specify) 3)	P	P	P		P	P	P	P		P	P2)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

• 1. Mode combinations:
     B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
• 2. Elastography
• 3. Inter-operative: Liver, Biliary, Pancreas, Kidney
• 4. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(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)

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Image /page/10/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, with the words "powered by analogic" in smaller gray font below it.

System: 1300

Transducer: 9018 (E14C4t)

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	TissueHarmonicImaging	ContrastHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic)
Trans-rectal	P	P	P		P		P	P		P	P2),3)
Trans-vaginal	P	P	P		P		P	P		P	P 2), 3)
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult)
Cardiac Pediatric)
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Elastography
• 3. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(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)

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green lowercase letters. Below the word "ultrasound" is the text "powered by analogic" in a smaller font.

System: 1300

Transducer: 9019 (E10C4)

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

Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal	P	P	P	P	P	P		P	P 2)
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	P		P	P 2)
Trans-vaginal	P	P	P	P	P	P		P	P 2)
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. 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)

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the word "ultrasound" is the text "powered by analogic" in a smaller font.

System: 1300

Transducer: 9022 (10L2w)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P	P	P	P	P	P	P 2), P 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Elastography

3. Vector Flow Imaging (VFI)

(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)

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller font.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 1300

r

Transducer: 9023 (6C2s)

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

Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	CHI 3)	Combined(Specify 1)	Other
Ophthalmic
Fetal	P	P	P	P	P	P	P	P	P 2)
Abdominal	P	P	P	P	P	P	P	P	P 2)
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	P	P 2)
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Elastography

3. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(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) Prescription Use (Per 21 CFR 801.109)

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the green letters "bk" and the word "ultrasound" in green. Below the word "ultrasound" is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9024 (112C5b)

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	TissueHarmonicImaging	CHI 4)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative Specify 2)	P	P	P		P	P	P	P		P	P3)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)	P	P	P		P	P	P	P		P	P 3)
Musculoskeletal. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P		P	P	P	P		P	P 3)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Intra-operative: Liver, Biliary, Pancreas, Kidney
• 3. Elastography
• 4. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(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)

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9026 (X12C4)

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	TissueHarmonicImaging	CHI 4)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative Specify 2)	P	P	P		P	P	P	P		P	P 3)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Intra-operative: Pancreas, Kidney, Liver

Elastography 3)

• 4. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)
     (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)

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows the logo for BK Ultrasound. The logo features a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text, it says "powered by analogic" in a smaller, lighter font.

System: 1300

Transducer: 9029 (E13C2)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify )
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	E	E	E	E	E	E	E	E	E 2), 3)
Trans-vaginal	E	E	E	E	E	E	E	E	E 2), 3)
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal (Conv.)
Musculoskeletal (Superf.)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E: (LTF 10-13-2016)

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Elastography

3)Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(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)

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the green letters "bk" in lowercase. To the right of "bk" is the word "ultrasound" in green, with the words "powered by analogic" in smaller font below it.

System:1300

Transducer: 9032 (8L2)

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	TissueHarmonicImaging	CHI 4)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P		P	P 3)
Small Organ (Specify 2)	P	P	P		P	P	P	P		P	P 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal (Conventional)	P	P	P		P	P	P	P		P	P 3)
Musculoskeletal. (Superficial)	P	P	P		P	P	P	P		P	P 3)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P		P	P	P	P		P	P 3), 5)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Small Organ: Thyroid, Breast, Testes
• 3. Elastography

4. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

• 5. Vector Flow Imaging (VFI)
     (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)

{18}------------------------------------------------

Image /page/18/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller font, along with a gray circle containing a white symbol.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 1300

Transducer: 9038 (X14L4)

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	TissueHarmonicImaging	CHI 2)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic
Trans-rectal	E	E	E	E	E	E	E	E		E	E 3)
Trans-vaginal	E	E	E	E	E	E	E	E		E	E 3)
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA; E= added under Appendix E: LTF October 2017

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)
• 3. 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)

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the word "ultrasound" is the text "powered by analogic" in a smaller font.

System: 1300

Transducer: 9040 (6C2)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal	P	P	P	P	P	P		P	P 2)
Abdominal	P	P	P	P	P	P		P	P 2)
Intra-operative (Specify )
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)	P	P	P	P	P	P		P	P 2)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(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)

{20}------------------------------------------------

Image /page/20/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9048 (E14CL4b)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	P		P	P 2), 3)
Trans-vaginal	P	P	P	P	P	P		P	P 2), 3)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Elastography

3. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(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)

{21}------------------------------------------------

Image /page/21/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green lowercase letters. Below the text, it says "powered by analogic" in smaller, gray letters.

System: 1300

Transducer: 9051 (14L3)

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	TissueHarmonicImaging	ContrastHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P		P	P		P	P 3)
Small Organ (Specify) 4)	P	P	P		P		P	P		P	P 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)	P	P	P		P		P	P		P	P 3)
Musculoskeletal. (Superficial)	P	P	P		P		P	P		P	P 3)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P		P		P	P		P	P 2)P 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Vector Flow Imaging (VFI)
• 3. Elastography
• 4. Small Organ: breast, thyroid, testes

(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)

{22}------------------------------------------------

Image /page/22/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9052 (20R3)

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	TissueHarmonicImaging	CHI	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic)
Adult Cephalic
Trans-rectal	P
Trans-vaginal	P
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

(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)

{23}------------------------------------------------

Image /page/23/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, followed by a gray circle with a white sine wave inside.

System: 1300

Transducer: 9062 (N13C5)

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	TissueHarmonicImaging	ContrastHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify) 3)	P	M	PWD		P		P	P		P	P 2)
Intra-operative (Neuro)	P	M	PWD		P		P	P		P	P 2)
Laparoscopic
Pediatric	P	M	PWD		P		P	P		P	P 2)
Small Organ (Specify)
Neonatal Cephalic	P	M	PWD		P		P	P		P	P 2)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult)
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Elastography
• 3. Intra-operative: gallbladder

(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)

{24}------------------------------------------------

Image /page/24/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, with the words "powered by analogic" in smaller gray font below it. The logo is clean and modern, with a focus on the company's name and its association with ultrasound technology.

System: 1300

Transducer: 9063 (N11C5s)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	CWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative Specify 2)	P	P	P		P	P	P		P
Intra-operative (Neuro)	P	P	P		P	P	P		P
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Intra-operative: Gall Bladder

(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)

{25}------------------------------------------------

Image /page/25/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white line running through it, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9067 (E14C4)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	P		P	P 2)
Trans-vaginal	P	P	P	P	P	P		P	P 2)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Elastography

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

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Image /page/26/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the green letters "bk" and the word "ultrasound" in green. Below the word "ultrasound" are the words "powered by analogic" in a smaller font.

System: 1300

Transducer: 9070 (18L5)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	P	P 3)
Small Organ (Specify) 2)	P	P	P	P	P	P	P	P	P 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)	P	P	P	P	P	P	P	P	P 3)
Musculoskeletal. (Superficial)	P	P	P	P	P	P	P	P	P 3)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P	P	P	P	P	P	P 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Small Organ: thyroid, breast, testes, superficial anatomy

3. Elastography

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

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Image /page/27/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white "A" inside.

System: 1300 Transducer: 9081 (18L5s)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify )
Intra-operative (Neuro)
Laparoscopic
Pediatric	E	E	E	E	E	E		E	E 3)
Small Organ (Specify 2)	E	E	E	E	E	E		E	E 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal (Conv.)	E	E	E	E	E	E		E	E 3)
Musculoskeletal (Superf.)	E	E	E	E	E	E		E	E 3)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel	E	E	E	E	E	E		E	E 3)
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E: LTF 10-10-2016

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Small Organ: breast, thyroids, testes

3. Elastography

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

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Image /page/28/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green lowercase letters. Below the word "ultrasound" is the text "powered by analogic" in a smaller font, followed by a gray circle with a white cross inside.

System: 1300 Transducer: 9085 (5Cle)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal	E	E	E	E	E	E		E	E 2)
Abdominal	E	E	E	E	E	E		E	E 2)
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal (Conv.)	E	E	E	E	E	E		E	E 2)
Musculoskeletal (Superf.)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E LTF: 10-13-2016

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. 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)

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Image /page/29/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller font.

System: 1300 Transducer: 9086 (14L3e)

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

Clinical Application
Specific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify )
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N		N	N 3)
Small Organ (Specify 2)	N	N	N	N	N	N		N	N 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal (Conv.)	N	N	N	N	N	N		N	N 3)
Musculoskeletal (Superf.)	N	N	N	N	N	N		N	N 3)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel	N	N	N	N	N	N		N	N 3), 4)
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

2. Small Organ: breast, thyroid, testes

3. Elastography

4. Vector Flow Imaging (VFI)

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

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Image /page/30/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white line going through it, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, with the words "powered by analogic" in a smaller font below it.

System: 1300

Transducer: 9087 (5P1e)

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	CWD3)	TissueHarmonicImaging	ContrastHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal	N	N	N	N	N		N	N		N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N		N	N		N
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal 17)
Other (Specify)
Cardiac Adult 2)	N	N	N	N	N		N	N		N
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

1. Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

• 2. Adult Cardiac: Not for direct use on the heart
• 3. Continuous Wave Doppler (CWD/CW)

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

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Image /page/31/Picture/0 description: The image shows the logo for BK Ultrasound. The logo features a green circle with a white wave-like design inside, followed by the text "bk ultrasound" in green. Below the text, it says "powered by analogic" in gray with the analogic logo.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter: BK Medical ApS Mileparken 34 Herlev 2730 Denmark Tel: [phone] Fax: [phone] Contact: Karen Provencher Sr. Regulatory Affairs Specialist E-mail: [e-mail]

l.

Date Prepared: January 29, 2018

Device Names / Common Names / Classification Names: II.

Trade Name: Ultrasound System 1300 Common Name: Ultrasound Scanner System Classification Name: Ultrasonic pulsed doppler imaging system Product Code: IYN, IYO, ITX Class: || Regulation Number: 21 CFR §892.1550, §892.1560, §892.1570 Classification Panel: Radiology

lll. I dentification of Predicate or Legally Marketed Devices:

BK2300 Ultrasound Scanner System – K161960 (10/17/2016)

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IV. Device Description:

The Ultrasound System 1300 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.

The initial release of the 1300 system will include the BK1500 marketing configuration model.

The transducers are all multi-frequency transducers including:

• Phased Linear Array
• Convex / Curved Array .
• Linear Array. ●

The interaction with the patients is dependent upon the transducer type which may be:

• Surface Contact, ●
• Intra-operative, or ●
• Endocavity .

The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

V. Indications / 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 quidance.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult transcranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).

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Contraindications:

The Ultrasound System 1300 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.

Comparison of Technological Characteristics with the VI. Predicate Device:

Item	BK2300 UltrasoundScanner System(predicate device)	Ultrasound System1300(proposed device)
Modes ofoperation	B, M, PWD, CFM* andcombinations, TissueHarmonic Imaging,Vector Flow Analysis,Continuous WaveDoppler (CWD),Elastography, ContrastImaging	B, M, PWD, CFM* andcombinations, TissueHarmonic Imaging,Vector Flow Analysis,Continuous Wave Doppler(CWD), Elastography,Contrast Imaging
IntendedUse	The system is adiagnostic ultrasoundimaging system used byqualified and trainedhealthcare professionalsfor ultrasound imaging,human body fluid flowanalysis and punctureand biopsy guidance.	The system is adiagnostic ultrasoundimaging system used byqualified and trainedhealthcare professionalsfor ultrasound imaging,human body fluid flowanalysis and punctureand biopsy guidance.
ClinicalApplications	Fetal (includingObstetrics), Abdominal,Pediatric, Small Organ(also known as SmallParts), Adult Cephalic(cephalic is also knownas trans-cranial),	Fetal (includingObstetrics), Abdominal,Pediatric, Small Organ(also known as SmallParts), Adult Cephalic(cephalic is also known asAdult trans-cranial),
Item	BK2300 UltrasoundScanner System	Ultrasound System1300
	(predicate device)	(proposed device)
	Neonatal Cephalic(cephalic is also knownas trans-cranial), Intra-operative, Intra-operative Neuro (alsoknown as Neurosurgery),Trans-rectal, Trans-vaginal, Trans-esophageal (cardiac)Musculo-skeletal(Conventional andSuperficial), CardiacAdult, and PeripheralVessel (also known asPeripheral Vascular)	Neonatal Cephalic, Intra-operative, Intra-operativeNeuro (also known asNeurosurgery), Trans-rectal, Trans-vaginal,Musculo-skeletal(Conventional andSuperficial), CardiacAdult, and PeripheralVessel (also known asPeripheral Vascular)
Transducers	9002, 9009, 9011, 9015,9016, 9018, 9019, 9022,9023, 9024, 9026, 9029,9032, 9038, 9040, 9048,9051, 9052, 9062, 9063,9066, 9067, 9070, 9077,9081, 9085	Modified acoustic outputtables for:9002, 9009, 9011, 9015,9016, 9018, 9019, 9022,9023, 9024, 9026, 9029,9032, 9038, 9040, 9048,9051, 9052, 9062, 9063,9067, 9070, 9081, 9085New transducers:9008, 9086, 9087
Features	ECG (not monitoring)	ECG (not monitoring)
Features	Wi-Fi	Wi-Fi

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*CFM = Color Flow Mapping = Color Doppler and Amplitude (Power) Doppler

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VII. Performance Data:

The following performance data were provided in support of the substantial equivalence determination.

Non-clinical /Performance - Bench Testing:

Bench testing was performed and the 1300 system fulfilled the requirements of the following FDA consensus standards and requirements set forth in FDA quidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued on September 9, 2008 as it pertains to Track 3 devices:

IEC 60601-2-37 - Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment

IEC 62359 - Ultrasonics - Field Characterization - Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields

NEMA UD 2 - Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3

IEC 62366-1 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices

Testing to the above-mentioned standards was performed on the proposed Ultrasound System 1300. The results of these tests demonstrate that the proposed device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

Biocompatibility:

The main 1300 console is not patient contacting. However, the transducers are patient contacting and categorized per Section 5.2 and Table A1 of AAMI/ANSI/ISO 10993-1 according to their clinical use. The transducers comply with the applicable biocompatibility standard requirements.

Sterilization:

The Ultrasound System 1300 is not sold as a sterile device. The transducers require reprocessing prior to use. Testing to support

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recommended methods for reprocessing was performed in accordance with TIR-12 and TIR-30.

Electrical Safety & Electromagnetic Compatibility (EMC):

Electrical safety testing is compliant with the following standards:

• AAMI/ANSI/ES 60601-1: Medical electrical equipment Part . 1: General requirements for basic safety and essential performance
• IEC 60601-1-2: Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. The Ultrasound System 1300 complies with EN IEC 62304, Medical Device Software Life-Cycle Processes. The submission contains performance data which demonstrates conformance to special controls for medical devices containing software.

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:

The proposed Ultrasound System 1300 is substantially equivalent to the predicate BK2300 Ultrasound Scanner (K161960). The differences between the proposed and predicate device do not impact the safety and effectiveness of the proposed device. Performance testing supports that the proposed device is substantially equivalent to the legally marketed predicate device.

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.