Ultrasound System 1300

K231764 · Bk Medical Aps · IYN · Oct 23, 2023 · Radiology

Device Facts

• Record ID: K231764
• Device Name: Ultrasound System 1300
• Applicant: Bk Medical Aps
• Product Code: IYN · Radiology
• Decision Date: Oct 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

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.

Device Story

Ultrasound System 1300 is a mobile, software-controlled diagnostic ultrasound system for professional healthcare environments. It acquires, processes, and displays ultrasound data via a mobile console with a 19-inch clinical display and glass touchpad. The system supports various multi-frequency transducers for imaging, flow analysis, and biopsy guidance. It includes the Prostate Volume Assist (PVA) AI feature, which automates initial caliper placement for prostate volume calculations. Clinicians use the system to visualize anatomy and blood flow; the output assists in diagnostic decision-making and procedural guidance. The system provides thermal and mechanical indices for safety monitoring.

Clinical Evidence

No clinical studies were required. Bench testing confirmed compliance with safety and performance standards (IEC 60601-1, IEC 60601-2-37, IEC 62359). AI feature (PVA) validation used 13,952 diseased and 505 healthy images for training, with separate validation and test sets. Performance was verified by comparing automated caliper placement against manual placement by clinical experts (approx. 15 years' experience), showing mean deviations of 11% +/- 6% (transducer 9018) and 7% +/- 15% (transducer 9048).

Technological Characteristics

Mobile console with 19-inch optical bonded glass display and glass touch UI. Supports multi-frequency transducers (surface, endocavity, intraoperative). Connectivity includes DICOM (NEMA PS3.1-3.20). Software follows IEC 62304. Safety standards: ANSI/AAMI/ES 60601-1, IEC 60601-2-37, IEC 60601-1-2. Biocompatibility per ISO 10993-1. Features include B-mode, M-mode, VFI, Strain Elastography, CW Doppler, Contrast Imaging, PWD, and CFM.

Indications for Use

Indicated for fetal (obstetrics), abdominal, pediatric, small organ, adult cephalic (trans-cranial), neonatal cephalic, intra-operative, intra-operative neuro (neurosurgery), trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), cardiac adult, and peripheral vessel imaging in adult and pediatric populations. Contraindicated for ophthalmic use or any use causing the acoustic beam to pass through the eye. Cardiac adult application is not intended for direct use on the heart.

Regulatory Classification

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.

Predicate Devices

• Ultrasound System 1300 (K173569)

Reference Devices

• Ultrasound System 2300 (K223830)

Submission Summary (Full Text)

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October 23, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

BK Medical ApS c/o Bryan Behn Regulatory Affairs Director Mileparken 34 Herlev. 2730 DENMARK

Re: K231764

Trade/Device Name: Ultrasound System 1300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: September 22, 2023 Received: September 25, 2023

Dear Bryan Behn:

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K231764

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-raginal. Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).

Modes of Operation:

- · 2D (B-Mode) (including Tissue Harmonic imaging)
- · M-Mode
- · Vector Flow Imaging (VFI)
- Strain Elastography
- · CW Doppler
- · Contrast Imaging
- · PWD Mode
- · CFM Mode (Includes Color Doppler and Amplitude (Power) Doppler)

#### Environment:

The Ultrasound System 1300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices)

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 Medical, a GE Healthcare company. The logo features the letters "bk" in a bold, green font, stacked above the word "medical" in a smaller, green font. Below "medical" is the text "a GE Healthcare company" in a smaller, lighter font. To the right of the "bk" is a stylized graphic of three curved lines, also in green, that resemble sound waves or a signal.

## K231764

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| I. Submitter: | BK Medical ApS<br>Mileparken 34<br>Herlev 2730<br>Denmark |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | BK Medical ApS<br>Mileparken 34<br>Herlev 2730<br>Denmark |
| Primary Contact Person: | Inesa Cernajute<br>Senior Regulatory Affairs Specialist<br>BK Medical<br>Tel: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | October 18, 2023 |

#### 儿 Device Names / Common Names / Classification Names:

| Trade Names: | Ultrasound System 1300 |
|-----------------------|------------------------------------------|
| Common Name: | Ultrasound System |
| Classification Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN (primary), IYO, ITX, QIH (secondary) |
| Class: | II |
| Regulation Number: | 21 CFR §892.1550, §892.1560, §892.1570 |
| Classification Panel: | Radiology |

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#### III. Identification of Predicate or Legally Marketed Devices:

- Primary predicate device: Ultrasound System 1300 as cleared under 510(k) premarket notification No K173569.

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

- . Reference predicate device: Ultrasound System 2300 as cleared under 510(k) premarket notification No K223830.

| Trade Name: | Ultrasound System 2300 |
|-----------------------|------------------------------------------|
| Common Name: | Ultrasound System |
| Classification Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN (primary), IYO, ITX (secondary) |
| Class: | II |
| Regulation Number: | 21 CFR §892.1550, §892.1560, §892.1570 |
| Classification Panel: | Radiology |

The Ultrasound system 1300 is marketed under the marketing name bkSpecto

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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 system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a glass touchpad, a 19" Clinical display monitor (CDM). In addition to this a variety of system accessories are available such as baskets, foot switch, printer start-up kit, and extra holders.

| Catalog/<br>Reference<br>(REF) | Model | Model Description |
|--------------------------------|--------------------------------------|------------------------------------|
| 1300 | 1300-21<br>Image: Ultrasound machine | Model with rechargeable battery |
| 1300 | 1300-25 | Model without rechargeable battery |

Table 1: Ultrasound System 1300

The various configurations of the Ultrasound System 1300 are intended to be used with various multi-frequency transducers (see Table 2). The indicated uses are different and specific for each transducer listed.

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| Name Description | #Reference |
|----------------------------------------------------|------------|
| ENDOCAVITY TRANSDUCER E10C4 | 9019 |
| BIPLANE ENDOCAVITY TRANSDUCER E11C3b | 9008 |
| TRIPLANE ENDOCAVITY TRANSDUCER E14C4t | 9018 |
| ENDFIRE ENDOCAVITY TRANSDUCER E13C2 | 9029 |
| BIPLANE ENDOCAVITY TRANSDUCER E14CL4b | 9048 |
| CURVED ARRAY TRANSDUCER 9C2 | 9002 |
| SMALL CURVED ARRAY TRANSDUCER 6C2s | 9023 |
| CURVED ARRAY TRANSDUCER 6C2 | 9040 |
| CURVED ARRAY TRANSDUCER 5C1e | 9085 |
| PHASED ARRAY TRANSDUCER 5P1e | 9087 |
| HOCKEY STICK TRANSDUCER X18L5s | 9009 |
| WIDE LINEAR ARRAY TRANSDUCER 13L4w | 9011 |
| LINEAR ARRAY TRANSDUCER 8L2 | 9032 |
| LINEAR ARRAY TRANSDUCER 14L3 | 9051 |
| HIGH-FREQUENCY LINEAR ARRAY<br>TRANSDUCER<br>18L5 | 9070 |
| HIGH-FREQUENCY LINEAR ARRAY<br>TRANSDUCER<br>18L5s | 9081 |
| LINEAR ARRAY TRANSDUCER 14L3e | 9086 |
| 3D ENDOCAVITY TRANSDUCER X14L4 | 9038 |
| ANORECTAL TRANSDUCER 20R3 | 9052 |
| I-SHAPED INTRAOPERATIVE TRANSDUCER I14C5I | 9015 |
| T-SHAPED INTRAOPERATIVE TRANSDUCER I14C5T | 9016 |
| BIPLANE INTRAOPERATIVE TRANSDUCER I12C5b | 9024 |
| ROBOTIC DROP-IN TRANSDUCER X12C4 | 9026 |
| CURVED ARRAY CRANIOTOMY TRANSDUCER N13C5 | 9062 |
| BURR HOLE TRANSDUCER N11C5s | 9063 |

Table 2: Transducers used with Ultrasound System 1300

#### V. Indications / Intended Use:

### Indications for 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.

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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).

Modes of Operation:

- · 2D (B-Mode) (including Tissue Harmonic imaging)
- M-Mode
- · Vector Flow Imaging (VFI)
- Strain Elastography
- · CW Doppler
- Contrast Imaging
- PWD Mode
- · CFM Mode (Includes Color Doppler and Amplitude (Power) Doppler)

### Environment:

The Ultrasound System 1300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices).

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.

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#### Mi Comparison of Technological Characteristics with the Predicate Device

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

| | Ultrasound System 1300 | Ultrasound System 1300 | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Proposed device<br>(K231764) | Primary Predicate<br>(K173569) | Comment on<br>Comparison |
| Manufacturer | BK Medical ApS | BK Medical ApS | Same |
| Common Name | Ultrasound System | Ultrasound System | Same |
| Name<br>(Configuration<br>models) | bkSpecto (1300-21,<br>1300-25) | bkSpecto (1300-21) | Added:<br>- bkSpecto 1300-25- a<br>model without battery.<br>- Prostate Volume Assist<br>(PVA), AI software<br>feature. |
| Mode of Operation | B, M, PW, CFM, P, THI,<br>SE, CW<br>Combination modes:<br>2D+M, 2D+PW,<br>2D+C+PW, 2D+P+PW,<br>2D+2D, 2D+2D (Biplane<br>Imaging), 2D+(2D+C),<br>2D+(2D+P), 2D+THI,<br>2D+SE<br>· 2D (B-Mode)<br>(including Tissue<br>Harmonic imaging)<br>• M-Mode<br>· Vector Flow Imaging<br>(VFI) | B, M, PW, CFM, P, THI,<br>SE, CW<br>Combination modes:<br>2D+M, 2D+PW,<br>2D+C+PW, 2D+P+PW,<br>2D+2D, 2D+2D (Biplane<br>Imaging), 2D+(2D+C),<br>2D+(2D+P), 2D+THI,<br>2D+SE<br>· 2D (B-Mode)<br>(including Tissue<br>Harmonic imaging)<br>• M-Mode<br>• Vector Flow Imaging<br>(VFI) | Same - primary predicate<br>Equivalent - ref. predicate |
| | Ultrasound System 1300 | Ultrasound System 1300 | |
| Characteristic | Proposed device<br>(K231764) | Primary Predicate<br>(K173569) | Comment on<br>Comparison |
| | • Strain Elastography<br>• CW Doppler<br>• Contrast Imaging<br>• PWD Mode<br>• CFM Mode<br>(Includes Color<br>Doppler and<br>Amplitude (Power)<br>Doppler) | • Strain Elastography<br>• CW Doppler<br>• Contrast Imaging<br>• PWD Mode<br>• CFM Mode<br>(Includes Color<br>Doppler and<br>Amplitude (Power)<br>Doppler) | |
| Intended Use | Intended Use:<br>The system is a<br>diagnostic ultrasound<br>imaging system used by<br>qualified and trained<br>healthcare professionals<br>for ultrasound imaging,<br>human body fluid flow<br>analysis and puncture and<br>biopsy guidance. | Intended Use:<br>The system is a<br>diagnostic ultrasound<br>imaging system used by<br>qualified and trained<br>healthcare professionals<br>for ultrasound imaging,<br>human body fluid flow<br>analysis and puncture<br>and biopsy guidance. | Same |
| | Environment:<br>The Ultrasound System<br>1300 is intended for use<br>in the professional<br>healthcare environment<br>(e.g., hospitals, physician<br>offices).<br><br>Contraindications:<br>The Ultrasound System<br> | Environment:<br>The Ultrasound System<br>1300 is intended for use<br>in the professional<br>healthcare environment<br>(e.g., hospitals, physician<br>offices).<br><br>Contraindications:<br>The Ultrasound System<br>1300 is not intended for | |
| | Ultrasound System 1300 | Ultrasound System 1300 | |
| Characteristic | Proposed device<br>(K231764) | Primary Predicate<br>(K173569) | Comment on<br>Comparison |
| | causing the acoustic beam<br>to pass through the eye.<br>The Cardiac Adult<br>application is not<br>intended for direct use on<br>the heart. | causing the acoustic beam<br>to pass through the eye.<br>The Cardiac Adult<br>application is not<br>intended for direct use on<br>the heart. | |
| Indications/Clinical<br>Applications | • Fetal (including<br>Obstetrics)<br>• Abdominal<br>• Pediatric1<br>• Intraoperative1,2<br>• Intraoperative Neuro<br>(also known as<br>Neurosurgery)1<br>• Small Organ (Small<br>Parts)3<br>• Adult Cephalic<br>(cephalic is also known<br>as Adult trans-cranial)1<br>• Neonatal Cephalic1<br>• Transrectal<br>• Transvaginal<br>• Musculoskeletal<br>(Conventional)<br>• Musculoskeletal<br>(Superficial)<br>• Cardiac Adult<br>• Peripheral Vessel<br>(Peripheral) | • Fetal (including<br>Obstetrics)<br>• Abdominal<br>• Pediatric1<br>• Intraoperative1,2<br>• Intraoperative Neuro<br>(also known as<br>Neurosurgery)1<br>• Small Organ (Small<br>Parts)3<br>• Adult Cephalic<br>(cephalic is also known<br>as Adult trans-cranial)1<br>• Neonatal Cephalic1<br>• Transrectal<br>• Transvaginal<br>• Musculoskeletal<br>(Conventional)<br>• Musculoskeletal<br>(Superficial)<br>• Cardiac Adult<br>• Peripheral Vessel<br>(Peripheral) | Identical |
| | Ultrasound System 1300 | | |
| Characteristic | Proposed device<br>(K231764) | Primary Predicate<br>(K173569) | Comment on<br>Comparison |
| Application<br>Environment | Professional healthcare<br>facility environment | Professional healthcare<br>facility environment | Same |
| Users | Qualified Professional<br>users | Qualified Professional<br>users | Same |
| Patient Population | Adult, Pediatric | Adult, Pediatric | Same |
| Transducer types | Surface<br>Endocavity<br>Intraoperative | Surface<br>Endocavity<br>Intraoperative | Identical |
| System Transducers | 9002, 9008, 9009, 9011,<br>9015, 9016, 9018, 9019,<br>9023, 9024, 9026, 9029,<br>9032, 9038, 9040, 9048,<br>9051, 9052, 9062, 9063,<br>9070, 9081, 9085, 9086,<br>9087 | 9002, 9008, 9009, 9011,<br>9015, 9016, 9018, 9019,<br>9022, 9023, 9024, 9026,<br>9029, 9032, 9038, 9040,<br>9048, 9051, 9052, 9062,<br>9063, 9067, 9070, 9081,<br>9085, 9086, 9087 | Since 2017 the following<br>transducers have been<br>terminated:9022 and 9067 |
| Biocompatibility | The Ultrasound System<br>does not come in contact<br>with the patient. | The Ultrasound System<br>does not come in contact<br>with the patient. | Same |
| Hardware | Clinical display monitor<br>(CDM):<br>• 19" Optical bonded<br>glass front.<br>• Can be tilted and<br>moved sideways.<br><br>Cart:<br>• adjustable height and<br>with 4 lockable wheels<br><br>Keyboard:<br>Glass touch UI | Clinical display monitor<br>(CDM):<br>• 19" Optical bonded<br>glass front.<br>• Can be tilted and<br>moved sideways.<br><br>Cart:<br>• adjustable height and<br>with 4 lockable wheels<br><br>Keyboard:<br>Glass touch UI | Same - primary predicate<br>Equivalent - ref. predicate |
| | Ultrasound System 1300 | Ultrasound System 1300 | |
| Characteristic | Proposed device<br>(K231764) | Primary Predicate<br>(K173569) | Comment on<br>Comparison |
| | Scan engine:<br>• 3 Transducer ports<br>• 64 TX/RX channels | Scan engine:<br>• 3 Transducer ports<br>64 TX/RX channels | |
| OS Software | Windows 10 | Windows 8.1 Industrial | Updated to Windows 8 OS to Windows 10. |
| Options | - 3D Freehand<br>- 3D Professional<br>- DICOM Encrypted<br>- Vector Flow Imaging (VFI)<br>- Varian Interface<br>- Strain Elastography<br>- Needle Enhancement (X-shine)<br>- Wi-Fi<br>- bkViewer (SW running on a mac/windows pc) – not a medical device<br>- Prostate Volume Assist (PVA) | - 3D Freehand<br>- 3D Professional<br>- DICOM Encrypted<br>- Vector Flow Imaging (VFI)<br>- Varian Interface<br>- Strain Elastography<br>- Needle Enhancement (X-shine)<br>- Wi-Fi | - Proposed a new Prostate Volume Assist (PVA), AI software feature that has been recently cleared under K223830 for the Reference Predicate device Ultrasound System 2300. PVA provides a workflow improvement to an existing prostate volume measurement and calculation tool.<br>It will require the same biplane/triplane transrectal transducers (9008, 9018, 9048) that are being used for existing prostate volume calculations and measurements. |
| Image features | Speckle reduction, compound imaging, tissue harmonic imaging (thi), trapezoid scanning (virtual convex) strain, elastography (se) | Speckle reduction, compound imaging, tissue harmonic imaging (thi), trapezoid scanning (virtual convex) strain, elastography (se) | Same |
| | Ultrasound System 1300 | Ultrasound System 1300 | |
| Characteristic | Proposed device<br>(K231764) | Primary Predicate<br>(K173569) | Comment on<br>Comparison |
| UI Design | -19-inch Clinical Monitor<br>and touch input device<br>for user interaction.<br>-Touchpad track pad for<br>cursor control (Glass<br>Touch UI)<br>-Full configurable<br>interaction controls<br>(size/position) | -19-inch Clinical Monitor<br>and touch input device<br>for user interaction.<br>-Touchpad track pad for<br>cursor control (Glass<br>Touch UI)<br>-Full configurable<br>interaction controls<br>(size/position) | Same – primary predicate<br>Equivalent - ref. predicate |
| Standards | ELECTROMAGNETIC<br>COMPATIBILITY<br>Complies with<br>requirements for Class A<br>devices of IEC 60601-1-2<br><br>SAFETY<br>ANSI/ AAMI/ES 60601-<br>1,<br>IEC 60601-2-37<br><br>SOFTWARE/<br>FIRMWARE<br>IEC62304<br><br>CLEANING<br>VALIDATION<br>AAMI TIR12, AAMI<br>TIR30<br><br>DICOM<br>NEMA PS3.1-3.20<br>Digital Imaging and<br>Communications in<br>Medicine (DICOM) | ELECTROMAGNETIC<br>COMPATIBILITY<br>Complies with<br>requirements for Class A<br>devices of IEC 60601-1-<br>2<br><br>SAFETY<br>ANSI/ AAMI/ES 60601-<br>1,<br>IEC 60601-2-37<br><br>SOFTWARE/<br>FIRMWARE<br>IEC62304<br><br>CLEANING<br>VALIDATION<br>AAMI TIR12, AAMI<br>TIR30<br><br>DICOM<br>NEMA PS3.1-3.20<br>Digital Imaging and | Same - primary predicate<br>Equivalent - ref. predicate |
| | Ultrasound System 1300 | Ultrasound System 1300 | |
| Characteristic | Proposed device<br>(K231764) | Primary Predicate<br>(K173569) | Comment on<br>Comparison |
| | | Communications in<br>Medicine (DICOM) | |

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#### VII. Performance Data

#### Summary of non-clinical /Performance - Bench Testing

The proposed Ultrasound System 1300 and applied transducers, have been tested and conform to the following standards:

- . ANSI/AAMI/ES 60601-: 2005/ (R) 2012 and A1:2012, C1:2009/ (R) 2012 and A2:2010/ (R) 2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Ed. 4.0, 2014 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-37 Medical Electrical Equipment Part 2-37: Ed. 2.1, 2017 . Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
- IEC 62359: Ed. 2.1, 2017 Ultrasonics Field Characterization Test Methods for ● the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields
- AAMI/ANSI/ISO 10993-1: 2018 Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a Risk management Process
- AAMI TIR-12:2010 and AAMI TIR-30:2011 ●
- IEC 62304: 2006/A1:2016 - Medical Device Software Life-Cycle Processes (Software / Informatics)
- . NEMA PS3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM)
- ISO14971: 2019 Application of risk management to medical devices .

The following quality assurance measures are applied to the development of the system:

- · Risk Analysis
- Requirements Reviews
- · Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety testing (Verification)

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### AI Feature Summary of Testing - Prostate Volume Assist (PVA)

Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance.

| Patient Type | Training<br>Images | Deep<br>Learning<br>Validation<br>images | Test images<br>(Clinical<br>validation) | Comment |
|------------------|--------------------|------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------|
| Healthy | 505 | 190 | 975 | |
| Diseased | 13447 | 1189 | 1461 | Includes images from<br>Holland dataset that are<br>only used as Test<br>images. |
| Synthesized data | 4104 | 48 | 0 | |

- · The table summarizes number of datasets used for each different purpose.
• Gender: Male.

· Age: patients scheduled for prostates biopsies (54 - 78 yrs) and healthy patients 30 -60 yrs old; the specific age of each individual patient is not collected.

· Ethnicity/Country: Czech Republic, Holland. Note, European population is representative of the US population for the PVA - workflow improvement case.

· Mix of data from curved and linear arrays.

· For the testing process, the segmentation part of the algorithm is tested using a standard metric of similarity. The test passed. The final algorithm including both segmentation and caliper placement is verified by visual evaluations by clinical experts validation testing comparing the initial caliper placement by the algorithm compared to manual placement by clinical personnel. The purpose is to compare the prostate volume calculation of PVA with volume measurement performed by clinical personnel. The clinical personnel had an average of about 15 years' experience in ultrasound. We used a freeware tool developed by the Oxford Imaging Group for manual caliper placement on given images. For testing, we use two data sets that have not been part of the training of the algorithm. Representing the 9018, we clinical end-user test in the Czech Republic and representing the 9048 using data acquired by in Amsterdam, Holland. For the latter, we generated images that correspond the scanner preset. Prostate L, as the image depth is 6.5 cm, the recommended minimum depth for PVA. The human caliper setters scored the images individually. They received the following instructions; The calipers were set

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in pairs corresponding to a distance measurement, so calipers 1 and 2 form one distance measurement and calipers 3 and 4 form another distance measurement.

The validator used 2 distance measurements (using 4 calipers) on the transverse image and one distance measurement (using 2 calipers) on the sagittal image. The automatic initial placement was tested and determined for the 9018 to deviate 11% +/-6% compared to manual placement and for the 9048, the initial placement of the caliper is expected to deviate 7% +/- 15% compared to manual placement.

· The volumes used for test/validation purpose are completely distinct from the ones used during training process and there is no overlap between the two.

### Animal Testing

Not applicable - animal testing was not required to support substantial equivalence to the predicate device.

### Clinical Studies

Not applicable - clinical studies were not required to support substantial equivalence to the predicate device.

#### VIII. Conclusion

BK Medical ApS considers the proposed device to be as safe, as effective and performance is substantially equivalent to the predicate device(s).