Biim Diagnostic Ultrasound System

K173138 · Biim Ultrasound AS · IYO · Oct 27, 2017 · Radiology

Device Facts

• Record ID: K173138
• Device Name: Biim Diagnostic Ultrasound System
• Applicant: Biim Ultrasound AS
• Product Code: IYO · Radiology
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Biim™ Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: - Musculo-skeletal (conventional and superficial) - Needle guidance - Pediatric - Peripheral Vessel - Small Organ (breast, thyroid, parathyroid, testicles)

Device Story

Portable, software-controlled diagnostic ultrasound system; acquires/displays real-time ultrasound data. Components: wireless linear array transducer (L12-4), rechargeable battery, and COTS iOS/Android tablet running Biim app. Transducer communicates via Wi-Fi to tablet; user controls depth, image save, and freeze on tablet interface. Used by clinicians for imaging guidance (e.g., needle/catheter placement, nerve blocks) and diagnostic visualization. Output: high-resolution ultrasound images displayed on tablet; supports DICOM 3.0 storage/echo services. Benefits: portable, wireless imaging for point-of-care clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including system specifications, thermal, electromagnetic, and mechanical safety testing, and compliance with FDA-recognized consensus standards (IEC 60601 series, ISO 10993, ISO 14971).

Technological Characteristics

Wireless linear array transducer (4-12 MHz); 8 transmit/receive channels. Connectivity: Wi-Fi to COTS iOS/Android tablets. Materials: Biocompatible per ISO 10993. Power: User-replaceable 3.7V Li-ion battery. Safety: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2. Software: App-based, DICOM 3.0 compliant. Form factor: Handheld, 210g, 150x58x41mm.

Indications for Use

Indicated for diagnostic ultrasound imaging of the human body, including pediatric, small organ (breast, thyroid, parathyroid, testicles), musculoskeletal (conventional and superficial), peripheral vessel, and needle guidance applications. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Clarius Mobile Health Corp., Clarius Ultrasound System (K163138)

Reference Devices

• Philips Healthcare, Inc. Lumify Diagnostic Ultrasound System (K162549)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

October 27, 2017

Biim Ultrasound AS % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K173138

Trade/Device Name: Biim " Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX, LLZ Dated: September 27, 2017 Received: September 29, 2017

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

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

Sincerely.

Robert Oaks

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)

#### K173138

Device Name Biim™ Diagnostic Ultrasound System

Indications for Use (Describe)

The Biim™ Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

- · Musculo-skeletal (conventional and superficial)
- Needle guidance
- · Pediatric
- · Peripheral Vessel
- · Small Organ (breast, thyroid, parathyroid, testicles)

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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| System: | Biim ™™ Diagnostic Ultrasound System | | | | | | | | |
|------------------------------|-------------------------------------------------------------|--|-------------------|---|-----|-----|--------------------------|--------------------|---------------------------------------|
| Transducer: | Currently Supported (Note 1) | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging of the human body as follows: | | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | |
| General<br>(Track I<br>only) | Specific<br>(Tracks I & III) | | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(B+CD) | Other*<br>(Color<br>Power<br>Doppler) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| & Other | Pediatric | | N | | | | | | |
| | Small Organ (breast,<br>thyroid, testicles) | | N | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | | N | | | | | | |
| | Musculo-skel. (Superfic.) | | N | | | | | | |
| | Intravascular | | | | | | | | |
| | Other: (Gynecology) | | | | | | | | |
| | Other | | | | | | | | |
| | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | N | | | | | | |
| | Other: Needle guidance | | N | | | | | | |

## Table 1 - Indications for Use Form – Biim Diagnostic Ultrasound System

Prescription Use (Per 21 CFR 801.109)

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

#### Additional Comments:

*Examples of other modes of operation may include: A-mode, Amplitude Dopler, 3-D Imaging, Tissue Motion Doppler, and Color Velocity Imaging

1. Supported transducer models are: Biim L12-4 Linear Array Transducer See the corresponding table.

2. Includes imaging to assist in the placement of needles and catheters in vascular or other and imaging guidance for nerve block procedures.

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| Biim™ Diagnostic Ultrasound System | | | | | | | | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|-----------------|------------------------------------|
| System: | | | | | | | | | |
| Transducer: | | L12-4 Linear Array Transducer | | | | | | | |
| Intended Use: | | Diagnostic ultrasound imaging of the human body as follows: | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | |
| General<br>(Track I<br>only) | Specific<br>(Tracks I & III) | | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined (B+CD) | Other*<br>(Color Power<br>Doppler) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging | Fetal<br>Abdominal<br>Intra-operative (Abdominal organs and vascular)<br>Intra-operative (Neuro.)<br>Laparoscopic | | | | | | | | |
| & Other | Pediatric<br>Small Organ (breast, thyroid, testicles)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph. (non-Card.)<br>Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Intravascular<br>Other: (Gynecology)<br>Other: | | N | | | | | | |
| Cardiac | Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal (card.)<br>Intra-cardiac<br>Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel<br>Other: Needle guidance | | N | | | | | | |

## Table 2 - Indications for Use Form – Biim L12-4 Linear Array Transducer

Prescription Use (Per 21 CFR 801.109)

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

## Additional Comments:

*Examples of other modes of operation may include Dopler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

1. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.

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# biir

# 510(k) Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92(c) the following summary of information is provided:

| Date Prepared: | August 11, 2017 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Biim Ultrasound AS<br>Frydenlundsgt 9<br>Narvik, Norway 8516 |
| Contact Person: | Christopher Hartzog<br>CHRQ Consulting, LLC |
| Telephone: | 425.954.6312 |
| FR Numbers/Product<br>Codes: | 892.1560/IYO, Ultrasonic Pulsed Echo Imaging System<br>892.1570/ITX, Diagnostic Ultrasound Transducer |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Trade Name: | Biim™ Diagnostic Ultrasound System |
| Regulatory Class: | Class II |
| Classification Panel: | Radiology |
| Predicate Device: | (K163138) Clarius Mobile Health Corp., Clarius Ultrasound System (Primary<br>Predicate)<br>(K162549) Philips Healthcare, Inc. Lumify Diagnostic Ultrasound System<br>(Reference Device) |
| Intended Use/<br>Indications For Use: | The Biim Ultrasound System is intended for diagnostic ultrasound imaging of<br>the human body. Specific clinical applications include:<br>• Musculo-skeletal (conventional and superficial)<br>• Needle guidance<br>• Pediatric<br>• Peripheral Vessel<br>• Small Organ (breast, thyroid, parathyroid, testicles) |

Biim Ultrasound AS Frydenlundsgata 9 8516 Narvik Norway
Org no. 896 449 052

510(k) Summary

Biim Ultrasound Inc.
3651 FAU Blvd, Suite 400 Boca Raton, FL 33431 USA
EIN 47 - 1401793

Biim Ultrasound OY
Elektroniiekkatie 3 90590 Oulu Finland Y-tunnus:2664426-9

biimultrasound.com

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| Device Description: | The Biim Diagnostic Ultrasound System is a portable, general-purpose,<br>software-controlled sonography system based on a digital architecture used to<br>acquire and display high-resolution, real-time ultrasound data through a<br>commercial off-the-shelf iOS or Android device. The Biim Diagnostic Ultrasound<br>System supports wireless transducer connectivity of the ultrasound images to<br>the display device.<br><br>The Biim Diagnostic Ultrasound System consists of:<br>A commercial off-the-shelf iOS or Android display device Biim Ultrasound software running as an app on the display device The wireless Biim linear array transducer with Biim Ultrasound firmware. Lithium-Ion rechargeable battery Battery charger |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of the<br>Design and<br>Technological<br>Characteristics | The Biim Diagnostic Ultrasound System has similar indications for use,<br>construction, manufacturing materials, operating principals and specifications as<br>the predicate device.<br><br>The Biim Diagnostic Ultrasound System is similar to the Clarius Ultrasound<br>System in that it is also a portable, general-purpose, software-controlled,<br>diagnostic ultrasound system used to acquire and display high-resolution, real-<br>time ultrasound data through a commercial off-the-shelf (COTS) iOS or Android<br>display device. Comparable to the Clarius Ultrasound System, the Biim<br>Diagnostic Ultrasound System employs wireless transducers employing Wi-Fi-<br>based technology to communicate with tablet devices. This allows the user to<br>export ultrasound images and display them upon Apple iOS or Android portable<br>personal devices.<br><br>The principle difference between the Biim Diagnostic Ultrasound System and its<br>predicate Clarius device is that the Biim Diagnostic Ultrasound System includes<br>DICOM 3.0 storage and echo service class user features while the Clarius<br>device does not.<br><br>The Philips Lumify device is provided as a reference device due to its<br>comparable technology to the Biim Diagnostic Ultrasound System specifically its<br>use of DICOM 3.0 services and an L12-4 linear array transducer.<br><br>A comparison of the clinical, design and technological characteristics of the Biim<br>Diagnostic Ultrasound System to the currently marketed, primary predicate<br>device and reference device is provided in Table 1 and Table 2 below. |

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| | Submitted Device<br>Biim Ultrasound AS | Primary Predicate Device<br>Clarius Mobile Health | Reference Device<br>Philips Healthcare |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Clinical Uses | Biim Diagnostic<br>Ultrasound System<br>(this premarket<br>notification) | Clarius Ultrasound<br>System<br>(K163138) | Lumify Ultrasound<br>System<br>(K162549) |
| Intended Use | Diagnostic ultrasound<br>imaging of the human<br>body. | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body. | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body. |
| Indications for Use | | | |
| Pediatric applications | Yes | Yes | Yes |
| Small Organ (breast, thyroid,<br>testicles) applications | Yes | Yes | Yes |
| Musculo-skel. (Convent.)<br>applications | Yes | Yes | Yes |
| Musculo-skel. (Superfic.)<br>applications | Yes | Yes | Yes |
| Peripheral vessel<br>applications | Yes | Yes | Yes |
| Needle guidance<br>applications | Yes | Yes | |
| Patient Group | | | |
| Gender: Both sexes allowed | Yes | Yes | Yes |
| Patient age: Adult, Pediatric | Yes | Yes | Yes |
| | | Primary Predicate<br>Device | Reference Device |
| | Submitted Device | | |
| | Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare |
| Technical Features | Biim Diagnostic<br>Ultrasound System<br>(this premarket<br>notification) | Clarius Ultrasound<br>System<br>(K163138) | Lumify Ultrasound<br>System<br>(K162549) |
| System features | Wireless Transducer<br>iPad or Android Tablet<br>Console | Wireless Transducer<br>iPad or Android Tablet<br>Console | USB Transducer<br>Android Tablet Console |
| Transducer Types | L12-4 Linear Array -<br>Wireless | L7 Linear Array -<br>Wireless | L12-4 Linear Array -<br>USB Cable |
| | | C3 Curved Linear Array -<br>Wireless | C5-2 Curved Linear<br>Array - USB Cable |
| Transducer Frequency | 4 - 12 MHz | 4 - 13 MHz | 4 - 12 MHz |
| Global Maximum | $I_{spta.3}: ≤ 720 mW/cm2$ | $I_{spta.3}: ≤ 720 mW/cm2$ | $I_{spta.3}: ≤ 720 mW/cm2$ |
| Outputs/Worst Case Setting | MI ≤ 1.9 | MI ≤ 1.9 | MI ≤ 1.9 |
| (non-opthalmic) | TI ≤ 6.0 | TI ≤ 6.0 | TI ≤ 6.0 |
| | Display Feature for<br>Higher Outputs | Display Feature for<br>Higher Outputs | Display Feature for<br>Higher Outputs |
| Acoustic Output Display | MI Output Display | MI Output Display | MI Output Display |
| | TI Output Display | TI Output Display | TI Output Display |
| Modes of Operation | B-mode Grayscale<br>Imaging | B-mode Grayscale<br>Imaging, color velocity<br>and combined modes. | B-mode Grayscale<br>Imaging, Color Doppler<br>and combined modes. |
| No. Transmit Channels | 8 | Unknown | Unknown |
| No. Receive Channels | 8 | Unknown | Unknown |
| DICOM | DICOM 3.0 storage and<br>echo service class user<br>features. | None | DICOM 3.0 storage,<br>print, and modality<br>worklist service class<br>user features. |
| | NEMA PS3 2016 | | NEMA PS3 2016 |
| Patient Contact Materials | All patient contact<br>materials biocompatible<br>per ISO 10993 series | Biocompatible per<br>K163138 | Biocompatible per<br>K152899 |
| Product Safety Certification | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-2-37 | IEC 60601-2-37 | IEC 60601-2-37 |
| | Device with transducers:<br>Class II/internally<br>powered ME equipment. | Device with transducers:<br>Class II/internally<br>powered ME equipment. | Device with<br>transducers: Class<br>II/internally powered ME<br>equipment. |
| | Transducers: Type BF<br>Applied parts, IPX7 | Transducers: Type BF<br>Applied parts, IP37 | Transducers: Type BF<br>Applied parts, IP47 |
| | Ordinary<br>Equipment/Continuous<br>Operation | Ordinary<br>Equipment/Continuous<br>Operation | Ordinary<br>Equipment/Continuous<br>Operation |
| | | | Non AB/APG |
| | Submitted Device | Primary Predicate Device | Reference Device |
| | Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare |
| Technical Features | Biim Diagnostic<br>Ultrasound System<br>(this premarket<br>notification)<br>Non-AP/APG | Clarius Ultrasound<br>System<br>(K163138) | Lumify Ultrasound<br>System<br>(K162549) |
| EMC Compliance | IEC 60601-1-2<br>FCC Part 15<br>ETSI EN 300 328<br>ETSI EN 301 489<br>Bluetooth 2.0<br>IEEE 802.11 b/g | IEC 60601-1-2<br>FCC Part 15<br>ETSI EN 300 328<br>ETSI EN 301 489 | IEC 60601-1-2 |
| | Supported Display:<br>Apple iPad and Android<br>Tablets | Supported Display:<br>Apple iPad and Android<br>Tablets | Supported Display:<br>Android Tablets |
| | 256 gray shades in 2D | 256 gray shades in 2D | 256 gray shades in 2D |
| | Small, handheld and<br>battery operated probe. | Small, handheld and<br>battery operated probe. | Small, handheld probe. |
| | Remotely control the<br>ultrasound system | Remotely control the<br>ultrasound system | |
| | Ultrasound Transmit,<br>Receive and processing<br>functions for basic 2D<br>imaging | Ultrasound Transmit,<br>Receive and processing<br>functions for basic 2D<br>imaging | Ultrasound Transmit,<br>Receive and processing<br>functions for 2D and<br>color imaging |
| | Transmit voltage and<br>current monitoring with<br>hardware limits to ensure<br>safe and proper<br>operation. | Transmit voltage and<br>current monitoring with<br>hardware limits to ensure<br>safe and proper<br>operation. | Transmit voltage and<br>current monitoring with<br>hardware limits to<br>ensure safe and proper<br>operation. |
| | Power On/Off button | Power On/Off button | Power On/Off button |
| System Characteristics | User controls for depth,<br>image save and freeze. | User controls for depth,<br>image save and freeze. | User controls for depth,<br>image save and freeze. |
| | Led indicator for<br>On/Off/standby/error<br>status and Tablet link<br>status. | Led indicator for<br>On/Off/standby/error<br>status and Tablet link<br>status. | |
| | User replaceable battery<br>to allow for continuous<br>use. | User replaceable battery<br>to allow for continuous<br>use. | Receives power from<br>tablet via USB |
| | Probe wireless<br>connectivity to tablet | Probe WiFi wireless<br>connectivity to tablet | Probe USB cable<br>connection to tablet |
| | Small handheld probe:<br>• Height: 41 mm (1.61<br>in)<br>• Width: 58 mm (2.28<br>in)<br>• Length: 150 mm (5.90<br>in) | | |
| | | Small handheld probe | Small handheld probe |
| | Lightweight, ergonomic<br>design | Lightweight, ergonomic<br>design | Lightweight, ergonomic<br>design |
| | Submitted Device | Primary Predicate<br>Device | Reference Device |
| | Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare |
| Technical Features | Biim Diagnostic<br>Ultrasound System<br>(this premarket<br>notification) | Clarius Ultrasound<br>System<br>(K163138) | Lumify Ultrasound<br>System<br>(K162549) |
| | · Weight : 210 g (7.4 oz) | | |
| Operating Environmental<br>Limits | 5 to 90% RH non-<br>condensing<br>10°C (50°F) to 30°C<br>(86°F) | 620 hPa to 1060 hPa<br>15 to 95% RH<br>0°C (32°F) to 40°C<br>(104°F) | 700 hPa to 1060 hPa<br>15 to 95% RH<br>5°C (41°F) to 40°C<br>(104°F) |
| Storage Environmental<br>Limits | 5to 95% RH<br>-20°C (-4°F) to 60°C<br>(140°F) | 0 to 95% RH<br>-20°C (-4°F) `to 50°C<br>(122°F) | 500 hPa to 1060 hPa<br>0 to 95% RH<br>-34°C (-29°F) to 70°C<br>(158°F) |
| | Battery charger for<br>detachable battery | Battery charger for<br>replaceable battery | Receives power from<br>tablet via USB |
| Power Supply/Battery<br>Charger | Input: 100V - 240 V<br>Rating Frequency:<br>50/60Hz<br>Output: 5VDC 1.0 A | Input: 100V - 240 V<br>Rating Frequency:<br>50/60Hz<br>Output: 12VDC 1.5 A | |
| Battery | User replaceable<br>Li-lon battery pack, 3.7V | User replaceable<br>Li-lon battery pack, 3.7V | N/A - Probe receives<br>power from tablet via<br>USB cable |
| 510(k) Track | Track 3 | Track 3 | Track 3 |

## Table 1 - Predicate Comparison Chart - Clinical Uses

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Table 2 - Predicate Comparison Chart - Technical Features

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## Determination of Substantial Equivalence

They Biim Diagnostic Ultrasound System is a Track 3 system that employs the same fundamental scientific technology as that cleared with the Clarius Ultrasound System (K163138). All indications for use introduced by Biim Ultrasound are indications used by the predicate device.

| Summary of<br>Non-Clinical Tests: | The Biim Diagnostic Ultrasound System has been found to conform to the system<br>specifications, thermal, electromagnetic and mechanical safety, and to FDA<br>consensus, medical device safety standards, and international harmonized standards.<br>The Biim Diagnostic Ultrasound System and its applications comply with the following<br>standards: | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 1. | AAMI/ANSI/ES 60601-1:2005/(R)2012 And A1:2012 Medical electrical<br>equipment - Part 1: General requirements for basic safety and essential<br>performance | |
| | 2. | AAMI/ANSI/IEC 60601-1-2 Medical Electrical Equipment, Part 1: General<br>requirements for safety - Collateral standard: Electromagnetic<br>compatibility - Requirements and tests | |
| | 3. | IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular<br>requirements for the basic safety and essential performance of ultrasonic<br>medical diagnostic and monitoring equipment | |

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| 4. | IEC 62304 Medical device software - Software life cycle processes |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5. | AAMI/ANSI/IEC 62366-1:2015 Medical devices - Application of usability<br>engineering to medical devices |
| 6. | AAMI/ANSI/ISO 10993-1 Biological evaluation of medical devices - Part 1:<br>Evaluation and testing |
| 7. | AAMI/ANSI/ISO 10993-5:2014 Biological evaluation of medical devices -<br>Part 5: Tests for in vitro cytotoxicity |
| 8. | AAMI/ANSI/ISO 10993-10:2014 Biological evaluation of medical devices -<br>Part 10: Tests for irritation and delayed-type hypersensitivity |
| 9. | ISO 14971 Medical devices – application of risk management to medical<br>devices |
| The following quality assurance measures were applied to the development of the<br>system: | |
| | • Risk Analysis |
| | • Requirements Reviews |
| | • Design Reviews |
| | • Testing on unit level (Module verification) |
| | • Integration testing (System verification) |
| | • Final Acceptance Testing (Validation) |
| | • Performance testing (Verification) |
| | • Safety testing (Verification) |
| | • Usability validation |
| Patient contact materials are biocompatible. | |
| <b>Summary of<br/>Clinical Tests</b> | The Biim Diagnostic Ultrasound System introduces no new indications for use, modes,<br>features, or technologies as compared to the currently marketed and predicate device<br>that require clinical testing. The clinical safety and effectiveness of ultrasound systems<br>with these characteristics are well accepted for both the currently marketed predicate<br>and subject device. |
| <b>Conclusions:</b> | The Biim Diagnostic Ultrasound System has similar indications for use, construction,<br>manufacturing materials, operating principals and specifications as the predicate device.<br>Therefore, Biim Ultrasound AS considers the Biim Diagnostic Ultrasound System<br>substantially equivalent to the predicate device. |
| <b>514 Performance<br/>Standards:</b> | There are no Sec. 514 performance standards for this device. |
| <b>Prescription Status:</b> | This is a prescription device. The prescription device statement appears in the labeling. |
| <b>Sterilization Sites:</b> | Not applicable. No components supplied sterile. |
| <b>Track:</b> | This is a Track 3 device. |