(28 days)
No
The document does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The description focuses on standard ultrasound technology and software control.
No.
The device is clearly described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging of the human body," and it does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Biim™ Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging of the human body."
No
The device description explicitly states that the system consists of a wireless Biim linear array transducer with firmware, a lithium-ion rechargeable battery, and a battery charger, in addition to the software and display device. This indicates the presence of hardware components beyond just the software running on a commercial device.
Based on the provided information, the Biim™ Diagnostic Ultrasound System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging of the human body." This describes a system used to visualize internal structures of the body, which is the core function of an ultrasound machine.
- Device Description: The description details a system for acquiring and displaying real-time ultrasound data. This aligns with the function of an imaging device, not a device that performs tests on biological samples in vitro (outside the body).
- Input Imaging Modality: The input modality is "Ultrasound," which is an imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The listed anatomical sites are parts of the human body being imaged, not biological samples being tested.
- No mention of analyzing biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological specimen.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or treatment. The Biim Diagnostic Ultrasound System is an imaging device used to visualize the body directly.
N/A
Intended Use / Indications for 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)
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX, LLZ
Device Description
The Biim Diagnostic Ultrasound System is a portable, general-purpose, software-controlled sonography system based on a digital architecture used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf iOS or Android device. The Biim Diagnostic Ultrasound System supports wireless transducer connectivity of the ultrasound images to the display device.
The Biim Diagnostic Ultrasound System consists of:
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
Mentions image processing
Ultrasound Transmit, Receive and processing functions for basic 2D imaging
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body
Indicated Patient Age Range
Adult, Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Biim Diagnostic Ultrasound System introduces no new indications for use, modes, features, or technologies as compared to the currently marketed and predicate device that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both the currently marketed predicate and subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
| 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 | |||||||||
| (Track I | |||||||||
| only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | |||||||||
| (CD) | Combined | ||||||||
| (B+CD) | Other* | ||||||||
| (Color | |||||||||
| Power | |||||||||
| Doppler) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| & Other | Pediatric | N | |||||||
| Small Organ (breast, | |||||||||
| 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 | |||||||||
| 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
-
Supported transducer models are: Biim L12-4 Linear Array Transducer See the corresponding table.
-
Includes imaging to assist in the placement of needles and catheters in vascular or other and imaging guidance for nerve block procedures.
4
| 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 | |||||||||
| (Track I | |||||||||
| only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | |||||||||
| (CD) | Combined (B+CD) | Other* | |||||||
| (Color Power | |||||||||
| Doppler) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| & Other | Pediatric | ||||||||
| Small Organ (breast, thyroid, testicles) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intravascular | |||||||||
| Other: (Gynecology) | |||||||||
| Other: | N | ||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Intra-cardiac | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| 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
- Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.
5
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 |
| Frydenlundsgt 9 | |
| Narvik, Norway 8516 | |
| Contact Person: | Christopher Hartzog |
| CHRQ Consulting, LLC | |
| Telephone: | 425.954.6312 |
| FR Numbers/Product | |
| Codes: | 892.1560/IYO, Ultrasonic Pulsed Echo Imaging System |
| 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 |
| Predicate) | |
| (K162549) Philips Healthcare, Inc. Lumify Diagnostic Ultrasound System | |
| (Reference Device) | |
| Intended Use/ | |
| Indications For Use: | The Biim 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) |
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
6
| Device Description: | The Biim Diagnostic Ultrasound System is a portable, general-purpose,
software-controlled sonography system based on a digital architecture used to
acquire and display high-resolution, real-time ultrasound data through a
commercial off-the-shelf iOS or Android device. The Biim Diagnostic Ultrasound
System supports wireless transducer connectivity of the ultrasound images to
the display device.
The Biim Diagnostic Ultrasound System consists of:
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
Design and
Technological
Characteristics | The Biim Diagnostic Ultrasound System has similar indications for use,
construction, manufacturing materials, operating principals and specifications as
the predicate device.
The Biim Diagnostic Ultrasound System is similar to the Clarius Ultrasound
System in that it is also a portable, general-purpose, software-controlled,
diagnostic ultrasound system used to acquire and display high-resolution, real-
time ultrasound data through a commercial off-the-shelf (COTS) iOS or Android
display device. Comparable to the Clarius Ultrasound System, the Biim
Diagnostic Ultrasound System employs wireless transducers employing Wi-Fi-
based technology to communicate with tablet devices. This allows the user to
export ultrasound images and display them upon Apple iOS or Android portable
personal devices.
The principle difference between the Biim Diagnostic Ultrasound System and its
predicate Clarius device is that the Biim Diagnostic Ultrasound System includes
DICOM 3.0 storage and echo service class user features while the Clarius
device does not.
The Philips Lumify device is provided as a reference device due to its
comparable technology to the Biim Diagnostic Ultrasound System specifically its
use of DICOM 3.0 services and an L12-4 linear array transducer.
A comparison of the clinical, design and technological characteristics of the Biim
Diagnostic Ultrasound System to the currently marketed, primary predicate
device and reference device is provided in Table 1 and Table 2 below. |
7
| | Submitted Device
Biim Ultrasound AS | Primary Predicate Device
Clarius Mobile Health | Reference Device
Philips Healthcare |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Clinical Uses | Biim Diagnostic
Ultrasound System
(this premarket
notification) | Clarius Ultrasound
System
(K163138) | Lumify Ultrasound
System
(K162549) |
| Intended Use | Diagnostic ultrasound
imaging of the human
body. | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body. | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body. |
| Indications for Use | | | |
| Pediatric applications | Yes | Yes | Yes |
| Small Organ (breast, thyroid,
testicles) applications | Yes | Yes | Yes |
| Musculo-skel. (Convent.)
applications | Yes | Yes | Yes |
| Musculo-skel. (Superfic.)
applications | Yes | Yes | Yes |
| Peripheral vessel
applications | Yes | Yes | Yes |
| Needle guidance
applications | Yes | Yes | |
| Patient Group | | | |
| Gender: Both sexes allowed | Yes | Yes | Yes |
| Patient age: Adult, Pediatric | Yes | Yes | Yes |
| | | Primary Predicate
Device | Reference Device |
| | Submitted Device | | |
| | Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare |
| Technical Features | Biim Diagnostic
Ultrasound System
(this premarket
notification) | Clarius Ultrasound
System
(K163138) | Lumify Ultrasound
System
(K162549) |
| System features | Wireless Transducer
iPad or Android Tablet
Console | Wireless Transducer
iPad or Android Tablet
Console | USB Transducer
Android Tablet Console |
| Transducer Types | L12-4 Linear Array -
Wireless | L7 Linear Array -
Wireless | L12-4 Linear Array -
USB Cable |
| | | C3 Curved Linear Array -
Wireless | C5-2 Curved Linear
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
Higher Outputs | Display Feature for
Higher Outputs | Display Feature for
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
Imaging | B-mode Grayscale
Imaging, color velocity
and combined modes. | B-mode Grayscale
Imaging, Color Doppler
and combined modes. |
| No. Transmit Channels | 8 | Unknown | Unknown |
| No. Receive Channels | 8 | Unknown | Unknown |
| DICOM | DICOM 3.0 storage and
echo service class user
features. | None | DICOM 3.0 storage,
print, and modality
worklist service class
user features. |
| | NEMA PS3 2016 | | NEMA PS3 2016 |
| Patient Contact Materials | All patient contact
materials biocompatible
per ISO 10993 series | Biocompatible per
K163138 | Biocompatible per
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:
Class II/internally
powered ME equipment. | Device with transducers:
Class II/internally
powered ME equipment. | Device with
transducers: Class
II/internally powered ME
equipment. |
| | Transducers: Type BF
Applied parts, IPX7 | Transducers: Type BF
Applied parts, IP37 | Transducers: Type BF
Applied parts, IP47 |
| | Ordinary
Equipment/Continuous
Operation | Ordinary
Equipment/Continuous
Operation | Ordinary
Equipment/Continuous
Operation |
| | | | Non AB/APG |
| | Submitted Device | Primary Predicate Device | Reference Device |
| | Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare |
| Technical Features | Biim Diagnostic
Ultrasound System
(this premarket
notification)
Non-AP/APG | Clarius Ultrasound
System
(K163138) | Lumify Ultrasound
System
(K162549) |
| EMC Compliance | IEC 60601-1-2
FCC Part 15
ETSI EN 300 328
ETSI EN 301 489
Bluetooth 2.0
IEEE 802.11 b/g | IEC 60601-1-2
FCC Part 15
ETSI EN 300 328
ETSI EN 301 489 | IEC 60601-1-2 |
| | Supported Display:
Apple iPad and Android
Tablets | Supported Display:
Apple iPad and Android
Tablets | Supported Display:
Android Tablets |
| | 256 gray shades in 2D | 256 gray shades in 2D | 256 gray shades in 2D |
| | Small, handheld and
battery operated probe. | Small, handheld and
battery operated probe. | Small, handheld probe. |
| | Remotely control the
ultrasound system | Remotely control the
ultrasound system | |
| | Ultrasound Transmit,
Receive and processing
functions for basic 2D
imaging | Ultrasound Transmit,
Receive and processing
functions for basic 2D
imaging | Ultrasound Transmit,
Receive and processing
functions for 2D and
color imaging |
| | Transmit voltage and
current monitoring with
hardware limits to ensure
safe and proper
operation. | Transmit voltage and
current monitoring with
hardware limits to ensure
safe and proper
operation. | Transmit voltage and
current monitoring with
hardware limits to
ensure safe and proper
operation. |
| | Power On/Off button | Power On/Off button | Power On/Off button |
| System Characteristics | User controls for depth,
image save and freeze. | User controls for depth,
image save and freeze. | User controls for depth,
image save and freeze. |
| | Led indicator for
On/Off/standby/error
status and Tablet link
status. | Led indicator for
On/Off/standby/error
status and Tablet link
status. | |
| | User replaceable battery
to allow for continuous
use. | User replaceable battery
to allow for continuous
use. | Receives power from
tablet via USB |
| | Probe wireless
connectivity to tablet | Probe WiFi wireless
connectivity to tablet | Probe USB cable
connection to tablet |
| | Small handheld probe:
• Height: 41 mm (1.61
in)
• Width: 58 mm (2.28
in)
• Length: 150 mm (5.90
in) | | |
| | | Small handheld probe | Small handheld probe |
| | Lightweight, ergonomic
design | Lightweight, ergonomic
design | Lightweight, ergonomic
design |
| | Submitted Device | Primary Predicate
Device | Reference Device |
| | Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare |
| Technical Features | Biim Diagnostic
Ultrasound System
(this premarket
notification) | Clarius Ultrasound
System
(K163138) | Lumify Ultrasound
System
(K162549) |
| | · Weight : 210 g (7.4 oz) | | |
| Operating Environmental
Limits | 5 to 90% RH non-
condensing
10°C (50°F) to 30°C
(86°F) | 620 hPa to 1060 hPa
15 to 95% RH
0°C (32°F) to 40°C
(104°F) | 700 hPa to 1060 hPa
15 to 95% RH
5°C (41°F) to 40°C
(104°F) |
| Storage Environmental
Limits | 5to 95% RH
-20°C (-4°F) to 60°C
(140°F) | 0 to 95% RH
-20°C (-4°F) `to 50°C
(122°F) | 500 hPa to 1060 hPa
0 to 95% RH
-34°C (-29°F) to 70°C
(158°F) |
| | Battery charger for
detachable battery | Battery charger for
replaceable battery | Receives power from
tablet via USB |
| Power Supply/Battery
Charger | Input: 100V - 240 V
Rating Frequency:
50/60Hz
Output: 5VDC 1.0 A | Input: 100V - 240 V
Rating Frequency:
50/60Hz
Output: 12VDC 1.5 A | |
| Battery | User replaceable
Li-lon battery pack, 3.7V | User replaceable
Li-lon battery pack, 3.7V | N/A - Probe receives
power from tablet via
USB cable |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
Table 1 - Predicate Comparison Chart - Clinical Uses
8
Table 2 - Predicate Comparison Chart - Technical Features
9
10
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
Non-Clinical Tests: | The Biim Diagnostic Ultrasound System has been found to conform to the system
specifications, thermal, electromagnetic and mechanical safety, and to FDA
consensus, medical device safety standards, and international harmonized standards.
The Biim Diagnostic Ultrasound System and its applications comply with the following
standards: | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 1. | AAMI/ANSI/ES 60601-1:2005/(R)2012 And A1:2012 Medical electrical
equipment - Part 1: General requirements for basic safety and essential
performance | |
| | 2. | AAMI/ANSI/IEC 60601-1-2 Medical Electrical Equipment, Part 1: General
requirements for safety - Collateral standard: Electromagnetic
compatibility - Requirements and tests | |
| | 3. | 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 | |
11
| 4. | IEC 62304 Medical device software - Software life cycle processes |
|---|---|
| 5. | AAMI/ANSI/IEC 62366-1:2015 Medical devices - Application of usability |
| engineering to medical devices | |
| 6. | AAMI/ANSI/ISO 10993-1 Biological evaluation of medical devices - Part 1: |
| Evaluation and testing | |
| 7. | AAMI/ANSI/ISO 10993-5:2014 Biological evaluation of medical devices - |
| Part 5: Tests for in vitro cytotoxicity | |
| 8. | AAMI/ANSI/ISO 10993-10:2014 Biological evaluation of medical devices - |
| Part 10: Tests for irritation and delayed-type hypersensitivity | |
| 9. | ISO 14971 Medical devices – application of risk management to medical |
| devices | |
| The following quality assurance measures were applied to the development of the | |
| 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. | |
| Summary of | |
| Clinical Tests | The Biim Diagnostic Ultrasound System introduces no new indications for use, modes, |
| features, or technologies as compared to the currently marketed and predicate device | |
| that require clinical testing. The clinical safety and effectiveness of ultrasound systems | |
| with these characteristics are well accepted for both the currently marketed predicate | |
| and subject device. | |
| Conclusions: | The Biim Diagnostic Ultrasound System has similar indications for use, construction, |
| manufacturing materials, operating principals and specifications as the predicate device. | |
| Therefore, Biim Ultrasound AS considers the Biim Diagnostic Ultrasound System | |
| substantially equivalent to the predicate device. | |
| 514 Performance | |
| Standards: | There are no Sec. 514 performance standards for this device. |
| Prescription Status: | This is a prescription device. The prescription device statement appears in the labeling. |
| Sterilization Sites: | Not applicable. No components supplied sterile. |
| Track: | This is a Track 3 device. |