(28 days)
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)
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
The Biim Diagnostic Ultrasound System underwent non-clinical tests to assess its substantial equivalence to predicate devices, namely the Clarius Ultrasound System (K163138) and the Philips Healthcare Lumify Diagnostic Ultrasound System (K162549).
Acceptance Criteria and Device Performance:
The primary acceptance criteria for the Biim Diagnostic Ultrasound System are based on its compliance with established technical specifications, safety standards, and performance characteristics comparable to its predicate devices. The study essentially demonstrates that the Biim system meets these criteria by showing its similarity in:
- Clinical Uses and Indications for Use: The Biim system shares the same specific clinical applications including Pediatric, Small Organ (breast, thyroid, testicles), Musculo-skeletal (Convent. and Superfic.), Peripheral vessel, and Needle guidance applications, as well as the same patient groups (both sexes, adult, pediatric) as its primary predicate device.
- Technical Features: Key technical specifications and modes of operation are compared to demonstrate equivalence.
Here's a table summarizing the acceptance criteria (implied by the predicate device's characteristics) and the reported performance of the Biim system:
| Feature | Acceptance Criteria (Predicate Device) | Biim™ Diagnostic Ultrasound System Performance (Submitted Device) |
|---|---|---|
| Clinical Uses | ||
| Pediatric applications | Yes | Yes |
| Small Organ applications | Yes (breast, thyroid, testicles) | Yes (breast, thyroid, testicles) |
| Musculo-skel. (Convent.) | Yes | Yes |
| Musculo-skel. (Superfic.) | Yes | Yes |
| Peripheral vessel | Yes | Yes |
| Needle guidance | Yes | Yes |
| Patient Group | ||
| Gender | Both sexes allowed | Both sexes allowed |
| Patient age | Adult, Pediatric | Adult, Pediatric |
| Technical Features | ||
| System features | Wireless Transducer, iPad or Android Tablet Console (for predicate) | Wireless Transducer, iPad or Android Tablet Console |
| Transducer Types | L7 Linear Array - Wireless (Clarius); L12-4 Linear Array - USB Cable (Lumify) | L12-4 Linear Array - Wireless |
| Transducer Frequency | 4 - 13 MHz (Clarius); 4 - 12 MHz (Lumify) | 4 - 12 MHz |
| Global Maximum Outputs | $I_{spta.3}: ≤ 720 mW/cm^2$, MI ≤ 1.9, TI ≤ 6.0 | $I_{spta.3}: ≤ 720 mW/cm^2$, MI ≤ 1.9, TI ≤ 6.0 |
| Acoustic Output Display | MI Output Display, TI Output Display | MI Output Display, TI Output Display |
| Modes of Operation | B-mode Grayscale Imaging, color velocity and combined modes (Clarius); B-mode Grayscale Imaging, Color Doppler and combined modes (Lumify) | B-mode Grayscale Imaging |
| DICOM | None (Clarius); DICOM 3.0 storage, print, and modality worklist service class user features (Lumify) | DICOM 3.0 storage and echo service class user features (NEMA PS3 2016 compatible) |
| Patient Contact Materials | Biocompatible per ISO 10993 series | All patient contact materials biocompatible per ISO 10993 series |
| Product Safety Cert. | IEC 60601-1, IEC 60601-2-37 | IEC 60601-1, IEC 60601-2-37 |
| EMC Compliance | IEC 60601-1-2, FCC Part 15, ETSI EN 300 328, ETSI EN 301 489 | IEC 60601-1-2, FCC Part 15, ETSI EN 300 328, ETSI EN 301 489, Bluetooth 2.0, IEEE 802.11 b/g |
| Supported Display | Apple iPad and Android Tablets | Apple iPad and Android Tablets |
| Gray Shades in 2D | 256 | 256 |
| Probe Size/Weight | Small, handheld, battery operated probe, lightweight, ergonomic design | Small handheld probe, weight: 210 g (7.4 oz), lightweight, ergonomic design |
| Power Supply/Battery | User replaceable Li-Ion battery pack, 3.7V (predicate had various power/battery options) | User replaceable Li-Ion battery pack, 3.7V; Battery charger input: 100V-240V, 50/60Hz, output: 5VDC 1.0A |
| Operating Environment | 10°C (50°F) to 30°C (86°F), 5 to 90% RH non-condensing | Comparable to predicate |
| Storage Environment | -20°C (-4°F) to 60°C (140°F), 5 to 95% RH | Comparable to predicate |
Study Information:
-
Sample size used for the test set and the data provenance:
- No specific clinical test set details (sample size, data provenance like country of origin, retrospective or prospective nature) are provided for the Biim Diagnostic Ultrasound System. The submission states, "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." This implies that the testing relied on established performance parameters of the predicate devices and extensive non-clinical testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since no clinical testing was deemed necessary due to the device introducing no new indications or technologies, there is no mention of experts establishing ground truth for a test set. The validation relies on equivalence to predicate devices, supported by non-clinical engineering and safety tests.
-
Adjudication method for the test set:
- Not applicable, as no dedicated clinical test set with adjudicated ground truth is described.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and the submission focuses on hardware and software equivalence.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a diagnostic ultrasound imaging system; its performance is inherently tied to human operation and interpretation. The performance evaluation focuses on the system's ability to produce images comparable to predicate devices and adherence to safety standards.
-
The type of ground truth used:
- The "ground truth" for this submission is implicitly established by the performance and safety profiles of the predicate devices. The Biim system demonstrates substantial equivalence through non-clinical testing against recognized national and international standards (e.g., AAMI/ANSI/ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993 series, ISO 14971). This approach to "ground truth" validates that the device performs as expected for its intended use, similar to its legally marketed counterparts, and is safe.
-
The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense.
-
How the ground truth for the training set was established:
- Not applicable.
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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.
{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 Ionly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(B+CD) | Other*(ColorPowerDoppler) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominalorgans 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.) | |||||||||
| PeripheralVessel | 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 Ionly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler(CD) | Combined (B+CD) | Other*(Color PowerDoppler) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging | FetalAbdominalIntra-operative (Abdominal organs and vascular)Intra-operative (Neuro.)Laparoscopic | ||||||||
| & Other | PediatricSmall Organ (breast, thyroid, testicles)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)IntravascularOther: (Gynecology)Other: | N | |||||||
| Cardiac | Cardiac AdultCardiac PediatricTrans-esophageal (card.)Intra-cardiacOther (spec.) | ||||||||
| PeripheralVessel | Peripheral vesselOther: 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 ASFrydenlundsgt 9Narvik, Norway 8516 |
| Contact Person: | Christopher HartzogCHRQ Consulting, LLC |
| Telephone: | 425.954.6312 |
| FR Numbers/ProductCodes: | 892.1560/IYO, Ultrasonic Pulsed Echo Imaging System892.1570/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 (PrimaryPredicate)(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 ofthe 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 toacquire and display high-resolution, real-time ultrasound data through acommercial off-the-shelf iOS or Android device. The Biim Diagnostic UltrasoundSystem supports wireless transducer connectivity of the ultrasound images tothe 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 theDesign andTechnologicalCharacteristics | The Biim Diagnostic Ultrasound System has similar indications for use,construction, manufacturing materials, operating principals and specifications asthe predicate device.The Biim Diagnostic Ultrasound System is similar to the Clarius UltrasoundSystem 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 Androiddisplay device. Comparable to the Clarius Ultrasound System, the BiimDiagnostic Ultrasound System employs wireless transducers employing Wi-Fi-based technology to communicate with tablet devices. This allows the user toexport ultrasound images and display them upon Apple iOS or Android portablepersonal devices.The principle difference between the Biim Diagnostic Ultrasound System and itspredicate Clarius device is that the Biim Diagnostic Ultrasound System includesDICOM 3.0 storage and echo service class user features while the Clariusdevice does not.The Philips Lumify device is provided as a reference device due to itscomparable technology to the Biim Diagnostic Ultrasound System specifically itsuse of DICOM 3.0 services and an L12-4 linear array transducer.A comparison of the clinical, design and technological characteristics of the BiimDiagnostic Ultrasound System to the currently marketed, primary predicatedevice and reference device is provided in Table 1 and Table 2 below. |
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| Submitted DeviceBiim Ultrasound AS | Primary Predicate DeviceClarius Mobile Health | Reference DevicePhilips Healthcare | |
|---|---|---|---|
| Clinical Uses | Biim DiagnosticUltrasound System(this premarketnotification) | Clarius UltrasoundSystem(K163138) | Lumify UltrasoundSystem(K162549) |
| Intended Use | Diagnostic ultrasoundimaging of the humanbody. | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody. | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody. |
| 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 vesselapplications | Yes | Yes | Yes |
| Needle guidanceapplications | Yes | Yes | |
| Patient Group | |||
| Gender: Both sexes allowed | Yes | Yes | Yes |
| Patient age: Adult, Pediatric | Yes | Yes | Yes |
| Primary PredicateDevice | Reference Device | ||
| Submitted Device | |||
| Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare | |
| Technical Features | Biim DiagnosticUltrasound System(this premarketnotification) | Clarius UltrasoundSystem(K163138) | Lumify UltrasoundSystem(K162549) |
| System features | Wireless TransduceriPad or Android TabletConsole | Wireless TransduceriPad or Android TabletConsole | USB TransducerAndroid 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 LinearArray - 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 forHigher Outputs | Display Feature forHigher Outputs | Display Feature forHigher 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 GrayscaleImaging | B-mode GrayscaleImaging, color velocityand combined modes. | B-mode GrayscaleImaging, Color Dopplerand combined modes. |
| No. Transmit Channels | 8 | Unknown | Unknown |
| No. Receive Channels | 8 | Unknown | Unknown |
| DICOM | DICOM 3.0 storage andecho service class userfeatures. | None | DICOM 3.0 storage,print, and modalityworklist service classuser features. |
| NEMA PS3 2016 | NEMA PS3 2016 | ||
| Patient Contact Materials | All patient contactmaterials biocompatibleper ISO 10993 series | Biocompatible perK163138 | Biocompatible perK152899 |
| 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/internallypowered ME equipment. | Device with transducers:Class II/internallypowered ME equipment. | Device withtransducers: ClassII/internally powered MEequipment. | |
| Transducers: Type BFApplied parts, IPX7 | Transducers: Type BFApplied parts, IP37 | Transducers: Type BFApplied parts, IP47 | |
| OrdinaryEquipment/ContinuousOperation | OrdinaryEquipment/ContinuousOperation | OrdinaryEquipment/ContinuousOperation | |
| Non AB/APG | |||
| Submitted Device | Primary Predicate Device | Reference Device | |
| Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare | |
| Technical Features | Biim DiagnosticUltrasound System(this premarketnotification)Non-AP/APG | Clarius UltrasoundSystem(K163138) | Lumify UltrasoundSystem(K162549) |
| EMC Compliance | IEC 60601-1-2FCC Part 15ETSI EN 300 328ETSI EN 301 489Bluetooth 2.0IEEE 802.11 b/g | IEC 60601-1-2FCC Part 15ETSI EN 300 328ETSI EN 301 489 | IEC 60601-1-2 |
| Supported Display:Apple iPad and AndroidTablets | Supported Display:Apple iPad and AndroidTablets | Supported Display:Android Tablets | |
| 256 gray shades in 2D | 256 gray shades in 2D | 256 gray shades in 2D | |
| Small, handheld andbattery operated probe. | Small, handheld andbattery operated probe. | Small, handheld probe. | |
| Remotely control theultrasound system | Remotely control theultrasound system | ||
| Ultrasound Transmit,Receive and processingfunctions for basic 2Dimaging | Ultrasound Transmit,Receive and processingfunctions for basic 2Dimaging | Ultrasound Transmit,Receive and processingfunctions for 2D andcolor imaging | |
| Transmit voltage andcurrent monitoring withhardware limits to ensuresafe and properoperation. | Transmit voltage andcurrent monitoring withhardware limits to ensuresafe and properoperation. | Transmit voltage andcurrent monitoring withhardware limits toensure safe and properoperation. | |
| 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 forOn/Off/standby/errorstatus and Tablet linkstatus. | Led indicator forOn/Off/standby/errorstatus and Tablet linkstatus. | ||
| User replaceable batteryto allow for continuoususe. | User replaceable batteryto allow for continuoususe. | Receives power fromtablet via USB | |
| Probe wirelessconnectivity to tablet | Probe WiFi wirelessconnectivity to tablet | Probe USB cableconnection to tablet | |
| Small handheld probe:• Height: 41 mm (1.61in)• Width: 58 mm (2.28in)• Length: 150 mm (5.90in) | |||
| Small handheld probe | Small handheld probe | ||
| Lightweight, ergonomicdesign | Lightweight, ergonomicdesign | Lightweight, ergonomicdesign | |
| Submitted Device | Primary PredicateDevice | Reference Device | |
| Biim Ultrasound AS | Clarius Mobile Health | Philips Healthcare | |
| Technical Features | Biim DiagnosticUltrasound System(this premarketnotification) | Clarius UltrasoundSystem(K163138) | Lumify UltrasoundSystem(K162549) |
| · Weight : 210 g (7.4 oz) | |||
| Operating EnvironmentalLimits | 5 to 90% RH non-condensing10°C (50°F) to 30°C(86°F) | 620 hPa to 1060 hPa15 to 95% RH0°C (32°F) to 40°C(104°F) | 700 hPa to 1060 hPa15 to 95% RH5°C (41°F) to 40°C(104°F) |
| Storage EnvironmentalLimits | 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 hPa0 to 95% RH-34°C (-29°F) to 70°C(158°F) |
| Battery charger fordetachable battery | Battery charger forreplaceable battery | Receives power fromtablet via USB | |
| Power Supply/BatteryCharger | Input: 100V - 240 VRating Frequency:50/60HzOutput: 5VDC 1.0 A | Input: 100V - 240 VRating Frequency:50/60HzOutput: 12VDC 1.5 A | |
| Battery | User replaceableLi-lon battery pack, 3.7V | User replaceableLi-lon battery pack, 3.7V | N/A - Probe receivespower from tablet viaUSB 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
{9}------------------------------------------------
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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 ofNon-Clinical Tests: | The Biim Diagnostic Ultrasound System has been found to conform to the systemspecifications, thermal, electromagnetic and mechanical safety, and to FDAconsensus, medical device safety standards, and international harmonized standards.The Biim Diagnostic Ultrasound System and its applications comply with the followingstandards: | ||
|---|---|---|---|
| 1. | AAMI/ANSI/ES 60601-1:2005/(R)2012 And A1:2012 Medical electricalequipment - Part 1: General requirements for basic safety and essentialperformance | ||
| 2. | AAMI/ANSI/IEC 60601-1-2 Medical Electrical Equipment, Part 1: Generalrequirements for safety - Collateral standard: Electromagneticcompatibility - Requirements and tests | ||
| 3. | IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particularrequirements for the basic safety and essential performance of ultrasonicmedical 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 usabilityengineering 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 medicaldevices |
| The following quality assurance measures were applied to the development of thesystem: | |
| • 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 ofClinical Tests | The Biim Diagnostic Ultrasound System introduces no new indications for use, modes,features, or technologies as compared to the currently marketed and predicate devicethat require clinical testing. The clinical safety and effectiveness of ultrasound systemswith these characteristics are well accepted for both the currently marketed predicateand 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 Systemsubstantially equivalent to the predicate device. |
| 514 PerformanceStandards: | 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. |
§ 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.