SpeqT

K160420 · Signostics Limited · IYO · Mar 21, 2016 · Radiology

Device Facts

• Record ID: K160420
• Device Name: SpeqT
• Applicant: Signostics Limited
• Product Code: IYO · Radiology
• Decision Date: Mar 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging. The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

Device Story

Hand-held diagnostic ultrasound system; acquires ultrasound echo data via sector transducer (annular array); displays real-time B-mode images on off-the-shelf Android tablet. Used in clinical settings by trained healthcare professionals. Device includes automated bladder volume measurement functionality. System configured at factory to limit tablet access to approved functions only. Output used by clinicians for diagnostic imaging and bladder volume assessment; aids in clinical decision-making by providing non-invasive anatomical visualization and quantitative bladder data.

Clinical Evidence

Bench testing only. Evaluated imaging performance and measurement accuracy against predicate devices. Compliance with IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993 series, and NEMA UD-2/UD-3 standards confirmed. Internal clinical performance testing compared bladder volume measurements against Verathon BVI 9400, demonstrating equivalent or better performance.

Technological Characteristics

Hand-held sector ultrasound system; annular array transducer (3.5MHz center frequency, 8 elements). Materials: Sabic Cycoloy HC1204HF, Mitsui TPX-MED18, Sabic Versollan OM 1255NX-1. Connectivity: Android-based display. Power: Li-Ion battery. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993. Sterilization: Not specified (transducer IPX1 water resistance).

Indications for Use

Indicated for non-invasive diagnostic ultrasound imaging of the human body, specifically abdominal, musculoskeletal, pediatric, and small organ (prostate) applications. Includes automated bladder volume measurement. Requires trained users.

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

• SpeqRT Ultrasound System (K130659)
• Speq Ultrasound System (K090505)
• Philips Lumify Diagnostic Ultrasound System (K152899)
• Verathon BVI9400 bladder scanner (K071217)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

March 21, 2016

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

Re: K160420

Trade/Device Name: SpeqT Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 12, 2016 Received: February 16, 2016

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 [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 yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K160420

Device Name

SpeqT

Indications for Use (Describe)

The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.

The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume. See the attached Indications for Use form for specific imaging modes and applications.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

{3}------------------------------------------------

## Indications for Use

| 510(k) Number (if known) | K160420 |
|--------------------------|---------|
| Device Name | SpeqT |

### 510(k) Indications for Use Form

-

## TABLE 1 - SPEQT INDICATIONS FOR USE FORM

System: SpeqT Intended Use: Diagnostic ultrasound imaging of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|--------------------------|---------------------------|------------------------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| | General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| | Ophthalmic | Ophthalmic | | | | | | | |
| | | Fetal | | | | | | | |
| | | Abdominal | N | | | | | | |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | N | | | | | | |
| | | Small Organ (Specify)* | N | | | | | | |
| | | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | | | | | | | |
| | | Trans-vaginal | | | | | | | |
| | | Trans-urethral | | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | | |
| | | Musculo-skeletal<br>(Conventional) | N | | | | | | |
| | | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | | Intravascular | | | | | | | |
| | | Other (Specify) | | | | | | | |
| | | Cardiac Adult | | | | | | | |
| Cardiac | | Cardiac Pediatric | | | | | | | |
| | | Intravascular (Cardiac) | | | | | | | |
| | | Trans-esoph. (Cardiac) | | | | | | | |
| | | Intra-cardiac | | | | | | | |
| | | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | | Peripheral vessel | | | | | | | |
| | | Other (Specify) | | | | | | | |

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

Additional Comments:

*Small organ imaging is prostate

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{4}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## Indications for Use

| 510(k) Number (if known) | K160420 |
|--------------------------|---------|
| Device Name | SpeqT |

TABLE 2 - SPEQT INDICATIONS FOR USE FORM

| System: | SpeqT |
|---------------|-------------------------------------------------------------|
| Transducer: | B3-5 (P04200) |
| 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 | Combined (Specify) | Other* (Specify) |
|-----------------------|---------------------------------|---|---|-----|-----|---------------|--------------------|------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | N | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | | | | | | |
| | Small Organ (Specify) | N | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging & Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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

Additional Comments:

*Small organ imaging is prostate

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{5}------------------------------------------------

# 510(k) Summary

- 1. Sponsor: Signostics Ltd PO Box 1048, Pasadena 1284 South Road Clovelly Park, SA 5042 Australia
- 2. Contact Person: Stewart Bartlett Chief Operating Officer Telephone: [phone]
- 3. Date Prepared: January 22, 2016
- 4. Device Name : SpeqT
- 5. Proprietary/Marketed Names: Uscan

# 6. Common/Usual Name:

Diagnostic ultrasound system

# 7. Classification

Regulatory Class: II

Review Category: Tier II

Ultrasonic Pulsed Echo Imaging System

Diagnostic Ultrasound Transducer

(21 CFR 892.1560, 90-IYO)

(21 CFR 892.1570, 90-ITX)

Classification Panel: Radiology

# 8. Predicate Devices

SpeqRT Ultrasound System (K130659).

Speq Ultrasound System (K090505).

Philips Lumify Diagnostic Ultrasound System (K152899)

Verathon BVI9400 bladder scanner (K071217)

{6}------------------------------------------------

# 9. Risk Analysis Method Used

Signostics Ltd applied ISO-14971 to the design and development of the SpeqT. The conclusion from the risk analysis was the device was safe for its intended use and does not pose any unacceptable risks.

#### 10. Basis for Substantial Equivalence

Signostics Ltd believes the SpeqT system described in this Submission is substantially equivalent to the predicate devices as follows:

- a. SpeqRT Ultrasound System (K130659).
- b. Speq Ultrasound System (K090505).
- c. Philips Lumify Diagnostic Ultrasound System (K152899)
- Verathon BVI 9400 bladder scanner (K071217) d.

All systems transmit ultrasonic energy into patients, then process received echoes to generate images of anatomy and perform measurements. The SpeqT system is substantially equivalent to the SpeqRT Ultrasound System, Speq Ultrasound System, and Lumify Diagnostic Ultrasound System as they allow for the display of real-time Bmode imaging. The SpeqT system is also substantially equivalent to the Verathon BVI 9400 as both allow automatic measurement of volume of urine in a bladder. The Verathon BVI 9400 only displays an image if the measurement is printed.

| Transducer | Signostics<br>SpeqT | Signostics<br>SpeqRT<br>S3-5 (K130659) | Signostics<br>Signos (K090505) | Philips Lumify<br>(K152899) | Verathon BVI<br>9400 (K071217) |
|---------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Type | Sector | Sector | Sector | Electronic array | Sector |
| Geometry | Annular | Annular | Annular | Curved linear array<br>Linear array | Annular |
| Intended Uses | Adominal,<br>Pediatric,<br>Musculoskeletal,<br>Small Organ | Adominal, Fetal,<br>Pediatric, Cardiac,<br>Peripheral Vessel,<br>Musculoskeletal | Adominal, Fetal,<br>Pediatric, Cardiac,<br>Peripheral Vessel,<br>Musculoskeletal | Adominal, Fetal,<br>Pediatric, Cardiac,<br>Cardiac Fetal,<br>Gynecology,<br>Peripheral Vessel,<br>Musculoskeletal,<br>Small Organ,<br>Urology | Adominal, Fetal,<br>Pediatric, Cardiac,<br>Peripheral Vessel,<br>Musculoskeletal |
| Centre Frequency | 3.5MHz | 3.5MHz | 3.5MHz/7.5MHz | 3.5MHz/8.0MHz | 3.0MHz/1.74MHz |
| Element Outer<br>Diameter | 15mm | 15mm | 12mm/5.6mm | NA | 13mm |
| Number Elements | 8 | 8 | 1 | Unknown | 1 |
| Acoustic Output | | | | | |
| Max Ispta.3<br>(mW/cm²) | 5.69 | 162 | 26 | Unknown | 5 |
| Max MI | 0.823 | 0.679 | 0.56 | Unknown | 0.95 |
| Max TIS | 0.0903 | 0.160 | 0.05 | Unknown | Unknown |

The SpeqT Ultrasound System is substantialy equivalent to the predicates as follows:

{7}------------------------------------------------

The SpeqT system is a general ultrasound imaging device with automated bladder measurement functionality, and is intended for abdominal (including the bladder), pediatric (including the bladder), and small organ (prostate) scanning.

The SpeqT probe and transducer are almost identical in construction, materials (including patient contact materials), and design, to the SignosRT Personal Ultrasound probe and transducer (K130659). The differences are: the indications for use statement; the transducer field of view (120° for SpeqT versus 90° for SignosRT); and the display (Android off-the-shelf tablet for SpecT versus custom Windows CE tablet for SignosRT). The transducer operating frequency (3.5MHz) is also identical. Both systems contain sector transducers with annular (circular) acoustic elements generating pie shaped images, have identical operating frequency, identical outer diameter of acoustic crystal, identical acoustic output in B-mode, and both maintain MI and TI to be <1.0 at all times.

The predicate Philips Lumify (K152899) is similar to the SpeqT system as follows: both system use an off-the-shelf Android based display; both are indicated for small organs although the SpeqT is limited to prostate. The SpecT minimises risk associated by the Android display by configuring the system at the factory to limit user access to other tablet functions, and not allowing additional non-approved applications to be installed.

The SpecT is similar to the predicate Verathon BVI 9400 (K071217) as both automatically measure the urine volume in a bladder. The Verathon has a part of the device. The SpeqT can print to a wireless printer available as an accessory.

| Signostics<br>SpeqT | Signostics<br>SpeqRT<br>S3-5 (K130659) | Signostics<br>Signos (K090505) | Philips Lumify (K152899) | Verathon BVI 9400<br>(K071217) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The SpeqT is for non-<br>invasive imaging of<br>the human body and is<br>intended for the<br>following<br>applications:<br>Abdominal,<br>Musculoskeletal,<br>Pediatric, and Small<br>Organ. Users must<br>have ultrasound<br>training for<br>abdominal,<br>musculoskeletal,<br>pediatric, and small<br>organ imaging.<br>The SpeqT can also be<br>used to obtain an<br>image of the bladder<br>that is used to<br>automatically<br>determine bladder<br>volume. | The SpeqRT<br>ultrasound systemis<br>for non-invasive<br>imaging of the human<br>body and is intended<br>for the following<br>applications: Fetal,<br>Abdominal, Pediatric,<br>Musculo-skeletal,<br>Cardiac and<br>Peripheral Vessel.<br>Users must have<br>ultrasound training<br>before using the<br>device. | The Speq ultrasound<br>systemis for non-<br>invasive imaging of the<br>human body and is<br>intended for the<br>following applications:<br>Fetal, Abdominal,<br>Pediatric, Musculo-<br>skeletal, Cardiac and<br>Peripheral Vessel.<br>Users must have<br>ultrasound training<br>before using the<br>device. | The Lumify Ultrasound<br>Systemis intended for<br>diagnostic ultrasound<br>imaging in B- (2D) mode<br>and in color Doppler (color<br>flow). The systemis<br>indicated for diagnostic<br>ultrasound imaging and<br>fluid flow analysis in the<br>following applications:<br>Fetal/Obstetric, Abdominal,<br>Urology,<br>Gynecological, Cardiac<br>Fetal, Small Organ,<br>Musculoskeletal, Peripheral<br>Vessel, and Carotid.<br>Lumify is intended for use<br>in environments where<br>healthcare is provided by<br>healthcare<br>professionals, with the<br>exception of home,<br>ambulance, and air. | The BladderScan BVI<br>9400 projects<br>ultrasound energy<br>through the lower<br>abdomen of<br>the patient to obtain<br>an image of the<br>bladder which is used<br>to calculate bladder<br>volume<br>noninvasively. |

The indication for use statement of the SpeqT system and the predicates are summarised below:

{8}------------------------------------------------

The first part of the SpeqT statement of intended use is similar to the SpeqRT predicate (K130659) statement of intended use, with the exception of the addition of small organ imaging. However, the system performance and resolution required by small organ imaging is similar to that required by Peripheral Vessel and musculoskeletal imaging which is included in the SpeqRT predicate's statement of intended use. It should also be noted the Philips Lumify (K152899) intended use statement does include small organ and urology.

The second part of the SpegT statement of intended use is similar to the Verathon BVI 9400 (K071217) predicate. The second part of the intended use statement was added, as the SpeqT, unlike the SpeqRT and Lumify, contains a mode of operation substantially equivalent to the Verathon BVI 9400 where bladder volume measurements are automatically performed.

The slight differences in the intended use statements are not critical as they do not affect safety and performance. The totality of the first part of the intended use statement is included in the SpeqRT and Lumify predicate intended use statements. Bench testing has shown substantially equivalent imaging performance, and there is no evidence of adverse events due to either of these predicate systems. The second part of the intended use statement is substantially equivalent to the Verathon BVI 9400 system, and internal clinical performance testing comparing the SpegT and Verathon BVI 9400 shows the SpeqT to be equivalent or better performance than the Verathon BVI 9400.

#### Device Description 11.

The Signostics Ltd SpecT system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, on an off-the-shelf display. Automated bladder volume measurements are supported.

| System | |
|-------------------------|------------------------------------------------------------------------|
| Transducer frequencies: | 3-7MHz (B3-5 transducer) |
| Frame rate: | 16Fps (Imaging only) |
| Ultrasound lines/frame: | 128 lines for 120° frame |
| Fields of View: | 1-18 cm |
| External Video Output: | No |
| Liquid-Crystal Display: | Minimum of 1200x780 pixels |
| Materials | Sabic Cycoloy HC1204HF, Mitsui TPX-MED18, Sabic Versollan OM 1255NX-1 |
| Size: - | Probe only |
| Width: | 6.0 cm |
| Height: | 15.0 cm |
| Depth: | 3.2 cm |
| Weight: | 0.2 kg |
| Electrical | |
| External Power: | Input: 100-240 VAC, 50-60Hz<br>Output: 5 VDC @ 2A |
| Battery: | Li-Ion battery pack - Display (>3.5V, >3950mAh) Probe (>3.5V, 1350mAh) |

Technical specifications for the Signostics SpeqT system are as follows:

{9}------------------------------------------------

| Leakage Current: | IEC 60601-1 3rd Edition Compliant |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Breakdown Voltage: | 3000VAC |
| Safety Standards: | IEC 60601-1:2005, ES60601-1:2005, EN 60601-1:2006, IEC 60601-2-<br>37:2007, IEC 60601-1-2:2007, ISO 10993-1:2009, ISO-10993-5:2009,<br>ISO 10993-10:2002, ISO 10993-10:2010, ISO 10993-12:2007 |
| Protection Class: | Class II: per IEC 60601-1 |
| Degree of Protection: | Type BF: per IEC 60601-1 |

| Environmental | | |
|--------------------------|------------------------------------------------------------------------------------|--|
| Mechanical Shock : | Drop and push testing per IEC60601-1 | |
| Mechanical Vibration: | Random Acceleration Profile per JIS Z 0232:2004 5Hz-300Hz | |
| Drop Test (to concrete): | 1 meter | |
| Operating Temperature: | 5 to 40 C | |
| Humidity: | 15 to 90% RH, non-condensing | |
| Water Resistance: | Transducer IPX1 degree of protection against water | |
| Altitude: | 70kPa – 101.5kPa (0.7 – 1.015 standard atmospheres) (2500m or 8200 feet) operating | |
| Storage | | |
| Temperature: | -20 to 50 C | |
| Humidity: | 10 to 93% RH, non-condensing | |
| Pressure: | 50kPa – 101.5kPa (0.5 – 1.015 standard atmospheres) | |

#### Non-clinical Performance Data 12.

Signostics Ltd is applying FDA recognised standards as detailed in the tables above to evaluate the safety of the SpeqT.

The new SpeqT has been bench tested for imaging performance and measurement accuracy, with tests showing the SpeqT imaging performance and measurement accuracy to be substantially equivalent to the SpeqRT and Speq predicate devices.

The SpeqT has been tested by independent laboratories to IEC 60601-1:2005, IEC 60601-2-37:2007, IEC 60601-1-2:2007, ISO 10993-5:2009, ISO 10993-10:2002, ISO 10993-10:2010, ISO 10993-12:2007, NEMA UD-2-2004 (R2009), NEMA UD-3-2004(R2009) and found to comply with all standards.

The software and firmware in the SpeqT has been developed and verified according to IEC 62304:2006. The verification report (Appendix R), traceability (Appendix Q), and risk analysis (Appendix A) demonstrate the SpeqT operates as intended and risks mitigated in firmware have been verified.

The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices.