SPEQRT ULTRASOUND SYSTEM

K130659 · Signostics Pty, Ltd. · IYN · Apr 3, 2013 · Radiology

Device Facts

• Record ID: K130659
• Device Name: SPEQRT ULTRASOUND SYSTEM
• Applicant: Signostics Pty, Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The SpeqRT ultrasound system is for non-invasive of the human body and is intended for the following applications: Fetal. Abdominal. Pediatric. Musculo-skeletal. Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device.

Device Story

Hand-held diagnostic ultrasound system; acquires echo data via transducers (S3, S3-5); processes signals for B-mode, M-mode, and Pulsed-Wave Doppler (PWD) imaging; displays output on integrated 18-bit active matrix TFT LCD. Operated by trained clinicians in clinical settings. Provides real-time anatomical visualization and structural measurements to aid diagnosis. Benefits include portable, non-invasive assessment of internal structures.

Clinical Evidence

Bench testing only. Performance and measurement accuracy compared against predicate devices (Signos Personal Ultrasound K090505 and Siemens Acuson P10 K063761) to confirm substantial equivalence. No clinical data provided.

Technological Characteristics

Hand-held ultrasound system; 3MHz and 3-5MHz transducer frequencies; B-mode, M-mode, PWD modes. Materials: Sabic Cycoloy HC1204HF, Mitsui TPX-MED18, Sabic Versollen OMX1255NX-1. Power: Li-Ion battery or 100-240 VAC external. Dimensions: 6.8 x 11.5 x 2.0 cm; 0.13 kg. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1. Protection: Class II, Type BF. Transducer IPX5 water resistance.

Indications for Use

Indicated for diagnostic ultrasound imaging of fetal, abdominal, pediatric, musculo-skeletal, cardiac, and peripheral vessel applications in human patients. Requires trained users. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Pie Medical 50S Tringa (K020112)
• Siemens Acuson P10 (K063761)
• Sonosite iLook (K021628)
• Signos Personal Ultrasound (K090505)

Submission Summary (Full Text)

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K13065

Signostics Ltd

1.

# SpeqRT Ultrasound System. 510(k)

## 510(k) Summary

Sponsor: Signostics Ltd Lot 1, 40 - 46 West Thebarton Road PO Box 736, Torrensville Thebarton, SA 5031

Australia

### Contact Person: 2. Varda Swery Quality and Regulatory Manager Telephone: [phone]

- 3. Date Prepared: September 25, 2012
- Device Name: 4. SpeqRT

## ട്. Proprietary/Marketed Names: Signos RT Personal Ultrasound SignosRT

•

Sonimage P3

### 6. Common/Usual Name:

Diagnostic ultrasound system and transducer

#### 7. Classification

Regulatory Class: II

Review Category: Tier II

Ultrasonic Pulsed Doppler Imaging System

Diagnostic Ultrasound Transducer

Classification Panel: Radiology

#### 8. Predicate Devices .

Pie Medical 50S Tringa (K020112)

Siemens Acuson P10 (K063761)

Sonosite iLook (K021628)

Signos Personal Ultrasound (K090505)

- (21 CFR 892.1550, 90-IYN)
(21 CFR 892.1570, 90-ITX)

APR 3 2013

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#### Risk Analysis Method Used 9.

Signostics Ltd applied ISO-14971 to the design and development of the SpeqRT ultrasound system. 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 SpeaRT ultrasound system described in this Submission is substantially equivalent to the predicate devices as follows:

- Pie Medical 50S Tringa (K020112); a.
- b. Siemens Acuson P10 (K063761);
- Sonosite iLook (K021628): and C.
- d. Signos Personal Ultrasound (K090505)

The SpegRT ultrasound system is substantially equivalent to the predicate devices listed above. All systems transmit ultrasonic energy into patients, then process received echoes to produce on-screen images of anatomic structures within the body. All systems allow for B-mode imaging and measurements of structures to aid in diagnosis equivalent to the SpeqRT ultrasound system. The Sonosite iLook, Pie Medical 50S Tringa and Signos Personal Ultrasound allow for M-mode imaging equivalent to the SpeqRT ultrasound system. The Sonosite iLook allows for Pulsed-Wave Doppler imaging equivalent to the SpeqRT ultrasound system. The indication for use statement of the SpeqRT ultrasound system is identical to the Signos Personal Ultrasound system (K090505). The SpeqRT ultrasound system display size is identical to the Signos Personal Ultrasound (K090505).

The SpeqRT ultrasound system, predicate Signos Personal Ultrasound system (K090505), and predicate Siemens Acuson P10 system (K063761) have all been bench tested for imaging performance and measurement accuracy, and have shown the SpeqRT imaging performance and measurement accuracy to be substantially equivalent to the predicate devices.

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### Device Description 11.

The Signostics Ltd SpeqRT ultrasound 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, M-Mode, or Spectral Doppler) on an LCD display.

Technical specifications for the Signostics SpeqRT ultrasound system are as follows:

| System | | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--|---------|------------|
| Transducer frequencies: | 3MHz (S3 transducer) & 3-5MHz (S3-5 transducer) | | | | |
| Frame rate: | 8Fps or 16Fps (Imaging only) | | | | |
| Ultrasound lines/frame: | 128 lines for 90° frame | | | | |
| Fields of View: | 1-18 cm for 3MHz, 0-18cm for 3-5MHz | | | | |
| External Video Output: | No | | | | |
| Liquid-Crystal Display: | 18 bit, 262,000 Color, Active Matrix TFT LCD | | | | |
| Materials | Sabic Cycoloy HC1204HF, Mitsui TPX-MED18, Sabic Versollen OMX1255NX-1 | | | | |
| Size: - | | | | | |
| Width: | 6.8 cm | | | | |
| Height: | 11.5 cm | | | | |
| Depth: | 2.0 cm | | | | |
| Weight: | 0.13 kg | | | | |
| Electrical | | | | | |
| External Power: | Input: | 100-240 VAC,<br>50-60Hz | | Output: | 5 VDC @ 2A |
| Battery: | Li-Ion battery pack (2 Whr) | | | | |
| Leakage Current: | 10 μA maximum | | | | |
| Primary Breakdown Voltage: | 3000VAC | | | | |
| Safety Standards: | IEC 60601-1:1988 + A1:1991 + A2:1995, IEC 60601-1:2005, UL60601-<br>1:2003, IEC 60601-2-37:2001+ A1: 2004 + A2: 2005, IEC 60601-2-<br>37:2007, IEC 60601-1-2:2007, ISO 10993-1:2003 | | | | |
| 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: | 10Hz-55Hz/50G |
| Drop Test (to concrete): | 1 meter |
| Operating Temperature: | 0 to 40 C |
| Humidity: | 20 to 80% RH, non-condensing |
| Water Resistance: | Transducer IPX5 degree of protection against water |
| Altitude: | 0.7 - 1.05 standard atmospheres (2500m or 8200 feet) operating |
| Storage | |
| Temperature: | -20 to 45 C |
| Humidity: | 20 to 80% RH, non-condensing |

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a stylized wave pattern.

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

April 3, 2013

Signostics, Pty Ltd c/o Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K130659

Trade/Device Name: SpeqRT Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN. ITX Dated: March 8, 2013 Received: March 12, 2013

Dear Mr. Job.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the SpeqRT Ultrasound System, as described in your premarket notification:

### Transducer Model Number

### S3 (P03479)

S3-5 (P03611)

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Job

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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

Smh

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

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# Indications for Use

510(k) Number (if known): K130659

Device Name: SpeqRT Ultrasound System

Indications for Use:

The SpeqRT ultrasound system is for non-invasive of the human body and is intended for the following applications: Fetal. Abdominal. Pediatric. Musculo-skeletal. Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

K130659 Page 1 of 4

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#### 1.3 Indications for Use

The SpeqRT ultrasound system is intended for the uses described in the following Indications for Use Forms.

### 510(k) Indications for Use Form 1.3.1

### TABLE 1 - SPEQRT ULTRASOUND SYSTEM INDICATIONS FOR USE FORM

| System: | SpeqRT ultrasound system |
|---------------|-------------------------------------------------------------|
| 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 | N | N | | | | | |
| | Abdominal | N | N | N | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N | N | | | | | |
| Cardiac | Cardiac Pediatric | N | N | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | | | |
| | Other (Specify) | | | | | | | |

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use:

(Per 21 CFR 801.109)

K130659 Page 2 of 4

September 25, 2012

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# TABLE 2 - SPEQRT ULTRASOUND SYSTEM INDICATIONS FOR USE FORM

System:

SpeqRT ultrasound system

Transducer: S3 (P03479)

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 | N | N | | | | | |
| | Abdominal | N | N | N | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N | N | | | | | |
| Cardiac | Cardiac Pediatric | N | N | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | | | |
| | Other (Specify) | | | | | | | |

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use:_____________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

K130659 Page 3 of 4

# September 25, 2012

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# Table 3 - SpeqRT ultrasound system Indications For Use Form

System:

SpeqRT ultrasound system

Transducer: S3-5 (P03611)

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 | N | N | | | | | |
| | Abdominal | N | N | N | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N | N | | | | | |
| Cardiac | Cardiac Pediatric | N | N | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | | | |
| | Other (Specify) | | | | | | | |

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use: ________X

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Per 21 CFR 801.109)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (

Smh R)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130659 Page 4 of 4

September 25, 2012

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