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.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SpeqRT Ultrasound System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Measurement	Device Performance	Study Type
Substantial Equivalence	Equivalence to predicate devices (Pie Medical 50S Tringa, Siemens Acuson P10, Sonosite iLook, Signos Personal Ultrasound) in:	Demonstrated substantial equivalence in overall function (transmits ultrasonic energy, processes echoes, displays images for anatomic structures).	Bench Testing
	B-mode imaging capabilities	Equivalent	Bench Testing
	M-mode imaging capabilities	Equivalent (except Siemens Acuson P10, which doesn't have M-mode)	Bench Testing
	Pulsed-Wave Doppler imaging capabilities	Equivalent (to Sonosite iLook)	Bench Testing
	Measurement Accuracy	Substantially equivalent	Bench Testing
	Indication for Use statement	Identical to Signos Personal Ultrasound (K090505)	Comparison
	Display size	Identical to Signos Personal Ultrasound (K090505)	Comparison
Risk Analysis	Safe for intended use; no unacceptable risks	Conclusion: Device was safe for intended use and did not pose any unacceptable risks.	Risk Analysis (ISO-14971)
Safety Standards Adherence	Conformance to listed safety standards (e.g., IEC 60601-1, UL60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1)	Applied and evaluated according to standards. Specific performance metrics not detailed, but implicit in compliance.	Compliance testing/Evaluation against standards
Mechanical Integrity	Drop and push testing (IEC60601-1)	Performed (details not quantified, but implied compliance)	Testing
	Mechanical Vibration (10Hz-55Hz/50G)	Performed (details not quantified, but implied compliance)	Testing
	Drop Test (1 meter to concrete)	Performed (details not quantified, but implied compliance)	Testing
Environmental Performance	Operating Temperature (0 to 40 C)	Conforms (implied)	Testing
	Humidity (20 to 80% RH, non-condensing)	Conforms (implied)	Testing
	Water Resistance (Transducer IPX5)	Conforms (implied)	Testing
	Altitude (0.7 - 1.05 standard atmospheres)	Conforms (implied)	Testing
	Storage Temperature (-20 to 45 C)	Conforms (implied)	Testing
	Storage Humidity (20 to 80% RH, non-condensing)	Conforms (implied)	Testing

2. Sample Size Used for the Test Set and Data Provenance

The submission describes bench testing for imaging performance and measurement accuracy. Details regarding the exact "sample size" of images or measurements acquired during this bench testing are not specified in the provided document. The data provenance is implied to be laboratory-generated or controlled data from bench tests, not patient data from a specific country, and it would be retrospective in nature to compare against predicate device performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for a test set in the context of comparative performance data to a gold standard. The basis for substantial equivalence relies on comparisons to predicate devices through bench testing.

4. Adjudication Method for the Test Set

No adjudication method is described as the study primarily involves bench testing and direct comparison to existing device specifications and performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to predicate devices through technical specifications and bench testing, not on assessing human reader improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a form of standalone performance was done through bench testing of the SpeqRT ultrasound system for its imaging performance and measurement accuracy. This testing was conducted independently and then compared to the performance of predicate devices.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be the known physical properties of the phantoms/test objects used, or the established performance specifications of the predicate devices against which the SpeqRT was compared. This is a technical ground truth, not a clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not describe any machine learning or AI components that would require a "training set." Therefore, a sample size for a training set is not applicable or mentioned.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied, this question is not applicable.

Summary

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K13065

Signostics Ltd

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: +61 (8) 8152 9400

1. 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.

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,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, UL60601-1:2003, IEC 60601-2-37:2001+ A1: 2004 + A2: 2005, IEC 60601-2-37:2007, 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 (301) 796-6881.

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:

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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(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& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult	N	N
Cardiac	Cardiac Pediatric	N	N
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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

Page 26

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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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(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& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult	N	N
Cardiac	Cardiac Pediatric	N	N
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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

Page 27

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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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(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& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult	N	N
Cardiac	Cardiac Pediatric	N	N
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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

Page 28

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.