(22 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The description focuses on standard ultrasound imaging modes and processing.
No
The device is described as a "diagnostic ultrasound system" and its purpose is to "acquire ultrasound echo data and display it," indicating it is used for imaging and diagnosis, not treatment.
Yes
The Device Description explicitly states, "The Signostics Ltd SpeqRT ultrasound system is a hand-held, diagnostic ultrasound system with an on-screen display."
No
The device description explicitly states it is a "hand-held, diagnostic ultrasound system" and describes hardware components like an "on-screen display" and the ability to "acquire ultrasound echo data," indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non-invasive of the human body" and lists various anatomical sites for ultrasound imaging. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description: The description focuses on acquiring and displaying ultrasound echo data to create images. This is a diagnostic imaging device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is a diagnostic ultrasound system used for medical imaging in vivo (within the living body).
N/A
Intended Use / 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.
The SpeqRT ultrasound system is intended for the uses described in the following Indications for Use Forms.
Diagnostic ultrasound imaging of the human body as follows:
Clinical Application: Fetal (B, M); Abdominal (B, M, PWD); Pediatric (B, M); Musculo-skeletal (Conventional) (B, M); Cardiac Adult (B, M); Cardiac Pediatric (B, M); Peripheral vessel (B, M, PWD).
Product codes
IYN, ITX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac, Peripheral Vessel.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Users must have ultrasound training before using the device.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020112, K063761, K021628, K090505
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
-
- 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
1
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.
2
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, | |||
| 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.
3
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.
4
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)
5
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
6
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 | Color | |||
| Doppler | 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) | ||||||||
| Peripheral | ||||||||
| 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
Page 26
7
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 | Color | |||
| Doppler | 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) | ||||||||
| Peripheral | ||||||||
| 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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8
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 | Color | |||
| Doppler | 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) | ||||||||
| Peripheral | ||||||||
| 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
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