(36 days)
Signos RT Bladder scanner projects ultrasound energy through the lower abdomen of a patient to obtain an image of the bladder that is used to non-invasively determine bladder volume. Users must have ultrasound training before using the device.
The Signostics Ltd SignosRT Bladder 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 LCD display to enable non-invasive volume measurement of a patients bladder.
Here's a breakdown of the acceptance criteria and study information for the SignosRT Bladder device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Volume Accuracy (on a phantom) | Max of ±9.6% |
| Specified Volume Accuracy Standard | ±15% |
| Lateral Resolution (compared to predicate) | Identical to predicate SpeqRT Personal Ultrasound System |
| Axial Resolution (compared to predicate) | Identical to predicate SpeqRT Personal Ultrasound System |
| Compliance with Safety Standards | Complies with 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) |
| Software/Firmware Development & Verification | Developed and verified according to IEC 62304:2006 (Verification reports, traceability, and risk analysis demonstrate proper operation and mitigated risks) |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific imaging performance and measurement accuracy tests. The document mentions "bench tested for imaging performance and measurement accuracy" and "measured volume accuracy on a phantom," implying a phantom study rather than a human subject study for these metrics.
- Data Provenance: The studies were non-clinical (bench testing, phantom studies). The sponsor, Signostics Ltd, is based in Australia, but it's not explicitly stated where the specific bench tests were conducted.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Since the primary tests mentioned relate to phantom measurements, "experts" in the clinical sense (e.g., radiologists) would not be directly involved in establishing ground truth for these objective metrics.
-
Adjudication method for the test set:
- This information is not provided. Not applicable for phantom and bench testing where objective measurements are compared against known values.
-
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 is mentioned. This device is a diagnostic ultrasound system for bladder volume measurement, not an AI-assisted diagnostic tool for interpretation by human readers. The document states its purpose "is to acquire ultrasound echo data and display it in B-Mode on an LCD display to enable non-invasive volume measurement of a patients bladder."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics like "measured volume accuracy on a phantom" and "measured lateral and axial resolution" are standalone performance metrics of the device itself (including its algorithms) without human intervention in the measurement process for those specific metrics. The device is a "bladder scanner projects ultrasound energy...to obtain an image of the bladder that is used to non-invasively determine bladder volume" and computes "an estimated bladder volume" via algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For volume accuracy, the ground truth was based on phantom measurements. Phantoms are designed with known physical properties and dimensions, allowing for a precise and objective ground truth for physical measurements like volume.
-
The sample size for the training set:
- This information is not explicitly provided. The document states the "algorithms used to calculate bladder volume are identical for the SignosRT Bladder and the predicate SpeqRT Personal Ultrasound System." This suggests that the bladder volume calculation algorithms were likely developed and "trained" (meaning optimized or validated, rather than machine learning training in the modern sense) on data from previous systems or general principles of ultrasound physics, but specific training set details are absent.
-
How the ground truth for the training set was established:
- This information is not explicitly provided. Given that the algorithms are stated to be "identical" to a predicate device, their development and validation (establishing ground truth) would likely have been part of the predicate device's history, using methods such as controlled phantom studies or potentially clinical data where actual bladder volumes were measured by other means (e.g., catheterization) for correlation.
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January 14, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Signostics Limited % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K143493
Trade/Device Name: SignosRT Bladder Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO ITX Dated: December 28, 2014 Received: January 7, 2015
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.
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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 yours,
Robert A. Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K143493
Device Name Signos RT Bladder
Indications for Use (Describe)
Signos RT Bladder scanner projects ultrasound energy through the lower abdomen of a patient to obtain an image of the bladder that is used to non-invasively determine bladder volume. Users must have ultrasound training before using the device.
Contraindications
The SignosRT Bladder Scanner is designed for percutaneous scanning only. Do not attempt intracavity imaging; in particular, trans-esophageal, trans-rectal scans are contraindicated.
The SignosRT Bladder Scanner is contraindicated for pregnant patients.
Type of Use (Select one or both, as applicable)
🇿 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Indications for Use Form
TABLE 1 - SIGNOSRT BLADDER INDICATIONS FOR USE FORM
System: SignosRT Bladder Intended Use: Diagnostic ultrasound imaging of the human body as follows: Clinical Application Mode of Operation PWD General Specific B M CWD Color Combined Other* (Track I Only) (Tracks I & III) Doppler (Specify) (Specify) Ophthalmic Ophthalmic Fetal Abdominal N Intra-operative (Specify) Intra-operative(Neuro) Laparoscopic Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Fetal Imaging Trans-rectal & Other Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Other (Specify) Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Cardiac Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel Vessel Other (Specify)
N= new indication; P=previously cleared by FDA; E=added under AppendixE Additional Comments:
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.
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TABLE 2 - SIGNOSRT BLADDER SCANNER INDICATIONS FOR USE FORM
System: SignosRT Bladder
Transducer: S3 (P03479)
Diagnostic ultrasound imaging of the human body as follows : Intended Use:
| 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 Imaging& Other | Fetal | |||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative(Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Specify) |
N= new indication; P=previously cleared by FDA; E=added under AppendixE Additional Comments:
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.
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510(k) Summary
1. Sponsor:
Signostics Ltd PO Box 1048, Pasadena 1284 South Road Clovelly Park, SA 5042 Australia
2. Contact Person: Stewart Bartlett Quality and Regulatory Manager Telephone: +61 (8) 7424 0600
-
- Date Prepared: December 28, 2014
-
- De vice Name : SignosRT Bladder
-
- Proprietary/Marketed Names: SignosRT Bladder
6. Common/Usual Name:
Diagnostic ultrasound system and transducer
7. Classification
Regulatory Class: II
Review Category: Tier II
Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO)
(21 CFR 892.1570, 90-ITX)
Diagnostic Ultrasound Transducer
Classification Panel: Radiology
8. Predicate Devices
Portascan Bladder Scanner (K033906)
SignosRT Ultrasound System (K130659)
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9. Risk Analysis Method Used
Signostics Ltd applied ISO-14971 to the design and development of the SignosRT Bladder. 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 - Technological Characteristics
Signostics Ltd believes the SignosRT Bladder described in this Submission is substantially equivalent to the predicate devices as follows:
The SignosRT Bladder 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 anatomy. All systems allow for B-mode imaging and measurements of volume of a bladder. The indication for use statement of the SignosRT Bladder is identical to the Portascan. The SignosRT Personal Ultrasound system (K130659) is a general ultrasound imaging device with an intended use statement covering a number of areas, including the abdomen which includes the bladder.
All systems enable an estimated bladder volume to be calculated from a single scan or from two scans for more accurate results. The algorithms used to calculate bladder volume are identical for the SignosRT Bladder and the predicate SpeqRT Personal Ultrasound System.
The SignosRT Bladder is identical in construction, materials, and controls to the SignosRT Personal Ultrasound (K130659), with the only difference being the indications for use statement and the software configuration. The patient contact materials are identical. The transducer and operating frequency (3.5MHz) are 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, and both maintain MI and TI to be <1.0 at all times.
The predicate SignosRT Personal Ultrasound has a remote display mode to allow streaming of the video to a larger display. The SignosRT Bladder also has support to allow streaming of the video to a larger display.
The predicate Portascan has printer as part of the device. The SignosRT Bladder scanner and predicate SignosRT Ultrasound System both can be connected directly to a USB PictBridge printer for full-size printouts, or transfer images to a PC running SigViewer accessory software to print images.
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11. Device Description
The Signostics Ltd SignosRT Bladder 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 LCD display to enable non-invasive volume measurement of a patients bladder.
Technical specifications for the Signostics SignosRT Bladder are as follows:
| System | |||||
|---|---|---|---|---|---|
| Transducer frequencies: | 3MHz (S3 transducer) | ||||
| Frame rate: | 8Fps or 16Fps (Imaging only) | ||||
| Ultrasound lines/frame: | 128 lines for 90° frame at 10cm | ||||
| Fields of View: | 1-18 cm for 3MHz | ||||
| External Video Output: | No | ||||
| Liquid-Crystal Display: | 18 bit, 262,000 Color, Active Matrix TFT LCD | ||||
| Materials | Sabic Cycoloy HC1204HF, Mitsui TPX-MED18, Sabic VersollenOMX1255NX-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 $ μ $ A maximum | ||||
| Primary Breakdown Voltage: | 3000VAC | ||||
| Safety Standards: | IEC 60601-1:2005, ES60601-1:2005, IEC 60601-2-37:2007, IEC60601-1-2:2007, 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 ES60601-1 |
| Mechanical Vibration: | Random Acceleration Profile per JIS Z 0232:2004 5Hz-300Hz |
| Drop Test (to concrete): | 1 meter |
| Operating Temperature: | 0 to 40 C |
| Humidity: | 20 to 80% RH, non-condensing |
| Water Resistance: | Transducer IPX7 lens, IPX1 probe degree of protection against water |
| Altitude: | 0.7 – 1.05 standard atmospheres (2500m or 8200 feet) operating |
| Storage | |
| Temperature: | -20 to 45 C |
| Humidity: | 10 to 90% RH, non-condensing |
| Altitude: | 0.5 – 1.05 standard atmospheres storage |
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12. Non-clinical Performance Data
The SignosRT Bladder has been bench tested for imaging performance and measurement accuracy, with tests showing the SignosRT Bladder imaging performance and measurement accuracy to be substantially equivalent to the predicate devices. The measured lateral and axial resolution for the SignosRT Bladder is identical to the predicate SpeqRT Personal Ultrasound System. The measured volume accuracy on a phantom was a maximum of +-9.6%. well within the specified +-15%.
The SignosRT Bladder Scanner device 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 SignosRT Bladder has been developed and verified according to IEC 62304:2006. The verification reports (Appendix R and V), traceability (Appendix Q), and risk analysis (Appendix A) demonstrate the SignosRT Bladder 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.
§ 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.