(777 days)
X894632
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No
The document describes a standard diagnostic ultrasound system and probe, focusing on the physical principles of ultrasound and Doppler imaging. There is no mention of AI, ML, image processing, or any data-driven algorithms that would suggest the use of AI/ML technology. The description is purely about the hardware and its basic function.
No
The device description states it "perform[s] diagnostic examinations" and can "demonstrate anatomical structures" and "investigation of vascular flow." There is no mention of treating or alleviating a condition.
Yes
The "Device Description" clearly states that the PSH-25GT, when used with the diagnostic ultrasound system, is used to "perform diagnostic examinations" and describes how it uses sound waves to "demonstrate anatomical structures" and "investigation of vascular flow".
No
The device description explicitly states it is a probe (PSH-25GT) used with a diagnostic ultrasound system (SSH-140A), which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transcranial doppler applications" and "diagnostic examinations" using ultrasound. This involves examining structures and blood flow within the body.
- Device Description: The description details the use of ultrasound waves to visualize anatomical structures and vascular flow. This is an in vivo (within a living organism) diagnostic method.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention the analysis of any such specimens.
Therefore, this device is a diagnostic ultrasound system and transducer intended for in vivo use, not an IVD.
N/A
Intended Use / Indications for Use
The PSH-25GT and P3-2 probes are intended for transcranial doppler applications.
Product codes
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Device Description
The PSH-25GT, when used with the SSH-140A diagnostic ultrasound system, utilizes high frequency sound waves, beyond the range of human hearing, to perform diagnostic examinations. These sound waves are a form of non-ionizing radiation which can be used to demonstrate anatomical structures. Ultrasonic waves are easily focussed for the examination of small quantities of material and short time span phenomena. Additionally, ultrasound is especially beneficial in the examination of soft tissues. Doppler imaging permits investigation of vascular flow via the use of non-ionizing energy, rather than requiring the employment of ionizing radiation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
cephalic structures
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
X894632
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the word "TOSHIBA" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is horizontally oriented and appears to be a logo or brand name.
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHEL. I DRIVE. P.O. BOX 2068. TUSTIN, CA 92 581-2068 PHONE (7'4' 30-500
Appendix X
510(k) Summary
Image /page/0/Picture/5 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K941593'. The characters are written in a bold, slightly irregular style, giving them a casual, handwritten appearance. The contrast between the characters and the background is high, making them easily readable.
Date: 31 March 1994 Submitter: Toshiba America Medical Svstems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92681-2068 Contact: Steven M. Kay (714) 730-5000 Classification Name: Diagnostic Ultrasonic Transducer Classification: Class II per 21 CFR 892.1570 Device Tier: 2, per the December 15, 1993 DRAERD Triage Pilot Program Common Name: Transcranial Doppler Transducer Proprietary Name: PSH-25GT Model Name: PSH-25GT Establishment Registration Number: 2020563
Compliance With Performance Standards:
This device complies with the Performance Standards for Electronic Products, 21 CFR 1010, as administered by the Center for Devices and Radiological Health and with CDRH guidances "Revised 510(k) Diagnostic Ultrasound Guidance for 1993" and "510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices". It also complies with the Japanese (JIS) and European (IEC-601-1) voluntary standards and the ISO-9001 manufacturing standard.
Substantial Equivalence Summary:
The PSH-25GT is to be used with the Toshiba SSH-140A Track I Diagnostic Ultrasound system and claims substantial equivalency to the PSF-37FT, which was cleared for use with the SSH-140A Diagnostic Ultrasound System via X894632 and with the P3-2 Transcranial Doppler transducer distributed by Advanced Techrology Labs (ATL).
The PSH-25GT and PSF-37FT probes are manufactured by Toshiba Corporation of Japan and distributed by TAMS, have the same methods of manufacture, follow the same software verification and validation procedures and employ the same general technology. While the PSH-25GT and PSF-37FT mainly differ in their indications for use (transcranial doppler vs cardiac, respectively), the PSH-25GT and P3-2 probes are intended for transcranial doppler applications.
1
Summary of Safety and Effectiveness
The PSH-25GT, when used with the SSH-140A diagnostic ultrasound system, utilizes high frequency sound waves, beyond the range of human hearing, to perform diagnostic examinations. These sound waves are a form of non-ionizing radiation which can be used to demonstrate anatomical structures. Ultrasonic waves are easily focussed for the examination of small quantities of material and short time span phenomena. Additionally, ultrasound is especially beneficial in the examination of soft tissues. Doppler imaging permits investigation of vascular flow via the use of non-ionizing energy, rather than requiring the employment of ionizing radiation. Use of non-ionizing doppler radiation makes the PSH-25GT/SSH-140A combination highly applicable for visualizing cephalic structures. The application of ALARA (as low as reasonably achievable) principles minimize any potential harmful effects. At diagnostic levels, the benefits of using ultrasound for imaging procedures far outweigh its risks.
The PSH-140A
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- Iabelling clearly specifies "Caution: Federal law restricts this device to use by or on the order of a physician";
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- is intended for a specific application which is familiar to medical practice and is substantially equivalent to devices legally entered into commercial distribution:
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- when used with the SSH-140A, employs software safety features to prevent acoustic intensities from exceeding Pre-enactment guidelines;
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- probe/ultrasound generator system electical safety is assured through proper grounding and, where local codes require, is certified through electrical certification performed by a nationally recognized testing agent (NRTL);
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- the probe operation manual informs the user to practice the principles of ALARA;
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- thermal and mechanical safety aspects comply with the IEC-601-1 standard;
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- cleaning and disinfection protocols are detailed in the transducer operations manuals. Agents for cleaning and disinfection are readily available through common suppliers and labeling cautions the user to follow the agent's manufacturer's instructions.