(511 days)
No
The description details standard Doppler ultrasound technology and signal processing (FFT) without mentioning AI or ML algorithms for analysis or interpretation.
No
The device is described as detecting and analyzing vascular disease, evaluating stenosis, and measuring flow velocity, all of which are diagnostic functions. There is no mention of treating or alleviating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Detection and analysis of vascular disease" and "Evaluation of degree and site of a stenosis," which are diagnostic purposes. The device analyzes spectral distribution of blood flow and allows for storage of annotations including a "diagnosis," further supporting its diagnostic nature.
No
The device description explicitly states it is a "continuous wave Doppler ultrasound device with two pen-shaped split-D transducers" and provides physical dimensions and weight, indicating it is a hardware device with integrated software for signal processing and display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device, the Stenodoc, uses ultrasound to directly examine the peripheral vessels within the human body.
- The intended use describes direct examination of the patient's vascular system. It's about detecting and analyzing vascular disease in the patient, not analyzing a sample taken from the patient.
- The device description details a Doppler ultrasound system. This is a non-invasive imaging technique applied externally to the body.
Therefore, based on the provided information, the Stenodoc is a medical device used for in-vivo (within the living body) diagnosis, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Detection and analysis of vascular disease in peripheral vessels.
Evaluation of degree and site of a stenosis. Detection of occlusions and flow disturbances. Determination of vessel type and location. Measurement of relative flow velocity. Not intended for fetal use.
Product codes
Not Found
Device Description
Stenodoc is a mains independent portable continuous wave Doppler ultrasound device with two pen-shaped split-D transducers operating at 4 MHz and 8 MHz. A 512 point fast Fourier transform (FFT) is performed on the returned signal. The spectral distribution of blood flow is represented as a frequency over time diagram with intensities represented by different shades of gray. The diagram is displayed on a liquid crystal display (LCD). Measurements can be annotated with the patient's name, vessel name and a diagnosis and can be stored on a built-in hard-disk for later evaluation.
Size: 3" x 13.5" x 10" (Height/Width/Depth) Weight: 9 lbs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
continuous wave Doppler ultrasound
Anatomical Site
peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Summary of Safety and Effectiveness
510(k) Diagnostic Ultrasound Devices
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 and was prepared April 27, 1995.
| Submitter: | SPECS USA, Inc.
Suite 312
2. North Tamiami Trail
Sarasota, FL 34236
Phone: (813) 362-4877
MAY 24 1996 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Ulrich R. Herken, Manager R&D |
| Common Name: | Bidirectional Vascular Doppler with Spectral Analysis. |
| Proprietary Name: | Stenodoc |
| Classification Name: | Nonfetal ultrasonic monitor, 21 CFR 892.1540. |
| Classification: | Classification of this ultrasonic device under Section 513 of the
act is Class II. |
| Predicate Device: | The Stenodoc Bidirectional Vascular Doppler with Spectral
Analysis is substantially equivalent to the Multigon 500A Vas-
cular Spectrum Analyzer with Doppler, Reference K850435,
which was declared substantially equivalent to predicate devices
May 5, 1986. |
| Description: | Stenodoc is a mains independent portable continuous wave
Doppler ultrasound device with two pen-shaped split-D trans-
ducers operating at 4 MHz and 8 MHz. A 512 point fast Fourier
transform (FFT) is performed on the returned signal. The spec-
tral distribution of blood flow is represented as a frequency over
time diagram with intensities represented by different shades of
gray. The diagram is displayed on a liquid crystal display
(LCD). Measurements can be annotated with the patient's name,
vessel name and a diagnosis and can be stored on a built-in hard-
disk for later evaluation.
Size: 3" x 13.5" x 10" (Height/Width/Depth) Weight: 9 lbs. |
| Intended use: | Detection and analysis of vascular disease in peripheral vessels.
Evaluation of degree and site of a stenosis. Detection of occlu-
sions and flow disturbances. Determination of vessel type and
location. Measurement of relative flow velocity. Not intended
for fetal use. |
VII
1
510(k) Diagnostic Ultrasound Devices
| Characteristic | STENODOC™ | Multigon 500A |
|---|---|---|
| Device Type | Bidirectional Doppler | Bidirectional Doppler |
| Ultrasound mode | continuous wave | continuous wave |
| Transducers | 4 and 8MHz split D | 4 and 8MHz split D |
| ISPTA 8 MHz Probe |