STENODOC

K946349 · Specs USA, Inc. · IYO · May 24, 1996 · Radiology

Device Facts

• Record ID: K946349
• Device Name: STENODOC
• Applicant: Specs USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended 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.

Device Story

Stenodoc is a portable, mains-independent continuous wave Doppler ultrasound device; utilizes 4 MHz and 8 MHz split-D transducers to detect blood flow signals. Device performs 512-point Fast Fourier Transform (FFT) on signals to generate spectral distribution of blood flow; displays frequency-over-time diagrams with intensity-based grayscale on an integrated LCD. Used by clinicians in clinical settings for peripheral vascular assessment. Output includes visual spectral diagrams and calculated hemodynamic parameters (max/mode/mean frequency, spectral broadening, pulsatility, resistance index). Data can be annotated with patient/vessel information and stored on an internal hard disk for review. Enables clinicians to identify stenosis, occlusions, and flow disturbances, facilitating diagnosis and management of peripheral vascular disease.

Clinical Evidence

Bench testing only. Comparison of technical specifications and performance metrics (I_SPTA, frequency detection, FFT resolution) provided against predicate device.

Technological Characteristics

Portable continuous wave Doppler ultrasound; 4 MHz and 8 MHz split-D transducers. 12-bit AD-converter. 512-point FFT spectral analysis. 9.5-inch LCD. Dimensions: 3" x 13.5" x 10"; Weight: 9 lbs. Mains-independent power. Internal hard disk storage.

Indications for Use

Indicated for patients requiring evaluation of peripheral vascular disease, including detection of stenosis, occlusions, flow disturbances, and measurement of relative flow velocity. Not for fetal use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Multigon 500A Vascular Spectrum Analyzer with Doppler (K850435)

Submission Summary (Full Text)

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510(k) Diagnostic Ultrasound Devices
K946349

# Summary of Safety and Effectiveness

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: [phone]
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 Vascular 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 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 harddisk 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 occlusions and flow disturbances. Determination of vessel type and location. Measurement of relative flow velocity. Not intended for fetal use.

K946349 STENODOC
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510(k) Diagnostic Ultrasound Devices

Summary of technological characteristics of Stenodoc and the predicate device.

| 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 |
| I_{SPTA} 8 MHz Probe | < 94 mW/cm^{2} | 90 mW/cm^{2} |
| I_{SPTA} 4 MHz Probe | < 80 mW/cm^{2} | 69 mW/cm^{2} |
| Maximum Doppler frequency detection | 32 kHz | 35 kHz |
| AD-Converter | 12 bit | 8 bit |
| Spectral Analysis | 512 pt. FFT/direction | 256 pt. FFT overall |
| FFT calculation every | 10 ms | 6.5 ms |
| Physical Device Type | Laptop-Computer style | Desktop-Computer Style |
| Display | 9.5" diagonal LCD | 9" diagonal tube |
| Calculations | Maximum, Mode and Mean frequency, spectral broadening, pulsatility and resistance index | Maximum, Mode and Mean frequency, Spectral broadening |

K946349 STENODOC®
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