ULTRAMAX/MODEL NUMBER A1

K960044 · Entlab OY · LWI · Aug 2, 1996 · Radiology

Device Facts

• Record ID: K960044
• Device Name: ULTRAMAX/MODEL NUMBER A1
• Applicant: Entlab OY
• Product Code: LWI · Radiology
• Decision Date: Aug 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Ultramax ultrasonic diagnostic system is intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity.

Device Story

Ultramax is a handheld A-scan, pulse-echo ultrasonic diagnostic system used by physicians to detect fluid in maxillary and frontal sinuses. Device utilizes a single 3 MHz, 8 mm unfocused flat transducer to emit ultrasonic pulses at a fixed 300 Hz repetition rate. Input signals are reflected echoes from sinus structures; device processes these to determine presence of fluid. Output is displayed via a bar of light-emitting diodes (LEDs), where low intensity is indicated by LED brightness and high intensity by the breadth of the echo complex. Controls include receiver gain and depth range selection (0-4 cm or 0-8 cm). Device is battery-operated, portable, and intended for clinical use to aid in sinusitis diagnosis, potentially reducing need for more invasive procedures.

Clinical Evidence

Bench testing only. Performance parameters reported: MI 0.1195, ISPTA.3 0.230 mW/cm², ISPPA.3 0.956 W/cm². All values are within FDA limits for diagnostic ultrasound.

Technological Characteristics

A-scan pulse-echo ultrasound; 3 MHz unfocused flat 8 mm epoxy transducer; 9V rechargeable battery power; LED bar display; receiver gain and depth range controls; handheld form factor (22 cm, 170 g).

Indications for Use

Indicated for patients with suspected maxillary or frontal sinusitis to assist physicians in detecting fluid in the sinus cavity.

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

• Echosine 1000 ultrasound system

Submission Summary (Full Text)

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K960044/51
Page 1 of 3
11 AUG - 2 1996

## 14. 510(k) Summary

| **Submitter:** Entlab Oy
address Jaakkolantie 3
city Hämeenlinna
code FIN 13100
country Finland
phone [phone]
fax [phone]

**Contact person:** Dr. Matti Revonta
Ultramax Canada Inc.
5571 Sandiford Place
V7E 5M5 Richmond, B.C.
Canada
tel [phone]
fax [phone]
Date 18th December 1995

**The device:**
Trade name Ultramax, an ultrasonic system to assist in the diagnosis of maxillary and frontal sinusitis
Common name Ultramax Sinus Scanner
Classification Nasal Sinus scanning/measurement device
name/class 77LWI

**The device to which the equivalence is claimed:**
Trade name Echosine 1000 ultrasound system for scanning sinus cavities
Common name Echosine Sinus Scanner
Classification Nasal Sinus Scanning/measurement device
name/class 77LWI
Manufacturer American Electromedics Corp.
Sagamore Park Road, Hudson, NH 03051
phone [phone]
510(k) number Not found |
| --- |

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K960044/51 PAGE 2 of 3

12
Comparison of the technological characteristics: a summary.

| | Ultramax | Echosine |
| --- | --- | --- |
| Description of the method and target organs | Ultrasound system to scan nasal sinuses | Ultrasound system to scan nasal sinuses |
| Target population | Patients with suspected sinusitis | Patients with suspected sinusitis |
| Method to detect sinusitis | shows liquids in the sinuses | shows liquids in the sinuses |
| Ultrasound mode | pulse-echo | pulse-echo |
| Measuring Range | 0-40 or 0-80mm | 0-30 or 0-80mm |
| Leds/Markers on the display | 2.5 mm or 5 mm | 2 mm steps |
| Image freeze | yes | yes |
| Controls | receiver gain depth range | receiver gain depth range CRT focus |
| Probe design contact material | round flat epoxy | round epoxy |
| Beam | unfocused | focused |
| Probe frequency | 3 MHz | 3.5 MHz |
| Probe diameter | 8 mm | 13 mm |
| Probe area | 50 mm² | 133 mm² |
| Pulse duration | 0.9 us | 0.3- 0.5 us |
| Maximum Ultrasonic Power | | 0.9 mW |
| MI (mean) | 0.0962 | |
| Pulse repetition fr. | 300 Hz fixed | ... cont. |

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K 960044/51 PAGE 3 of 3

continued:

| | Ultramax | Echosine |
| --- | --- | --- |
| Display | a bar of light emitting diodes (LEDs) | cathode ray tube (CRT) |
| Echo display mode | | |
| -low intensity | brightness of one LED | amplitude of a peak on CRT |
| -high intensity | breadth of the echo complex | breadth of the echo complex |
| Hard copy | Polaroid camera (optional) | printer (optional) |
| Power supply | 9 V rechargeable battery + 120V charging unit | 120V 50-60Hz mains |

Conclusions:
The Ultramax and the Echosine diagnostic ultrasound systems are substantially equivalent.

Description of the device

Indications for use: Ultramax ultrasonic diagnostic system is intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity.

Principles of operation: The Ultramax is an A-scan, pulse-echo device, equipped with a single unfocused flat 8 mm 3 MHz transducer. Pulse repetition rate is fixed at 300 Hz. The only controls on the device are the receiver gain, and the range that can be selected between "8" (0-8 cm), "4" (0-4 cm) and "4E" (4-8 cm). These selections do not effect the emitted acoustic power.

Power source: Rechargeable 9 V battery. Charging unit with 110 V hospital grade charger.

Composition: Probe, probe cable (optional), extension tube, hand held unit, charging unit, gel bottle (empty), calibration check rod.

Measures: Length 22 centimeters, weight 170 grams.

Performance parameters: Maximum values are for MI: 0.1195, $I_{SPTA.3}$ 0.230 mW/cm² and $I_{SPPA.3}$ 0.956 W/cm². The results are all less than those for diagnostic use, given by the FDA.