(213 days)
Not found 510(k) number
Not Found
No
The device description details a simple A-scan ultrasound system with basic controls and no mention of advanced processing or learning algorithms.
No
The device is intended for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" states that the system is "intended to assist the physician in the diagnosis of maxillary and frontal sinusitis."
No
The device description explicitly states it is a "pulseecho device, equipped with a single unfocused flat 8 mm 3 MHz transducer," which is a hardware component.
Based on the provided information, the Ultramax ultrasonic diagnostic system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Ultramax Function: The Ultramax uses ultrasound to directly examine the sinus cavity within the body. It does not analyze samples taken from the body.
Therefore, the Ultramax falls under the category of an in vivo diagnostic device, as it performs the diagnostic procedure directly on the patient's body.
N/A
Intended Use / 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.
Product codes
77LWI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
maxillary and frontal sinuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not found 510(k) number
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
AUG - 2 1996
14. 510(k) Summary
| Submitter: | Entlab Oy |
|---|---|
| address | Jaakkolantie 3 |
| city | Hämeenlinna |
| code | FIN 13100 |
| country | Finland |
| phone | +358-17-675-9203 |
- phone +358-17-675-9203 f ax
- Dr. Matti Revonta Contact person: Ultramax Canada Inc. 5571 Sandiford Place V7E 5M5 Richmond, B.C. Canada tel 604-241-1019 fax 604-241-1019
- 18th December 1995 Date
The device:
- Ultramax, an ultrasonic system to assist Trade name in the diagnosis of maxillary and frontal sinusitis
Ultramax Sinus Scanner Common name
Nasal Sinus scanning/measurement device Classification 77LWI name/class
The device to which the equivalence is claimed:
- Echosine 1000 ultrasound system for Trade name scanning sinus cavities
Echosine Sinus Scanner Common name
Nasal Sinus Scanning/measurement device Classification 77LWI name/class
American Electromedics Corp. Manufacturer Sagamore Park Road, Hudson, NH 03051 phone 603-880-6300
Not found 510(k) number
11
1
K 9600044/51 PACE 2 ol 3
| 1 | 2 |
|---|---|
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 | $50 mm^2$ | $133 mm^2$ |
| 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 | |
| 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 |
2
K 9600 44/51 PAGE 3 of 3
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, pulseecho 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, Isrn.; 0.230 mW/cm² and Isepx.3 0.956 W/cm². The results are all less than those for diagnostic use, given by the FDA.