(385 days)
Not Found
Not Found
No
The device is a simple ultrasound gel pad, a passive material for transmission, with no mention of any computational or analytical capabilities.
No.
The device is an ultrasound transmission gel pad used with an Ultrasonic Blood Flow Detector; it does not directly treat or prevent a disease or condition.
No
The device is described as an "ultrasound transmission gel pad" which is used in conjunction with an "Ultrasonic Blood Flow Detector". Its function is to facilitate the transmission of ultrasound waves, not to diagnose a condition itself. Its performance studies focus on safety and effectiveness for ultrasound transmission, not diagnostic accuracy.
No
The device description clearly states it is a physical pad consisting of foam tape, hydrogel, and polyester film, indicating it is a hardware device, not software.
Based on the provided information, the Ultra Ease Ultrasound Gel Pad is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Ultra Ease Ultrasound Gel Pad is described as an "ultrasound transmission gel" used in conjunction with an "Ultrasonic Blood Flow Detector." Its purpose is to facilitate the transmission of ultrasound waves into the body for the purpose of auscultating peripheral vascular perfusion.
- No Sample Analysis: The device does not analyze any samples taken from the body. It is a topical product applied to the skin to improve the performance of another medical device (the Ultrasonic Blood Flow Detector).
Therefore, the Ultra Ease Ultrasound Gel Pad falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ultra Ease Ultrasound Gel Pad is indicated for use as an ultrasound transmission gel to be used in conjunction with an Ultrasonic Blood Flow Detector to auscultate peripheral vascular perfusion.
Product codes (comma separated list FDA assigned to the subject device)
Unknown
Device Description
Ultra Ease Ultrasound Gel Pad is a non-irritating, rectangular shaped pad, that consists of a medical grade foam tape ring, a solid hydrogel transmission layer, and a polyester film cover. The pads are individually packaged in heat sealed paper/poly/foil/poly pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Skin contact materials have passed a Primary Skin Irritation Test, a Repeated Insult Patch Tests (on 50 human subjects) and an Agarose Overlay Cytotoxicity Test to demonstrate pad safety. Clinical evaluation shows the pads are effective for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 for Ultra Ease Ultrasound Gel Pad
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- General Information
| Device Generic Name: | Ultrasound Gel Pad |
|---|---|
| ---------------------- | -------------------- |
Device Trade Name:
ultrasound.sci.utah
Minnetonka, MN 55343
Ultra Ease Ultrasound Gel Pad
LecTec Corporation Applicant's Name and Address: 10701 Red Circle Drive
510(k) Number:
Unknown
Aquasonic Ultrasonic Transmission Gel and Aquaflex Ultrasound Gel Pad
Parker Laboratories Orange, New Jersey 07050
Date of Judgement of Substantial
Equivalence:
Unknown
ll. Description of Conditions for Which the Device is Indicated
Ultra Ease Ultrasound Gel Pad is indicated for use as an ultrasound transmission gel to be used in conjunction with an Ultrasonic Blood Flow Detector to auscultate peripheral vascular perfusion.
1
111. Device Description
Ultra Ease Ultrasound Gel Pad is a non-irritating, rectangular shaped pad, that consists of a medical grade foam tape ring, a solid hydrogel transmission layer, and a polyester film cover. The pads are individually packaged in heat sealed paper/poly/foil/poly pouches.
IV. Alternatives
Other ultrasound transmission gels are alternatives for the Ultra Ease Ultrasound Gel Pad.
V. Potential Adverse Effects
Potential adverse effects associated with Ultra Ease Ultrasound Gel Pad are the same as those associated with other ultrasound transmission gels.
VI. Summary of Studies
Skin contact materials have passed a Primary Skin Irritation Test, a Repeated Insult Patch Tests (on 50 human subjects) and an Agarose Overlay Cytotoxicity Test to demonstrate pad safety. Clinical evaluation shows the pads are effective for the intended use.
VII. Conclusion
The information presented for the Ultra Ease Ultrasound Gel Pad demonstrates that it will perform in a safe and effective manner, as intended.