Who is the manufacturer of ULTRA EASE?

Lectec Corp. filed the 510(k) submission for ULTRA EASE (K950943).

What is the FDA product code for ULTRA EASE?

IYO. It is classified under 21 CFR 892.1560 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ULTRA EASE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ULTRA EASE?

Aquasonic Ultrasonic Transmission Gel; Aquaflex Ultrasound Gel Pad.

Who can help prepare an FDA 510(k) submission like ULTRA EASE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ULTRA EASE

K950943 · Lectec Corp. · IYO · Mar 7, 1996 · Radiology

Device Facts

Record ID	K950943
Device Name	ULTRA EASE
Applicant	Lectec Corp.
Product Code	IYO · Radiology
Decision Date	Mar 7, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1560
Device Class	Class 2

Intended 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.

Device Story

Ultra Ease Ultrasound Gel Pad; rectangular pad consisting of medical grade foam tape ring, solid hydrogel transmission layer, and polyester film cover. Used as acoustic coupling medium for Ultrasonic Blood Flow Detectors; facilitates ultrasound transmission during auscultation of peripheral vascular perfusion. Applied by clinician to patient skin; replaces traditional liquid gels. Benefits include ease of use, reduced mess, and consistent coupling. Packaged in heat-sealed pouches.

Clinical Evidence

Bench testing: Primary Skin Irritation Test, Repeated Insult Patch Test (n=50), and Agarose Overlay Cytotoxicity Test. Clinical evaluation confirms effectiveness for intended use as ultrasound transmission medium.

Technological Characteristics

Rectangular pad; medical grade foam tape ring; solid hydrogel transmission layer; polyester film cover. Non-irritating. Individually packaged in heat-sealed paper/poly/foil/poly pouches.

Indications for Use

Indicated for use as an ultrasound transmission gel in conjunction with Ultrasonic Blood Flow Detectors for auscultation of peripheral vascular perfusion in patients requiring vascular assessment.

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

Aquasonic Ultrasonic Transmission Gel
Aquaflex Ultrasound Gel Pad

Related Devices

K131905 — SOLID GEL PAD · Bluemtech · Jul 18, 2013
K031894 — SCANTEC PAD · Sonotech, Inc. · Jul 18, 2003
K163024 — Ultra/Phonic Conductivity Gel · Pharmaceutical Innovations, Inc. · Jan 8, 2018
K031018 — AUTOGEL PAD · Rich-Mar Corp. · Dec 8, 2003
K021132 — UNI-PATCH ULTRASOUND COUPLING GEL · The Ludlow Company LP · May 15, 2002

Submission Summary (Full Text)

{0} K950943 # Summary of Safety and Effectiveness for Ultra Ease Ultrasound Gel Pad ## I. General Information Device Generic Name: Ultrasound Gel Pad Device Trade Name: Ultra Ease Ultrasound Gel Pad Applicant's Name and Address: LecTec Corporation 10701 Red Circle Drive Minnetonka, MN 55343 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 ## II. 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} ## III. 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.