KILTEX PROBE COVER

K961029 · Kiltex Corp. · IYO · Jul 25, 1996 · Radiology

Device Facts

• Record ID: K961029
• Device Name: KILTEX PROBE COVER
• Applicant: Kiltex Corp.
• Product Code: IYO · Radiology
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The ultrasound probe covers are intended to be used as a sheath for endocavity ultrasound transducers.

Device Story

Natural latex sheath; used as protective cover for endocavity ultrasound transducers; prevents cross-contamination; manufactured using same formula and equipment as historical natural latex prophylactics; distributed by CIVCO Medical Instruments; used in clinical ultrasound settings; provides barrier protection for patient and transducer.

Clinical Evidence

No clinical data. Bench testing performed to meet ASTM D-3492 standards for latex condoms.

Technological Characteristics

Natural latex material; endocavity sheath form factor; manufactured to ASTM D-3492 standards for latex condoms.

Indications for Use

Indicated for use as a protective sheath for endocavity ultrasound transducers during ultrasound procedures.

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

• CIVCO Medical Instruments ultrasound probe covers (K895614)

Submission Summary (Full Text)

{0}

K961029

JUL 25 1996

# SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

Prior to 1976, the Young Rubber Company produced natural latex prophylactics without a reservoir end that were sold both as ultrasound probe covers and natural latex condoms. Carter-Wallace, Inc. in 1986 acquired the Young Rubber Company and continued this production of condoms and ultrasound probe covers, aka endocavity ultrasound transducer natural latex sheaths. In 1987, Kiltex Corporation began producing natural latex prophylactics for Carter-Wallace using the identical formula and equipment as used by Carter-Wallace. In August 1992, CIVCO Medical Instruments Co., Inc. contracted with Kiltex Corporation to manufacture under their (CIVCO's) 510(K) #K895614 natural latex prophylactics to be sold and used solely as ultrasound probe covers. These probe covers are identical to those formerly (prior to August 1992) manufactured by Carter-Wallace, Inc. for CIVCO Medical Instruments Co., Inc. Since August 1992, CIVCO Medical Instruments Co., Inc. has continually marketed and sold Kiltex's production of probe covers.

To date, there is no ASTM or FDA written standard for probe covers. However, the Kiltex ultrasound probe covers have been manufactured to meet the standards for latex condoms as set forth in ASTM D-3492.

Kiltex Corporation

by Timothy J. Killian
President

July 2, 1996