(133 days)
Not Found
No
The device description is for natural latex prophylactics used as ultrasound probe covers, with no mention of AI or ML technology.
No
The device description states it is a natural latex prophylactic to be sold and used solely as an ultrasound probe cover, which is a barrier device for medical instruments, not a device intended to treat or manage a disease or condition.
No
Explanation: This device is described as natural latex prophylactics (condoms) used as ultrasound probe covers. It is an accessory for an imaging modality (ultrasound) but does not itself diagnose, monitor, or treat a disease or condition.
No
The device description clearly states it is a physical product (natural latex prophylactics) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the intended use is "solely as ultrasound probe covers." This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (natural latex) and its function as a cover for an ultrasound probe.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on biological or chemical processes.
The device is a medical device, specifically an accessory for an ultrasound machine, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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): 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.
Not Found
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.
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
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
date