(129 days)
Not Found
No
The device is a physical cover for an ultrasound transducer and the description focuses on its material properties and barrier function, with no mention of software, algorithms, or data processing.
No
The device is a protective cover for ultrasound transducers, intended to prevent the transfer of microorganisms and maintain a sterile field, not to treat a medical condition.
No
The device is a protective cover for diagnostic ultrasound transducers. It is explicitly stated that the cover allows the use of diagnostic ultrasound transducers but it does not perform diagnostic functions itself. Its primary purpose is to prevent transfer of microorganisms and maintain a sterile field.
No
The device is a physical cover made of polyurethane and polyethylene, designed to be placed over an ultrasound transducer. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments." Its primary function is to provide a barrier to prevent the transfer of microorganisms and fluids during ultrasound procedures. It facilitates the use of the ultrasound transducer, but it does not perform any diagnostic testing on biological samples in vitro (outside the body).
- Device Description: The description reinforces that the device is a physical cover made of polyurethane or polyethylene film. It describes how it is used with the ultrasound transducer and coupling gel, but it does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, calibrators, controls, or analytical procedures typically associated with IVD devices. The performance studies focus on the physical barrier properties of the cover, not on the accuracy or reliability of diagnostic results obtained from analyzing biological samples.
In summary, the device is an accessory for an ultrasound transducer, designed to maintain hygiene and sterility during diagnostic imaging procedures. It does not perform any diagnostic testing itself, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker curing reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
Product codes
ITX
Device Description
CIVCO Poly Ultrasound Transducer Cover - this device provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries. Devices are manufactured as a one-piece design that provides a covering that helps prevent the transmission of pathogens from one patient to another. Materials are polyurethane (CIV-Flex) and polyethylene extruded thermoplastic film.
Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required - the sterile or non-sterile Poly Ultrasound Transducer Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary. The removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:
General Purpose CIV-Flex (polyurethane) Transducer Covers (sterile and non-sterile)
General Purpose Polyethylene Transducer Covers (sterile and non-sterile)
Accordion-folded Polyethylene Transducer Covers (sterile)
Intraoperative Polyethylene Transducer Covers (sterile)
Endocavity CIV-Flex (polyurethane) Transducer Covers (sterile and non-sterile)
Surgi Intraoperative (polvethylene) Transducer Covers (sterile)
Intraoperative (polyethylene) Cord and System Drapes (sterile)
Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Poly transducer covers are also combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
body surface, endocavity, and intra-operative
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare worker
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)
Biocompatibility tests for cytotoxicity, acute systemic toxicity, irritation, sensitization, hemolysis, and material mediated pyrogen were conducted in accordance with ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP). Testing results demonstrated subject materials / devices to be non-toxic, non-sensitizing, non-irritating, nonhemolytic, and non-pyrogenic.
Physical / mechanical properties were tested for material strength and elasticity. The cover should not tear or pinhole during application, removal, scanning, or attaching / removing a disposable needle guide.
Viral penetration testing was conducted by an independent laboratory using a protocol adapted from that used to evaluate barrier properties of surgeon's glove materials to penetration by bloodborne pathogens. This testing demonstrated that the polyurethane and polyethylene transducer covers provide an effective barrier to the prevention of microbial migration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for CIVCO Medical Instruments. The logo features a stylized globe on the left, followed by the word "CIVCO" in bold, sans-serif font. Below "CIVCO" are the words "MEDICAL INSTRUMENTS" in a smaller, sans-serif font with wide letter spacing. The overall design is simple and professional, conveying a sense of global reach and medical expertise.
JUN 2 0 1997
B2 of B4
Solutions for Ultrasound
CIVCO Poly Ultrasound Transducer Cover 510 (k) SUMMARY
Date Summary Prepared: 30 January 1997
This summary of the safety and effectiveness information upon which the substantial equivalence determination is based is being submitted in accordance with the requirements of SMDA 1990.
Submitter's Name: Address: Telephone No.: Contact Person:
CIVCO Medical Instruments Company, Inc. 102 First Street South, Kalona, IA 52247 (319) 656-4447 fax: (319) 656-4451 J. William Jones, Manager - Regulatory Affairs
Establishment Registration Number: 1937223 CIVCO Medical Instruments is registered as a medical device manufacturer.
Device Trade / Proprietary Name: Device Common / Usual Name: Device Classification Name:
CIVCO Poly Ultrasound Transducer Cover Ultrasound Transducer Cover / Sheath / Drape Ultrasonic Diagnostic Transducer Accessories
Classification: Classification Panel: Classification Procode: Class II under 21 CFR 892.1570 90 Radiology ITX
Description of Predicate Device(s): The CIVCO Poly Ultrasound Transducer Cover is equivalent to CIVCO's currently, legally marketed Scan Drape, 510(k) reference number K844472.
ORIGINALS ARE CODED RED
sheet 1 of 3
102 First Street South • Kalona, IA 52247 USA Phone: 319/656-4447 • Fax: 319/656-4451 E-mail: info@civcomedical.com
Image /page/0/Picture/19 description: The image contains two logos side by side. The logo on the left is a circular seal with the text "QUALITY ASSURED FIRM" around the top and "ISO 9001" in the center. Below the text is the acronym "SQS". The logo on the right features a checkmark above the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES" and a crown above the checkmark. The logos appear to represent quality assurance and national accreditation.
1
510 (k) SUMMARY con't.
Description of Subject Device Submitted for Premarket Notification: CIVCO Poly Ultrasound Transducer Cover - this device provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries. Devices are manufactured as a one-piece design that provides a covering that helps prevent the transmission of pathogens from one patient to another. Materials are polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film.
Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required - the sterile or non-sterile Poly Ultrasound Transducer Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary. The removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:
General Purpose CIV-Flex™ (polyurethane) Transducer Covers (sterile and non-sterile) General Purpose Polyethylene Transducer Covers (sterile and non-sterile) Accordion-folded Polyethylene Transducer Covers (sterile) Intraoperative Polyethylene Transducer Covers (sterile) Endocavity CIV-Flex™ (polyurethane) Transducer Covers (sterile and non-sterile) Surgi™ Intraoperative (polvethylene) Transducer Covers (sterile) Intraoperative (polyethylene) Cord and System Drapes (sterile)
Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Poly transducer covers are also combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.
Intended Use / Indications for Use: Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and material to the patient and healthcare worker during reuse of the transducer (both sterile and nonsterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
The intended use and indications for use place CIVCO Poly Ultrasound Transducer Covers in device body contact categories as follows:
- a) surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration (✓ | OR | Over-The-Counter Use |
|------------------|--------------|----|----------------------|
|------------------|--------------|----|----------------------|
(Optional Format 1-2-96)
ORIGINATERE CODED RED