(49 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 an ultrasound transducer, designed to prevent the transfer of microorganisms and body fluids, and maintain a sterile field. It does not directly treat or diagnose a disease or condition, which is the primary function of a therapeutic device.
No
The device is a protective cover for an ultrasound transducer, designed to prevent the transfer of microorganisms and maintain sterility during ultrasound procedures. It does not perform any diagnostic function itself.
No
The device description clearly states it is a physical cover made of synthetic polyisoprene, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a protective cover for ultrasound transducers to prevent the transfer of microorganisms and body fluids during ultrasound procedures. This is a barrier function for infection control, not a diagnostic test performed in vitro (outside the body) on specimens.
- Device Description: The device is a physical cover made of synthetic polyisoprene. Its function is mechanical protection and barrier creation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze specimens (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Input Imaging Modality: While it's used with ultrasound, the device itself doesn't perform the imaging or interpret the results. It's an accessory to the imaging equipment.
IVD devices are typically used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Synthetic Polyisoprene Ultrasound Transducer Cover is a protective cover or sheath The Synthetic I virylsoprene Offransducer / probe / scanhead instruments. The cover is used with placed over an ultrasound transduor 7 probe Foody surface, endocavily, and the transdicer in Scanning and necule galadu procedured to rasound. The cover also helps to intra-operative ulagnostic, interventional; of the patient and healthcare in prevent transfer of the transducer (both sterile and non-sterile covers). The cover also worker during reuse of the transducer (both sterile and non-sterile cover also worker dunny rease of the transadoes (secrile field (sterile covers only). Synthetic provides a means for maintenantes of a stonio ficial when treating a patient with known type I Polylsoprene is facex-free and therefore benoments. I sensitized. Transducer hypers are furnished sterile & non-sterile; single use patient / procedure, disposable.
The intended use and indications for use place Synthetic Polyisoprene Ultrasound The Intondou aso an in device body contact categories as follows:
- surface devices, intact skin / mucosal membranes / breached surfaces, a) limited contact duration (
§ 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
DEC 2 8 2001
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
(As required by 21 CFR 807.92)
Synthetic Polyisoprene Ultrasound Transducer Cover
A. General Information
| Submitter's Name: | CIVCO Medical Instruments Co., Inc. |
|---|---|
| Address: | 102 First Street South, Kalona, IA 52247 |
| Telephone No.: | phone (319) 656-4447 fax: (319) 656-4451 |
| Contact Person: | Theresa Leinen, Quality Systems Administrator |
Establishment Registration Number: 1937223 CIVCO Medical Instruments Co., Inc. is registered as a medical device manufacturer.
| Device Trade: | Synthetic Polyisoprene Ultrasound Transducer
Cover |
|-----------------------------|-------------------------------------------------------|
| Device Common: | Ultrasound Transducer Cover / Sheath / Drape |
| Device Classification Name: | Ultrasonic Diagnostic Transducer Accessories |
| Classification: | Class II under 21 CFR 892.1570 |
| Classification Panel: | Radiology |
| Classification Procode: | 90 ITX |
Performance Standards: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
B. Device Description
Classification Procode:
The Synthetic Polyisoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer geometries. The cover is manufactured as either a one-or two-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another.
The cover material is polyisoprene synthetic rubber similar to that of non-latex medical examination / surgical gloves. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:
General Purpose Synthetic Polyisoprene Transducer Covers (sterile and non-sterile)
Endocavity Synthetic Polyisoprene Transducer Covers (sterile and non-sterile)
Surgi-Tip™ Intraoperative* Synthetic Polyisoprene Transducer Covers (sterile) *Polyethylene cord cover w/ Synthetic Polyisoprene tip
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. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.
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C. Intended Use / Indications for Use
The Synthetic Polyisoprene Ultrasound Transducer Cover is a protective cover or sheath The Synthetic I virylsoprene Offransducer / probe / scanhead instruments. The cover is used with placed over an ultrasound transduor 7 probe Foody surface, endocavily, and the transdicer in Scanning and necule galadu procedured to rasound. The cover also helps to intra-operative ulagnostic, interventional; of the patient and healthcare in prevent transfer of the transducer (both sterile and non-sterile covers). The cover also
worker during reuse of the transducer (both sterile and non-sterile cover also worker dunny rease of the transadoes (secrile field (sterile covers only). Synthetic provides a means for maintenantes of a stonio ficial when treating a patient with known type I Polylsoprene is facex-free and therefore benoments. I sensitized. Transducer hypers are furnished sterile & non-sterile; single use patient / procedure, disposable.
The intended use and indications for use place Synthetic Polyisoprene Ultrasound The Intondou aso an in device body contact categories as follows:
- surface devices, intact skin / mucosal membranes / breached surfaces, a) limited contact duration (Nancy Brogdon |
|---------------------------------------------------------------|----------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013721 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-the-Counter Use
(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
| ✓ | | |
Synthetic Polyisoprene
CIVCO Medical Instruments CO., Inc 02 November 2001
Synthetic Polyisoprene Ultrasound Transducer Cover