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510(k) Data Aggregation
(179 days)
These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized.
Contour Fabricators, Inc. Ultrasound Probe Drapes provide an efficient flexible covering to fit various specific ultrasound probes. These ultrasound probe drapes are constructed primarily of polyurethane film, a customary ultrasound probe drape material. Some drape designs additionally utilize an inner layer of polyethylene film to provide an extended cable cover. This extended cable cover has no patient contact and, at most, incidental user contact. Most product versions include a pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands that are customarily used to control extra "bulk" of drape material in the vicinity of the application procedure. Each Ultrasound Probe Drape is roll- or telescope-folded during its manufacturing to facilitate user application to the ultrasound probe. Each folded Ultrasound Probe Drape then is wrapped with a suitable piece of "CSR-wrap" (medical paper customarily used for this purpose). The wrapped, folded Ultrasound Probe Drape is then placed, along with the pre-sterilized foil packet of ultrasound coupling gel and the synthetic elastomer bands if provided, into a medical device pouch for terminal sterilization and distribution.
The provided 510(k) summary describes the acceptance criteria and the study that indicates the Contour Fabricators, Inc. (CFI) Ultrasound Probe Drape meets these criteria, primarily through demonstrating substantial equivalence to a predicate device and compliance with recognized consensus standards.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
This product is a medical device (ultrasound probe drape) rather than an AI/software device. Hence, the "acceptance criteria" here relate to safety, effectiveness, and substantial equivalence to a predicate device, rather than performance metrics like sensitivity/specificity.
| Acceptance Criterion (CFI Device) | Reported Device Performance (CFI Device) |
|---|---|
| Intended Use: For use during medical ultrasound imaging procedures involving limited-duration unbroken-skin patient contact, to maintain a sterile field (sterile covers only), protect patient/healthcare worker from contaminants, and protect the ultrasound probe. | Substantially equivalent to predicate device: provides a thin, conformal protective cover/drape system for ultrasound transducer/probe usage in body-surface patient environments, maintaining a sterile field, protecting from contaminants, and protecting the probe. Single patient/procedure, disposable, furnished sterile or non-sterile, can include coupling gel. |
| Material Composition: Primarily polyurethane film; some designs also use polyethylene film. Can include pre-sterilized ultrasound coupling gel and synthetic elastomer bands. | Constructed primarily of polyurethane film. Some designs utilize polyethylene film. Typically includes pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands. These are customary materials used effectively and safely for many years in medical devices. |
| Design: Tubular bags or loose "socks," open on one end and closed on the other, to accommodate various ultrasound transducer/probe geometries. Applied over the transducer/probe with open end along the cable and closed end against the working face. | Configured as tubular bags or loose "socks," open on one end and closed on the other, with dimensional configurations to accommodate differences in ultrasound transducer/probe geometries. Designed identical to predicate device for application. |
| Manufacturing: Validated heat-seal fabrication processes, operations in certified ISO 14644-1:1999(E) Class 8 cleanrooms. Sterile barrier packaging validated per ISO 11607. EtO sterilization (if applicable) by certified subcontractor validated per ISO 11135. | CFI's device group is made using validated heat-seal fabrication processes, with specification-compliance-controlling operations conducted in certified, validated ISO 14644-1:1999(E) Class 8 cleanrooms. Sterile barrier packaging (when applicable) is validated per ISO 11607. EtO sterilization (when applicable) is conducted by an appropriately certified, audited sterilization subcontractor utilizing processes validated per ISO 11135. All operations are subject to the CFI quality management system. The predicate device uses similar manufacturing processes. |
| Safety (Biocompatibility): No adverse effects to healthcare worker and patient for limited contact ( |
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