(87 days)
The Cervix Coil Latex Sheath allows use of the coil in MR scanning procedures for endocavitary exams of the cervix while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the coil. The latex coil cover is furnished as a non-sterile, single use (patient/procedure), disposable device.
The Cervix Coil Latex Sheath has been specifically designed to fit over the Picker Hammersmith Endocavitary Cervix Coil. The sheath has an extension on the closed end that can be depressed into the center of the coil. This allows placement of the cervix within the MR coil ring without interference from the sheath. This disposable sheath prevents transfer of microorganisms, body fluids, and particulate material during reuse of the coil.
Here's a breakdown of the acceptance criteria and study information for the Cervix Coil Latex Sheath, based on the provided document:
The device, a "Cervix Coil Latex Sheath," is a Class II device intended to allow the use of an MRI coil in endocavitary exams of the cervix while preventing the transfer of microorganisms, body fluids, and particulate material. It's a non-sterile, single-use, disposable device. The submission focuses on demonstrating substantial equivalence to a predicate device, the CIVCO Latex Ultrasound Transducer Covers (K970515), rather than providing detailed acceptance criteria and a study to meet those criteria in a typical performance study format. The "study" here is essentially the comparison and justification of equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the predicate device, and the "reported device performance" is the claim that the Cervix Coil Latex Sheath shares these characteristics.
| Parameter | Predicate Device (CIVCO Latex Ultrasound Transducer Cover, K970515) - Implied Acceptance Criteria | Cervix Coil Latex Sheath - Reported Device Performance |
|---|---|---|
| Design | One-piece, open one end, closed other, various dimensional configurations to accommodate ultrasound geometries, externally applied. | One-piece, open one end, closed other with dimensional configurations to accommodate the Hammersmith Endocavitary Cervix Coil, externally applied. |
| Material | Natural rubber latex, formulation conforms with 21 CFR, 177.2600, manufactured according to cGMP. | Same (Natural rubber latex, formulation conforms with 21 CFR, 177.2600, manufactured according to cGMP). |
| Manufacturing | Dip-molding, packaging in class 10,000 clean room. | Same (Dip-molding, packaging in class 10,000 clean room). |
| Safety | Non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic. | Same (Implied to be non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic due to identical material and manufacturing). |
| Effectiveness | Sufficient physical and material properties (strength, elasticity), effective barrier to microbial migration. | Same (Implied to have sufficient physical/material properties and be an effective barrier to microbial migration due to identical material and manufacturing). |
| Intended Use / Indications | Protective cover for diagnostic ultrasound transducers, prevents transfer of microorganisms/body fluids/particulate material during reuse, maintains sterile field (for sterile covers). | Allows use of coil in MR scanning for endocavitary exams of cervix, helps prevent transfer of microorganisms/body fluids/particulate material during reuse. |
| Device Body Contact Category | Surface devices, intact skin/mucosal membranes/breached surfaces, limited contact ( |
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.