(75 days)
A protective cover for a mechanical breast biopsy device reusable holster / cable assembly that helps prevent contamination [blood, body fluids, ultrasound gel, etc.] of the holster control buttons, and thus allowing for reprocessing of the holster between patient uses; covers are single use, disposable.
The CIV-Flex™ Holster Cover device provides a thin, conformal protective covering for the disposable probe / reusable holster and cable assembly components of the Ethicon Endo-Surgery Mammotome® mechanical breast biopsy device. The cover is manufactured as a one-piece sleeve design that is open on both ends with a tapered fit to the holster / probe geometry. The cover material is transparent for visualization of the holster control buttons during use. Cover material is polyurethane film. Material system is free of any latex natural rubber. Covers are packaged sterile in a pouch for single patient / procedure, disposable use. Cover is supplied with latex free Kraton® thermoplastic elastomer bands for use in securing the cover to the holster and cable.
The information provided describes a 510(k) premarket notification for the CIV-Flex™ Holster Cover, focusing on demonstrating substantial equivalence to a predicate device, the CIVCO Poly [CIV-Flex™] Ultrasound Transducer Cover (K970513). As this is a submission for a protective cover, the "performance" and "acceptance criteria" are related to its physical properties, biocompatibility, and ability to act as a barrier, rather than diagnostic accuracy metrics typically found in AI/ML device studies.
Here's an analysis of the provided text, structured to address your specific points where applicable, and noting when information is not present or relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" in a quantitative, metric-based format as one might expect for a diagnostic device. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing various parameters and highlighting that the new device meets the same performance and safety standards established for the predicate.
The "Effectiveness" section offers the closest information to performance, focusing on mechanical integrity and barrier properties.
| Parameter (effectively "Acceptance Criteria") | CIV-Flex™ Holster Cover Performance (Reported Performance) |
|---|---|
| Intended Use / Indications for Use | Same as predicate, except adapted for mechanical breast biopsy reusable holster/cable assembly. Prevents contamination, allowing reprocessing. |
| Design | Same as predicate. One-piece, geometry conforming cover. |
| Material | Same as predicate. Polyurethane, thermoplastic. CIVCO trade name CIV-Flex™. Used for over 10 years. (Generally Recognized As Safe - GRAS for this context) |
| Manufacturing | Same as predicate. Extruded/blown thin film, cut/heat seal, packaged in Class 10,000 cleanroom. Sterile packaging per ANSI/AAMI/ISO 11607. Sterilized by ethylene oxide gas. |
| Quality Systems | Same as predicate. FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485. |
| Sterility | Same as predicate. 100% EtO method validated per ANSI/AAMI/ISO 11135. SAL 10-6. |
| Device Body Contact Category | Same as predicate. Surface devices, intact skin/mucosal membranes/breached surfaces; limited contact duration ( |
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.