(87 days)
The MASCT device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
The Nastech MASCT device is similar to the non-powered breast aspirators manufactured by Nastech Pharmaceutical Company, Inc. and Pro-Duct Health, Inc. used to elicit and collect nipple aspirate fluid (NAF) from the excretory ducts (tubuli lactiferi or galactophori). The device is comprised of a rigid polycarbonate cup in which the sample collection container is inserted. Negative pressure (vacuum) is produced by nonpowered (hand) actuations of a lever like handle. The expressed NAF sample is collected on a membrane filter and washed into the sample container using an appropriate fixative solution.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nastech Pharmaceutical Company, Inc. Mammary Aspiration Specimen Cytology Test (MASCT) device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the study's stated objective to demonstrate the device's ability to collect sufficient samples for cytological analysis and to support the claim that the collected cells can be used to identify differences associated with premalignant or malignant conditions.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sample Collection Success | All breasts evaluated yield nipple aspirate fluid (NAF). | 100% of breasts evaluated yielded nipple aspirate fluid. |
| Sample Sufficiency for Cytological Analysis | All collected samples are clinically useful and sufficient for cytological analysis by a pathologist. | All samples were sufficient for cytological analysis; the pathologist was able to read all samples and obtain cytology results. |
| Cytological Data Quality | The device enables the collection of cells that can be used to identify differences (normal, premalignant, malignant) through cytological examination. | 97% of samples were Class I (normal/benign); 3% were Class IIa (benign). These results support the claim for identifying cell differences. |
| Sample Weight (Implicit) | While not an explicit "acceptance criterion," the viability of collecting samples above a minimal weight threshold for practical handling/analysis is implied. | Mean sample weight was 6.6 mg, range |
§ 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.