(192 days)
The NAFD 100 (and its components) is indicated for the collection of nipple aspirate fluid for cytological evaluation. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells.
The NAFD 100 is intended to non-invasively extract samples of breast cancer screening, providing a sample for a "Pap smear" for the breast. Virtually all breast cancers originate in the epithelial cells of fluid ducts that are present in a woman's breast. The case for routine, early breast screening is compelling. By the time a mammogram or manual clinical examination finds an abnormality, the cancerous lesion is already formed. The longer cancer has to develop in the body, it becomes stronger and more difficult to treat. A screening test using Nipple Aspirate Fluid (NAF) would be similar to a Pap smear, allowing a physician to detect abnormalities before a breast cancer is formed, or to screen for the possible presence of cancer. The routine use of the Pap smear has reduced the incidence of cervical cancer mortality by 70%, through early screening. Breast cancer screening could reasonably be expected to yield the same type of results. The NAFD 100 incorporates both hardware and disposable components, for use in a physician's office, and was developed to maximize patient comfort, and minimize risk to the patient. The system consists of three components: System console Powerhead Disposable patient interface
Here's an analysis of the provided text regarding the NAFD 100 device's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides very limited, and somewhat indirect, specifications regarding clear acceptance criteria for the device's performance. The primary performance metric mentioned is the collection rate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Consistency with other NAF collection methods | "The NAFD 100 has a collection of rate of 54%, which is consistent with other collection methods currently used." |
| Effective collection from "non-secretors" | "From the Journal of the National Cancer Institute published study non-secretors can be expected to average of 40% of those tested." (Implied: the device should be able to collect from this population, and 54% demonstrates this ability.) |
| Biocompatibility | "The materials used to manufacture the NAFD 100 comply with the requirements of ISO 10993-1." (This is a pass/fail criterion, not a performance metric.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "use on human subjects" for fit, form, and performance testing, but the number of subjects is not provided.
- Data Provenance: The document states "Fit, form and performance testing was conducted to evaluate its use on human subjects." This implies prospective human subject testing. The country of origin is not specified but is presumably the US, given the FDA submission. The reference to the "Journal of the National Cancer Institute published study" for non-secretors suggests external, potentially retrospective, data supporting the prevalence of non-secretors, but it's not a study of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The study described focuses on the collection rate of nipple aspirate fluid, not the cytological evaluation itself. Therefore, there's no mention of experts establishing a diagnostic ground truth for the test set related to pre-malignant or malignant cells based on the collected fluid in this document.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the study focuses on fluid collection efficacy, not diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not described. The document discusses the device's ability to collect fluid, not its impact on human reader performance for cytological evaluation.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The NAFD 100 is a physical medical device for fluid collection, not an algorithm.
7. Type of Ground Truth Used:
For the primary performance metric (collection rate), the ground truth was the successful physical collection of nipple aspirate fluid. The document does not describe the use of expert consensus, pathology, or outcomes data for the collection study itself. The mention of "pre-malignant versus malignant cells" refers to the intended use of the collected fluid, not the ground truth used to evaluate the device's collection capability.
8. Sample Size for the Training Set:
Not applicable. The NAFD 100 is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as it's not an AI/ML algorithm.
§ 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.