(87 days)
Mammary Aspiration Specimen Cytology Test (MASCT; Nastech Pharmaceutical Company, Inc.), Pro·Duct Catheter (Pro·Duct Health, Inc.)
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No
The device description and performance studies focus on a mechanical fluid collection method and cytological analysis, with no mention of AI or ML.
No
The device is used for the collection of nipple aspirate fluid for diagnostic cytological testing, not for treating any condition or disease.
Yes
The device is intended for the collection of nipple aspirate fluid for cytological testing, which can be used in the "determination and/or differentiation of normal versus premalignant versus malignant cells." This directly supports diagnostic purposes.
No
The device description clearly outlines physical components like a polycarbonate cup, sample collection container, lever-like handle, membrane filter, and sample container, indicating it is a hardware device for fluid collection.
Based on the provided information, the MASCT device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "collection of nipple aspirate fluid for cytological testing." It further clarifies that the collected fluid is used "in the determination and/or differentiation of normal versus premalignant versus malignant cells." This clearly indicates that the device is used to collect a sample from the human body for the purpose of providing information about a person's health status through in vitro examination of that sample.
- Device Description: The description details how the device collects the sample (nipple aspirate fluid) and prepares it for analysis (collected on a membrane filter and washed into a sample container with fixative). This process is part of the in vitro diagnostic workflow.
- Cytological Testing: The core purpose of collecting the fluid is for cytological testing, which is a laboratory-based examination of cells. This is a classic example of an in vitro diagnostic procedure.
While the device itself is a collection tool, its intended use is directly tied to an in vitro diagnostic test (cytological testing of the collected fluid). Therefore, the device is considered an IVD device because it is an accessory to an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nastech conducted in-vitro and clinical studies to verify and validate the device design. The results of that testing supported the conclusion that the MASCT device is safe and effective for its intended use. In addition, it is substantially equivalent to the identified predicate for all relevant parameters (e.g. intended use, target population, materials, etc.).
The specific claim of determining and/or differentiating normal, premalignant and malignant cells based upon cytological is supported by a clinical study conducted by Nastech. The results, based on cytological evaluation and/or measurable weight changes on the sample collection membrane filter showed that all breasts evaluated (100%) with bilateral mammary aspiration technique using the Nastech MASCT yielded nipple aspirate fluid. Sample weights ranged from
§ 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.
0
510(k) Summary - 21 CFR § 807.92(c)
Submitter's Name and Contact Information Nastech Pharmaceutical Company, Inc (Nastech) 45 Adams Avenue Hauppauge, NY 11788
Contact Person Peter C. Aprile, R.Ph. Vice President, Regulatory and Quality Affairs
Summary Preparation Date 10 February, 2003
Device Names Trade Name: Mammary Aspiration Specimen Cytology Test (MASCT) Common Name: Breast Aspirator Classification Name: Gastroenterology-Urology Biopsy Instrument (21CFR § 876.1075)
Substantially Equivalent Device
Substantial equivalence was claimed to Mammary Aspiration Specimen Cytology Test (MASCT; Nastech Pharmaceutical Company, Inc.) and Pro·Duct Catheter (Pro·Duct Health, Inc.)
Device Description
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.
Intended Use
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.
Technological Characteristics
The MASCT is a device which is substantially equivalent 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 from the excretory ducts (tubuli lactiferi or galactophori). The subject device shares similar design, material and operating characteristics as the predicates and devices to which the predicate devices
1
claim substantial equivalence. The subject device and predicate devices are comprised of polymer cups which are placed over the breast nipple and are used in conjunction with a non-powered mechanism for applying a gentle vacuum enabling expression of nipple aspirate fluid.
Data Supporting Substantial Equivalence
Nastech conducted in-vitro and clinical studies to verify and validate the device design. The results of that testing supported the conclusion that the MASCT device is safe and effective for its intended use. In addition, it is substantially equivalent to the identified predicate for all relevant parameters (e.g. intended use, target population, materials, etc.).
The specific claim of determining and/or differentiating normal, premalignant and malignant cells based upon cytological is supported by a clinical study conducted by Nastech. The results, based on cytological evaluation and/or measurable weight changes on the sample collection membrane filter showed that all breasts evaluated (100%) with bilateral mammary aspiration technique using the Nastech MASCT yielded nipple aspirate fluid. Sample weights ranged from