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.

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.

AI/ML Overview

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 <1 to 37 mg. Even samples reported as <1 mg due to weighing variability were sufficient for cytological analysis.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 60 samples (from 30 patients, right and left breasts).
Data Provenance: The study was a "clinical study conducted by Nastech," implying it was prospective and likely conducted in the country where Nastech is based (USA, as inferred from the address). No specific country of origin for the data is explicitly stated beyond "clinical study by Nastech."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: One pathologist is explicitly mentioned as reading all samples.
Qualifications of Experts: The text only states "pathologist" and "trained individuals" for cytological examinations. No specific experience level (e.g., "10 years of experience") is provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not explicitly stated. The text indicates that "the pathologist was able to read all of the samples and cytology results were obtained," implying a single pathologist's assessment formed the basis of the results. There is no mention of multiple experts or an adjudication process for resolving discrepancies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is a fluid collection device, not an AI or image analysis tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant or applicable to the stated purpose of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: No. This device is a manual fluid collection tool. Standalone algorithm performance is not applicable. The device's output (nipple aspirate fluid) requires human intervention (a pathologist) for interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The ground truth for the interpretability of the samples was established by pathological evaluation (cytological analysis) of the collected nipple aspirate fluid. The study primarily aimed to prove that the device successfully collects samples suitable for such analysis, not to validate the accuracy of cytological interpretation against a "true" disease state (e.g., biopsy). It showed that the yielded cytology results were either Class I or Class IIa (both benign).

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not mention a training set. This is not an AI/machine learning device, so the concept of a "training set" for algorithm development is not applicable. The clinical study described served as the validation (test) set for the device's performance in collecting samples.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there was no training set for an algorithm.

Summary

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K030443

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

Intended Use

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

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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 <1 to 37 mg and all samples evaluated cytologically were deemed to be clinically useful.

The mean mammary aspiration sample weight was 6.6 mg, with a range of <1 to 37 mg, While 13% of the samples were reported as <1 mg due to weighing variability from the small volume of the samples, all of the samples were sufficient for cytological analysis in that the pathologist was able to read all of the samples and cytology results were obtained. Fifty-eight of sixty samples or 97% (30 patients, right and left breasts) were Class I, and two of 60 (3%) were Class IIa. Both Class IIa findings were benign. Therefore, these clinical data support the claim that cells collected with the MASCT can be used in cytological examinations by trained individuals to identify differences in cells which may be associated with either premalignant or malignant conditions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

MAY - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter C. Aprile, R.Ph. Vice President, Regulatory and Quality Affairs Nastech Pharmaceutical, Inc. 45 Adams Avenue Hauppauge, New York 11788-3605

Re: K030443

Trade/Device Name: Mammary Aspiration Specimen Cytology Test Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: February 10, 2003 Received: February 11, 2003

Dear Mr. Aprile:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Peter C. Aprile, R.Ph.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Miriam C. Provost

For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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·· INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_O30443

Device Name: Mammary Aspiration Specimen Cytology Test (MASCT)

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030443

Regulation Number and Section

§ 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.