MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST

K030443 · Nastech Pharmaceutical Company, Inc. · KNW · May 9, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030443
• Device Name: MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
• Applicant: Nastech Pharmaceutical Company, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

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.

Device Story

Manual breast aspirator; collects nipple aspirate fluid (NAF) from excretory ducts. Device consists of rigid polycarbonate cup and sample collection container. Negative pressure generated via hand-actuated lever. NAF collected on membrane filter; washed into container using fixative. Used by clinicians to obtain samples for cytological analysis. Pathologists evaluate samples to identify normal, premalignant, or malignant cells; aids in clinical assessment of breast tissue.

Clinical Evidence

Clinical study (n=30 patients, 60 breasts) evaluated MASCT performance. 100% of breasts yielded NAF. Sample weights ranged <1 to 37 mg (mean 6.6 mg). 100% of samples were sufficient for cytological analysis. Cytology results: 97% Class I, 3% Class IIa (benign). Results support device capability to collect samples suitable for identifying premalignant or malignant conditions.

Technological Characteristics

Non-powered breast aspirator. Materials: Polycarbonate cup. Principle: Manual vacuum generation via lever-actuated mechanism. Form factor: Handheld cup assembly. Standalone device; no software or electronic components. Sterilization: Not specified.

Indications for Use

Indicated for the collection of nipple aspirate fluid from the excretory ducts for cytological testing to differentiate between normal, premalignant, and malignant cells.

Regulatory Classification

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.

Predicate Devices

• Mammary Aspiration Specimen Cytology Test (MASCT) (Nastech Pharmaceutical Company, Inc.)
• Pro·Duct Catheter (Pro·Duct Health, Inc.)

Submission Summary (Full Text)

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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

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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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