NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT

K012088 · Nastech Pharmaceutical Company, Inc. · KNW · Dec 18, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012088
• Device Name: NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
• Applicant: Nastech Pharmaceutical Company, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 18, 2001
• 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 laboratory cytological testing.

Device Story

MASCT device collects nipple aspirate fluid (NAF) from breast excretory ducts for cytological analysis; consists of rigid polycarbonate cup and sample collection container; manual lever-actuated mechanism generates negative pressure (vacuum) to express fluid; NAF collected on membrane filter and washed into container using fixative solution; used in clinical setting; healthcare provider places cup over nipple to elicit sample; output is collected fluid sample for laboratory testing; aids in diagnostic cytology; benefits patient by facilitating non-invasive specimen collection.

Clinical Evidence

Nastech conducted in-vitro and clinical studies to verify and validate device design. Results supported safety and effectiveness for the intended use.

Technological Characteristics

Polycarbonate cup; manual lever-actuated vacuum mechanism; non-powered; membrane filter for sample collection; fixative solution wash; standalone device.

Indications for Use

Indicated for the collection of nipple aspirate fluid from the excretory ducts for laboratory cytological testing.

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

• Windy Hill Technology DucPrep™ Breast Aspirator

Submission Summary (Full Text)

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Kci2088

### 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

DEC 1 82001

Contact Person Peter C. Aprile, R.Ph. Senior Director, Regulatory and Ouality Affairs

Summary Preparation Date 17 May 2001

#### 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 Windy Hill Technology DucPrep™ Breast Aspirator.

### Device Description

The Nastech MASCT device is similar to the non-powered breast pumps Manufactured by Windy Hill Technology 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 non-powered (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 laboratory cytological testing.

### Technological Characteristics

The MASCT is a device that is substantially equivalent to the non-powered breast pumps Manufactured by Windy Hill Technology used to elicit and collect nipple aspirate fluid from the excretory ducts (tubuli lactiferi or galactophori). The Nastech device shares similar design, material and operating characteristics as the Windy Hill Device and devices to which the Windy Hill device claims substantial equivalence. The subject device and predicate device are comprised of polymer cups that 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.

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Kci2088

# 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.).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 82001

Mr. Peter C. Aprile, R.Ph. Senior Director. Regulatory and Quality Affairs Nastech Pharmaceutical Company, Inc. 45 Adams Avenue Hauppauge, New York 11788

Re: K012088

Trade/Device Name: Mammary Aspiration Specimen Cytology Test Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 10, 2001 Received: October 18, 2001

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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 yours,

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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KC/2088

## INDICATIONS FOR USE STATEMENT

## 510(k) Number (if known): K012088

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 laboratory cytological testing.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109) (Division Sign-Off) (Division of General, Restorative Divisiourological Devices

510(k) Number K012088