NAFD 100

K020848 · Neomatrix, LLC · KNW · Sep 23, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020848
• Device Name: NAFD 100
• Applicant: Neomatrix, LLC
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

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.

Device Story

NAFD 100 is a system for non-invasive collection of nipple aspirate fluid (NAF) for breast cancer screening. System consists of a console, powerhead, and disposable patient interface. Used in physician offices to extract fluid samples for cytological analysis, functioning similarly to a Pap smear. By collecting epithelial cells from breast ducts, the device provides samples for identifying abnormalities before lesion formation. Physicians use the collected fluid to differentiate between normal, pre-malignant, and malignant cells, potentially enabling earlier detection of breast cancer and improving treatment outcomes.

Clinical Evidence

Bench testing and human subject fit, form, and performance testing conducted. Device demonstrated a 54% collection rate, consistent with other current collection methods. No specific clinical trial data regarding diagnostic sensitivity or specificity provided.

Technological Characteristics

System comprises a console, powerhead, and disposable patient interface. Materials comply with ISO 10993-1 biocompatibility requirements. Device is a non-invasive biopsy instrument (Product Code: KNW).

Indications for Use

Indicated for the collection of nipple aspirate fluid for cytological evaluation to determine or differentiate between normal, pre-malignant, and malignant cells in women.

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

• Pro•Duct Catheter (K000135)
• Nastech Mammary Aspiration Specimen Cytology Tests (K012088)
• Medela's Breast Pump (K950750)

Submission Summary (Full Text)

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## SEP 2 3 2002

K020848

### 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

| Name: | NeoMatrix, LLC |
|-----------------|------------------------------------------------|
| Address: | 16 Technology<br>Suite 118<br>Irvine, CA 92618 |
| CONTACT PERSON: | Kevin Morton |

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

| Trade Name: | NAFD 100 |
|----------------------|--------------------------------------------|
| Common Name: | Gastroenterology-urology biopsy Instrument |
| Classification Name: | Same |

Equivalent Devices:

| Manufacturer: | Pro•Duct Health, Inc |
|---------------|----------------------------------------------------|
| Name: | Pro•Duct Catheter |
| Status: | Currently in commercial distribution |
| 510(k) # | K000135 |
| Manufacturer: | Nastech Pharmaceutical Company, Inc |
| Name: | Nastech Mammary Aspiration Specimen Cytology Tests |
| Status: | Currently in commercial distribution |
| 510(k) # | K012088 |
| Manufacturer: | Medela, Inc |
| Name: | Medela's Breast Pump |
| Status: | Currently in commercial distribution |
| 510(k) # | K950750 |

Device Description:

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:

2

System console Powerhead Disposable patient interface

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K020848

#### Indications for Use:

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.

#### Biocompatibility:

The materials used to manufacture the NAFD 100 comply with the requirements of ISO 10993-1.

#### Data Supporting Substantial Equivalence:

NeoMatrix conducted laboratory and fit, form, and performance testing to demonstrate the safe and efficacy of the NAFD 100. Laboratory testing was conducted to evaluate specific device performance parameters. Fit, form and performance testing was conducted to evaluate its use on human subjects. The NAFD 100 has a collection of rate of 54%, which is consistent with other collection methods currently used. From the Journal of the National Cancer Institute published study non-secretors can be expected to average of 40% of those tested.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 23 2002

Neomatrix, LLC Salvadore F. Palomares Regulatory Consultant 16 Technology Drive Suite 118 Irvine, California 92618

Re: K020848

Trade/Device Name: NAFD 100 Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: July 1, 2002 Received: July 2, 2002

Dear Mr. Palomares:

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 mav 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. Salvadore F. Palomares

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" (21 CFR 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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| 510(k): | |
|---------|--|
|---------|--|

| Device Name: | NAFD 100 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The NAFD 100 (and its components) is indicated for<br>the collection of nipple aspirate fluid for cytological<br>evaluation. The collected fluid can be used in the<br>determination and/or differentiation of normal<br>versus pre-malignant versus malignant cells. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) Or Over the Counter Use

*Stick Rhode*
(Division Sign-Off)

510(K) NUMBER *K020848*