(192 days)
Not Found
No
The summary describes a device for collecting fluid samples and mentions performance testing related to collection rate, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is indicated for the collection of nipple aspirate fluid for cytological evaluation to determine and/or differentiate cell types, which is a diagnostic purpose, not a therapeutic one.
Yes
The device collects nipple aspirate fluid for cytological evaluation to determine and/or differentiate normal versus pre-malignant versus malignant cells, indicating its use in diagnosing the presence of disease or abnormalities.
No
The device description explicitly states that the NAFD 100 incorporates both hardware and disposable components, including a system console, powerhead, and disposable patient interface. This indicates it is not a software-only device.
Based on the provided text, the NAFD 100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the collection of nipple aspirate fluid for cytological evaluation. While the collected fluid can be used for diagnostic purposes (determining and/or differentiating cell types), the device itself is focused on the sample collection process, not the diagnostic testing of the sample.
- Device Description: The description emphasizes the hardware and disposable components used for extracting the fluid, comparing it to a "Pap smear" for the breast, which is a sample collection method.
- Lack of Diagnostic Function: The text does not describe any component or function of the NAFD 100 that performs a diagnostic test on the collected fluid. It's a tool for obtaining the sample that will then be analyzed elsewhere.
IVD devices are typically instruments, reagents, or systems intended for use in the in vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NAFD 100's role is to provide the specimen, not to perform the in vitro examination itself.
N/A
Intended Use / 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.
Product codes
KNW
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:
System console
Powerhead
Disposable patient interface
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's office
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
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.
Key Metrics
Collection rate of 54%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
SEP 2 3 2002
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 |
| Suite 118 | |
| 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
1
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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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 depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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 (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" (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 (800) 638-2041 or (301) 443-6597 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
4
| 510(k): | |
|---|---|
| --------- | -- |
| Device Name: | NAFD 100 |
|---|---|
| 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. |
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