(168 days)
Not Found
No
The device description explicitly states it is a non-powered, hand-actuated device for fluid collection and does not mention any computational or analytical capabilities.
No
The device is described as intended for the "collection of nipple aspirate fluid for laboratory cytological testing," which is a diagnostic purpose, not a therapeutic one.
No
The device is described as a collection device for nipple aspirate fluid (NAF) for "laboratory cytological testing." It does not perform the diagnostic test itself; it only collects the sample. The diagnosis would be made by the laboratory testing, not by the device.
No
The device description clearly states it is comprised of a rigid polycarbonate cup and a lever-like handle, indicating it is a physical, hardware-based device, not software-only.
Based on the provided information, the MASCT device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of nipple aspirate fluid. The fluid itself is then sent for laboratory cytological testing. The MASCT device is a tool for sample collection, not for performing the diagnostic test itself.
- Device Description: The description focuses on the mechanism for creating vacuum and collecting the fluid. It doesn't describe any components or processes that would analyze the fluid or provide a diagnostic result.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or interpretation of the collected fluid to diagnose a condition. The diagnostic step happens after the sample is collected, in a separate laboratory setting.
In essence, the MASCT device is a sample collection device that provides the material for an IVD test, but it is not the IVD test itself.
N/A
Intended Use / Indications for Use
The MASCT device is intended for use in the collection of nipple aspirate fluid for laboratory cytological testing.
Product codes
KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast nipple (for collecting nipple aspirate fluid)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Windy Hill Technology DucPrep™ Breast Aspirator.
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
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.
1
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.).
2
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 (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). 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
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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