(168 days)
The MASCT device is intended for use in the collection of nipple aspirate fluid for laboratory cytological testing.
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.
The provided text describes a 510(k) summary for the Nastech Mammary Aspiration Specimen Cytology Test (MASCT) device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The document explicitly states that "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." However, it does not provide specific details about the acceptance criteria, the reported device performance, the study design (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies with human readers.
Therefore, the following response will reflect the information available and indicate where details are missing.
Description of Acceptance Criteria and Proving Study for the Nastech Mammary Aspiration Specimen Cytology Test (MASCT)
The provided 510(k) summary indicates that Nastech conducted studies to support the safety and effectiveness of the MASCT device and its substantial equivalence to a predicate device. However, the document does not explicitly define specific numerical acceptance criteria and does not detail the results of the studies in terms of specific performance metrics against such criteria. The basis for acceptance appears to be the successful demonstration of substantial equivalence to a legally marketed predicate device (Windy Hill Technology DucPrep™ Breast Aspirator).
1. Table of Acceptance Criteria and Reported Device Performance
As the document does not present specific acceptance criteria or quantitative performance metrics, a table cannot be fully populated. The primary "acceptance criterion" implied by the 510(k) process is demonstrating substantial equivalence to a predicate device in terms of safety, effectiveness, and technological characteristics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | Demonstrated safe in in-vitro and clinical studies. (Specific metrics not provided) |
| Effectiveness | Demonstrated effective for its intended use in in-vitro and clinical studies. (Specific metrics not provided) |
| Substantial Equivalence (to Windy Hill Technology DucPrep™ Breast Aspirator) | Demonstrated to share similar design, material, and operating characteristics, and intended use as the predicate device. |
| Intended Use Fulfilled | Successfully collects nipple aspirate fluid for laboratory cytological testing. (Specific success rates not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Nastech conducted in-vitro and clinical studies," but does not provide any specific sample sizes for these studies, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for any test sets.
4. Adjudication Method for the Test Set
The document does not provide any information regarding an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Given the nature of a device for collecting biological samples, such a study focusing on human reader improvement with AI would not be directly applicable, as the device's function is collection, not interpretation via AI.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study. The MASCT device is a physical instrument for sample collection, not an algorithm. Therefore, an "algorithm only" performance study is not relevant to this device.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any studies. For a device collecting samples for cytological testing, relevant ground truth might involve the clinical diagnosis, pathology reports from biopsies, or long-term patient outcomes, but this is not detailed.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This is consistent with the device being a physical collection instrument rather than an AI/ML-based diagnostic algorithm.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this device, the document does not provide information on how ground truth for a training set was established.
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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 (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.
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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
§ 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.