The DucPrep Breast Aspirator device is used to elicit fluid from multiple ductal orifices for subsequent cytological evaluation and/or to identify ductal orifices for subsequent cannulation with the WHT Fuji Catheter.

Device Description

The Windy Hill Technology DucPrep breast aspirator device is similar to nonpowered breast pumps used to express mill in lactating women. The device is comprised of a rigid polycarbonate cup which is connected to a small piece of polymer tubing. A flexible, silicone insert is placed inside of the rigid polycarbonate cup prior to device placement around the breast nipple. The tubing is attached to a standard syringe which is used to pull a gentle vacuum to express breast ductal fluid. The device is packaged in a Tyvek® pouch.

AI/ML Overview

The provided text describes a medical device, the Windy Hill Technology DucPrep™ Breast Aspirator, and its clearance process, but it does not contain acceptance criteria or detailed study results that prove the device meets specific acceptance criteria.

The document states:

"WHT conducted laboratory and clinical testing to demonstrate the safe and effective use of the WHT Device."
"Laboratory testing was conducted to evaluate specific device performance parameters."
"Clinical testing was conducted to evaluate human use of the device in human subjects. This testing supported that use of the Windy Hill Technology DucPrep Breast Aspirator is both safe and effective for its intended use."

However, it does not provide any quantitative or qualitative acceptance criteria (e.g., "device must reliably express fluid in X% of cases," or "flow rate must be Y ml/min") nor does it present the reported device performance data against any such criteria. It also does not explicitly describe the studies in a way that allows for the extraction of the requested information (sample sizes, ground truth, expert qualifications, etc.).

Therefore, I cannot fully complete the table or answer all your questions as the specific details are not present in the provided text.

Here's what can be inferred or stated based on the available information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document (Simply stated that testing "supported that use... is both safe and effective")

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Clinical testing was conducted in "human subjects." The country of origin and whether it was retrospective or prospective is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The purpose of the device is for "subsequent cytological evaluation" and "to identify ductal orifices for subsequent cannulation," implying that the end analysis would involve medical experts (e.g., pathologists for cytology, and clinicians for cannulation), but the document does not detail how ground truth was established for the device's performance in its own studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not mentioned. This device is a physical aspirator, not an AI-powered diagnostic tool engaging human readers for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the device enables the collection of samples for "cytological evaluation" (pathology) or for "identifying ductal orifices" (clinical observation/procedure). However, it does not explicitly state what ground truth was used to validate the aspirator's own performance (e.g., its ability to elicit fluid, or its safety).
The sample size for the training set:
- Not applicable/Not specified. This is a physical device, and the concept of a "training set" as understood in AI/algorithm development does not apply here.
How the ground truth for the training set was established:
- Not applicable.

Summary

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EXHIBIT G:

510(k) SUMMARY - (21 CFR § 807.92(c))

Submitter's Name and Contact Information Windy Hill Technology, Inc. ("WHT") 1010 Hamilton Court Menlo Park, California 94025 Telephone: 650.566.2330 Facsimile: 650.566.2345

Contact Person Angela B. Soito. Director, Regulatory and Quality Affairs

Summary Preparation Date September 30, 1999

Davice Names

Device Names
Trade Name:	Windy Hill Technology DucPrep™ Breast Aspirator
Common Name:	Breast Aspirator
Classification Name:	Gastroenterology-Urology Biopsy Instrument (21CFR § 876.1075)

Substantially Equivalent Devices

Substantial Equivalence was claimed to the Diagnostic, Inc. Breast Aspirator, the WHT Fuji Catheter and nonpowered breast milk pumps.

Device Description

Intended Use

The DucPrep device is used to elicit fluid from multiple ductal orifices for subsequent cytological evaluation or to identify ductal orifices for subsequent cannulation with the WHT Fuii Catheter.

Technological Characteristics

The DucPrep device is substantially equivalent to the Diagnostic, Inc. Breast Aspirator, the WHT Fuji Catheter and nonbowered breast milk pumps. The subject device differs from the WHT Fuji Catheter in that the latter device is a catheter, as opposed to a pump, and allows for the collection of breast ductal fluid from individual ductal orifices. The DucPrep device shares similar design, material and operating characteristics as the Diagnostic, Inc. Breast Aspirator and nonpowered breast pumps. The subject device and these two predicate devices (i.e., the Diagnostic, Inc. Breast Aspirator and nonpowered breast pumps) are comprised of polymer cups which are placed over the breast nipple and are used in conjunction with a nonpowered mechanism for applying a gentle vacuum enabling fluid expression.

Data Supporting Substantial Equivalence

WHT conducted laboratory and clinical testing to demonstrate the safe and effective use of the WHT Device. Laboratory testing was conducted to evaluate specific device performance parameters. Clinical testing was conducted to evaluate human use of the device in human

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subjects. This testing supported that use of the Windy Hill Technology DucPrep Breast Aspirator is both safe and effective for its intended use.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 23 1999

Ms. Angela B. Soito Director, Regulatory and Quality Affairs Windy Hill Technology, Inc. 1010 Hamilton Court Menlo Park, California 94025

K993342 Re: Trade Name: DucPrep™ Breast Aspirator Regulatory Class: II Product Code: KNW Dated: October 4, 1999 Received: October 5, 1999

Dear Ms. Soito:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Angela B. Soito

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours,

Russell W. Ayres

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT H:

INDICATIONS FOR USE STATEMENT

K993342 510(k) Number (if known): __

Device Name: Windy Hill Technology DucPrep™ Breast Aspirator

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

	Russell L. Taggart Sr.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K993342

Prescription Use
(Per 21 CFR § 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.