The Fuji Catheter is designed to perform contrast enhanced radiography of breast milk ducts. It may also be used for the collection of cells and/or fluid for cytological analysis.

Device Description

The Windy Hill Technology Fuii Catheter is a dual lumen device with a flexible shaft. The hub located at the proximal end of the Fuii Catheter has two branches which each correspond with a single port. The entry port is used for saline or contrast infusion and is marked with an arrow pointing in the distal direction of the catheter. The corresponding entry lumen is located at the distal end of the catheter, adjacent to the 1 cm marker. The exit port is used for fluid collection and for quidewire introduction and is marked with an arrow pointing in the proximal direction of the catheter. The corresponding exit lumen is located at the distal tip of the catheter. The device is provided sterile and is intended for single use only.

AI/ML Overview

This document describes a medical device, the Windy Hill Technology Fuji Catheter, submitted for 510(k) clearance, which is a premarket submission made to FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device). Therefore, the provided text does not contain information about acceptance criteria or a study designed to prove a device meets specific performance criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Based on the provided text, here’s a breakdown of the information that is available, and what is not:

A table of acceptance criteria and the reported device performance: Not applicable. This document is for a 510(k) submission for a manual surgical instrument, not a device with quantifiable performance metrics like sensitivity/specificity that would require acceptance criteria in this format. The submission relies on demonstrating substantial equivalence to predicate devices through laboratory, preclinical, and clinical testing in terms of safety and effectiveness for its intended use.
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical testing was conducted to evaluate human use of the device in pre-mastectomized or lumpectomized breasts," but the number of subjects is not provided.
- Data Provenance: The preclinical testing used a "human cadaver model." The clinical testing was on "pre-mastectomized or lumpectomized breasts" (implying human subjects, and likely prospective data collection for the study). Country of origin is not specified, but the applicant (Windy Hill Technology, Inc.) is based in Menlo Park, California, USA, suggesting the studies likely occurred in the USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. For a manual surgical instrument, "ground truth" in the context of diagnostic accuracy (like for an imaging AI) is not the relevant paradigm. The "clinical testing" would likely focus on ease of use, safety, and ability to perform the intended function (e.g., successful contrast delivery, successful fluid collection), which would be observed and assessed by medical professionals during the procedure, rather than establishing a diagnostic ground truth against which the device's output is compared.
Adjudication method for the test set: Not applicable/not provided. Since this is not a diagnostic reader study, an adjudication method for reconciling expert opinions on diagnostic outcomes is not relevant here.
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. This device is a "manual surgical instrument," not an AI or imaging device designed to be read by human readers. Therefore, an MRMC study and AI assistance are not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical instrument, not an algorithm.
The type of ground truth used: For the clinical testing, the "ground truth" would be related to the successful performance of the device's intended functions (contrast enhanced radiography of breast milk ducts, collection of cells/fluid for cytological evaluation) and safety observations, rather than a diagnostic 'ground truth' in the sense of a disease state. Pathology or cytological evaluation of collected samples would be considered the ground truth for the use of the device in collecting samples, but not for the device's intrinsic function itself.
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The "testing" mentioned refers to traditional engineering, preclinical, and clinical evaluations.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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, Regulatory and Quality Affairs Manager

Summary Preparation Date October 30, 1998

Device Names Trade Name: Windy Hill Technology Fuji Catheter Common Name: Breast Duct Catheter Classification Name: Manual Surqical Instrument (21CFR § 878.4800)

Substantially Equivalent Devices

Substantial Equivalence was claimed to the Manan™ Galactography Kit, the Manan™ Chiba Needle and the Manan™ Acura Breast Localization Needle.

Device Description

Intended Use

The Windy Hill Technology Fuji Catheter is designed to perform contrast enhanced radiography of breast milk ducts. It may also be used for the collection of cells and/or fluid for cytological evaluation.

Technological Characteristics

The Windy Hill Technology Device is substantially equivalent to the Manan™ Galactography Kit, the Manan™ Chiba Needle and the Manan™ Acura Breast Localization Needle. The main difference between the subject and predicate devices is that the WHT device contains two device lumens which combines the functions of the predicate devices to allow for fluid infusion and fluid collection.

Data Supporting Substantial Equivalence

WHT conducted laboratory, preclinical and clinical testing to demonstrate the safe and effective use of the WHT Device. Laboratory testing was conducted to evaluate specific device performance parameters and, in some cases, to compare these results with those obtained with a predicate device. Performance was also evaluated in preclinical testing using a human cadaver model. Clinical testing was conducted to evaluate human use of the device in pre-mastectomized or lumpectomized breasts. This testing supported that use of the Windy Hill Technology Fuji Catheter is both safe and effective for its intended use.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human figures, possibly representing a family or community, with their arms raised in a gesture of support or unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 9 1999

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

Re: K983867

Trade Name: Windy Hill Technology Fuji Catheter Regulatory Class: II Product Code: KNW Dated: April 27, 1999 Received: April 29, 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 (OS) 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 vour 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 yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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EXHIBIT H:

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K983862

Device Name: Windy Hill Technology Fuji Catheter

Indications for Use:

The Fuji Catheter is designed to perform contrast enhanced radiography of breast milk ducts. It may also be used for the collection of cells and/or fluid for cytological analysis.

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

Prescription Use
(Per 21 CFR § 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

bcelle

(Optional Format 1-2-96)

(Division B ign-Off) Division oNGeneral Restorative Devices K9838 510(k) Number _

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.