(219 days)
Not Found
Not Found
No
The description focuses on the mechanical design and function of a catheter for contrast radiography and fluid collection, with no mention of AI or ML capabilities.
No.
The device is used for contrast enhanced radiography and collection of cells/fluid for cytological analysis, which are diagnostic procedures, not therapeutic ones.
Yes
The device performs contrast-enhanced radiography and collects cells/fluid for cytological analysis, both of which are diagnostic procedures to identify or characterize a disease or condition.
No
The device description clearly describes a physical, dual-lumen catheter with a flexible shaft and ports, indicating it is a hardware device.
Based on the provided information, the Fuji Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing is performed outside the body (in vitro).
- Fuji Catheter's Intended Use: The primary intended use of the Fuji Catheter is for contrast enhanced radiography of breast milk ducts. This is an in vivo procedure, meaning it's performed inside the body.
- Secondary Use: While it can be used for the collection of cells and/or fluid for cytological analysis, the device itself is the tool for collection, not the diagnostic test performed on the collected sample. The cytological analysis would be the IVD test, performed separately on the collected sample.
Therefore, the Fuji Catheter is a medical device used for an in vivo procedure and sample collection, not an in vitro diagnostic test itself.
N/A
Intended Use / Indications for 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.
Product codes
KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
breast milk ducts
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
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Manan™ Galactography Kit, Manan™ Chiba Needle, Manan™ Acura Breast Localization Needle
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
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
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.
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.
1
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)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
bcelle
(Optional Format 1-2-96)
(Division B ign-Off) Division oNGeneral Restorative Devices K9838 510(k) Number _