(79 days)
Diagnostic, Inc. Breast Aspirator
WHT Fuji Catheter, nonpowered breast milk pumps
No
The device description and performance studies focus on mechanical aspiration and do not mention any computational or data-driven components indicative of AI/ML.
No
The device is described as being used to "elicit fluid from multiple ductal orifices for subsequent cytological evaluation and/or to identify ductal orifices for subsequent cannulation." This indicates a diagnostic purpose rather than a direct therapeutic intervention. It is used to collect samples or identify sites for further procedures, not to treat a condition itself.
Yes
The device is used to collect fluid for subsequent cytological evaluation, which is a diagnostic procedure.
No
The device description clearly outlines physical components such as a rigid polycarbonate cup, polymer tubing, silicone insert, and a standard syringe, indicating it is a hardware-based medical device.
Based on the provided information, the DucPrep Breast Aspirator device itself is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- DucPrep's function: The DucPrep Breast Aspirator is a device used to collect a specimen (breast ductal fluid). It is a tool for sample collection, not for performing the diagnostic test itself.
- Subsequent evaluation: The description explicitly states the fluid is collected for subsequent cytological evaluation. This evaluation, which would be performed on the collected fluid, is the diagnostic part of the process, and it would likely involve other devices or procedures (like microscopy, staining, etc.).
Think of it like a blood collection tube. A blood collection tube is used to collect a blood sample, but it's not an IVD itself. The diagnostic tests are performed on the blood in the tube using other IVD devices or methods.
Therefore, the DucPrep Breast Aspirator is a specimen collection device used in conjunction with subsequent diagnostic procedures.
N/A
Intended Use / Indications for 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.
Product codes
KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast nipple / breast
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
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.
Key Metrics
Not Found
Predicate Device(s)
Diagnostic, Inc. Breast Aspirator
Reference Device(s)
WHT Fuji Catheter, nonpowered breast milk pumps
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. 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
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.
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
1
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:
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.
(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 |
OR
Prescription Use
(Per 21 CFR § 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)