(267 days)
Not Found
Not Found
No
The summary describes a physical filter for breast pumps and vacuum lines, with no mention of software, algorithms, or any terms related to AI/ML.
No
The device is intended to remove particulate matter and prevent the passage of breast milk in vacuum lines and breast pumps. This function is for filtration and maintenance of the equipment, not for treating a disease or condition in a patient.
No
The device is described as a filter designed to remove particulate matter and prevent the passage of breast milk, which indicates a mechanical or barrier function rather than a diagnostic one. It does not mention analyzing or detecting conditions.
No
The device description and intended use clearly describe a physical filter, which is a hardware component, not software.
Based on the provided information, the White River Hydrocheck Micro Filter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove particulate matter and prevent the passage of breast milk in vacuum lines and breast pumps. This is a mechanical function related to the operation of a medical device (breast pump), not a diagnostic test performed on a sample taken from the body.
- Lack of Diagnostic Activity: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly points to a physical filter, not a diagnostic assay or instrument.
Therefore, the White River Hydrocheck Micro Filter is a component used with a medical device (breast pump) for functional purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The White River Hydrocheck Micro Filter is designed to remove particulate matter and prevent the passage of breast milk in vacuum lines and vacuum controlled breast pumps.
Product codes
85 HGX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest the feathers. The text "DEPARTMENT OF HEALTH & HL AAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
Ms. Jackie Dark General Manager White River Concepts 924 C Calle Negocio San Clemente, California 92673 Re: K970488
Hydrocheck Micro Filter for Breast Pumps Dated: October 8, 1997 Received: October 10, 1997 Regulatory class: II 21 CFR §884.5160/Product code: 85 HGX
Dear Ms. Dark:
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, 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 (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 Radiation Control provisions, or other Federal laws or regulations.
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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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,
W.Lilian Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of 1
510(k) Number (if known):K970488
Device Name:White River Hydrocheck Micro Filter
Classification Panel: 80KDQ
Indications for Use:
The White River Hydrocheck Micro Filter is designed to remove particulate matter and prevent the passage of breast milk in vacuum lines and vacuum controlled breast pumps.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | or | Over-the-Counter Use |
| Robert D. Stelling (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, | ||
| and Radiological Devices | ||
| 510(k) Number | K970488 |