HYDROCHECK MICRO FILTER

K970488 · White River Concepts · HGX · Nov 4, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K970488
• Device Name: HYDROCHECK MICRO FILTER
• Applicant: White River Concepts
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

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.

Device Story

Hydrocheck Micro Filter acts as inline barrier for vacuum-controlled breast pumps; prevents breast milk ingress into vacuum lines; removes particulate matter. Used in clinical or home settings by nursing mothers or healthcare providers. Protects pump mechanism from contamination; maintains vacuum integrity. Device is passive mechanical filter.

Clinical Evidence

Bench testing only.

Technological Characteristics

Passive mechanical filter; inline configuration for vacuum lines; materials unspecified; non-electronic; no software.

Indications for Use

Indicated for use in vacuum lines and vacuum controlled breast pumps to remove particulate matter and prevent breast milk passage.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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, 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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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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. Astley)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970488