WHITE RIVER MINI MANUAL BREAST PUMP

K971231 · White River Concepts · HGY · May 19, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971231
• Device Name: WHITE RIVER MINI MANUAL BREAST PUMP
• Applicant: White River Concepts
• Product Code: HGY · Obstetrics/Gynecology
• Decision Date: May 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5150
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The White River Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.

Device Story

Manual breast pump; operated by breastfeeding mothers; used for milk collection and lactation management. Device applies manual suction to breast tissue to express milk. Used in home settings. Output is expressed breast milk collected in a reservoir. Benefits include sustained lactation and relief of engorgement or nipple discomfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual suction-based breast pump; non-powered; handheld form factor. Materials and sterilization methods not specified.

Indications for Use

Indicated for breastfeeding mothers requiring lactation support, milk collection, or relief from breast engorgement, sore, or cracked nipples.

Regulatory Classification

Identification

A nonpowered breast pump is a manual 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

MAY 19 1997

White River Concepts
% Smith Associates
Attn: Mr. E.J. Smith
P.O. Box 4341
Crofton, Maryland 21114

Re: K971231
Mini Manual Breast Pump
Dated: April 3, 1997
Received: April 3, 1997
Regulatory Class: I
21 CFR 884.5150/Procode: 85 HGY

Dear Mr. Smith:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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,

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

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510(k) Number (if known): K971231

Device Name: White River Mini Manual Breast Pump

Classification Panel: 85HGY

Indications for Use:

The White River Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.

Target Population: Mothers who are breastfeeding


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Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Nithy
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971231

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-the-Counter Use ☑