WHITE RIVER AUTOMATIC BREAST PUMP

K964679 · White River Concepts · HGX · Jun 10, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K964679
• Device Name: WHITE RIVER AUTOMATIC BREAST PUMP
• Applicant: White River Concepts
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Jun 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Indications for Use

The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.

Device Story

Device is a vacuum-powered suction system for expressing breast milk in hospital settings. It utilizes existing hospital wall vacuum infrastructure. System comprises two primary components: a vacuum regulator and a single-patient-use breast pump set. The regulator modulates wall suction to safe levels for breast milk expression. The pump set provides the interface for milk collection. Operated by nursing staff or patients in clinical environments. Output is expressed breast milk. Benefits include consistent, hygienic milk expression for breastfeeding mothers.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vacuum-powered suction regulator; single-patient-use breast pump set; hospital wall vacuum interface; mechanical regulation of suction pressure.

Indications for Use

Indicated for mothers breastfeeding in a hospital setting requiring milk expression via wall vacuum systems.

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
JUN 10 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

White River Concepts
% Mr. E.J. Smith
Smith Associates
1468 Harwell Avenue
Crofton, Maryland 21114

Re: K964679
White River Automatic Breast Pump, Model 2000
Intermittent Wall Suction Breast Pump Regulator
Dated: March 13, 1997
Received: March 13, 1997
Regulatory class: II
21 CFR §884.5160/Product code: 85 HGX

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,


Enclosure

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K964679
Page 1 of 1

510(k) Number (if known):

Device Name: White River Automatic Breast Pump

Classification Panel: 80KDP, 85HGX

Indications for Use:

The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.

Target Population: Mothers who are breast feeding in the hospital setting.


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Concurrence of CDRH, Office of Device Evaluation (ODE)

D. L. (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K964679

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use ☑

OB
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