WHITE RIVER AUTOMATIC BREAST PUMP by WHITE RIVER CONCEPTS

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 Description

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device: the "White River Automatic Breast Pump, Model 2000 Intermittent Wall Suction Breast Pump Regulator."

This document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter states that the device has been reviewed and determined to be "substantially equivalent" to devices marketed prior to May 28, 1976. This substantial equivalence determination means that the FDA found the device to be as safe and effective as a legally marketed predicate device.

To provide the requested information, such as acceptance criteria, performance data, sample sizes, ground truth establishment, or details about comparative effectiveness studies, you would need to refer to the actual 510(k) submission document (K964679) itself, which is not provided here. The 510(k) clearance letter is merely the FDA's formal decision, not the full submission detailing the testing and performance of the device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 100 1997

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

参 Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device 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 (301) 594-4616. 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" (2) 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,

Nilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throath and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{1}------------------------------------------------

K964679

Page 1 of 1

510(k) Number (if known):

Device Name: White River Automatic Breast Pump

80KDP, 85HGX Classification Panel:

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Kar R. Sterling

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K964674

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

OB

Regulation Number and Section

§ 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).