(214 days)
The Double Up Breast Pump is indicated to facilitate expression of milk from the breasts of lactating women
Double Up Breast Pump
The provided document is a 510(k) Pre-Market Notification letter from the FDA regarding the "Double Up Breast Pump." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth, or adjudication methods. The 510(k) clearance process sometimes relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies that would typically include the details you've requested.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based solely on the provided text. The document is primarily a regulatory approval letter.
{0}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Ms. Debbie Shaw President The Natural Choice Company, Inc. 1155 Chess Drive, Suite 105 Foster City, California 94404
Re: K964396 Double Up Breast Pump Dated: May 1, 1997 Received: May 5, 1997 Regulatory class: II 21 CFR §884.5160/Product code: 85 HGX
Dear Ms. Shaw:
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" (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,
Lillian Yin, Ph.D.
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}------------------------------------------------
1164376/3
510(k) Number K964396
Device Name Double Up Breast Pump
Indications For Use
"
The Double Up Breast Pump is indicated to facilitate expression of milk from the breasts of lactating women
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
urrence of CDRH, Office of Device Evaluation (ODE)
Peter L. Setting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
Prescription Usc (Per 21 CFR 801 1091
ﺎ ﻣﺴﻠﺴﻞ ﺍﻟﺴﺮ
Ør
Over-The-Counter Use
§ 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).