(30 days)
The Simply Go™ Breast Pump is an electrically operated suction device used to express and collect milk from the breast(s) of lactating woman.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Evenflo Company, Inc. regarding their SimplyGo™ Hands Free Breast Pump. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a medical device.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on substantial equivalence to a predicate device, not on a standalone performance study with specific acceptance criteria as one might see for a novel, higher-risk device or a device requiring de novo classification.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another person, representing the department's mission of protecting the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Don Huber Director Product Integrity Evenflo Company, Inc. 225 Byers Road MIAMISBURG OH 45342
K092770 Re:
Trade/Device Name: SimplyGo" Hands Free Breast Pump Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: September 9, 2009 Received: September 9, 2009
Dear Mr. Huber:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Evenflo, a company that makes baby products. The logo is composed of two ovals, one containing the word "evenflo" in a stylized font, and the other containing the words "Best for Baby". The words "Best for Baby" are in a script font, and the word "for" is smaller than the other words.
Evenflo Company, Inc. 225 Byers Road Miamisburg, Ohio 45342 (937) 415-3300 Registration No. 9046462
SPECIAL 510(K): PREMARKET NOTIFICATION
SIMPLY GO™ BREAST PUMP 510(k) NUMBER K 092770
STATEMENT FOR INDICATIONS FOR USE
Device Name: SimplyGo™ Hands Free Breast Pump
510(k) Number:
STATEMENT FOR INDICATIONS OF USE: The Simply Go™ Breast Pump is an electrically operated suction device used to express and collect milk from the breast(s) of lactating woman.
Heit Reema
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 247770 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fvenflo Comnanv. Inc.
CONFIDENTIAL
§ 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).