EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "evenflo" in a bold, sans-serif font. The word is black and appears to be slightly stylized. There is a black shape in the upper left corner of the image, partially obscuring the word. The background is white. **Eventlo Company, Inc.** 707 Crossroads Court Vandalia, Ohio 45377 (937) 415-3300 # DEC_022002 # 510(K) PREMARKET NOTIFICATION EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT #### 1. Name of the Device - Proprietary Name Evenflo Comfort Select Auto-cycle Breast Pump a. Kit - Classification Name Powered Breast Pump b. #### Intended Use 2. The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast. #### 3. Device Description The Evenflo Comfort Select Auto-cycle Breast Pump is an electrically powered breast pump that uses the principle of negative suction to express milk from the breast. The Evenflo pump is sold in single and dual models. The dual model allows the user to pump one or both breasts at a time, and is designed with ergonomics in mind so as to be comfortable for the user. The single model applies the same ergonomics but is used to pump only one breast at a time. Evenflo believes its Comfort Select Auto-cycle Breast Pump is substantially equivalent to lawfully marketed breast pumps. #### Establishment Registration Number 4. The Evenflo establishment registration number is 1519363. The company address is: Evenflo Company, Inc. 1000 Evenflo Dr. P.O. Box 709 Canton, GA 30114 770-704-2000 Fax: 770-704-2002 #### న్ Classification of the Device 21 CFR §884.5160 states that powered breast pumps are class II medical devices. {1}------------------------------------------------ KO22A33 page 2 rossroads Cour # Performance Standards for the Device The Food and Drug Administration has established no performance standards for breast pumps. #### Proposed Product Labeling 7. An initial copy of Evenflo Breast Pump product labeling is included in this notification (Appendix B). #### Predicate Product(s) 8. The Evenflo Comfort Select Auto-cycle Breast Pump is substantially equivalent to the following powered breast pumps currently marketed: ### Manufacturer Medela The First Years Evenflo ### Breast Pump Trade Name Double Pumping Mini-Electric Natural Comfort Personal Comfort Dual Breast Pump #### 510(k) statement 9. Evenflo's 510(k) statement is attached. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes. ### Public Health Service Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850 DEC 02 2002 Mr. Matthew G. McCarty Product Safety Engineer Evenflo Company, Inc. 707 Crossroads Court VANDALIA OH 45377 ### Re: K022933 Trade/Device Name: Evenflo Comfort Select Auto-Cycle Breast Pump kit Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: 85 HGX Dated: August 30, 2002 Received: September 4, 2002 Dear Mr. McCarty: 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Henry C. Broglin Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of # 510(k) Number (if known): YO3QQ33 Evenflo Comfort Select Breast Pump Device Name: Evenflo Comfort Select Dual Breast Pump Indications for Use: The Evenflo Comfort Select Breast Pump and Comfort Select Dual Breast Pump are The Evelifie Bottery/electric powered suction device used to express milk from the breast of lactating women. : (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Offic ver the counter\$\checkmark\$ (Division Sign-Division of Reproductio and Radiological Devi 510(k) Number 0012