EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP

{0}------------------------------------------------ 4/26/99 Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the digit '9', then the digit '8', the digit '3', two instances of the digit '7', and ends with the digit '6'. The '6' is written in a bold, stylized manner, contrasting with the lighter strokes of the other characters. # 510(k) Summary Submitter: Evenflo Company, Inc. 797 Crossroads Court Northwoods Business Center II Vandalia, Ohio 45377 Phone: (937) 415-3300 Fax: (937) 415-3112 Contact Name: Westly Hetrick Date Prepared: October 9, 1998 Common Name: Breast Pump - Trade Name: Evenflo Comfort Control Breast Pump Evenflo Comfort Control Dual Breast Pump | Classification Name: Powered Breast Pump | |------------------------------------------| | Class II Device - 21 C.F.R. § 884.5160 | #### Substantial Equivalence: Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pumps are substantially equivalent to the following currently marketed breast pumps: | Company | Product Name | 510(k) Clearance Number | |--------------|----------------------------------------------------------|-------------------------| | Medela, Inc. | Little Hearts Deluxe Battery Breast Pump | [Unknown] | | Medela, Inc. | Mini-Electric Breast Pump | K901344 | | Medela, Inc. | Pump In Style | K950750 | | Ameda Egnell | Express and Premiere (Sold as: Purely Yours Breast Pump) | K973501 | #### General Description: The Evenflo Comfort Control Adjustable Speed Breast Pump with Automatic Cycling, and the Evenflo Comfort Control Dual Adjustable Speed Breast Pump with Automatic Cycling are diaphragm type pumps, driven by small DC motors, that create cycling negative pressure. The negative pressure generated by the pump is sufficient to overcome the resistance to the outflow of milk that is created by the muscles, yet gentle enough to prevent tissue damage to the user. The cycling speed and the strength of the negative pressure are controlled by individual rotary controls located on the pump unit. The combination of cycling speed and negative pressure control allow for a range of pressures to be selected. When used as a single collection pump, the maximum negative pressure ranges from 173 mm Hg to 56 mm Hg, and when used in the dual mode, it ranges from 173 mm Hg to 43 mm Hg. {1}------------------------------------------------ Evenflo Comfort Control Breast Pump 510(k) Summary Page 2 # Design and Materials: All food or human contact components are manufactured from material that meets FDA food additive criteria as set forth in 21 Code of Federal Regulations Parts 176, 177 and 178. #### Intended Use: The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use batterv/electric powered suction devices used to express mills from the breast of lactating women. These devices are not intended for hospital use. #### Technology Considerations: The following is a chart showing the similarities and difference between the Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump and its predicate devices: | | Evenflo Comfort<br>Control | Medela<br>Pump In Style | Ameda Egnell | Medela<br>Little Hearts | Medela<br>Mini Electric | |----------------------------------------------------|--------------------------------|-------------------------|---------------------------------|--------------------------------|---------------------------------| | Intended Use | To Express Milk | To Express Milk | To Express Milk | To Express Milk | To Express Milk | | Power Source | AC Adapter or 2 C<br>Batteries | AC Adapter | AC Adapter or 6 AA<br>Batteries | AC Adapter or 2 D<br>Batteries | AC Adapter or 2 AA<br>Batteries | | Single or Double Pumping | Yes | Yes | Yes | Single Only | Single Only | | Adjustable Suction Levels | Yes | Yes | Yes | Yes | Yes | | Adjustable Cycle Speed | Yes | No | Yes | No | No | | Overflow Protection | Yes, valve in horn | Yes, reservoir<br>type | Yes, reservoir type | Yes, non-woven fiber | No | | Highest Vacuum Setting (in Hg) | 6.8 | 7.3 | 6.7 | 6.5 | 6.8 | | Highest Vacuum Setting (mm Hg) | 173 | 185 | 170 | 165 | 173 | | Lowest Vacuum Setting (in Hg) | 1.7 | 3.7 | 1.2 | 3.7 | 4.3 | | Lowest Vacuum Setting (mm Hg) | 43 | 94 | 30 | 94 | 109 | | Range of Cycle Speeds<br>(Cycles/Minute) | 54~36 | 49 | 60~29 | 33 | 31 | | Nipple Adapter | Yes | Yes | Yes | Yes | Yes | | Time to 75% Initial Vacuum on<br>Batteries (hours) | 7 | NA | 1 | 20 | 3 | | Time to 0% Initial Vacuum on<br>Batteries (hours) | 10 | NA | 5 | 37 | 13 | ## Non-Clinical Testing: Evenflo conducted performance testing on its Comfort Control Pumps and each of the predicate devices. These tests measured the negative pressure generated by each pump and plotted the result as a function of time. Through these tests, a comparison of vacuum pressure and cycle speed could be determined. Tests were also conducted to determine the expected useful life of the battery for each pump. ## Conclusion: It is Evenflo Inc.'s conclusion that the Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are substantially equivalent to its predicate devices. Based upon the test data submitted, the Comfort Control provides sufficient vacuum pressure to effectively express and collect milk from lactating women. {2}------------------------------------------------ Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing shapes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 6 1903 Donald E. Segal Akin. Gump. Strauss. Hauer & Feld 1333 New Hampshire Avenue, NW Suite 400 Washington, DC 20036 Re: K983776 Evenflo Comfort Control Dual Breast Pump Dated: April 15, 1999 Received: April 15, 1999 Regulatory Class: II 21 CFR 884.5160/Procode: 85 HGX Dear Mr. Segal: 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 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). 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 vour 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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) 594-4613. 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/cdrts/dsmaldsmamain.html". Sincerely yours, CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Statement 510(k) Number: K983776 Device Name: Evenflo Comfort Control Breast Pump Evenflo Comfort Control Dual Breast Pump Indications For Use: The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use battery/electric powered suction devices used to express milk from the breast of lactating women. These devices are not intended for hospital use. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel A. Segerson on Sign-Off ivision of Reproductive. Abdominal, El and Radiological Dev 510(k) Number Prescription Use Over -The-Counter Use OR (Per 21 C.F.R. § 801.109) (Optional Format 1-2-96)