EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP

{0}------------------------------------------------ # K131153 | 510(k) Summary | |----------------| | Page 1 of 4 | # JUN 1 8 2013 | Date of Preparation: | 17-Jun-2013 | |--------------------------------------------------------------------------------------|----------------------------------------------------------------| | Evenflo Feeding, Inc.<br>9277 Centre Pointe Dr., Suite 160<br>West Chester, OH 45069 | Tel - 513-870-1629<br>Fax - 513-870-1646 | | Official Contact: | Mr. Wade Halma<br>Product Integrity Engineering Manager | | Proprietary or Trade Name: | Evenflo Advanced Double Electric Breast Pump | | Common/Usual Name: | Powered breast pump | | Classification Name: | Powered breast pump<br>HGX - CFR 884.5160<br>Class 2 - OTC | | Predicate Devices: | K973501 - Ameda - Purely Yours<br>K102600 - Evenflo - SimplyGo | #### Device Description: The Evenflo Advanced Double Electric Breast Pump is an electrically powered breast pump that uses negative pressure to express milk from a lactating woman's breasts. A reciprocating vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels between 25 and 254 mmHg. The flange system is convertible between single and double pumping. Four buttons on the user interface allow the user to select one of 32 settings (eight vacuum levels and four cycle rates for each vacuum level) and the LED interface displays the selected setting. Additionally, there are three different flange sizes that allow the user to select the size that best fits their breasts. These features allow the user to customize the device, improving the comfort of their pumping experience. The device can be powered by six "AA" batteries or the provided mains adapter. #### Indications for Use: The Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from lactating woman's breasts. This is for a single user. | Patient Population: | Lactating women | |---------------------|-----------------| | Environment of use: | Home | | Contraindications: | None | {1}------------------------------------------------ K131153 . : . | Attribute | New device<br>Advanced Double<br>Electrical Breast Pump | Ameda<br>Purely Yours<br>K973501 | EvenFlo<br>SimplyGo<br>K102600 | |--------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Intended Use | Express milk | Express milk | Express milk | | Patient population | Lactating women | Lactating women | Lactating women | | Environment of use | Home | Home | Home | | OTC | Yes | Yes | Yes | | Power Source | AC / Battery | AC / Battery | AC / Battery | | Pump Style | Reciprocating Vacuum Pump | Single-Stroke Reciprocating<br>Vacuum Pump | Reciprocating Vacuum Pump | | Single/double Pumping | Both | Both | Single | | Adjustable Suction Levels | Yes | Yes | Yes | | Cycle Speed | 30 - 80 | 30 - 60 | 46 (fixed) | | Overflow Protection | Yes (diaphragm) | Yes (diaphragm) | Yes (float) | | Vacuum range - double (mmHg) | 25-254 | 75-200 | N/A | | Vacuum range - single (mmHg) | 25-270 | 75-270 | 3-254 | | Cycling/Suction Control Mechanism | Microprocessor | Microprocessor | Mechanical cycling with suction regulator | | Accessories | Flange<br>Soft Flange<br>Bottle<br>Tubing<br>Check valve<br>Diaphragm | Flange<br>Soft Flange<br>Bottle<br>Tubing<br>Check valve<br>Diaphragm | Flange (horn)<br>Soft Flange (horn insert)<br>Bottle<br>Check valve<br>Overflow Valve | | Flanges and Inserts come in multiple sizes | Yes | Yes | No | | Software | Boiling water | Boiling water | Boiling water | | Cleaning method for Accessories | Identical to Predicate<br>K102600 | N/A | ISO 10993 Compliant | | Materials | UL 1431 | UL 1431 | UL 1431 | | Electrical Safety | | | | . : : : . : : : 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 . ・ : . 510(k) Summary : · {2}------------------------------------------------ ## 510(k) Summary Page 3 of 4 17-Jun-2013 The Evenflo Advanced Double Electric Breast Pump is viewed as substantially equivalent to the predicate devices because: #### Indications - Indications for use are to express milk of lactating women. This is for a single user. . Discussion - Indications for Use statements between the subject device and the predicate device are not identical, but the intended use of the three devices-to express milk from the breasts of lactating women-is the same. ### Technology - - The technology of a reciprocating vacuum pump to express milk and the flange and . collection bottle system are identical to the predicate. The power source, user controls, ability to adjust vacuum and frequency settings and performance specifications are identical to the predicates. Discussion - The technology and principle of operation for the proposed device is identical to the predicates - Evenflo SimplyGo - K102600 and the Ameda Purely Yours - K973501. #### Materials - - The materials which are in contact with the user and the expressed milk are identical to . the predicate. Discussion - The materials are identical to the predicate - Evenflo SimplyGo - K102600. #### Environment of Use - The environment of use, home, is identical to the predicates. Discussion - The environment of use is identical to the predicates - Evenflo SimplyGo -K102600 and the Ameda Purely Yours - K973501. #### Patient Population - The patient population is lactating women which is identical to the predicates. . Discussion - The user population is identical to the predicates - Evenflo SimplyGo -K102600 and the Ameda Purely Yours - K973501. #### Non-clinical Testing Summary - We have performed a number of bench tests to demonstrate the Evenflo Advanced Dual Electric Breast Pump performs within its specifications and within the performance specification ranges of the predicate devices. These tests included: - Vacuum testing ● - General Electrical Safety UL 1431, FCC 15A, CISPR 11:2009 . - Sound Pressure . - Operational Forces to assemble and disassemble components . - Check Valve . - Battery Life {3}------------------------------------------------ # 510(k) Summary Page 4 of 4 17-Jun-2013 In addition, we performed comparative vacuum and cycle testing with the proposed device and the predicates. It was demonstrated that the proposed device is substantially equivalent to the predicate device. # Substantial Equivalence Conclusion - The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 18, 2013 Evenflo Feeding, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313 Re: K131153 Trade/Device Name: Evenflo Advanced Double Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: May 26, 2013 Received: June 4, 2013 Dear Mr. Job: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {5}------------------------------------------------ Page 2 - Mr. Mark Job 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 (reporting of medical device-related adverse events) (21 CFR 803); 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. 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/Industrv/default.htm. Sincerely, Image /page/5/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black against a white background. The letters "P.L" are stylized with a circular design inside the letters. for Benjamin R. Fisher, Ph.D. Director™ Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use Statement Page 1 of 1 510(k) Number: K131153 Device Name: Evenflo Advanced Double Electric Breast Pump Indications for Use: The Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user. Prescription Use (Part 21 CFR 801 Subpart D) Over-the-counter use XX (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) or Concurrence of CDRH, Office of Device Evaluation (ODE) # Herbert - R. Merner - S