PJ'S SERENITY

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 20, 2015 Limerick, Inc. Patricia Kelly 2150 N. Glenoaks Blvd. Burbank, CA 91504 K132220 Re: Trade/Device Name: PJ's Serenity Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: February 2, 2015 Received: February 6, 2015 Dear Patricia Kelly, 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ Page 2 - Patricia Kelly 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Benjamin R. Fisher -S Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K132220 Device Name PJ's Screnity Indications for Use (Describe) The Electric Breast Pump, model PJ2012 is used to express and collect milk from the breast to alleviate engorgement of the breast, maintain the ability of lactation and provide mother's milk for future feeding when separation of mother and baby occurs. The device is intended for multiple uses. | Type of Use (Select one or both, as applicable) | <table style="border:none;"><tr><td><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</td><td><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------| | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* · {3}------------------------------------------------ Submission Number K13220/S004 ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: : | Date: | 2014/06/13 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Limerick, Inc. | | Primary Contact Person: | Patricia Kelly | | | President | | | Limerick, Inc. | | | Tel: (818) 566-3060 | | | Fax: (818) 566-1260 | | Secondary Contact Person: | Joan Ortiz | | | Vice President | | | Limerick, Inc. | | | Tel: (818) 566-3060 | | | Fax: (818) 566-1260 | | Device:Trade Name: | PJ's Serenity Model PJ2012 | | Common/Usual Name: | Powered breast pump | | Classification Names: | Powered breast pump | | Regulation Number: | CFR884.5160 | | Product Code: | HGX | | Predicate Device(s) | K051926, PJ's Comfort breast pump<br>K012275, PJ's Comfort portable breast pump | | Device Description: | The Electric Breast Pump, model PJ2012<br>is designed and manufactured by Limerick, Inc. It is<br>intended to express and collect milk from a lactating<br>woman's breast. This action helps to alleviate<br>engorgement of the breast, maintain the woman's<br>ability to lactate, and provide a mother's milk for<br>future feedings when separation of the mater and<br>baby occur.<br><br>The product uses a Single-Chip Microcontroller to<br>imitate a baby's suckling action. The device is<br>ergonomically designed to create comfortable milk<br>stimulation, massage, and suction from the breast.<br>There are 80 vacuum levels and 30 speeds available<br>to imitate the rhythm and action of a baby's<br>suckling. Selection of the vacuum and speed is<br>made by adjusting the control knobs on the front<br>panel of the pump. The control panel is soft and<br>viewing is provided by a LCD screen. Once<br>programmed, the pump's electronic memory stores<br>the selected rhythm and intensity of the device. | | Indications for Use: | The Electric Breast Pump, model PJ2012 is<br>used to express and collect milk from the breast to<br>alleviate engorgement of the breast, maintain the<br>ability of lactation and provide mother's milk for<br>future feeding when separation of mother and baby<br>occurs. The device is intended for multiple users. | | Technology: | The Electric Breast Pump, model PJ2012<br>is designed to mechanically interface with a<br>mother's breast via breast shield and withdraw, ther<br>collect, the breast milk. The device incorporates a<br>microcontroller with embedded firmware. The<br>microcontroller is a Microchip PIC18F26K22. The<br>firmware was developed using MicroEngineering<br>Labs PICBasic Pro. The device incorporates a<br>pump driven by an electric motor to produce a<br>vacuum. The device incorporates an air valve to<br>selectively allow air into the vacuum system. The<br>device incorporates an LCD display to provide<br>information to the user. The firmware provides a<br>means for the user to start and stop pump operation. | {4}------------------------------------------------ : {5}------------------------------------------------ While in operation, it provides a means for the user to adjust the speed of the pump motor and adjust the maximum vacuum level reached. The motor speed is controlled using pulse width modulation of the power applied to the motor. The maximum vacuum level is controlled by monitoring the output of a vacuum sensor and comparing the vacuum level with the user setting. When the level is reached, the air valve is opened. The LCD display shows the settings for the motor speed and vacuum levels using an arbitrary numeric scale, such as 1 to 30. The LCD also shows an elapsed time in minutes from the start of pump cycling. | Specification | Predicate Device | Predicate Device | Proposed Device | Discussion of<br>Differences | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | PJ's Comfort | PJ's Comfort portable | PJ's Serenity | | | K Number | K051926 | K012275 | K132220 | | | Indications for<br>Use | The intended use of the<br>electrically powered<br>(diaphragm type)<br>suction device is to<br>express milk from the<br>breast of lactating<br>women. | The intended use of the<br>electrically powered<br>(diaphragm type)<br>suction device is to<br>express milk from the<br>breast of lactating<br>women. | The Electric Breast<br>Pump, model PJ2012 is<br>used to express and<br>collect milk from the<br>breast to alleviate<br>engorgement of the<br>breast, maintain the<br>ability of lactation and<br>provide mother's milk<br>for future feeding when<br>separation of mother<br>and baby occurs. The<br>device is intended for<br>multiple users. | The<br>Indications<br>for Use<br>statements<br>between the<br>subject and<br>predicate<br>devices are<br>not identical,<br>but the<br>intended use<br>of the<br>devices-to<br>express milk<br>from the<br>breast of<br>lactating<br>women-is<br>the same. | | Patient<br>Population | Breastfeeding<br>Women | Breastfeeding<br>Women | Breastfeeding<br>Women | Same | | Pump Type | Diaphragm | Diaphragm | Diaphragm | Same | | Vacuum Range | 40-270mm Hg | 150-220 mm Hg | 15-270<br>mm Hg. | Similar | | Cycle Levels | 16-70 cycles/min. | 30-45 cycles/min. | 15- 275 cycles/min | The<br>difference in<br>cycle rate<br>between the | | | | | | subject and<br>predicate<br>devices does<br>not represent<br>new<br>technology,<br>and raises no<br>new types of<br>safety and<br>effectiveness<br>questions. | | Filter Between<br>kit and pump | Yes | Yes | Yes | Same | | Adjustable<br>Suction Levels | Yes | Yes | Yes | Same | | Software | Yes | Yes | Yes | Same | | Anatomical<br>Sites | Breast | Breast | Breast | Same | | Energy Used<br>And/or delivered | AC<br>Battery<br>Car adapter | AC<br>Battery<br>Car adapter | AC | No battery<br>No Car<br>adapter for<br>PJ's Serenity<br>as it is only<br>used in<br>hospital | | Designed and<br>Materials | All food or human<br>contact components<br>are manufactured<br>from materials that<br>meet FDA food<br>additive criteria as<br>set forth in 21 Code<br>of Federal<br>Regulations Part 176,<br>177 and 178. | All food or human<br>contact components<br>are manufactured<br>from materials that<br>meet FDA food<br>additive criteria as set<br>forth in 21 Code of<br>Federal Regulations<br>Part 176, 177 and<br>178. | All food or human<br>contact components<br>are manufactured<br>from materials that<br>meet FDA food<br>additive criteria as set<br>forth in 21 Code of<br>Federal Regulations<br>Part 176, 177 and<br>178. | Same | | Performance | Stimulation, suction<br>and collect | Stimulation, suction<br>and collect | Stimulation, suction<br>and collect | Same | | Standards Met | IEC60601-1 2005,<br>3rd Edition<br>IEC60601-2: 2007,<br>3rd Edition<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | IEC60601-1 2005, 3rd<br>Edition<br>IEC60601-2: 2007,<br>3rd Edition<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | IEC60601-1 2005, 3rd<br>Edition<br>IEC60601-2: 2007,<br>3rd Edition<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Same | | Biocompatibility | Not cytotoxic<br>irritating or dermal<br>sensitizer | Not cytotoxic<br>irritating or dermal<br>sensitizer | Not cytotoxic<br>irritating or dermal<br>sensitizer | Same | | Mechanical<br>Safety | Electromechanical<br>cycling suction<br>regulator | Electromechanical<br>cycling suction<br>regulator | Electromechanical<br>cycling suction<br>regulator | Same | | Operating<br>Temperature | 5-40 degree C | 5-40 degree C | 5-40 degree C | Same | | Electrical Safety | | | | | | Bench Test | Performs within<br>specifications | Performs within<br>specifications | Performs within<br>specifications | Same | | 1-Micron filter | Provides a barrier.<br>against bacteria, fluid<br>and virus from<br>entering the pump | Provides a barrier<br>against bacteria, fluid<br>and virus from<br>entering the pump | Provides a barrier<br>against bacteria, fluid<br>and virus from<br>entering the pump | Same | | Accessory Kit | 2 silicone breast cups<br>2 braces<br>2 bottle caps<br>2 silicone gaskets<br>2 storage containers<br>2 tubes with "Y"<br>adapter<br>2 tube connectors<br>1 filter<br>1clamp | 2 silicone breast cups<br>2 braces<br>2 bottle caps<br>2 silicone gaskets<br>2 storage containers<br>2 tubes with "Y"<br>adapter<br>2 tube connectors<br>1 filter<br>1clamp | 2 silicone breast cups<br>2 braces<br>2 bottle caps<br>2 silicone gaskets<br>2 storage containers<br>2 tubes with "Y"<br>adapter<br>2 tube connectors<br>1 filter<br>1clamp | Same | | Packaging | Corrugated | Corrugated | Corrugated | Same | ## Determination of Substantial Equivalence: {6}------------------------------------------------ {7}------------------------------------------------ Submission Number K13220/S004 ## Summary of non-clinical tests: The sponsor has performed bench testing to demonstrate the electric breast pump performs within the specifications: PJ's Serenity Model number PJ2012 Vacuum levels 15-270 mm Hg. Cycles/min PJ's Serenity Model number PJ2012 has met acceptance criteria of performance testing including: biocompatibility (in vivo cytotoxicity, irritation, and sensitization testing), software validation, EMC, electrical safety, and vacuum pressure / cycle rate testing. #### Conclusion: Limerick, Inc considers the PJ's Serenity electric breast pump to be substantially equivalent to the predicated devices.