Evolve Breast Pump

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 18, 2019 Hygeia II Medical Group, Inc. Brett Nakfoor CEO 6241 Yarrow Drive Carlsbad, CA 92011 Re: K190465 Trade/Device Name: Evolve Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 18, 2019 Received: September 20, 2019 Dear Brett Nakfoor: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Sharon Andrews Acting Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K190465 Device Name Evolve breast pump Indications for Use (Describe) The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) |X | 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}------------------------------------------------ # 510(K) SUMMARY - K190465 In accordance to CFR Title 21, Sec. 807.92 the following summary is provided. #### SUBMITTER: Hygeia II Medical Group, Inc. 6214 Yarrow Drive, Suite A Carlsbad, CA 92011 Phone: (714) 515-7571 ## PRIMARY CONTACT PERSON: Brett Nakfoor CEO Hygeia II Medical Group (714) 515-7571 #### SECONDARY CONTACT PERSON: John Conklin Product Development Hygeia II Medical Group (714) 515-7571 DATE PREPARED: October 16, 2019 #### Device Information Trade Name: Evolve Breast Pump Common Name: Powered Breast Pump Classification Name: Powered Breast Pump Classification Panel: Obstetrics/Gynecology Requlation: 21 CFR 884.5160 Device Classification: Class II Product Code: HGX Product Code Name: Pump, Breast, Powered #### Predicate Device Information ### Hygeia EnDeare Breast Pump, K081932 This predicate has not been subject to a design-related recall. {4}------------------------------------------------ ## Device Description The Evolve Breast Pump, is an electrically powered breast pump from an external AC-DC power supply; the device is provided non-sterile. The Evolve Breast Pump is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The Evolve breast pump is designed as a multi-user breast pump and available in a corded model (external AC-DC power supply). The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women. The Evolve Breast Pump has a backlit, LCD display for user display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression - and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes. The Evolve Breast Pump is intended for repeated use by multiple users in home environment. The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts. ## Indications for Use The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts. {5}------------------------------------------------ ## Comparison of Technological Characteristics The Evolve Breast Pump has identical indications for use and uses the same fundamental technology as the legally marketed predicated devices to which substantial equivalency is claimed, EnDeare Breast Pump (K081932). The modifications that are subject to this submission include the device's form-factor, user interface, vacuum source - performance specification, and firmware: - a) Form-factor/dimension physical size of subject device is smaller and has a different shape than the predicate in order to improve aesthetics - b) User interface to improve aesthetics, the subject device has an LCD user display versus predicate device's printed indicators and subject device has button controls versus rotary knob controls on predicate device - c) Vacuum source/performance The subject device provides negative pressure vacuum (suction) through a DC-powered, reciprocating-based pump and an electromechanical vacuum release solenoid where vacuum speed and strength are controlled electronically. The predicate device provides negative pressure vacuum through a DCpowered, reciprocating-based pump with a mechanical vacuum release design. Thus, subject device has vacuum speed and strength controlled electronically while predicate has vacuum speed controlled electronically and vacuum strength controlled mechanically (by user). - d) Firmware The embedded logic of the subject device has been changed to handle modifications listed above; user interface changes, control and management of reciprocating pump and electromechanical solenoid - e) Backflow protection backflow protection mechanism changed from hydrophobic filter to diaphragm A summary of the technological characteristics compared to the legally marketed predicate device (K081932) are shown in the following table. {6}------------------------------------------------ | | Evolve<br>K190465 | EnDeare<br>(Predicate Version)<br>K081932 | Comment | | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Indications for Use | The Evolve powered breast<br>pump is to be used by<br>lactating women to express<br>and collect milk from their<br>breasts. | The EnDeare powered breast<br>pump is indicated to express<br>and collect milk from the<br>breasts of lactating women. | Same | | | Environment of<br>Use | Home | Hospital, Home | Subject device marketed for<br>home use | | | User Interface - Controls | | | | | | User Control | State-dependent controls:<br>On-Off button | State-dependent controls:<br>On-Off switch | Change to soft-touch button<br>versus a switch | | | | Stimulation and Expression<br>Mode button | No Mode button | Subject device supports 2<br>pumping modes; Stimulation<br>& Expression, predicate has<br>1 mode. | | | | Performance controls:<br>Strength and Speed<br>adjustment via buttons | Performance controls:<br>Speed and Strength<br>adjustment via rotary knob<br>and pressure collar | Change to soft-touch<br>buttons versus rotary<br>controls | | | Visual Indicator | LCD<br>Backlit, liquid-crystal display | Printed graphics on pump<br>case | Addition of LCD display | | | Pumping Options | Single pumping<br>Double pumping | Single pumping<br>Double pumping | Same | | | Adjustable Suction<br>Level | Yes | Yes | Same | | | Adjustable Speed<br>Level | Yes | Yes | Same | | | Accessories | Personal Accessory Set:<br>● breast shield<br>● diaphragm<br>● valve<br>● tubing<br>● bottles<br>AC-DC power-adapter-cord | Personal Accessory Set:<br>● breast shield<br>● filter<br>● valves<br>● tubing<br>● bottles<br>AC power cord, rechargeable<br>battery | Same<br>Hygeia Personal Accessory<br>Set | | | Cleaning | Breast pump - wipe with<br>clean, damp cloth<br>Tubing - replace if milk<br>appears in tubing<br>Breast pump kit and bottles –<br>wash and sanitize | Breast pump - wipe with<br>clean, damp cloth<br>Tubing - wash or sanitize only<br>if milk or condensation in<br>tubing<br>Breast pump kit and bottles –<br>wash and sanitize | Same except tubing shall be<br>replaced for subject device if<br>milk appears in tubing | | | Specifications | | | | | | | | | | | | Power Source | AC-DC 100 - 240 Vac<br>adapter, 50/60 Hz | 100 - 120 Vac power cord,<br>50/60 Hz | Subject has AC-DC adapter<br>integrated into power cord,<br>predicate uses standard AC<br>power cord | | | Batteries | None | Rechargeable, Nickel-metal<br>Hydride, 12.0V, 2200mAh | Predicate device offers<br>battery-powered model | | | Rechargeable<br>Battery<br>operation/charge<br>time | NA | Operation time:<br>Approximately 2 hours<br>Charge time:<br>Approximately 3.5 hours | | | | Software/firmware | Yes | Yes | Both devices have<br>embedded logic facilitating<br>device operation; subject<br>device has additional logic<br>for user display, solenoid<br>control | | | Vacuum aggregate<br>type | Reciprocating pump | Reciprocating pump | Same | | | Vacuum<br>Regulation type | Electronic | Mechanical | Subject device uses<br>electronically-controlled<br>regulator versus predicate<br>device's manual set-point<br>regulator | | | Maximum vacuum<br>(mmHg) | -283 mmHg<br>(-20 mmHg) | -250 mmHg<br>(±20 mmHg) | Subject device provides<br>higher vacuum strength | | | Vacuum range -<br>double and single<br>pumping (mmHg) | Stimulation<br>-75 to -175 mmHg<br>(±20 mmHg)<br>Expression<br>-140 to -283 mmHg<br>(±20 mmHg) | -50 to -250mmHg<br>(±20 mmHg) | Subject device provides an<br>overall wider vacuum range<br>than predicate | | | Cycling Control<br>Mechanism | Electronic | Electronic | Same | | | Cycle Speed<br>Range<br>(Cycles/Minute =<br>CPM) | Stimulation<br>75 to 92 CPM<br>(±8 CPM)<br>Expression<br>32 to 49 CPM<br>(±8 CPM) | 40 - 60 Cycles/Minute<br>(±10 CPM) | Subject device provides an<br>overall wider cycle speed<br>range than predicate | | | Adjustable<br>Cycle Speed<br>Levels | Yes | Yes | Same | | | Backflow<br>protection | Yes, silicone diaphragm | Yes, hydrophobic filter | Subject device provides<br>closed system via silicone<br>diaphragm design | | {7}------------------------------------------------ The differences in technological characteristics do not raise different questions of safety and effectiveness. {8}------------------------------------------------ ## Summary of Performance Data, Non-Clinical Testing The Evolve Breast Pump complies with voluntary standards for electrical safety, electromagnetic compatibility, and use in the home environment. The following performance data is provided in support of the substantial equivalence determination: ### Risk/Hazard - Risk Analysis in accordance with ISO 14971:2007 was used to assess impact of . modifications to the device ### Electrical Safety and Electromagnetic Compatibility (EMC) - Electrical safety testing per IEC 60601-1:2005 (3rd Edition) with US deviations per . AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 standard - . Electromagnetic compatibility testing per IEC 60601-1-2: 2014 (4th edition) standard, Medical Electrical Equipment Part 1 - 2 ### Firmware Testing - . The software/firmware verification and validation was provided in accordance with the FDA Guidance document, "The Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005 {9}------------------------------------------------ #### K190465 Page 7 of 7 ## Performance Testing The Evolve Breast Pump was tested to demonstrate it meets its performance specifications. The testing involved measurement of vacuum and cycles for minimum and maximum settings for both single and double pumping mode, and for stimulation and expression mode. Also, backflow protection was tested. Specifications were met and within required, acceptable range for pump operation, cycle rate, and vacuum pressure. ## Conclusion The performance testing demonstrates that the Evolve Breast Pump is substantially equivalent to the predicate device.