Smartpump 3.0 Double Electric Breast Pump

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 23, 2022 Lansinoh Laboratories Lindsay Ewers Director of Quality Assurance 99 Canal Center Plaza. Suite 550 Alexandria, VA 22314 Re: K222726 > Trade/Device Name: Smartpump 3.0 Double Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: December 2, 2022 Received: December 2, 2022 Dear Lindsay Ewers: 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. 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. {1}------------------------------------------------ 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 and Part 809); 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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, Reginald K. Avery -S for Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K222726 Device Name Smartpump 3.0 Double Electric Breast Pump Indications for Use (Describe) The Lansinoh® Smartpump 3.0 Double Electric Breast Pump is intended to express and collect the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for a single user. | 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}------------------------------------------------ #### 1. SUBMITTER | Applicant: | Lansinoh Laboratories, Inc.<br>99 Canal Center Plaza, Suite 550<br>Alexandria, VA 22314 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------| | Contact: | Lindsay Ewers<br>Director of Quality Assurance<br>Lansinoh Laboratories, Inc.<br>(727)-542-3743<br>lewers@lansinoh.com | | Submission Correspondent: | Lindsay Ewers<br>Director of Quality Assurance<br>Lansinoh Laboratories, Inc.<br>-(727)-542-3743<br>lewers@lansinoh.com | | Date Prepared: | December 22, 2022 | #### 2. DEVICE | Device Trade Name: | Smartpump 3.0 Double Electric Breast Pump | |---------------------|-------------------------------------------| | Device Common Name: | Powered breast pump | | Regulation Name: | Powered breast pump | | Regulation Number: | 21 CFR 884.5160 | | Regulatory Class: | Class II | | Product Code: | HGX | #### 3. PREDICATE DEVICE Predicate Device: Lansinoh® Smartpump™ Double Electric Breast Pump (DEBP 2.2) [K182749] The predicate device has not been subject to a design-related recall. #### DEVICE DESCRIPTION 4. The Lansinoh Smartpump 3.0 Double Electric Breast Pump is a double electric breast pump intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pumps can be powered by a rechargeable 7.4 V, 1,500 mAh lithium-ion battery or by an AC adapter that is provided with each pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor-controlled DC electric motor. The user interface consists of a front panel keypad {4}------------------------------------------------ and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference. #### INTENDED USE/INDICATIONS FOR USE ર. The Lansinoh® Smartpump 3.0 Double Electric Breast Pump is intended to express and collect the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for a single user. #### SUBSTANTIAL EQUIVALENCE 6. ### Technological Comparisons The table below compares the key technological feature of the subject devices to the predicate device (Lansinoh® Smartpump™ Double Electric Breast Pump (DEBP 2.2) [K182749]). | | Subject Device<br>Lansinoh® Smartpump 3.0 Double<br>Electric Breast Pump | Predicate Device<br>Lansinoh® Smartpump™ Double<br>Electric Breast Pump (DEBP 2.2) | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K222726 | K182749 | | Indications For Use | The Lansinoh® Smartpump 3.0<br>Double Electric Breast Pump is<br>intended to express and collect the<br>breastmilk of a nursing woman for the<br>purpose of feeding collected breastmilk<br>to a baby. The pump is intended for a<br>single user. | The Lansinoh® Smartpump™ Double<br>Electric Breast Pump is intended to<br>express and collect the breastmilk of a<br>nursing woman for the purpose of<br>feeding collected breastmilk to a baby.<br>The pump is intended for multiple<br>users, and single users. | | Applicant | Lansinoh Laboratories | Lansinoh Laboratories | | Classification<br>Regulation | 884.5160 | 884.5160 | | Product Code | HGX | HGX | | Regulatory Class | Class II | Class II | | Patient Population | Lactating Women | Lactating Women | | Suction Modes | Stimulation and Expression | Stimulation and Expression | | Suction Levels<br>(stimulation) | 59-236 mmHg | 46-140 mmHg | | Cycles per Second<br>(stimulation) | 1.36-2.69 | 1.61-2.33 | | Suction Levels<br>(expression) | 89 mmHg - 280 mmHg | 95 mmHg - 280 mmHg | | Cycles per Second<br>(expression) | 0.53-1.83 | 0.58 - 1.69 | Table 1: Technological Comparison {5}------------------------------------------------ | | Subject Device<br>Lansinoh® Smartpump 3.0 Double<br>Electric Breast Pump | Predicate Device<br>Lansinoh® Smartpump™ Double<br>Electric Breast Pump (DEBP 2.2) | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Suction Settings | 8 | 8 | | Expression modes | 3 | 3 | | Power Supply | AC Adapter<br>Replaceable, rechargeable 7.4 V, 1,500<br>mAh lithium-ion polymer battery | AC Adapter<br>6 AA alkaline batteries | | Pumping Option | Single or Double | Single or Double | | Back Flow Protection | Yes | Yes | | Let Down Function | Yes | Yes | | Cycling/Suction Control<br>Mechanism | Microprocessor with internal program<br>memory | Microprocessor with internal program<br>memory | | Program Memory | 32K flash ROM, 2K RAM memory | 32K flash ROM, 2K RAM memory | | Communication with<br>mobile app | Bluetooth BLE 4.2 | Bluetooth version 4.1 | | Expected Use Life | 500 hours | 500 hours | | Accessories | Tubing with Velcro Strap; Flange Cap;<br>Diaphragm; Breast Flange Body;<br>Comfort Fit Breast Flange (Cone);<br>Cone Soft Edge; White Valve; 5 oz<br>Container; Container Ring; Sealing<br>Disk; Storage Lid | Tubing with Velcro Strap; Flange Cap;<br>Diaphragm; Breast Flange Body;<br>Comfort Fit Breast Flange (Cone);<br>Cone Soft Edge; White Valve; 5 oz<br>Container; Container Ring; Sealing<br>Disk; Storage Lid | | Wireless Connectivity | Bluetooth BLE 4.2 with an optional<br>mobile app | Bluetooth with an optional mobile app | The subject device has the same intended use, but different technological characteristics compared to the predicate. The subject and predicate device operate at different cycle speeds, levels, and suction strengths for stimulation and expression modes, and power supply. The predicate device is also indicated for multiple and single users while the subject device is indicated for single users only. The differences in the indications and technological characteristics do not raise different questions of safety and effectiveness. #### 7. PERFORMANCE DATA ## Biocompatibility Testing The patient contacting components, in their final finished form, are identical to the Smartpump 1.0 Double Electric Breast Pump cleared in K182749 in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). Therefore, no additional biocompatibility testing was conducted. {6}------------------------------------------------ The milk contacting components are those components that are provided in the pump kit. All materials in contact with milk have been tested to meet FDA's Food Additive criteria (21 CFR 175-179) ## Electrical safety and electromagnetic compatibility (EMC) The Smartpump 3.0 Double Electric Breast Pump was tested in accordance with IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance including US deviations, with the exception of Clause 11.7 regarding biocompatibility. The device passed all tests. The Smartpump 3.0 Double Electric Breast Pump was tested in accordance with the FDArecognized standard IEC 60601-1-2:2014+A1:2021, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests. The device passed all tests. The Smartpump 3.0 Double Electric Breast Pump was tested in accordance with IEC 60601-1-11:2015, Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. The device passed all tests The Smartpump 3.0 Double Electric Breast Pump was tested in accordance with the FDArecognized standard, IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems, and found to comply with all relevant sections. ## Software Verification and Validation Testing Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." and in accordance with IEC 62304:2016, Medical device software - Software life cycle processes. The software for this device was considered as a Moderate level of concern. Cybersecurity documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" ## Sterilization, Cleaning, and Shelf-Life ### Sterilization and Cleaning The device is reusable, provided non-sterile, and is not sterile when used. Cleaning instructions are provided in the labeling. ### Shelf-Life Shelf-life is not applicable due to the low likelihood of time-dependent product degradation. However, in accordance with IEC 60601-1:2005/(R)2012 the subject devices expected use-life is 500 hours. In testing, the devices were demonstrated to operate within specifications for up to 500 hours of continuous operation at the maximum setting (Expression mode 3, Level 8). {7}------------------------------------------------ # Bench Testing The following bench testing was performed to demonstrate substantial equivalence: - Battery life Testing . Battery life was measured with the pumps at the highest level ((Expression Mode 3, Level 8). The "fail time" was defined as the number of minutes the pump could run at this level before dropping below specifications. Testing supports that the battery life of the device, as noted in the labeling, is approximately 2 hours. - Suction Pressure Stability Testing ● Devices were evaluated for suction performance at each of the available settings. The suction curves for each cvcle mode and suction level demonstrated that the device meets its specifications and performs within the specified working ranges of pressure and cycle speed for each mode/level. - Backflow Testing ● The Lansinoh pumps are designed as a closed milk collection system. The diaphragm provides a physical barrier, preventing breastmilk from flowing into the tubing or pump body. There have been no changes to the Backflow Protection mechanism materials used in the subject device since its previous clearance in K182749. Therefore, Backflow Protection data from K182749 can be leveraged to support the biocompatibility of the subject devices. The purpose of the backflow test is to demonstrate that the design prevents backflow into the tubing and pump. Devices were tested at maximum pressure/cycle settings (Expression Mode 3, Level 8) at various orientations to simulate worst-case conditions. The testing demonstrated that no milk was present in test devices' tubing during and following the test; therefore, the diaphragm was demonstrated to prevent back flow of milk into the tubing and pump. #### CONCLUSION 8. The results of the testing described above demonstrate that the Smartpump 3.0 Double Electric Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.