The Lansinoh® Signature Pro™ 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 multiple users, and single users.

The Lansinoh® Smartpump™M Double Electric Breast Pump is intended to express and collect the breasmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users.

Device Description

The Lansinoh Powered Breast Pumps are 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 pump can be powered by 6 AA batteries or by an AC adaptor that is provided with the 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 and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.

The purpose of this 510(k) is to update the indications for use statement to include use by multiple users. The labeling has been revised to clarify that the collection kits are for single users only and are not to be shared with other users.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) and Lansinoh® Smartpump™ Double Electric Breast Pump (DEPB 2.2). The purpose of this submission is to update the indications for use to include multiple users, leveraging the previously cleared Lansinoh Double Electric Breast Pump (K122474) as the predicate.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table with pass/fail thresholds in the typical sense for a diagnostic AI device. Instead, it focuses on demonstrating that the new devices' performance characteristics are similar to or do not raise new questions of safety and effectiveness compared to the predicate device, especially considering the expanded "multiple user" indication. The performance data presented are primarily focused on hardware and safety aspects of the breast pump, not an AI or diagnostic algorithm.

However, we can infer some criteria and reported performance from the "Device Comparison Table" and "Performance Data" sections:

Feature/Test	Acceptance Criteria (Inferred from Predicate/Standard)	Reported Device Performance
Primary Indication for Use	Be intended to express and collect breastmilk for feeding to a baby. (No new questions of safety/effectiveness compared to predicate, despite "multiple user" inclusion).	The Lansinoh® Signature Pro™ and Smartpump™ are intended to express and collect breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users. (Different from predicate in that it allows multiple users, but this difference does not alter the intended use or raise different questions of safety/effectiveness).
Suction Levels (Stimulation)	Within a clinically acceptable and safe range (Predicate: 55-140 mmHg).	46-140 mmHg. (Similar; slightly lower suction level but does not raise different questions of safety and effectiveness).
Cycles per Second (Stimulation)	Within a clinically acceptable and safe range (Predicate: 1.55-2.4).	1.61-2.33. (Similar; slightly different cycle rates but does not raise different questions of safety and effectiveness).
Suction Levels (Expression)	Within a clinically acceptable and safe range (Predicate: 80-220 mmHg).	95-280 mmHg. (Different; higher pressure levels for expression than the predicate, but this difference does not raise different questions of safety and effectiveness).
Cycles per Second (Expression)	Within a clinically acceptable and safe range (Predicate: 0.61-1.52).	0.58-1.69. (Similar; slightly different cycle rate but does not raise different questions of safety and effectiveness).
Suction Settings	Same as predicate (8).	8. (Same)
Expression Modes	Same as predicate (3).	3. (Same)
Power Supply	Same as predicate (6 AA batteries, AC adapter).	a) 6 AA alkaline batteries b) AC Adapter. (Same)
Pumping Option	Same as predicate (Single or Double).	Single or Double. (Same)
Back Flow Protection	Presence and effectiveness in preventing milk from entering tubing/pump. (Yes).	Yes. (Same). Demonstrated at maximum pressure/cycle settings (Expression Mode 3, Level 8) and various orientations, no milk was present in tubing, confirming diaphragm prevents backflow.
Let Down Function	Presence. (Yes).	Yes. (Same)
Cycling/Suction Control Mechanism	Same as predicate (Microprocessor).	Microprocessor. (Same)
Communication with mobile app (Smartpump only)	No alteration of intended use or new questions of safety/effectiveness (N/A for predicate).	Bluetooth. (Different; SmartPump has Bluetooth capability, but this does not alter the intended use or raise different questions of safety and effectiveness).
Bench Performance (Suction Curves)	Meets specifications and performs within specified working ranges of pressure and cycle speed for each mode/level.	Demonstrated that the device meets its specifications and performs within the specified working ranges of pressure and cycle speed for each mode/level.
Battery Life	Meets specified battery life (approx. 90 minutes).	Approximately 90 minutes at the highest level (Expression Mode 3, Level 8).
Cleaning	Instructions provided for reusable, non-sterile device.	Cleaning instructions are provided in the labeling.
Shelf-life	Not applicable due to low degradation likelihood; expected use-life of 500 hours (per IEC 60601-1:2005/(R)2012).	Demonstrated to operate within specifications for up to 500 hours of continuous operation at the maximum setting.
Biocompatibility	Patient-contacting materials meet FDA's Food Additive criteria (21 CFR 175-179) and are equivalent to predicate (K122474).	No changes to patient-contacting materials since previous clearance (K122474). All milk-contacting components tested to meet FDA's Food Additive criteria. (Leverages K122474 data).
Electrical Safety & EMC	Meets applicable test limits per ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2007.	Demonstrated to meet applicable test limits for electrical safety and EMC per the cited standards.
Software Function (if applicable)	Functions as intended, consistent with a minor level of concern (per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005).	Documentation consistent with a minor level of concern demonstrated the software functions as intended.
Cybersecurity (if applicable)	Appropriate mitigations implemented based on device risk level.	Evaluated through a risk-based approach; appropriate mitigations implemented based upon the level of risk of the devices.

2. Sample Size Used for the Test Set and the Data Provenance:

The document describes various performance tests, but it does not specify exact sample sizes (e.g., number of units tested) for each. For example:

Bench Performance (Suction Curves, Battery Life, Backflow Test, Shelf-Life): "Devices were evaluated," "Devices were tested." No specific number of devices is mentioned.
Biocompatibility: Leveraged data from K122474, implying no new testing sample for this submission. The materials are the same.
Electrical Safety and EMC: "The device was tested." No specific number of devices is mentioned.
Software and Cybersecurity: "The software was evaluated," "Cybersecurity for the subject devices was evaluated."

Data Provenance: The tests appear to be conducted by the manufacturer, Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti., which is based in Turkey. The studies mentioned (Bench Performance, Battery Life, Backflow Test, Shelf-Life, Electrical Safety, EMC, Software, Cybersecurity) are retrospective relative to the submission date, as they were completed to support the 510(k). They are engineering/performance verification tests conducted in a lab environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable as the device is a breast pump, not a diagnostic device that requires expert interpretation for ground truth. The "ground truth" here is determined by engineering specifications and objective measurements (e.g., pressure, cycle rates, battery life, absence of milk in tubing).

4. Adjudication Method for the Test Set:

This information is not applicable as the device is a breast pump. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for diagnostic devices where human experts disagree on interpretations (ground truth). The performance tests described are objective engineering measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a breast pump and does not involve AI assistance for human readers or interpretation of medical cases.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

This information is not applicable. The device is a breast pump. While it has a microprocessor and software, it's not an "algorithm" in the diagnostic AI sense, and its performance is about mechanical function, not diagnostic accuracy.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is based on:

Engineering Specifications: Defined parameters for suction levels, cycle rates, battery life, etc.
Objective Measurements: Using testing equipment to measure pressure, time, and physical presence of milk (for backflow).
Industry Standards: Compliance with standards like ANSI/AAMI ES60601-1:2005/(R)2012 for electrical safety and IEC 60601-1-2:2007 for EMC.
FDA Regulations: Compliance of patient-contacting materials with FDA's Food Additive criteria (21 CFR 175-179).
Prior Clearance Data (K122474): For biocompatibility, the ground truth established for the predicate device was leveraged.

8. The Sample Size for the Training Set:

This information is not applicable. This is not an AI or machine learning device requiring a training set. The software mentioned is likely embedded control software for the pump's operation, not a learning algorithm.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set mentioned or implied for this device.

Summary

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June 12, 2019

Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti. % Lindsay Ewers Director of Quality Assurance Lansinoh Laboratories 333 N. Fairfax Street, Suite 400 Alexandria, VA 22314

Re: K182749

Trade/Device Name: Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) Lansinoh® Smartpump™ Double Electric Breast Pump (DEPB 2.2) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: May 16, 2019 Received: May 17, 2019

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.

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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-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 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 M. Andrews Assistant Division 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

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Indications for Use

510(k) Number (if known) K182749

Device Name

Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) Lansinoh® Smartpump™ Double Electric Breast Pump (DEPB 2.2)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Exempted New Part 613 Subchapter S Project
One-Time Community SEP New Subchapter S Project

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Device Common Name:	Powered Breast Pump
Device Trade Name:	Lansinoh® Signature Pro™ Double Electric Breast Pump(DEBP 2.1) and Lansinoh® Smartpump™ Double ElectricBreast Pump (DEBP 2.2)
Submitter:	Lansinoh Laboratories Saglık Gerecleri San. Tic. Ltd. Sti.10006 sokak, No:64A.O.S.B. Cigli - Izmir 35620TURKEYTel: 0090 232 328 05 06Fax: 0090 232 328 05 58www.lansinoh.com.tr
Company Contact:	Barbaros KaradağGeneral ManagerLansinoh Laboratories Saglık Gerecleri San. Tic. Ltd. Sti.Tel: +90 232 328 05 06barbaroskaradag@lansinoh.com.tr
Date Prepared:	June 11, 2019
Classification Regulation:	21 CFR 884.5160, Class II, Powered Breast Pump
Panel:	Obstetrics/Gynecology
Product Code:	HGX - Powered Breast Pump

Indication for Use:

The Lansinoh® Smartpump™ 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 multiple users, and single users.

Device Description:

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and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.

Device Comparison Table:

	New Device	Predicate Device	SubstantialEquivalenceComparison
Manufacturer	Lansinoh LaboratoriesSaglik Gerecleri TasarimSan. Tic. Ltd. Sti.	Lansinoh LaboratoriesSaglik GerecleriTasarim San. Tic. Ltd.Sti.	N/A
Device Name	Lansinoh® SignaturePro™ Double ElectricBreast Pump (DEBP 2.1)and Lansinoh®Smartpump™ DoubleElectric Breast Pump(DEBP 2.2)	Powered Breast Pump	N/A
510(k) #	K182749	K122474	N/A
Intended Use	The Lansinoh® SignaturePro™ Double ElectricBreast Pump is intendedto express and collect thebreastmilk of a nursingwoman for the purpose offeeding collectedbreastmilk to a baby. Thepump is intended formultiple users, and singleusers.The Lansinoh®Smartpump™ DoubleElectric Breast Pump isintended to express andcollect the breastmilk of anursing woman for thepurpose of feedingcollected breastmilk to ababy. The pump isintended for multiple	The Powered BreastPump is intended toexpress and collect thebreast milk of a nursingwoman for the purposeof feeding the collectedmilk to a baby. ThePowered Breast Pump isintended for a singleuser.	Different; theindications for use ofthe subject devices aredifferent from thepredicate in that thesubject device isintended for multipleusers. However, thisdifference does not alterthe intended use of thedevice as compared tothe predicate.
	New Device	Predicate Device	SubstantialEquivalenceComparison
	users, and single users.
Suction Levels(stimulation)	46-140 mmHg	55 - 140 mmHg	Similar; the subjectdevices have a slightlylower suction level.However, this differencedoes not raise differentquestions of safety andeffectiveness.
Cycles per Second(stimulation)	1.61-2.33	1.55 - 2.4	Similar; the subjectdevices have a slightlydifferent cycle rates.However, this differencedoes not raise differentquestions of safety andeffectiveness.
Suction Levels(expression)	95 - 280 mmHg	80 – 220 mmHg	Different; the subjectdevice has higherpressure levels forexpression than thepredicate. However,this difference does notraise different questionsof safety andeffectiveness.
Cycles per Second(expression)	0.58 - 1.69	0.61 - 1.52	Similar; the subjectdevices have a slightlydifferent cycle rate.However, this differencedoes not raise differentquestions of safety andeffectiveness.
Suction Settings	8	8	Same
Expression modes	3	3	Same
Power Supply	a) 6 AA alkaline batteriesb) AC Adapter	a) 6 AA alkalinebatteriesb) AC Adapter	Same
Pumping Option	Single or Double	Single or Double	Same
Back FlowProtection	Yes	Yes	Same
Let Down Function	Yes	Yes	Same
	New Device	Predicate Device	SubstantialEquivalenceComparison
Cycling/SuctionControl Mechanism	Microprocessor	Microprocessor	Same
Communicationwith mobile app(Smartpump only)	Bluetooth	N/A	Different; the subjectdevice (SmartPump) hasBluetooth capability.The addition ofBluetoothcommunication does notalter the intended use orraise different questionsof safety andeffectiveness.

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Performance Data:

Bench Performance

Suction Curves

Devices were evaluated for suction performance at each of the available settings. The suction curves for each cycle 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.

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 90 minutes.

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).

Backflow Test

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. The purpose

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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.

Biocompatibility

There have been no changes to the patient contacting materials used in the subject device since its previous clearance in K122474. Therefore, biocompatibility data from K122474 can be leveraged to support the biocompatibility of the subject devices.

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 EMC

The device was tested for electrical safety in accordance with (ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012) and EMC in accordance with (IEC 60601-1-2:2007). The device was demonstrated to meet applicable test limits for electrical safety and EMC per the cited standards.

Software and Cybersecurity

The software was evaluated as a minor level of concern per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005. Documentation consistent with a minor level of concern demonstrated the software functions as intended.

Cybersecurity for the subject devices was evaluated through a risk-based approach. Appropriate mitigations were implemented based upon the level of risk of the devices.

Substantial Equivalence Conclusion:

The purpose of this 510(k) is to establish substantial equivalence of the Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) and Lansinoh® Smartpump™ Double Electric Breast Pump (DEBP 2.2) to the previously cleared Lansinoh Double Electric Breast Pump (K122474).

The subject device indications are different from that of the predicate in that they allow for multiple users. This difference does not alter the intended use of the subject device from that of the predicate.

The subject devices have slightly different technological characteristics as described in the table above. However, the technological differences do not alter the intended use of the subject device as compared to the predicate or raise different questions of safety and effectiveness. The technological differences were evaluated through performance testing that demonstrated that the subject device is as safe and effective as the predicate.

Therefore, the subject devices are substantially equivalent to the predicate.

Regulation Number and Section

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).