The Lucy Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Lucy Breast Pump is intended for a single user.

Device Description

The Lucy Breast Pump (Lucy) is a cordless, software-controlled, battery powered breast pump that is intended for use by lactating women to express and collect breast milk. The Lucy Breast Pump is intended for a single user and provided as a non-sterile device. The user has the option to pump from one breast (single pumping) or two breasts simultaneously (double pumping). The fully assembled Lucy Breast Pump, consisting of the Flange, Pump Body, Pump Diaphragm, and Container Assembly, is designed to work in the user's nursing bra that allows it to be used handsfree. The Lucy Breast Pump provides two operational modes (stimulation and expression), with three vacuum/cycle levels in stimulation mode and four vacuum/cycle levels in expression mode. Switching between modes and changing the levels within each mode is done through the physical interface on the pump.

AI/ML Overview

The FDA 510(k) summary for the Lucy Breast Pump (K213311) details non-clinical performance testing conducted to demonstrate substantial equivalence to its predicate device, the Medela Pump In Style (K200508).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (from text)	Reported Device Performance (from text)
Electrical Safety/EMC	Compliance with various standards including: ANSI/AAMI ES60601-1:2005/(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012, IEC 60601-1-11:2015, ANSI/AAMI/IEC 60601-1-2:2014, IEC 62133-2:2017, UN 38.3, UL 1642, UL 2054 2nd edition.	"Testing was conducted in accordance with" the listed standards, implying compliance. The document states, "The performance data demonstrate that the subject device is as safe and effective as the predicate device," which includes electrical safety aspects.
Biocompatibility	User-contacting materials to be non-cytotoxic, non-irritating, and non-sensitizing, based on ISO 10993-5:2009 and ISO 10993-10:2010, and FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."	"The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing."
Performance Bench Testing	Vacuum Pressure and Cycle Rate: Device must meet established specifications at all settings.Backflow: Liquid should not backflow into the pump.Use-Life: Device must maintain specifications throughout its proposed use-life.Battery Performance: Battery must remain functional during its stated use-life.Battery Status Indicator: Indicator must reflect the minimum number of pumping sessions remaining at each color level as stated in labeling.Battery Charging: Demonstrate the duration of time needed to fully recharge the battery.	"Vacuum pressure and cycle rate testing was conducted at all settings and demonstrated that the device met its specifications.""Backflow testing was conducted to demonstrate that liquid does not backflow into the pump.""Use-life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use-life.""Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.""Battery status indicator testing was conducted to demonstrate that the battery status indicator reflects the minimum number of pumping sessions remaining at each color level as stated in device labeling.""Battery charging testing to demonstrate the duration of time needed to fully recharge the battery."
Software	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005 FDA guidance document) to support a moderate level of concern.	"Software verification and validation was conducted in accordance with the 2005 FDA guidance document... to support a moderate level of concern."
Reprocessing	Cleaning validation study in accordance with the 2015 FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."	"A cleaning validation study was conducted and supporting information provided in accordance with the 2015 FDA guidance document..."

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

The provided document describes non-clinical bench testing. It does not mention a "test set" in the context of human subjects or a clinical study. Therefore, information regarding sample size, data provenance, or retrospective/prospective nature is not applicable here as the studies are focused on device performance tests.

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

Not applicable. The reported studies are non-clinical bench tests (e.g., electrical, biocompatibility, performance, software V&V, reprocessing validation) and do not involve human subject data requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of human subject data demanding adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The provided document focuses on non-clinical performance and safety testing to establish substantial equivalence based on engineering and material specifications, not a clinical comparison of reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The Lucy Breast Pump is a physical medical device, not an AI algorithm for diagnostic or prognostic purposes. While it has embedded software, the performance studies are related to the hardware's functional and safety aspects.

7. Type of Ground Truth Used:

For the non-clinical tests described, the "ground truth" is established by:

Engineering specifications and industry standards: For electrical safety, EMC, vacuum pressure, cycle rate, use-life, and battery performance.
Regulatory guidance and international standards: For biocompatibility (ISO 10993) and cleaning validation.
Internal design specifications: For how the device is intended to perform (e.g., backflow prevention, battery indicator accuracy).

8. Sample Size for the Training Set:

Not applicable. The Lucy Breast Pump is not an AI/ML device that requires a training set of data. The "software" referred to is embedded control software for device operation, not machine learning software trained on data.

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

Not applicable, as there is no training set for this type of device.

Summary

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February 9, 2022

Willow Innovations, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. Warren, NJ 07059

Re: K213311

Trade/Device Name: Lucy Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: January 7, 2022 Received: January 11, 2022

Dear Dave Yungvirt:

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.

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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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213311

Device Name Lucy Breast Pump

Indications for Use (Describe)

The Lucy Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Lucy Breast Pump is intended for a single user.

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 K213311

I. SUBMISSION INFORMATION

Submitter's Name:	Willow Innovations, Inc.
Submitter's Address:	1975 W. El Camino Real, Suite 306Mountain View, CA 94040
Submitter's Telephone:	Phone: 925-989-8681Fax: 650-938-5814
Contact Person:	Nelson LamVice President of Clinical, Regulatory, Qualitynlam@willowpump.com
Date Summary Prepared:	February 2, 2022

II. DEVICE INFORMATION

Trade/Device Name:	Lucy Breast Pump
Common Name:	Powered Breast Pump
Regulation Number:	21 CFR 884.5160
Regulation Name:	Powered Breast Pump
Regulatory Class:	II
Product Code:	HGX (Pump, Breast, Powered)

III. PREDICATE DEVICE INFORMATION

Predicate Name:	Pump In Style®
Predicate Manufacturer:	Medela LLC
510(k) Number:	K200508

The predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The Lucy Breast Pump provides two operational modes (stimulation and expression), with three vacuum/cycle levels in stimulation mode and four vacuum/cycle levels in expression mode.

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Switching between modes and changing the levels within each mode is done through the physical interface on the pump.

V. INDICATIONS FOR USE

The Lucy Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Lucy Breast Pump is intended for a single user.

VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS

The following table compares the subject device to the predicate with respect to the intended use and technological characteristics:

Attribute	Subject Device	Predicate Device	Comparison
	K213311	K200508
	Willow Innovations, Inc.	Medela LLC
Indications for Use	The Lucy Breast Pump is apowered breast pump to beused by lactating women toexpress and collect milkfrom their breasts. TheLucy Breast Pump isintended for a single user.	Pump In Style® isa powered breastpump to be usedby lactatingwomen to expressand collect milkfrom their breasts.This poweredbreast pump isintended for asingle user and isintended to be usedin a homeenvironment.	The subject and predicate deviceindications for use are notidentical; however, they have thesame intended use (i.e., to collectmilk from the breasts of lactatingwomen).
Single-User Device	Yes	Yes	Same
Pumping Options	Single or Double	Single or Double	Same
Design	Combined pump andcollection system to beplaced within nursing bra	Pump kit incontact withbreast, withvacuum tubinggoing to the pump	Different: The assembled subjectdevice is placed within a nursingbra, while the pump component ofthe predicate device is not part ofthe physical pump kit, but rather isseparate from the pump kit andconnected via vacuum tubing.This difference does not raisedifferent questions of safety andeffectiveness (S&E)
User Control	On / Off buttonMode button(Stimulation/Expression)Suction Increase buttonSuction Decrease button	On / Off buttonLet-Down buttonSuction IncreasebuttonSuction Decreasebutton	Similar
Visual Indicator	LED Light	No visual indicator	Different: The subject deviceincludes an LED that providesinformation to the user of batterycharge state as well as the statusof device operation. This
			difference does not raise differentquestions of S&E.
BreastShields/Flange	Circular Shape –Polypropylene flange	Oval Shape –Polypropylene andthermoplasticelastomerpolypropylenebreast shields	Different: These componentshave different shapes andmaterials. The differences do notraise different questions of S&E,as they have the same function tofit over the nipple, create a sealduring a pumping session, and totransfer expressed milk to thecollection bottle.
Replaceable/detachablecomponents of thebreast pump	FlangePump diaphragmContainer BackContainer BowlContainer Duckbill ValveCharging Cable	Breast ShieldMembraneConnector BodyConnector CapTubingPower Supply	Different: The subject andpredicate devices have differencesin replaceable device components.These differences do not raisedifferent questions of S&E.
Power Source	Internal Non-ReplaceableRechargeable Li-IonBatteryCharged with AC PowerAdapterInput: 100-240V Vac,50/60Hz 0.28AOutput: 5V DC 2A max	Direct Plug-in -Switching PowerSupply:Input: 100-240VAC, 50/60Hz,0.7A.Output: 9VDC, 2AExternal Battery:Pack AA batteries(Alkaline, Ni-MH)Portable VehicleAdapter:Switching vehiclepower adapterInput Rating: 12-24VDCOutput Rating:9VDC, 1.0A	Different: The subject deviceoperates only under battery power,while the predicate device can beoperated using three powersources. Differences in powersources do not raise differentquestions of S&E.
Control Mechanism	Microcontroller	Microcontroller	Same
Software	Embedded	Embedded	Same
Electrical InsulationClass	Class II (double insulated)	Class II (doubleinsulated)	Same
IP-Protection	IP-22	IP-22	Same
Protection Type	BF	BF	Same
Vacuum Type	Diaphragm-type assembly	Accumulator	Different: Differences in vacuumtype do not raise differentquestions of S&E.
Maximum Vacuum	-295 mmHg	-295 mmHg	Same
Vacuum Range(single and doublepumping)	-75 to -280 mmHg	-50 to -240 mmHg	Different: The vacuum range ishigher for the subject device thanthe predicate device. Thisdifference does not roise different
			questions of S&E, as themaximum vacuum for bothdevices is the same.
Cycle Speed Range	30 - 100 cycles/minute	20-140cycles/minute	Different: The subject andpredicate devices have differencesin their cycle speed ranges.Differences in cycle speed rangesdo not raise different questions ofS&E.
Backflow/OverflowProtection	Yes - Diaphragm preventsoverflow of milk into thepumping mechanism.	Yes - connectorwith siliconemembraneprevents milkoverflow into thetubing andpumpingmechanism.	Similar

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The subject and predicate device have the same intended use, i.e., to express and collect milk from the breasts of lactating women.

The subject and predicate device have different technological features as noted in the table above. These technological differences do not raise different questions of safety or effectiveness.

VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

Non-clinical testing was conducted to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device, as follows:

Electrical Safety/Electromagnetic Compatibility:

Testing was conducted in accordance with:

I ANSI/AAMI ES60601-1:2005/(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 -Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
י IEC 60601-1-11:2015 - Medical electrical equipment - Part 1-11: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
ANSI/AAMI/IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: Electromagnetic י disturbances - Requirements and tests
י 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
. UN 38.3 - (Article 38.3 of Part 3 of the UN Manual of transport tests and standards for dangerous goods) - Certification for Lithium Batteries
I UL 1642 - UL Standard for Safety Lithium Batteries
י UL 2054 2nd edition - Household and Commercial Batteries

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Biocompatibility:

Biocompatibility testing was conducted in accordance with the 2020 FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Testing included:

Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests . for in vitro cytotoxicity
. Sensitization per ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Irritation per ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests " for irritation and skin sensitization

The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.

Performance Bench Testing:

Bench testing was conducted to demonstrate pump performance met established specifications in the following areas:

Vacuum pressure and cycle rate testing was conducted at all settings and demonstrated that the device met its specifications.
י Backflow testing was conducted to demonstrate that liquid does not backflow into the pump.
י Use-life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use-life.
ı Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
ı Battery status indicator testing was conducted to demonstrate that the battery status indicator reflects the minimum number of pumping sessions remaining at each color level as stated in device labeling.
ı Battery charging testing to demonstrate the duration of time needed to fully recharge the battery.

Software:

. Software verification and validation was conducted in accordance with the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" to support a moderate level of concern.

Reprocessing

A cleaning validation study was conducted and supporting information provided in ● accordance with the 2015 FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

VIII. CONCLUSION

The subject and predicate device have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject device is as safe and effective as the predicate device and supports the determination of substantial equivalence.

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).