Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard breast pump with software control for modes and levels, but there is no mention of AI or ML capabilities, training data, or performance metrics typically associated with AI/ML algorithms.

Therapeutic

No
A breast pump is a device that helps lactating women express milk, which is a supportive function rather than directly treating or diagnosing a medical condition.

Diagnostic

No

The device is a breast pump, not a diagnostic tool. Its purpose is to express and collect milk, not to identify or assess medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components (Flange, Pump Body, Pump Diaphragm, Container Assembly) and mentions physical interfaces for control, indicating it is a hardware device with software control, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Lucy Breast Pump is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to "express and collect milk from their breasts." This is a physical process involving the body, not a diagnostic test performed on a sample taken from the body.
Device Description: The description details a mechanical pump designed to extract fluid from the body. It doesn't mention any components or functions related to analyzing biological samples.
Lack of Diagnostic Function: IVD devices are used to diagnose diseases or conditions, monitor treatments, or screen for health issues by analyzing samples like blood, urine, or tissue. The Lucy Breast Pump has no such diagnostic function.
Anatomical Site: The anatomical site is the breasts, which is where the physical action of pumping occurs, not where a diagnostic sample is typically collected for analysis.

In summary, the Lucy Breast Pump is a medical device used for a therapeutic/supportive purpose (collecting breast milk), not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

HGX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Breasts

Indicated Patient Age Range

Lactating women

Intended User / Care Setting

Home environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
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 disturbances - Requirements and tests
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
UL 1642 - UL Standard for Safety Lithium Batteries
UL 2054 2nd edition - Household and Commercial Batteries

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.
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:

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 according with the 2015 FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

Key Results:
The performance data demonstrate that the subject device is as safe and effective as the predicate device and supports the determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K200508

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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.

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); 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 306
Mountain View, CA 94040
Submitter's Telephone:	Phone: 925-989-8681
Fax: 650-938-5814
Contact Person:	Nelson Lam
Vice President of Clinical, Regulatory, Quality
nlam@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 (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.

4

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 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.	Pump In Style® is
a powered breast
pump to be used
by lactating
women to express
and collect milk
from their breasts.
This powered
breast pump is
intended for a
single user and is
intended to be used
in a home
environment.	The subject and predicate device
indications for use are not
identical; however, they have the
same intended use (i.e., to collect
milk from the breasts of lactating
women).
Single-User Device	Yes	Yes	Same
Pumping Options	Single or Double	Single or Double	Same
Design	Combined pump and
collection system to be
placed within nursing bra	Pump kit in
contact with
breast, with
vacuum tubing
going to the pump	Different: The assembled subject
device is placed within a nursing
bra, while the pump component of
the predicate device is not part of
the physical pump kit, but rather is
separate from the pump kit and
connected via vacuum tubing.
This difference does not raise
different questions of safety and
effectiveness (S&E)
User Control	On / Off button
Mode button
(Stimulation/Expression)
Suction Increase button
Suction Decrease button	On / Off button
Let-Down button
Suction Increase
button
Suction Decrease
button	Similar
Visual Indicator	LED Light	No visual indicator	Different: The subject device
includes an LED that provides
information to the user of battery
charge state as well as the status
of device operation. This
			difference does not raise different
questions of S&E.
Breast
Shields/Flange	Circular Shape –
Polypropylene flange	Oval Shape –
Polypropylene and
thermoplastic
elastomer
polypropylene
breast shields	Different: These components
have different shapes and
materials. The differences do not
raise different questions of S&E,
as they have the same function to
fit over the nipple, create a seal
during a pumping session, and to
transfer expressed milk to the
collection bottle.
Replaceable/
detachable
components of the
breast pump	Flange
Pump diaphragm
Container Back
Container Bowl
Container Duckbill Valve
Charging Cable	Breast Shield
Membrane
Connector Body
Connector Cap
Tubing
Power Supply	Different: The subject and
predicate devices have differences
in replaceable device components.
These differences do not raise
different questions of S&E.
Power Source	Internal Non-Replaceable
Rechargeable Li-Ion
Battery
Charged with AC Power
Adapter
Input: 100-240V Vac,
50/60Hz 0.28A
Output: 5V DC 2A max	Direct Plug-in -
Switching Power
Supply:
Input: 100-240
VAC, 50/60Hz,
0.7A.
Output: 9VDC, 2A

External Battery:
Pack AA batteries
(Alkaline, Ni-MH)

5

6

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

7

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.