(229 days)
Not Found
No
The summary describes a standard electromechanical breast pump with user-controlled modes and optional app connectivity. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's operation.
No.
The device is a breast pump used to express and collect breast milk, which is not considered a therapeutic function.
No
The document explicitly states the device's intention is to "express milk from lactating women in order to collect breast milk from their breasts." There is no indication of diagnosis, detection, or monitoring of any medical condition.
No
The device description clearly states it is an "electromechanical breast pump" consisting of physical components like a Pump, Flange, Flextube, and Milk Bag/Container, and operates on a battery. While it has optional software control via a mobile app, the core device is hardware.
Based on the provided information, the Willow® Generation 3 Breast Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express milk from lactating women in order to collect breast milk from their breasts." This is a physical process of extracting a bodily fluid, not a diagnostic test performed on a sample of that fluid.
- Device Description: The description details a mechanical pump designed to fit on the breast and extract milk. It does not describe any components or processes for analyzing or testing the breast milk itself.
- Lack of Diagnostic Elements: There is no mention of analyzing the composition of the milk, detecting biomarkers, or providing any diagnostic information based on the milk.
- Performance Studies: The performance studies focus on the mechanical and electrical functionality of the pump (vacuum levels, battery life, etc.), not on the accuracy or reliability of any diagnostic results.
IVD devices are designed to perform tests in vitro (outside the body) on samples of bodily fluids or tissues to diagnose diseases or conditions. The Willow Breast Pump's function is purely to collect a bodily fluid, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Willow® Generation 3 Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Product codes
HGX
Device Description
The Willow Gen 3 is a small electromechanical breast pump intended for lactating women to express and collect breast milk. It is a reusable single user device which is provided non-sterile. The device consists of a Pump, Flange, Flextube, and either Milk Bag (single use, disposable) or Milk Container (multiple use, reusable) assembled into one unit and is designed to fit on the user's breast. The pump component does not come into direct or indirect contact with the breast milk. Users can pump one breast using one Willow Pump or pump both breasts simultaneously using two Willow pumps. The device operates on a battery which can be charged with the provided charger using a standard 120V wall outlet.
Two pumping modes are provided: stimulation and expression. The pump is controlled by the user through either the tactile buttons on the pump or optionally through the Mobile App or Apple Watch App.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Lactating women / Not Found
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)
Software was evaluated for a minor level of concern as recommended in the 2005 FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The addition of the optional feature to control the pump via mobile app or Apple Watch did not change the level of concern. No new questions of safety and effectiveness were raised with testing.
Electrical safety and electromagnetic compatibility testing were completed per the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 ● (Consolidated Text) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-6 Edition 3.1 2013-10 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-11 Edition 2.0 2015-01 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
- ANSI AAMI IEC 60601-1-2:2014 - Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances - Requirements and tests
All testing passed and all requirements were met. No new questions of safety and effectiveness were raised with this testing.
Performance testing was conducted to demonstrate that the device meets its specifications and performs as intended. These tests included:
- Vacuum level verification at each level/cycle ●
- Use life testing
- Battery performance testing ●
- . Battery status indicator testing
All testing passed and all requirements were met. No new questions of safety and effectiveness were raised with this testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Willow® Wearable Breast Pump 2.0 (K191577)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 16, 2023
Willow Innovations, Inc. Shruti Javakumar Director of Global Regulatory Affairs 1975 W. El Camino Real, Suite 306 Mountain View, CA 94040
Re: K230570
Trade/Device Name: Willow® Generation 3 Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 13, 2023 Received: September 13, 2023
Dear Shruti Jayakumar:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Jason Roberts -S
Jason R. Roberts, 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
3
Indications for Use
510(k) Number (if known) K230570
Device Name Willow® Generation 3 Breast Pump
Indications for Use (Describe)
The Willow® Generation 3 Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device 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)
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4
willow
WILLOW INNOVATIONS, INC. GEN 3 BREAST PUMP
510(K) SUMMARY
| Sponsor/Submitter: | Willow Innovations, Inc.
1975 W. El Camino Real, Suite 306
Mountain View, CA 94040 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shruti Jayakumar
Director of Global Regulatory Affairs
Phone: 408-335-3106
Email: shruti.jayakumar@onewillow.com |
| Date Prepared: | September 12, 2023 |
| Device Trade Name: | Willow® Generation 3 Breast Pump |
| Common Name: | Powered Breast Pump |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Pump, Breast, Powered |
| Product Code: | HGX (Powered, Breast, Pump) |
| Predicate Device: | Willow® Wearable Breast Pump 2.0 (K191577), Willow Innovations, Inc.
(submitted under manufacturer name "Exploramed NC7, Inc.")
The predicate device has not been subject to a design-related recall. |
| Indications for Use: | The Willow® Generation 3 Breast Pump is intended to express milk from
lactating women in order to collect breast milk from their breasts. The
device is intended for a single user. |
Device Description
The Willow Gen 3 is a small electromechanical breast pump intended for lactating women to express and collect breast milk. It is a reusable single user device which is provided non-sterile. The device consists of a Pump, Flange, Flextube, and either Milk Bag (single use, disposable) or Milk Container (multiple use, reusable) assembled into one unit and is designed to fit on the user's breast. The pump component does not come into direct or indirect contact with the breast milk. Users can pump one breast using one Willow Pump or pump both breasts simultaneously using two Willow pumps. The device operates on a battery which can be charged with the provided charger using a standard 120V wall outlet.
Two pumping modes are provided: stimulation and expression. The pump is controlled by the user through either the tactile buttons on the pump or optionally through the Mobile App or Apple Watch App.
5
Predicate Device Comparison
| Attribute | Predicate Device:
Willow Gen 2 (K191577) | Subject Device:
Willow Gen 3 |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Willow Innovations, Inc.
(previous company name was
Exploramed NC7, Inc.) | Same |
| Trade Name | Willow Wearable Breast Pump
2.0 | Willow Generation 3 Breast Pump |
| Common Name | Powered Breast Pump | Same |
| Regulation | Class II, 21 CFR Part 884.5160 | Same |
| Product Code | HGX | Same |
| Indications for Use | The Willow Breast Pump is
intended to express milk from
lactating women in order to
collect milk from their breasts.
The device is intended for a
single user. | The Willow Breast Pump is
intended to express milk from
lactating women in order to collect
breast milk from their breasts.
The device is intended for a single
user.
Same. The word "breast" has only
been added for clarification. |
| Intended Use | Express breast milk from breast | Same |
| Target Population | Lactating women | Same |
| Single User | Yes | Same |
| Non-Sterile | Yes | Same |
| Reusable | Yes | Same |
| Direct User Contact | Yes | Same |
| Breast Interface Material | Polypropylene | Same |
| Technological
Characteristics | Electrical pressure control
pumping system to generate
suction | Same |
| Closed System? | Yes | Same |
| Power Source | AC Adaptor or Li-Ion Battery | Same |
| Attribute | Predicate Device:
Willow Gen 2 (K191577) | Subject Device:
Willow Gen 3 |
| Suction Levels | 60-245 mmHg | 40-245 mmHg |
| | | Same upper limit |
| Maximum Suction Level
(mmHg) | 270 mmHg | Same |
| Adjustable Suction Levels
and number of settings | Yes, 7 levels. | Same |
| Suction Cycles
(cycles/second) | 1-1.5 | 0.7 to 1.5 |
| | | Same upper limit |
| Backflow Protection | Yes | Same |
| Control Mechanism | Microcontroller | Same |
| Single or Double Pumping | Both | Same |
| # of Phases | Two (2):
Stimulation
Expression | Same |
| Milk Collection Apparatus | Milk Bag and Flange
•
Milk Container and Container
Flange | Same |
| Milk collection volume
(ounces) | 4 oz | Same |
| Flange / Container Flange
Sizes | Flange: 21mm, 24mm and 27mm | Same |
| Number of Reusable
Components (in addition
to pump) | 2 for disposable Milk Bag
(Flextube and Flange)
• 3 for reusable Milk Container
(Flextube, Container Flange,
and Milk Container) | Same |
| Mobile App (optional) | View pumping history | Expanded features to allow user to
control the pump |
6
willow
WILLOW INNOVATIONS, INC. GEN 3 BREAST PUMP
CONFIDENTIAL
The technological characteristics of the Gen 3 and the previously cleared breast pump are similar to the predicate. The indications for use of the subject and predicate devices are the same. The minor modifications to the suction levels, cycles, and app features do not raise new questions of safety or effectiveness. These changes were made to improve the user experience and ensure continued reliability
7
WILLOW INNOVATIONS, INC. GEN 3 BREAST PUMP
of the device. The mechanism of action and the principles of operation remain the same as the previously cleared Willow Gen 2 (K191577).
Summary of Non-Clinical Performance Testing
Software
Software was evaluated for a minor level of concern as recommended in the 2005 FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The addition of the optional feature to control the pump via mobile app or Apple Watch did not change the level of concern. No new questions of safety and effectiveness were raised with testing.
Electrical Safety and Electromagnetic Compatibility
Electrical safety and electromagnetic compatibility testing were completed per the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 ● (Consolidated Text) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-6 Edition 3.1 2013-10 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-11 Edition 2.0 2015-01 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
- ANSI AAMI IEC 60601-1-2:2014 - Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances - Requirements and tests
All testing passed and all requirements were met. No new questions of safety and effectiveness were raised with this testing.
Performance Testing
Performance testing was conducted to demonstrate that the device meets its specifications and performs as intended. These tests included:
- Vacuum level verification at each level/cycle ●
- Use life testing
- Battery performance testing ●
- . Battery status indicator testing
All testing passed and all requirements were met. No new questions of safety and effectiveness were raised with this testing.
Substantial Equivalence
Per the FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," issued July 28, 2014, the predicate is legally marketed (cleared in K191577), the devices have the same intended use, and they have the same technological characteristics. The minor technological differences between the Willow Gen 3 and its predicate device do not raise any new questions of safety or effectiveness. The results from the testing meet the previous performance requirements established for Willow Gen 2. The conclusions drawn from the nonclinical tests demonstrate that the Willow Gen 3 is as safe and effective and performs as well as the previously cleared Willow Gen 2. Thus, the Willow Gen 3 and the Willow Gen 2 are substantially equivalent.