The Evolve Breast Pump, is an electrically powered breast pump from an external AC-DC power supply; the device is provided non-sterile. The Evolve Breast Pump is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The Evolve breast pump is designed as a multi-user breast pump and available in a corded model (external AC-DC power supply). The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women. The Evolve Breast Pump has a backlit, LCD display for user display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression - and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes. The Evolve Breast Pump is intended for repeated use by multiple users in home environment. The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Evolve Breast Pump (K190465), comparing it to a predicate device, the Hygeia EnDeare Breast Pump (K081932).

However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) which would typically be relevant for AI/ML devices. This is a breast pump, not a diagnostic device.

Instead, the "acceptance criteria" for a breast pump would relate to its functional performance, electrical safety, electromagnetic compatibility, and software/firmware robustness. The "study" proving it meets these criteria refers to the non-clinical performance data provided to the FDA.

Based on the provided text, here's an attempt to answer your questions, interpreting "acceptance criteria" and "study" in the context of a breast pump's regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a tabulated format with corresponding performance for each criterion. Instead, it describes general performance specifications that were met. Below is a reconstruction based on the information provided, focusing on the functionality of the breast pump.

Acceptance Criteria (Interpreted from specifications)	Reported Device Performance (Evolve Breast Pump)
Electrical Safety	Complies with IEC 60601-1:2005 (3rd Edition) with US deviations per AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 standard.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2: 2014 (4th edition) standard.
Firmware Verification & Validation	Verification and validation provided in accordance with FDA Guidance document, "The Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005.
Vacuum Performance (Maximum)	Achieves -283 mmHg (±20 mmHg).
Vacuum Range (Stimulation Mode)	-75 to -175 mmHg (±20 mmHg).
Vacuum Range (Expression Mode)	-140 to -283 mmHg (±20 mmHg).
Cycle Speed Range (Stimulation Mode)	75 to 92 CPM (±8 CPM).
Cycle Speed Range (Expression Mode)	32 to 49 CPM (±8 CPM).
Backflow Protection	Yes, via silicone diaphragm; effectively prevents milk from entering tubing/pump.
User Interface Functionality	Soft-touch buttons for On/Off, Stimulation/Expression Mode, Strength/Speed adjustments responsive and functional. LCD display provides clear information.
Single and Double Pumping Functionality	Supports both single and double pumping modes.
Multi-User Capability	Designed for repeated use by multiple users in home environment.

The document states, "Specifications were met and within required, acceptable range for pump operation, cycle rate, and vacuum pressure."

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

The document does not specify a "test set" in the context of patient data or clinical imaging for AI/ML. For this medical device (a breast pump), the "testing" involves hardware and software performance.

Sample Size: Not applicable in the traditional sense of patient data. Testing was performed on the device itself.
Data Provenance: Not applicable. The testing was non-clinical, likely conducted by the manufacturer in a lab environment.

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

Not applicable. The ground truth for a breast pump's performance is objective measurement against engineering specifications (e.g., vacuum pressure, cycle rate, electrical safety standards). It does not involve expert interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. This is not a diagnostic device requiring adjudication of expert interpretations.

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

Not applicable. This is a breast pump, not an AI-assisted diagnostic device. No human readers or AI assistance are involved in its primary function.

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

Not applicable. While the device contains firmware/software, the "standalone" performance concept typically applies to AI algorithms whose output is a diagnosis or risk assessment. Here, the "standalone" performance would be the pump's mechanical and electronic function, which was tested.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission is based on:

Engineering Specifications and Measurements: Direct physical measurements of vacuum (mmHg) and cycle rates (CPM) against predefined ranges.
Regulatory Standards: Compliance with international and national standards for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and risk management (ISO 14971).
Software Verification & Validation Best Practices: Adherence to FDA guidance for software in medical devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data in the typical sense. The firmware/software development process would involve iterative testing and refinement, but not "training" on a dataset to learn patterns.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of AI/ML. The firmware's functionality is designed and verified against established engineering principles and requirements, not learned from a dataset with pre-established ground truth labels.

Summary

{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 and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 18, 2019

Hygeia II Medical Group, Inc. Brett Nakfoor CEO 6241 Yarrow Drive Carlsbad, CA 92011

Re: K190465

Trade/Device Name: Evolve Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 18, 2019 Received: September 20, 2019

Dear Brett Nakfoor:

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.

{1}------------------------------------------------

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-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 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 Andrews Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190465

Device Name Evolve breast pump

Indications for Use (Describe)

The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

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}------------------------------------------------

510(K) SUMMARY - K190465

In accordance to CFR Title 21, Sec. 807.92 the following summary is provided.

SUBMITTER:

Hygeia II Medical Group, Inc. 6214 Yarrow Drive, Suite A Carlsbad, CA 92011 Phone: (714) 515-7571

PRIMARY CONTACT PERSON:

Brett Nakfoor CEO Hygeia II Medical Group (714) 515-7571

SECONDARY CONTACT PERSON:

John Conklin Product Development Hygeia II Medical Group (714) 515-7571

DATE PREPARED: October 16, 2019

Device Information

Trade Name: Evolve Breast Pump Common Name: Powered Breast Pump Classification Name: Powered Breast Pump Classification Panel: Obstetrics/Gynecology Requlation: 21 CFR 884.5160 Device Classification: Class II Product Code: HGX Product Code Name: Pump, Breast, Powered

Predicate Device Information

Hygeia EnDeare Breast Pump, K081932 This predicate has not been subject to a design-related recall.

{4}------------------------------------------------

Device Description

The Evolve Breast Pump, is an electrically powered breast pump from an external AC-DC power supply; the device is provided non-sterile.

The Evolve Breast Pump is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The Evolve breast pump is designed as a multi-user breast pump and available in a corded model (external AC-DC power supply).

The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women.

The Evolve Breast Pump has a backlit, LCD display for user display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression - and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes.

The Evolve Breast Pump is intended for repeated use by multiple users in home environment.

The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.

Indications for Use

The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

{5}------------------------------------------------

Comparison of Technological Characteristics

The Evolve Breast Pump has identical indications for use and uses the same fundamental technology as the legally marketed predicated devices to which substantial equivalency is claimed, EnDeare Breast Pump (K081932). The modifications that are subject to this submission include the device's form-factor, user interface, vacuum source - performance specification, and firmware:

a) Form-factor/dimension physical size of subject device is smaller and has a different shape than the predicate in order to improve aesthetics
b) User interface to improve aesthetics, the subject device has an LCD user display versus predicate device's printed indicators and subject device has button controls versus rotary knob controls on predicate device
c) Vacuum source/performance The subject device provides negative pressure vacuum (suction) through a DC-powered, reciprocating-based pump and an electromechanical vacuum release solenoid where vacuum speed and strength are controlled electronically. The predicate device provides negative pressure vacuum through a DCpowered, reciprocating-based pump with a mechanical vacuum release design. Thus, subject device has vacuum speed and strength controlled electronically while predicate has vacuum speed controlled electronically and vacuum strength controlled mechanically (by user).
d) Firmware The embedded logic of the subject device has been changed to handle modifications listed above; user interface changes, control and management of reciprocating pump and electromechanical solenoid
e) Backflow protection backflow protection mechanism changed from hydrophobic filter to diaphragm

A summary of the technological characteristics compared to the legally marketed predicate device (K081932) are shown in the following table.

{6}------------------------------------------------

	EvolveK190465	EnDeare(Predicate Version)K081932	Comment
Indications for Use	The Evolve powered breastpump is to be used bylactating women to expressand collect milk from theirbreasts.	The EnDeare powered breastpump is indicated to expressand collect milk from thebreasts of lactating women.	Same
Environment ofUse	Home	Hospital, Home	Subject device marketed forhome use
User Interface - Controls
User Control	State-dependent controls:On-Off button	State-dependent controls:On-Off switch	Change to soft-touch buttonversus a switch
	Stimulation and ExpressionMode button	No Mode button	Subject device supports 2pumping modes; Stimulation& Expression, predicate has1 mode.
	Performance controls:Strength and Speedadjustment via buttons	Performance controls:Speed and Strengthadjustment via rotary knoband pressure collar	Change to soft-touchbuttons versus rotarycontrols
Visual Indicator	LCDBacklit, liquid-crystal display	Printed graphics on pumpcase	Addition of LCD display
Pumping Options	Single pumpingDouble pumping	Single pumpingDouble pumping	Same
Adjustable SuctionLevel	Yes	Yes	Same
Adjustable SpeedLevel	Yes	Yes	Same
Accessories	Personal Accessory Set:● breast shield● diaphragm● valve● tubing● bottlesAC-DC power-adapter-cord	Personal Accessory Set:● breast shield● filter● valves● tubing● bottlesAC power cord, rechargeablebattery	SameHygeia Personal AccessorySet
Cleaning	Breast pump - wipe withclean, damp clothTubing - replace if milkappears in tubingBreast pump kit and bottles –wash and sanitize	Breast pump - wipe withclean, damp clothTubing - wash or sanitize onlyif milk or condensation intubingBreast pump kit and bottles –wash and sanitize	Same except tubing shall bereplaced for subject device ifmilk appears in tubing
Specifications

Power Source	AC-DC 100 - 240 Vacadapter, 50/60 Hz	100 - 120 Vac power cord,50/60 Hz	Subject has AC-DC adapterintegrated into power cord,predicate uses standard ACpower cord
Batteries	None	Rechargeable, Nickel-metalHydride, 12.0V, 2200mAh	Predicate device offersbattery-powered model
RechargeableBatteryoperation/chargetime	NA	Operation time:Approximately 2 hoursCharge time:Approximately 3.5 hours
Software/firmware	Yes	Yes	Both devices haveembedded logic facilitatingdevice operation; subjectdevice has additional logicfor user display, solenoidcontrol
Vacuum aggregatetype	Reciprocating pump	Reciprocating pump	Same
VacuumRegulation type	Electronic	Mechanical	Subject device useselectronically-controlledregulator versus predicatedevice's manual set-pointregulator
Maximum vacuum(mmHg)	-283 mmHg(-20 mmHg)	-250 mmHg(±20 mmHg)	Subject device provideshigher vacuum strength
Vacuum range -double and singlepumping (mmHg)	Stimulation-75 to -175 mmHg(±20 mmHg)Expression-140 to -283 mmHg(±20 mmHg)	-50 to -250mmHg(±20 mmHg)	Subject device provides anoverall wider vacuum rangethan predicate
Cycling ControlMechanism	Electronic	Electronic	Same
Cycle SpeedRange(Cycles/Minute =CPM)	Stimulation75 to 92 CPM(±8 CPM)Expression32 to 49 CPM(±8 CPM)	40 - 60 Cycles/Minute(±10 CPM)	Subject device provides anoverall wider cycle speedrange than predicate
AdjustableCycle SpeedLevels	Yes	Yes	Same
Backflowprotection	Yes, silicone diaphragm	Yes, hydrophobic filter	Subject device providesclosed system via siliconediaphragm design

{7}------------------------------------------------

The differences in technological characteristics do not raise different questions of safety and effectiveness.

{8}------------------------------------------------

Summary of Performance Data, Non-Clinical Testing

The Evolve Breast Pump complies with voluntary standards for electrical safety, electromagnetic compatibility, and use in the home environment.

The following performance data is provided in support of the substantial equivalence determination:

Risk/Hazard

Risk Analysis in accordance with ISO 14971:2007 was used to assess impact of . modifications to the device

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety testing per IEC 60601-1:2005 (3rd Edition) with US deviations per . AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 standard
. Electromagnetic compatibility testing per IEC 60601-1-2: 2014 (4th edition) standard, Medical Electrical Equipment Part 1 - 2

Firmware Testing

. The software/firmware verification and validation was provided in accordance with the FDA Guidance document, "The Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005

{9}------------------------------------------------

K190465 Page 7 of 7

Performance Testing

The Evolve Breast Pump was tested to demonstrate it meets its performance specifications. The testing involved measurement of vacuum and cycles for minimum and maximum settings for both single and double pumping mode, and for stimulation and expression mode. Also, backflow protection was tested. Specifications were met and within required, acceptable range for pump operation, cycle rate, and vacuum pressure.

Conclusion

The performance testing demonstrates that the Evolve Breast Pump is substantially equivalent to the predicate device.

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).