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

Device Description

The Elvie Pump is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout and bra adjustor. All components (minus the pump) are reusable and may be manually cleaned. The kit components may be purchased separately and are available in different sizes and configurations.
The Elvie Pump includes piezoelectric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes.
The Elvie Pump is a battery-powered electro-mechanical device that contains software. It can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed and pumping history information.
All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.

AI/ML Overview

This document is a 510(k) summary for the Elvie Pump and does not describe acceptance criteria or a study that proves the device meets specific performance criteria through clinical trials or comparative effectiveness studies. Instead, it outlines the device's characteristics, its intended use, and its substantial equivalence to a predicate device based on non-clinical performance tests.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided text.

However, I can provide the information available from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a formal way for a clinical study comparing the Elvie Pump against specific performance metrics linked to patient outcomes or clinical effectiveness. Instead, it lists non-clinical performance tests that demonstrate the device meets its own specifications, which serve as internal "acceptance criteria" for engineering and safety.

Non-Clinical Performance Test Category	Device Performance (as reported)
Biocompatibility	Patient-contacting components are biocompatible (per ISO 10993-5, ISO 10993-10).
Software Validation	Validated for a minor level of concern (per FDA guidance May 11, 2005); includes cybersecurity assessment and validation of milk measurement algorithm.
Simulated Use Testing (Usability)	Compliant with IEC 62366-1.
Use Life Testing	Supports proposed use life.
Electrical Safety	Compliant with IEC 60601-1 and IEC 60601-1-11.
Electromagnetic Compatibility	Compliant with IEC 60601-1-2.
Cleaning Validation	Reprocessing instructions in labeling are validated.
Device Performance (Vacuum & Backflow)	Meets specifications for vacuum performance and backflow.

2. Sample sized used for the test set and the data provenance

Not mentioned in the document. The listed tests are non-clinical (e.g., biocompatibility on materials, software validation, electrical safety), not clinical studies with human test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document describes non-clinical engineering and safety tests, not studies requiring expert-established ground truths for clinical evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study.

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

No MRMC comparative effectiveness study was mentioned. The device is a powered breast pump, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers.

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

While the device includes software and has a "milk measurement algorithm," the document only states that the "milk measurement algorithm" was validated as part of software validation. It does not provide details of a standalone performance study for this specific algorithm or its performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests:

Biocompatibility: Standards (ISO 10993) and established laboratory protocols.
Software Validation: Requirements specifications, internal validation protocols, and FDA guidance.
Usability: IEC 62366-1 standard.
Electrical Safety/EMC: Relevant IEC 60601 series standards.
Cleaning Validation: Effectiveness against microbial load reduction/soil removal as per internal protocols.
Device Performance (Vacuum/Backflow): Engineering specifications for the Elvie Pump.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning model's development with a training set for clinical applications. The "software" and "microcontroller" mentioned are likely for controlling the pump's mechanical functions and user interface, not for AI-based analysis requiring training data in the traditional sense.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI/machine learning model.

Summary

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October 10, 2018

Chiaro Technology Limited % Marc C. Sanchez, Esq. Regulatory Attorney Contract In-House Counsel and Consultants, LLC 53516 Bickett Chapel Hill, NC 27517

Re: K181863 Trade/Device Name: Elvie Pump Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: July 11, 2018 Received: July 12, 2018

Dear Marc C. Sanchez:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael T. Bailey -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181863

Device Name Elvie Pump

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510k Submission Elvie Pump

510(K) Summary - K181863

The following information is provided as required by 21 CFR 807.87 for the Elvie Pump 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence is based.

Sponsor:	Chiaro Technology Limited63-66 Hatton GardenLondon EC1N 8LE United KingdomEstablishment Registration: 3012098706
Manufacturer:	Jabil Circuit (Shanghai) LTD.600 Tian Lin Road, Shanghain, China 200233Establishment Registration: 3005210579
Contact:	Marc C. Sanchez, Esq.Contract In-House Counsel and Consultants, LLC53516 Bickett Chapel Hill NC 27517Ph: 202.765.4491E-mail: msanchez@fdaatty.com
Date Prepared:	October 9, 2018
Proprietary Name:	Elvie Pump
Common Name:	Powered breast pump
Regulation Number:	21 CFR 884.5160, Powered breast pump
Regulatory Class:	Class II
Product Code:	HGX (pump, breast, powered)
Predicate Device(s):	Medela Freestyle (K150499)

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

Device Description:

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Traditional 510k Submission Elvie Pump

The Elvie Pump includes piezoelectric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes.

The Elvie Pump is a battery-powered electro-mechanical device that contains software. It can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed and pumping history information.

All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.

Indications for Use:

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

The subject and predicate device have the same intended use.

Comparison of Technological Characteristics:

The Elvie Pump uses the same fundamental technology and mode of action as the predicate device, the Medela Freestyle powered electric breast pump (K150499). The table below summarizes the key specifications of the Elvie Pump and the predicate.

Attribute	Predicate DeviceMedela Freestyle	Subject DeviceElvie Pump
510(k) number	K150499	K181863
Product code	HGX	HGX
Classification Name	Pump, Breast, Powered	Pump, Breast, Powered
Indications for Use	The Freestyle is a powered breast pumpto be used by lactating women toexpress and collect milk from theirbreasts. The Freestyle is intended for asingle user.	The Elvie Pump is a powered breastpump to be used by lactating womento express and collect milk from theirbreasts. The Elvie Pump is intendedfor a single user.
Intended Use	Express milk from breast	Express milk from breast

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Traditional 510k Submission

	Yes	Elvie Pump
Single User Device	Yes	Yes
Single / DoublePumping	Both	Both
Patient Population	Lactating women	Lactating women
Environment ofUse	Home	Home
Over the Counter(OTC)	Yes	Yes
Power Source	AC adaptor or Rechargeable Li-IonBattery	Rechargeable Li-Polymer Battery
Adjustable SuctionLevels	Yes	Yes
BackflowProtection	Yes	Yes
Suction Level(mmHg)	40-245	40-220
Cycles perSecond	1.7-1.93	1.1-2.0
Cycles perSecond	0.83-1.36	0.6-1.0
Two-phaseExpression	Yes	Yes
User Interface	Pump body	Pump body and/or mobile app
Software	Yes	Yes
ControlMechanism	Microcontroller	Microcontroller
Portable	Yes	Yes
Milk QuantityMeasurement	No	Yes

As evidenced by the table above, there are differences in technological characteristics between the subject and predicate device. These differences in technological characteristics do not raise different questions of safety or effectiveness.

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Summary of Non-Clinical Test Reports:

The following performance tests were conducted on the Elvie Pump device:

. Biocompatibility testing demonstrating that the patient contacting device components are biocompatibility, including the following specific tests:
- Cytotoxicity per ISO 10993-5 O
- Irritation per ISO 10993-10 O
- o Sensitization per ISO 10993-10
. Software validation for a minor level of concern per the FDA guidance document "Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, including cybersecurity assessment and validation of the milk measurement algorithm
Simulated use testing (usability study) per IEC 62366-1 Application of Usability Engineering to Medical Devices
. Use life testing to support the proposed use life
Electrical safety testing per IEC 60601-1 and IEC 60601-1-11 ●
Electromagnetic compatibility testing per and IEC 60601-1-2
Cleaning validation on the reprocessing instructions included in the labeling
. Device performance testing including evaluation of vacuum performance and backflow demonstrating that the subject device meets its specifications

Conclusion:

The Elvie 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).