The Electric Breast Pump (F5055) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

Device Description

The Electric Breast Pump (F5055) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump (F5055) is intended for a single user. The proposed device is electrically powered and software-controlled. The device operates via a microprocessor-driven air pump, which generates suction on the breast to extract milk. The proposed device is available in one model, F5055. The provided non-sterile and is not to be sterilized by the user prior to use. The device includes a breast shield assembly, bottles, pump unit, tubing, an adapter, and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body that contacts the user's breast.

AI/ML Overview

The provided text is a 510(k) Summary for an Electric Breast Pump (F5055). This document details the manufacturer's claim of substantial equivalence to a predicate device, as required for FDA premarket notification.

However, the provided text does not contain information related to an AI/ML powered medical device, nor does it discuss acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance. The device described is an "Electric Breast Pump," a hardware device with software controls, but it does not appear to involve AI or machine learning for diagnostic or assistive functions that would require the typical performance study details asked in the prompt.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving an AI/ML device's performance based on the provided text, as the text describes a non-AI/ML medical device.

To directly answer your prompt based on the provided text, focusing on the type of acceptance criteria and performance testing presented for this specific device (an electric breast pump):

The acceptance criteria for this medical device are primarily focused on safety and effectiveness as demonstrated through non-clinical performance testing, and comparison of technological characteristics and indications for use with a legally marketed predicate device.

Here's a breakdown of the "acceptance criteria" (implicitly, the aspects where the device must perform acceptably) and the study/testing performed, as per the document, rather than a typical AI/ML study:

Acceptance Criteria and Reported Device Performance (as inferred for an Electric Breast Pump):

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance / How Met
Intended Use	Must be same as predicate.	Met: "The Electric Breast Pump (F5055) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user." (Same as predicate)
Technological Characteristics	Must be substantially equivalent; differences must not raise new questions of safety/effectiveness.	Met: Similar design principles (diaphragm pump, microprocessor control, adjustable suction, backflow protection). Differences (power source, specific suction levels, suction strength range, cycle speed) are deemed not to raise different questions of safety and effectiveness.
Biocompatibility	Must meet relevant ISO standards for patient contact materials.	Met: "Meets Attachment G recommendations (FDA Guidance document "Use of International Standard ISO 10993-1...")"
Electrical Safety	Must meet relevant IEC standards for medical electrical equipment.	Met: "Testing per IEC 60601-1:2010 + AMD2:2020," "Testing per IEC 60601-1-2:2014/AMD1: 2020," "Testing per IEC 60601-1-11:2015/AMD1:2020"
Electromagnetic Compatibility (EMC)	Must meet relevant IEC standards.	Met: Included in "Testing per IEC 60601-1-2:2014/AMD1: 2020"
Software Functionality	Software must be verified and documented as per FDA guidance.	Met: "Software documentation and verification in accordance with the FDA Guidance document "Content of Premarket Submissions for Device Software Functions" (June 2023)"
Key Performance Parameters	Suction strength, cycle speed, battery indication, and backflow effectiveness must meet design specifications throughout device life.	Met: "Suction strength, cycle speed, battery indicator, and backflow testing to demonstrate that the device met design specifications throughout its stated use life."

Regarding the specific questions posed, adapted to the context of this non-AI/ML device:

A table of acceptance criteria and the reported device performance: See table above.
Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for the non-clinical performance tests (e.g., how many units were tested for electrical safety, or how many cycles for pump performance).
- Data provenance is not explicitly stated in terms of country of origin for the testing itself, nor is it described as retrospective or prospective data collection from human subjects. The tests are non-clinical, so they are likely laboratory-based.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is largely not applicable to this type of device and testing. There is no "ground truth" establishment by experts in the sense of image interpretation or diagnostic accuracy.
- The "ground truth" for non-clinical performance testing typically refers to the established engineering specifications and international standards (e.g., IEC, ISO) that the device must meet. The "experts" involved would be qualified test engineers and quality assurance personnel performing and verifying these tests. Their qualifications are not detailed in this summary.
Adjudication method for the test set:
- This is not applicable as there is no subjective interpretation or consensus process like in clinical image review. Performance criteria are objective and quantitative (e.g., measured suction strength within a range, successful completion of electrical safety tests).
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:
- Definitely not applicable. This is not an AI/ML diagnostic or assistive device. No human reader studies (MRMC) are mentioned or necessary for this type of product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of AI/ML algorithm performance. The "standalone" performance here refers to the device itself meeting its engineering specifications rather than an algorithm's diagnostic accuracy. The non-clinical tests (suction strength, cycle speed, etc.) represent the standalone performance of the device.
The type of ground truth used:
- For this device, the "ground truth" is defined by engineering specifications, international safety standards (IEC, ISO), and functional requirements. For example, a certain suction strength is a specified operating range, and the test verifies the device achieves this.
The sample size for the training set:
- Not applicable. This device does not use a "training set" in the sense of machine learning. The design and development process for such a hardware device involves prototyping, testing, and refinement, but not machine learning training on a dataset.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model for this device. Ground truth for the device's functionality is established by engineering and regulatory standards.

Summary

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October 17, 2024

Fimilla (Shanghai) maternity & baby Articles Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K240218

Trade/Device Name: Electric Breast Pump (F5055) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Received: September 13, 2024

Dear Diana Hong:

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.

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"

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(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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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.

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

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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 -S

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

Submission Number (if known)

K240218

Device Name

Electric Breast Pump (F5055)

Indications for Use (Describe)

The Electric Breast Pump (F5055) is intended to express milk from lactating women and collect milk from their breast. The device is intended for 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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K240218

1. Date Prepared: 10/16/2024
1. Submitter Information

Fimilla (Shanghai) maternity & baby Articles Co., Ltd. No. 65 Lane 3029 HuaXu Road HuaXin Town QingPu District Shanghai P.R. China

Contact Person: Jason Liu Position: Deputy General Manager Tel: +86-18852957158 Email: liumingchun(@fimilla.com

Correspondent Information Ms. Diana

Hong (Primary Contact Person) Ms. Xingqi Wang (Alternative Contact Person)

Tel: +86-21-22815850 Fax: 360-925-3199

4. Device Information

Trade Name: Electric Breast Pump (F5055) Common Name: Electric Breast Pump Regulation Name: Powered Breast Pump Regulatory Class: II; Product Code: HGX (Pump, Breast, Powered); Regulation Number: 21 CFR 884.5160;

1. Identification of Predicate Device
  Device510(K) Number: K163136 Product Name: Youha electric breast pump Models: YH-8004, YH-8016, YH-8006IV, YH-8015 The predicate device has not been subject to a design-related recall.
1. Indications for Use:

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The Electric Breast Pump (F5055) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

7. Device Description

The proposed device is available in one model, F5055. The provided non-sterile and is not to be sterilized by the user prior to use. The device includes a breast shield assembly, bottles, pump unit, tubing, an adapter, and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body that contacts the user's breast. The main specifications of the subject device are shown in Table 1.

Model	F5055
Pumping option	Single or Double
Operating type	Key panel
Basic functions	Massage mode
Basic functions	Expression mode
Basic functions	Soothing mode
Power Supply	Li-ion battery and power adapter

Table 1 Main specifications of subject device

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below compares the intended use and technological characteristics of the subject and predicate device.

ITEM	Subject Device	Predicate Device (K163136)	Remark
Product	Electric Breast Pump (F5055)	Youha Electric Breast Pump	/
Product Code	HGX	HGX	Same
Regulation Number	21 CFR 884.5160	21 CFR 884.5160	Same
Class	II	II	Same
Indication for Use	The Electric Breast Pump (F5055) is intended to express milk from lactating women and collect milk from their breast.The device is intended for single user.	The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.	Same

General Comparison of the Subject and Predicate Device Table 1.

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PatientPopulation	Breastfeeding women	Breastfeeding women	Same
AnatomicalSites	Breast	Breast	Same
Direct usercontact	Yes	Yes	Same
Sterile	Provided Non-sterile	Provided Non-sterile	Same
Single User	Single Use	Single Use	Same
Re-useable	Yes	Yes	Same
Power Source	AC Adapter or Li-Ion Battery	AC/DC wall converter andRechargeable	Different

Table 2. Performance Comparison of the Subject and Predicate Device

ITEM	Subject Device	(Predicate Device K163136)	Remark
Product	Electric Breast Pump (F5055)	Youha Electric Breast Pump	/
Pump Type	Diaphragm	Diaphragm	Same
Pumping Options	Single and Double Pumping:F5055	Single and Double Pumping:YH-8004/YH-8016Single Pumping Only:YH-8006IV/YH-8015	Same

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Cycling/SuctionMechanism	Control	Microprocessor	Microprocessor	Same
Adjustable Suction levels		Yes	Yes	Same
SuctionLevels	Massage mode	F5055: 9	YH8004:6YH8016:6YH8015:9YH8006IV:10	Different
	Expression mode	F5055: 9	YH8004:6YH8016:6YH8015:9YH8006IV:10
	Soothing mode	F5055: 9	N/A
Suction Strength		70-280mmHg	34-280mmHg	Different
Cycle speed		20-135 cycles/min	16-122cycles/min	Different
Backflow Protection		Yes	Yes	Same

The subject and predicate device have similar indications for use statements and the same intended use - the expression and collection of breast milk. The technological differences between the subject and predicate devices are the power source, suction levels, suction strength, and cycle speed. These differences do not raise different questions of safety and effectiveness.

1. Summary of Non-Clinical Performance Testing

Biocompatibility

Meets Attachment G recommendations (FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 2023))
Electrical Safety and Electromagnetic Compatibility
Testing per IEC 60601-1:2010 + AMD2:2020 Medical equipment - Part 1: General requirements for basic safety and essential performance
Testing per IEC 60601-1-2:2014/AMD1: 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Testing per IEC 60601-1-11:2015/AMD1:2020 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment

Software

Software documentation and verification in accordance with the FDA Guidance document "Content of Premarket Submissions for Device Software Functions" (June 2023)

Performance Testing

Suction strength, cycle speed, battery indicator, and backflow testing to demonstrate that the device

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met design specifications throughout its stated use life.

1. Conclusion
  The results of the performance testing described above demonstrate that the Electric Breast Pump (F5055) is as safe and effective as the predicate device and supports a 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).