The Motif Aura Glow breast pump (Model Motif Aura Glow) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

Device Description

The Motif Aura Glow breast pump (Model Motif Aura Glow) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts, it is intended for a single user. The Motif Aura Glow breast pump (Model Motif Aura Glow) is powered by a lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from massage, expression, cluster feeding, and general pumping modes and control the vacuum levels within those modes.

Massage, expression, and general pumping modes consist of 9 vacuum levels. Cluster feeding mode consists of 5 vacuum levels. The Motif Aura Glow breast pump (Model Motif Aura Glow) is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 75-120 cycles per minute in massage mode, vacuum levels from 120-245 mmHg with cycling rates from 30-85 cycles per minute in expression mode, vacuum levels from 40-200 mmHg with cycling rates from 45-120 cycles per minute in cluster feeding mode, and vacuum levels from 60-245 mmHg with cycling rates from 30-120 cycles per minute in general pumping mode. The Motif Aura Glow breast pump (Model Motif Aura Glow) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

AI/ML Overview

Based on the provided FDA Clearance Letter for the Motif Aura Glow breast pump (Model Motif Aura Glow), here's an analysis of the acceptance criteria and the study that proves the device meets them:

Important Note: This document is an FDA Clearance Letter, which is a summary of the FDA's decision regarding substantial equivalence. It does not contain detailed study reports or raw data typically found in clinical trial results or full submission documents. Therefore, some of the requested information (especially quantitative effectiveness data for AI-assisted human reading, if this were an AI device) is not present here, as this is a breast pump, not an AI diagnostic device. I will address each point based on the information available and indicate where information is not applicable (N/A) or not provided in this specific document.

Device: Motif Aura Glow breast pump (Model Motif Aura Glow)

Device Type: Powered Breast Pump (Medical Device, not an AI/Software as a Medical Device for diagnostic purposes)
Product Code: HGX
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a breast pump and not a diagnostic AI device, the "acceptance criteria" revolve around functional performance, safety, and equivalence to a predicate device, rather than diagnostic metrics like sensitivity/specificity.

Acceptance Criterion	Reported Device Performance	Source of Performance Data
Functional & Performance Specifications
Vacuum Range: Massage Mode	-40 to -160 (±5) mmHg	Performance Testing (Vacuum level verification)
Vacuum Range: Expression Mode	-120 to -245 (±5) mmHg	Performance Testing (Vacuum level verification)
Vacuum Range: Cluster Feeding Mode	-40 to -200 (±5) mmHg	Performance Testing (Vacuum level verification)
Vacuum Range: General Pumping Mode	-60 to -245 (±5) mmHg	Performance Testing (Vacuum level verification)
Cycle Speed: Massage Mode	75 to 120 (±2) cycles/minute	Performance Testing (Vacuum level verification)
Cycle Speed: Expression Mode	30 to 85 (±2) cycles/minute	Performance Testing (Vacuum level verification)
Cycle Speed: Cluster Feeding Mode	45 to 120 (±2) cycles/minute	Performance Testing (Vacuum level verification)
Cycle Speed: General Pumping Mode	30 to 120 (±2) cycles/minute	Performance Testing (Vacuum level verification)
Backflow Protection	Verified liquid does not backflow into the tubing	Performance Testing (Backflow protection testing)
Use Life	Maintains specifications throughout its proposed use life	Performance Testing (Use life testing)
Battery Performance	Battery remains functional during its stated battery use-life	Performance Testing (Battery performance testing)
Battery Status Indicator	Remains functional during its stated battery life	Performance Testing (Battery status indicator testing)
Software Functionality	Evaluated at Basic Documentation level; Device motor unit operates on embedded software; Software updates by end-users are not supported.	Software Evaluation
Safety and Regulatory Compliance
Biocompatibility	Information provided in accordance with ISO 10993-1	Biocompatibility testing
Electrical Safety	Tested in accordance with: ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, IEC 60601-1-11:2015	Electrical Safety testing
Electromagnetic Compatibility (EMC)	Tested in accordance with: IEC 60601-1-2:2014	EMC testing
Sterility	Provided not sterile	Device Description
Milk-contacting components compliance	Compliant with 21 CFR 174-179	Device Description
Single-user intention	Intended for a single user	Indications for Use & Device Description

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

Test Set Sample Size: The document does not specify the sample sizes for the individual performance, safety, or biocompatibility tests. It only states that "Testing was conducted" and "Performance testing was conducted." For a physical device like a breast pump, "test set" typically refers to the number of units tested. This information is not detailed in the summary letter.
Data Provenance: The manufacturer is "Shenzhen TPH Technology Co., Ltd." in Shenzhen, Guangdong, China. The testing was conducted as part of their 510(k) submission to the US FDA. The document does not specify whether the tests themselves were conducted in China or elsewhere, nor whether they were retrospective or prospective studies (this concept mostly applies to clinical data collection, which is not detailed here for this device type).

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

Not Applicable (N/A): For a breast pump, there isn't a concept of "ground truth" established by experts in the same way as for a diagnostic AI device (e.g., radiologists interpreting images). The acceptance criteria are based on engineering specifications, safety standards, and functional performance. The "ground truth" is typically defined by the device's design specifications and industry standards, verified through objective measurements and validated test methods.

4. Adjudication Method for the Test Set

N/A: As "ground truth" from human experts is not established for this device type, there is no adjudication method among experts. Performance is measured against predefined objective standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No: An MRMC comparative effectiveness study is typically conducted for diagnostic devices (especially AI-powered ones) to assess the impact of the device on human reader performance. This is a physical breast pump, not a diagnostic device, so such a study is not applicable.

6. If a Standalone Performance Study (Algorithm Only) was done

Yes, in essence. The performance testing (e.g., vacuum level verification, cycle speed, backflow protection, battery life) are "standalone" tests of the device's inherent functional capabilities against its specifications. The software evaluation was also a standalone assessment of the embedded control program. There isn't an "algorithm-only" performance in the sense of an AI model's output being compared to ground truth, but the physical and software functionalities were tested independently of human interaction for their core performance.

7. The Type of Ground Truth Used

Objective Engineering Specifications and International/National Standards: The "ground truth" for this device's performance acceptance is based on its own design specifications (e.g., stated vacuum ranges and cycle speeds), and adherence to recognized electrical safety (e.g., IEC 60601 series), EMC, and biocompatibility (e.g., ISO 10993-1) standards. For instance, a stated vacuum level of -160 mmHg is verified by direct measurement using calibrated equipment; the "ground truth" is the measurement itself, compared to the specification.

8. The Sample Size for the Training Set

N/A: This is a physical breast pump with embedded control software, not a machine learning/AI model that requires a "training set" of data in the common sense (e.g., for image classification or prediction). The software is a "fixed function" embedded control program.

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

N/A: As there is no "training set" in the context of machine learning, this question does not apply. The "ground truth" for the device's design and functionality is derived from engineering principles and regulatory requirements for powered breast pumps.

Summary

U.S. Food & Drug Administration FDA Clearance Letter

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 30, 2025

Shenzhen TPH Technology Co., Ltd.
Xiaoyan Yang
Quality Engineer
Room 203, 2nd floor, 29th Building, Lianchuang Technology Park, No.21 Bulan Road, Xialilang Community, Nanwan Street, Lo
Shenzhen, Guangdong 518100
CHINA

Re: K250365
Trade/Device Name: Motif Aura Glow breast pump (Model Motif Aura Glow)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Received: April 30, 2025

Dear Xiaoyan Yang:

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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K250365 - Xiaoyan Yang Page 2

(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 (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-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 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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K250365

Device Name
Motif Aura Glow breast pump (Model Motif Aura Glow)

Indications for Use (Describe)
The Motif Aura Glow breast pump (Model Motif Aura Glow) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It 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)

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:

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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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510(k) Summary – K250365

1. Submitter Information

Applicant: Shenzhen TPH Technology Co., Ltd.
Address: Room 203, 2nd floor, 29th Building, Lianchuang Technology Park, No.21 Bulan Road, Xialilang, Shenzhen, Guangdong 518100 CHN
Tel.: 86 (133) 024-76262

2. Correspondent Information

Contact: Yang Xiaoyan
Quality Engineer
Shenzhen TPH Technology Co., Ltd.
Email: yangxiaoyan@tph-tech.com

3. Date prepared: May 29, 2025

4. Device Information

Device Name: Motif Aura Glow breast pump (Model Motif Aura Glow)
Common Name: Powered Breast Pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Product Code: HGX (Pump, Breast, Powered)
Regulatory Class: Class II

5. Predicate Device Information

Device Name: Wearable Breast Pump (Model S12)
510(k) Number: K212180
Manufacturer: Shenzhen TPH Technology Co., Ltd.

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

6. Device Description

K250365 Page 1 of 4

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K250365 Page 2 of 4

updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

7. Indications for Use

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.

Table 1: Comparator Table for Subject and Predicate Devices

	Motif Aura Glow breast pump (Model Motif Aura Glow) K250365 Subject Device	Wearable Breast Pump (Model S12) K212180 Predicate Device	Comparison
Product Name	Motif Aura Glow breast pump (Model Motif Aura Glow)	Wearable Breast Pump (Model S12)	N/A
Product Code	HGX	HGX	Same
Regulation Number	21 CFR 884.5160	21 CFR 884.5160	Same
Regulatory Class	Class II	Class II	Same
Patient Population	Lactating Women	Lactating Women	Same
Indications for Use	The Motif Aura Glow breast pump (Model Motif Aura Glow) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.	The Wearable Breast Pump (Model S12) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.	Similar
Pump Options	Single	Single	Same
Cycling control mechanism	Microcontroller	Microcontroller	Same
Backflow Protection	Yes	Yes	Same
Suction Modes	Stimulation Mode, Expression Mode, Cluster feeding Mode,	Stimulation Mode and Expression Mode	Different

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	Motif Aura Glow breast pump (Model Motif Aura Glow) K250365 Subject Device	Wearable Breast Pump (Model S12) K212180 Predicate Device	Comparison
	General Pumping Mode
Suction levels	Cluster feeding mode – 5 Massage, Expression, General – 9	9	Different
Adjustable suction levels	Yes	Yes	Same
Vacuum range: Massage	-40 to -160 (±5) mmHg	-40 to -105 (±5) mmHg	Different
Vacuum range: Expression	-120 to -245 (±5) mmHg	-40 to -245 (±5) mmHg	Different
Vacuum range: Cluster feeding	-40 to -200 (±5) mmHg	N/A	Different
Vacuum range: General Pumping	-60 to -245 (±5) mmHg	N/A	Different
Cycle Speed: Massage	75 to 120 (±2) cycles/minute	70 to 114 cycles/minute	Different
Cycle Speed: Expression	30 to 85 (±2) cycles/minute	23 to 90 cycles/minute	Different
Cycle Speed: Cluster Feeding	45 to 120 (±2) cycles/minute	N/A	Different
Cycle Speed: General Pumping	30 to 120 (±2) cycles/minute	N/A	Different
Controls	On-Off switch, vacuum adjustment, mode change/power	On/Off button; Mode selection Increase/decrease vacuum button;	Similar
Power Supply	Li-Ion Battery	Li-Ion Battery	Same
Indicators	Yes, LED	Yes, LED	Similar
Design	Wearable pump with combined Milk Collector and Flange	Wearable pump with combined Milk Collector and Flange	Same

The indications for use of the subject and predicate device are identical, and they have the same intended use (i.e., for collection of breast milk from the breasts of lactating women).

The subject and predicate device have similar technological features, including wearable operation, power supply, and user interface. However, as shown in the table above, there are technological differences between the subject and predicate device, including different overall vacuum/cycle specifications and available modes. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility information was provided in accordance with Attachment G of the 2023 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."

Electrical Safety

Testing was conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), 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, and IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General

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requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

Electromagnetic Compatibility

Testing was conducted in accordance with IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: "General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests."

Software

Software was evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document "Content of Premarket Submissions for Device Software Functions."

Performance Testing

Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:

Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
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 remains functional during its stated battery life.

10. Conclusion

The results of the performance testing described above demonstrate that The Motif Aura Glow breast pump (Model Motif Aura Glow) 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).