The Ameda GLO Wearable Breast Pump ( Model W8S ) 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 Ameda GLO Wearable Breast Pump (Model W8S) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast. The device is an electrically powered, software-controlled, digital single user pump.

There are 4 modes available for the device which are Expression mode, Massage mode, Auto mode and Stimulation mode. There is a LED status display for W8S, including working mode and battery indicator can be shown on the pump body. The user interface includes on/off switch, mode selection/long press, and vacuum adjustment.

Ameda GLO Wearable Breast Pump (Model W8S) can be operated as a single or double pumping system, one on each breast. The pump is provided non-sterile and reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). W8 is designed not to be used during charging.

The breast pump does not incorporate any off-the-shelf (OTS) software. The device incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177 which is applicable for th subject device.

AI/ML Overview

The provided document is a 510(k) summary for the Ameda GLO Wearable Breast Pump (Model W8S). It outlines the device's characteristics and compares it to a predicate device (Wearable Breast Pump, Model W8, cleared under K242850) to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria for a novel functionality.

The document primarily states that performance data and testing were leveraged from the predicate device (K242850), indicating that a new, independent study for specific acceptance criteria for this particular device (Model W8S) was not conducted or detailed in this submission. Instead, confidence in the new device's performance is derived from the predicate device's established performance and the similarity in technological characteristics.

Therefore, many of the requested details such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study effect size, and standalone algorithm performance are not applicable or not provided in this type of submission for this particular device, as the performance evaluation relies on the predicate device.

However, based on the provided information, I can extract the following:

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

The document does not explicitly list "acceptance criteria" in a typical quantitative sense for this device. Instead, it refers to the "Device specifications were met for all tests conducted" for performance and use life verification tests, implying the acceptance criteria are the device's specifications. These specifications are compared to the predicate device.

Category	Acceptance Criteria (Implied)	Reported Device Performance (Leveraged from K242850)
Performance and Use Life Verification	Device specifications for:	Device specifications were met for all tests conducted.
- Vacuum pressure	(Not explicitly stated, but assumed to match predicate)	(Covered by "Device specifications were met")
- Cycle speed	(Not explicitly stated, but assumed to match predicate)	(Covered by "Device specifications were met")
- Backflow protection	(Not explicitly stated, but assumed to match predicate)	(Covered by "Device specifications were met")
- Battery capacity & service time	(Not explicitly stated, but assumed to match predicate)	(Covered by "Device specifications were met")
- Charging time	(Not explicitly stated, but assumed to match predicate)	(Covered by "Device specifications were met")
Biocompatibility	Non-cytotoxic, non-irritating, and non-sensitizing	Shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety & EMC	Compliance with specified IEC standards for medical electrical equipment safety, home healthcare, EMC, and lithium battery safety.	Complies with: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62133-2.
Software V&V	Compliance with FDA guidance "Content of Premarket Submissions for Device Software Functions."	Conducted in accordance with the guidance, Basic Documentation Level.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document states "Bench performance testing was conducted and leveraged from K242850." This implies the original testing for Model W8 (K242850) had a test set, but its details are not provided here for Model W8S.
Data Provenance: Not specified for the leveraged data. The company is based in Shenzhen, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as this is a breast pump, and the criteria primarily involve engineering and material safety standards, not diagnostic interpretation requiring expert consensus.

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

Not applicable for the types of tests described (e.g., vacuum pressure, cycle speed, material biocompatibility). These are objective measurements against defined specifications.

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 device is a breast pump, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical device (breast pump) with embedded software for control, not an AI algorithm.

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

The "ground truth" for performance is based on the device's technical specifications and compliance with recognized international standards (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility) outlined by regulatory bodies. For biocompatibility, the ground truth is the biological response to materials, determined through standardized assays (cytotoxicity, sensitization, irritation).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would typically have a "training set." The software is embedded control software, verified and validated against functional requirements.

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

Not applicable, as there is no "training set" in the context of this device. Software verification and validation are typically established through testing against functional requirements, design specifications, and relevant software development lifecycle documentation rather than a "ground truth" derived from data.

Summary

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March 20, 2025

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

Re: K250463

Trade/Device Name: Ameda GLO Wearable Breast Pump (Model W8S) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: January 18, 2025 Received: February 18, 2025

Dear Yang Xiaoyan:

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

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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,

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

510(k) Number (if known) K250463

Device Name

Ameda GLO Wearable Breast Pump ( Model W8S )

Indications for Use (Describe)

The Ameda GLO Wearable Breast Pump ( Model W8S ) 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)
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__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary – K250463

1. Submitter:	Shenzhen TPH Technology Co., Ltd.Room 203, 2nd floor, 29th Building, Lianchuang Technology Park, No.21 Bulan Road,Xialilang, Shenzhen, Guangdong 518100 CHNTel.: 86 (133) 024-76262
Contact Person:	Yang XiaoyanQuality EngineerShenzhen TPH Technology Co., Ltd.yangxiaoyan@tph-tech.com
Date Prepared:	March 18, 2025
2. DeviceInformation:	Device Name: Ameda GLO Wearable Breast Pump (Model W8S)Common Name: Powered breast pumpRegulation Number: 21 CFR 884.5160Regulation Name: Powered breast pumpProduct code: HGX (Pump, Breast, Powered)Classification Panel: Obstetrics/GynecologyRegulatory Class: Class II
3. Predicate DeviceInformation	Wearable Breast Pump (Model W8) cleared under K242850.The predicate device has not been subject to a design-related recall.
4. DeviceDescription:	The Ameda GLO Wearable Breast Pump (Model W8S) is a wearable powered breast pumpdesigned for lactating woman to express and collect milk from the breast. The device is anelectrically powered, software-controlled, digital single user pump.There are 4 modes available for the device which are Expression mode, Massage mode, Automode and Stimulation mode. There is a LED status display for W8S, including working modeand battery indicator can be shown on the pump body. The user interface includes on/offswitch, mode selection/long press, and vacuum adjustment.Ameda GLO Wearable Breast Pump (Model W8S) can be operated as a single or doublepumping system, one on each breast. The pump is provided non-sterile and reusable by a singleuser. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). W8 is designednot to be used during charging.The breast pump does not incorporate any off-the-shelf (OTS) software. The deviceincorporates embedded software which controls all the features of the product. All milkcontacting components of the device are compliant with 21 CFR 177 which is applicable for thsubject device.

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The Ameda GLO Wearable Breast Pump (Model W8S) is a powered breast pump intended to 5. Indications for be used by lactating women to express and collect milk from their breasts. It is intended for a Use: single user.

6. Comparison of Intended Use and Technological Characteristics of the Subject Device and Predicate Device

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

Item	Proposed DeviceAmeda GLO Wearable BreastPump (Model W8S)	Proposed DeviceWearable Breast Pump(Model W8)	Comment
Classification	Pump, Breast, Powered	Pump, Breast, Powered	Same
Regulation	Class II, 21 CFR 884.5160	Class II, 21 CFR 884.5160	Same
Product code	HGX	HGX	Same
Indications for Use	The Ameda GLO WearableBreast Pump (Model W8S) is apowered breast pump intended tobe used by lactating women toexpress and collect milk fromtheir breasts. It is intended for asingle user.	The Wearable Breast Pump(Model W8) is a poweredbreast pump intended to beused by lactating women toexpress and collect milk fromtheir breasts. It is intended fora single user.	Similar
Patient Population	Lactating women	Lactating women	Same
Anatomical Sites	Breast	Breast	Same
Single user	YES	YES	Same
Single/doublepump	Single	Single	Same
Media separation(backflowprotection)	YES	YES	Same
Cycling/SuctionControlMechanism	Microprocessor	Microprocessor	Same
Specifications
Power Supply	Li-ion battery	Li-ion battery	Same
Suction Strength(Stimulation)	40-170 mmHg	40-170 mmHg	Same
Cycle Speed:Stimulation	77 to 127 cycles/minute	77 to 127 cycles/minute	Same
Suction Strength(Expression)	120-245 mmHg	120-245 mmHg	Same
Cycle Speed:Expression	32 to 92 cycles/minute	32 to 92 cycles/minute	Same
Suction Strength(Massage)	40-140 mmHg	40-140 mmHg	Same
Cycle Speed:Massage	79-143 cycles/minute	79-143 cycles/minute	Same
Suction Strength	40-245mmHg	40-245mmHg	Same
(Auto)
Cycle Speed:Auto	32-136 cycles/minute	32-136 cycles/minute	Same
Suction levels	15	15	Same
User interface (LED display)
User control	On-Off switch, mode selection/long press, vacuum adjustment	On-Off switch, mode selection, vacuum adjustment	Different
Adjustable suction levels	YES	YES	Same
Wireless technology	No	No	Same
Component design	Milk collector and flange	Milk collector and flange	Same
Milk collectorCapacity	180 ml	180ml	Same
Flange size	24mm and 27mm	24mm and 27mm	Same
Material
Milk collector/Linker	Polypropylene	Polypropylene	Same
Flange/Valve/Diaphragm	Silicone	Silicone	Same
Pump motor/outer housing	ABS	ABS	Same

Table 1. Comparison to Predicate Device

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K250463 Page 3 of 4

In comparison to the predicate device, the subject device has the same intended use and indications for use - the expression and collection of breast milk.

As seen in the comparison table, the subject and predicate devices have minor different technological features, including differences in the user interface. These technological differences do not raise different questions of safety and effectiveness.

7. Summary of Non-Clinical Performance Testing:

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

Performance and Use Life Verification

Bench performance testing was conducted and leveraged from K242850 to evaluate the following device performance:

-Vacuum pressure

-Cycle speed
-Backflow protection
-Battery capacity & service time
-Charging time

Device specifications were met for all tests conducted.

Biocompatibility testing

The biocompatibility evaluation for the Ameda GLO Wearable Breast Pump (Model W8S) was leveraged from K242850 in accordance with 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,"" as follows:

Cytotoxicity (ISO 10993-5:2009) ●
Sensitization (ISO 10993-10:2021)
Irritation (ISO 10993-10:2021) ●

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K250463 Page 4 of 4

The user-contacting materials were identical to the subject device and shown to be non-cytotoxic, nonirritating, and non-sensitizing.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were leveraged from K242850, consisting of all the modules and accessories in the system. The system complies with the following standards:

IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-11:2015 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,
IEC 60601-1-2 :2014/A1:2021 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
IEC 62133-2 :2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

Software Verification and Validation Testing

Software verification and validation were leveraged from K242850 and conducted in the 2023 FDA guidance document, "Content of Premarket Submissions for Device Software Functions." with a Basic Documentation Level.

8. Substantial Equivalence Conclusion:

The results of the performance testing described above demonstrate that the Ameda GLO Wearable Breast Pump (Model W8S) 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).