(29 days)
Not Found
No
The document states that it "Does Not" mention AI, DNN, or ML. It also explicitly states that it "does not incorporate any off-the-shelf (OTS) software" and that the "device incorporates embedded software which controls all the features of the product," which points to rule-based or programmatic control rather than AI.
Yes.
A breast pump is considered a therapeutic device because it expresses and collects milk, which can be essential for the health of both the lactating woman and the infant, especially in cases where direct breastfeeding is not possible or sufficient.
No
Explanation: The device is described as a breast pump used to express and collect milk, with no mention of diagnosing any condition or disease.
No
The device is a physical, powered breast pump with hardware components (e.g., motor, battery, LED display, physical buttons) and embedded software that controls these physical functions. The detailed descriptions of performance bench testing, biocompatibility testing, electrical safety, and EMC testing all confirm it is a tangible hardware device, not software-only.
No
The device is a breast pump, which is used to externally express and collect milk. It does not perform in vitro examination of human specimens.
N/A
Intended Use / Indications for Use
The Lacevo Wearable Breast Pump (Model S70) 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.
Product codes
HGX
Device Description
The Lacevo Wearable Breast Pump (Model S70) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast.
There are 4 modes available for the device, Expression mode, Massage mode, Auto mode and Stimulation mode. There is an LED status display for the S70, and the working mode and battery indicator are shown on the pump body. The user interface includes an on/off switch, mode selection/long press, and vacuum adjustment.
S70 is operated as a single or double pumping system, one on each breast. The pump is provided non-sterile and is reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). S70 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 the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and Use Life Verification
Bench performance testing was conducted to evaluate 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 Wearable Breast Pump was conducted 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)
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Wearable Breast Pump device, 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 was conducted as recommended in the 2023 FDA Guidance Document, "Content of Premarket Submissions for Device Software Functions." with a Basic Documentation Level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
FDA 510(k) Clearance Letter - Lacevo Wearable Breast Pump
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 17, 2025
Shenzhen TPH Technology Co., Ltd.
Xiaoyan Yang
Quality Engineer
Room 203, 2nd floor,29th Building, Lianchuang Technology
No.21 Bulan Road, Xialilang Community, Nanwan Street, Longg
Shenzhen, guangdong
CHINA
Re: K250829
Trade/Device Name: Lacevo Wearable Breast Pump (Model S70)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: March 12, 2025
Received: March 19, 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"
Page 2
K250829 - 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-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 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-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-devices/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
Page 3
K250829 - Xiaoyan Yang Page 3
the DICE website (https://www.fda.gov/medical-devices/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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K250829
Device Name
Lacevo Wearable Breast Pump (Model S70)
Indications for Use (Describe)
The Lacevo Wearable Breast Pump (Model S70) 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.
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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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"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."
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
K250829
Page 1 of 4
1. Submitter:
Shenzhen TPH Technology Co., Ltd.
Room 203, 2nd floor, 29th Building, Lianchuang Technology Park No.21 Bulan Road, Xialilang Community, Nanwan Street, Longgang District, Shenzhen, China.
Tel.: +86-755-82703212
Contact Person: Xianzi Chen
Quality Engineer
Shenzhen TPH Technology Co., Ltd.
peter@tph-tech.com
Date Prepared: April 16, 2025
2. Device Information:
Device Name: Lacevo Wearable Breast Pump (Model S70)
Common Name: Powered breast pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered breast pump
Product code: HGX (Pump, Breast, Powered)
Classification Panel: Obstetrics/Gynecology
Regulatory Class: Class II
3. Predicate Device Information
Wearable Breast Pump (Model W8) cleared under K242850.
The predicate device has not been subject to a design-related recall.
4. Device Description:
The Lacevo Wearable Breast Pump (Model S70) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast.
There are 4 modes available for the device, Expression mode, Massage mode, Auto mode and Stimulation mode. There is an LED status display for the S70, and the working mode and battery indicator are shown on the pump body. The user interface includes an on/off switch, mode selection/long press, and vacuum adjustment.
S70 is operated as a single or double pumping system, one on each breast. The pump is provided non-sterile and is reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). S70 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 the subject device.
5. Indications for Use:
The Lacevo Wearable Breast Pump (Model S70) 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.
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K250829
Page 2 of 4
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.
Table 1. Comparison to Predicate Device
| Item | Subject Device
Lacevo Wearable Breast Pump (Model S70) | Predicate Device
Wearable Breast Pump (Model W8) K242850 | 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 Lacevo Wearable Breast Pump (Model S70) 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 W8) 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. | Similar |
| Patient Population | Lactating women | Lactating women | Same |
| Anatomical Sites | Breast | Breast | Same |
| Single user | YES | YES | Same |
| Single/double pump | Single | Single | Same |
| Media separation (backflow protection) | YES | YES | Same |
| Cycling/Suction Control Mechanism | Microprocessor | Microprocessor | Same |
| Specifications |
| Power Supply | Li-ion battery | Li-ion battery | Same |
| Suction Strength (Stimulation) | 40-150 mmHg | 40-170 mmHg | Different |
| Cycle Speed: Stimulation | 74 to 119 cycles/minute | 77 to 127 cycles/minute | Different |
| Suction Strength (Expression) | 105-245 mmHg | 120-245 mmHg | Different |
| Cycle Speed: Expression | 28 to 82 cycles/minute | 32 to 92 cycles/minute | Different |
| Suction Strength (Massage) | 40-120 mmHg | 40-140 mmHg | Different |
| Cycle Speed: Massage | 75-130 cycles/minute | 79-143 cycles/minute | Different |
| Suction Strength (Auto) | 40-245mmHg | 40-245 mmHg | Different |
| Cycle Speed: Auto | 28-125 cycles/minute | 32-136 cycles/minute | Different |
| Suction levels | 12 | 15 | Different |
| User interface | (LED display) | | |
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K250829
Page 3 of 4
| User control | On-Off switch, mode selection/long press, vacuum adjustment | On-Off switch, mode selection/long press, 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 collector Capacity | 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 |
In comparison to the predicate device, the subject device has the same intended use and similar indications for use – the expression and collection of breast milk.
As seen in the comparison table, the subject and predicate devices have different technological features, including the user interface, vacuum range, cycle speed range, suction levels. 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 to evaluate 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 Wearable Breast Pump was conducted 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)
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Wearable Breast Pump device, 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.
Page 8
K250829
Page 4 of 4
- 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 was conducted as recommended 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 Lacevo Wearable Breast Pump (Model S70) is as safe and effective as the predicate device and supports a determination of substantial equivalence.