(265 days)
Not Found
No
The summary describes a standard software-controlled electric breast pump with no mention of AI or ML capabilities, training data, or performance metrics typically associated with AI/ML devices.
No
A breast pump is intended to express milk, which is a supportive function rather than treating or preventing a disease or condition.
No
The device is an Electric Breast Pump, intended to express and collect milk from lactating women. Its function is to facilitate milk expression, not to diagnose a medical condition.
No
The device description explicitly lists hardware components such as a pump unit, tubing, adapter, breast shield assembly, and bottles, indicating it is a physical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express milk from lactating women and collect milk from their breast." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a mechanical pump that applies suction to extract milk. This aligns with a physical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This breast pump does not fit that definition.
N/A
Intended Use / Indications 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.
Product codes
HGX
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. The main specifications of the subject device are shown in Table 1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
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
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 met design specifications throughout its stated use life.
Key Metrics
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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
2
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
3
Indications for Use
Submission Number (if known)
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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4
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
-
- Date Prepared: 10/16/2024
-
- 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;
-
- 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.
- Identification of Predicate Device
-
- Indications for Use:
5
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 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. 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.
6
| Patient
| Population | Breastfeeding women | Breastfeeding women | Same |
|---|---|---|---|
| Anatomical | |||
| Sites | Breast | Breast | Same |
| Direct user | |||
| contact | 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 and | |
| Rechargeable | 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-8016 | |||
| Single Pumping Only: | |||
| YH-8006IV/YH-8015 | Same |
7
| Cycling/Suction
| Mechanism | Control | Microprocessor | Microprocessor | Same |
|---|---|---|---|---|
| Adjustable Suction levels | Yes | Yes | Same | |
| Suction | ||||
| Levels | Massage mode | F5055: 9 | YH8004:6 | |
| YH8016:6 | ||||
| YH8015:9 | ||||
| YH8006IV:10 | Different | |||
| Expression mode | F5055: 9 | YH8004:6 | ||
| YH8016:6 | ||||
| YH8015:9 | ||||
| YH8006IV: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.
-
- 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
8
met design specifications throughout its stated use life.
-
- 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.
- Conclusion