(254 days)
Not Found
No
The description explicitly states that the timing of the suction pattern is "preprogrammed in the device" and dependent on user-selected settings, indicating a fixed algorithm rather than adaptive AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
The device is intended for expressing and collecting milk from lactating women, which is a supportive function rather than treating or curing a medical condition.
No
Explanation: The device is described as an "electrically powered suction device intended to express and collect milk from a lactating woman's breasts." Its function is entirely for milk expression and collection, with no mention of diagnosing any medical condition.
No
The device description clearly outlines multiple hardware components including a pump unit, AC power adapter, power cable, flange kit, and bottle kit. It also mentions a DC motor and a membrane vacuum pump. While there is software involved (as indicated by the software evaluation section), it is embedded within and controls the hardware, making it a hardware device with embedded software, not a software-only medical 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 and collect milk from a lactating woman's breasts." This is a physical process performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a mechanical device that uses suction to collect breast milk. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly a medical device, but its function is to physically collect a bodily fluid, not to perform a diagnostic test on that fluid.
N/A
Intended Use / Indications for Use
The Evenflo Premium Double Electric Breast Pump (Model 4018) is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. It is intended for a single user.
Product codes
HGX
Device Description
The Evenflo Electric Breast Pump (Model 4018) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and should be cleaned and disinfected prior to first use according to the instructions for use. The breast pump can be used on one breast (single pumping) or on both breasts at the same time (double pumping).
The device consists of a pump unit, AC power adapter, power cable, AdvancedFit flange kit and bottle kit. The AdvancedFit flange kit consists of a flange body, flange insert, check valve (valve and membrane), diaphragm, diaphragm cap, and tubing for each breast, a tubing adapter to connect the kit to the pump unit and a tubing adapter plug to convert for single pumping. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power.
The breast pump uses cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is pre-programmed in the device. The device is capable of producing peak suction levels between -50 and -250 mmHg in double pumping mode and between -85 and -250 mmHg in single pumping modes at speeds between 30 and 80 cycles per minute. There are 9 distinct levels of suction and 6 speeds available for each suction level.
The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the nipple. The milk is 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) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
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)
Biocompatibility:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Irritation (ISO 10993-10:2010)
- Key Results: The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety:
Testing was conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015.
Electromagnetic Compatibility:
Testing was conducted in accordance with IEC 60601-1-2:2014.
Software:
Software was evaluated for a minor level of concern as recommended in the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Performance Testing:
- 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.
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).
0
Image /page/0/Picture/0 description: The image shows the logo for 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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
November 3, 2023
Evenflo Feeding, Inc. Michael Sewak Director of Quality 9277 Centre Pointe Drive. Suite 160 West Chester, OH 45069
Re: K230481
Trade/Device Name: Evenflo Premium Double Electric Breast Pump (Model 4018) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: October 1, 2023 Received: October 3, 2023
Dear Michael Sewak:
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" (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).
1
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 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.
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 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
2
Indications for Use
510(k) Number (if known) K230481
Device Name
Evenflo Premium Double Electric Breast Pump (Model 4018)
Indications for Use (Describe)
The Eventlo Premium Double Electric Breast Pump (Model 4018) is an electrically powered suction device intended to express and collect milk from a lactating woman's 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K230481 Page 1 of 4
510(k) Summary - K230481
1. Submitter Information
| Applicant: | Evenflo Feeding, Inc. |
|---|---|
| Phone: | (513) 870-1620 |
| Address: | 9277 Centre Pointe Drive, Suite 160 |
| West Chester, OH 45069. |
2. Correspondent Information
| Contact: | Michael Sewak |
|---|---|
| Director of Quality | |
| Email: | Michael.sewak@kcc.com |
| Phone: | Office Phone: (513) 745-4625 |
| Mobile Phone: (513) 773-8188 |
3. Date prepared: November 1, 2023
4. Device Information
| Device Name: | Evenflo Premium Double Electric Breast Pump (Model 4018) |
|---|---|
| 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: | Evenflo Model 2951 Advanced Double Electric Breast Pump |
|---|---|
| 510(k) Number: | K131153 |
| Manufacturer: | Evenflo Feeding Inc. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Evenflo Electric Breast Pump (Model 4018) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and should be cleaned and disinfected prior to first use according to the instructions for use. The breast pump can be used on one breast (single pumping) or on both breasts at the same time (double pumping).
The device consists of a pump unit, AC power adapter, power cable, AdvancedFit flange kit and bottle kit. The AdvancedFit flange kit consists of a flange body, flange insert, check valve (valve and membrane), diaphragm, diaphragm cap, and tubing for each breast, a tubing adapter to connect the kit to the pump unit and a tubing adapter plug to convert for single pumping. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power.
The breast pump uses cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast
4
milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the device. The device is capable of producing peak suction levels between -50 and -250 mmHg in double pumping mode and between -85 and -250 mmHg in single pumping modes at speeds between 30 and 80 cycles per minute. There are 9 distinct levels of suction and 6 speeds available for each suction level.
The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the nipple. The milk is 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) 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
The Evenflo Premium Double Electric Breast Pump (Model 4018) is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. It is intended for a single user.
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.
| | Evenflo Premium
Double Electric Breast
Pump, Model 4018
K230481
Subject Device | Evenflo Model 2951
Advanced Double
Electric Breast Pump
K131153
Predicate Device | Comparison |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 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 Evenflo Premium Double
Electric Breast Pump (Model
4018) is an electrically powered
suction device intended to
express and collect milk from a
lactating woman's breasts. It is
intended for a single user. | The Evenflo Advanced Double
Electric Breast Pump is an
electrically powered suction
device intended to express and
collect milk from lactating
woman's breasts. It is intended
for a single user. | Same Intended Use |
| Pump Options | Single or Double | Single or Double | Same |
| Cycling control
mechanism | Microcontroller | Microcontroller | Same |
| Backflow Protection | Yes | Yes | Same |
| Mobile Application | No | No | Same |
| Indicators | Yes, (2) 7-segment Digits
(Suction & Speed) | (12) Discrete LEDs
(8 Suction, 4 Speed) | Different. Differences in user
interface/indicators do not raise
different questions of safety and |
Table 1: Comparator Table for Subject and Predicate Devices
5
| effectiveness. | |||
|---|---|---|---|
| Single User | Yes | Yes | Same |
| Media separation | |||
| (backflow | |||
| protection) | Yes | Yes | Same |
| Expression pattern | 2-Phase | 2-Phase | Same |
| Suction levels | |||
| (Single pumping) | 85-250 mmHg | 25-270 mmHg | Different. Differences in massage |
| suction levels do not raise | |||
| different questions of safety and | |||
| effectiveness | |||
| Suction levels | |||
| (Double pumping) | 50-250 mmHg | 25-254 mmHg | Different. Differences in |
| pumping suction levels do not | |||
| raise different questions of safety | |||
| and effectiveness | |||
| Cycles per Minute | 30-80 cpm | 30-80 cpm | Same |
| Suction levels | 9 vacuum levels | 8 vacuum levels | Different. Differences in |
| available suction levels do not | |||
| raise different questions of safety | |||
| and effectiveness. | |||
| User Interface | 8 pushbuttons | 4 pushbuttons | Different. Differences in user |
| interface do not raise different | |||
| questions of safety and | |||
| effectiveness. | |||
| Adjustable Suction | |||
| Levels | Yes | Yes | Same |
| Design | Tabletop Milk Collector and | ||
| Flange | Tabletop Milk Collector and | ||
| Flange | Same | ||
| Included | |||
| Accessories | Flanges, Soft Flange Inserts, | ||
| Bottles, Tubing Check valves, | |||
| Diaphragms, Bottle Stands | Flanges, Soft Flange Inserts, | ||
| Bottles, Tubing Check valves, | |||
| Diaphragms | Similar | ||
| Power Supply | 7.4 VDC 2200 mAh Battery | 6 X AA (LR6) Primary Battery | Different. Differences in |
| available power supply do not | |||
| raise different questions of safety | |||
| and effectiveness as performance | |||
| is independently assessed for | |||
| each available power | |||
| configuration. |
The indications for use of the subject and predicate device are similar, and they have the same intended use (i.e., for collection of breast milk from the breasts of lactating women).
The subject and predicate devices have similar technological features, including available accessories, cycle speed levels, and overall design. However, as shown in the table above, there are technological differences between the subject and predicate device, including different overall vacuum specifications, power supply, user interface, and vacuum levels. 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 studies on the patient-contacting components of the subject device, including irritation, cytotoxicity, and sensitization testing were performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical
6
Devices - Part 1: Evaluation and testing within a risk management process", as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) ●
- Irritation (ISO 10993-10:2010) .
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
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 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 for a minor level of concern as recommended in the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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 Evenflo Premium Double Electric Breast Pump (Model) 4018 is as safe and effective as the predicate device and supports a determination of substantial equivalence.