(168 days)
The Hygeia Express Powered Breast Pump is a powered breast pump intended to express and collect milk from the breasts of a lactating woman. It is intended for a single user only.
The Hygeia Express Powered Breast Pump is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping). The device consists of a pump, Personal Accessory Set (PAS) pumping kit, and an AC adapter. The pump is also configurable with a wearable PAS kit which allows milk to flow into a cup pressed against the breast during use. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The Hygeia Express Powered Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four buttons allowing the user to power the device on/off, select between three pumping modes (massage, expression, and stimulation), and control vacuum strength within each mode (9 levels of vacuum strength in each mode). 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 preprogrammed in the device. The device is capable of producing peak suction levels between -50 and -250 ± 25 mmHg in at speeds between 20 and 150 ± 5 cycles per minute. There are 3 available pumping modes with 9 distinct levels of vacuum and cycle speed. When connected to the pump, the PAS pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination. 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.
The provided text is a 510(k) summary for the Hygeia Express Powered Breast Pump, which is a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of diagnostic or AI-powered devices.
Therefore, the requested information elements (acceptance criteria, study details, sample size, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission as they relate to the evaluation of a diagnostic or AI device's performance against clinical endpoints.
Instead, the document details non-clinical performance testing to ensure the device meets safety and functional requirements. Here's a breakdown of the relevant information provided:
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A table of acceptance criteria and the reported device performance: This document does not present a table of specific acceptance criteria in the format usually seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it describes general compliance with standards and successful completion of various engineering and safety tests.
Reported Device Performance (Functional/Safety Aspects):
- Vacuum Levels (Massage): 50-170 ± 25 mmHg
- Vacuum Levels (Expression): 70-250 ± 25 mmHg
- Vacuum Levels (Stimulation): 70-250 ± 25 mmHg
- Cycles per minute (Massage): 70-150 ± 5 cpm
- Cycles per minute (Expression): 36-136 ± 5 cpm
- Cycles per minute (Stimulation): 20-33 ± 5 cpm
- Overall Peak Suction: -50 to -250 ± 25 mmHg
- Overall Speed: 20 to 150 ± 5 cycles per minute
- Biocompatibility: Compliant with ISO 10993-1
- Electrical Safety: Compliant with ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015
- Electromagnetic Compatibility: Compliant with IEC 60601-1-2:2014
- Software Evaluation: Evaluated at the Basic Documentation level per FDA guidance.
- Vacuum level verification testing: Demonstrated that the devices meet mode/cycle specifications.
- Backflow protection testing: Verified liquid does not backflow into the tubing.
- Use life testing: Demonstrated that the device maintains its specifications throughout its proposed use life.
- Battery performance testing: Demonstrated that the battery remains functional during its stated battery use-life.
- Battery status indicator testing: Demonstrated that the battery status indicator remains functional during its stated battery life.
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Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical engineering and safety testing, not a test set of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth from experts is not established for an electrical breast pump's functional and safety testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 is a breast pump, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's evaluation is primarily based on industry standards (e.g., electrical safety, biocompatibility, EMC) and the device's design specifications for vacuum levels and cycles. No clinical ground truth from patient outcomes or pathology is mentioned as this is a functional device, not a diagnostic one.
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The sample size for the training set: Not applicable. This device does not use machine learning that requires a training set of data.
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How the ground truth for the training set was established: Not applicable.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" described is a series of non-clinical performance tests conducted in accordance with recognized industry standards and FDA guidance documents. These tests evaluate the device's physical and electrical characteristics, its ability to function as intended, and its safety. The document states that "The results of the performance testing described above demonstrate that the Hygeia Express Powered Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence."
The specific non-clinical tests cover:
- Biocompatibility: To ensure materials in contact with the body are safe.
- Electrical Safety: To ensure the device operates safely electrically.
- Electromagnetic Compatibility (EMC): To ensure the device doesn't interfere with or is interfered by other electronic devices.
- Software Evaluation: To ensure the integrated software functions correctly and safely (evaluated at a "Basic Documentation level" as recommended for this type of device).
- Performance Testing (Specific to Breast Pumps):
- Verification of vacuum levels at each mode/cycle (Massage, Expression, Stimulation) against specifications.
- Backflow protection testing to prevent milk contamination.
- Use life testing to demonstrate durability over its expected lifetime.
- Battery performance and status indicator testing to ensure reliable power.
The overall "acceptance criterion" is demonstrated substantial equivalence to a legally marketed predicate device (Electric Breast Pump, K211024) by showing that the subject device's differences in technological characteristics (mainly vacuum/cycle specifications) "do not raise different questions of safety and effectiveness" and that it passes the specified non-clinical performance tests.
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March 13, 2024
Hygeia II Medical Group, Inc. Brett Nakfoor CEO 6241 Yarrow Drive. Suite A Carlsbad, California 92011
Re: K233136
Trade/Device Name: Hygeia Express Powered Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 25, 2023 Received: September 27, 2023
Dear Brett Nakfoor:
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).
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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.
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 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
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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) K233136
Device Name
Hygeia Express Powered Breast Pump
Indications for Use (Describe)
The Hygeia Express Powered Breast Pump is a powered breast pump intended to express and collect milk from the breasts of a lactating woman. It is intended for a single user only.
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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510(k) Summary - K233136
1. Submitter Information
| Applicant: | Hygeia II Medical Group, Inc. |
|---|---|
| Phone: | (714) 515-7571 |
| Address: | 6241 Yarrow Drive Suite A Carlsbad CA92011 United States |
2. Correspondent Information
| Contact: | Brett Nakfoor,CEO, |
|---|---|
| Email: | bnakfoor@hygeiahealth.com |
| Phone: | (714) 515-7571 |
- Date prepared: March 11, 2024
4. Device Information
| Device Name: | Hygeia Express Powered Breast Pump |
|---|---|
| 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: | Electric Breast Pump |
|---|---|
| 510(k) Number: | K211024 |
| Manufacturer: | Shantou Huihengqi Electronic Technology Co., Ltd. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Hygeia Express Powered Breast Pump is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping).
The device consists of a pump. Personal Accessory Set (PAS) pumping kit, and an AC adapter. The pump is also configurable with a wearable PAS kit which allows milk to flow into a cup pressed against the breast during use. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The Hygeia Express Powered Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four buttons allowing the user to power the device on/off, select between three pumping modes (massage, expression, and stimulation), and control vacuum strength within each mode (9 levels of vacuum strength in each mode). 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
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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 ± 25 mmHg in at speeds between 20 and 150 ± 5 cycles per minute. There are 3 available pumping modes with 9 distinct levels of vacuum and cycle speed.
When connected to the pump, the PAS pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination.
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 Hygeia Express Powered Breast Pump is a powered breast pump intended to express and collect milk from the breasts of a lactating woman. It is intended for a single user only.
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.
| Hygeia ExpressPowered Breast PumpK233136Subject Device | Electric Breast PumpK211024Predicate 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 Hygeia Express PoweredBreast Pump is a powered breastpump intended to express andcollect milk from the breasts of alactating woman. It is intendedfor a single user only. | The Electric Breast Pump(Models 918, HF918) is apowered breast pump to be usedby lactating women to expressand collect milk from theirbreast. The Electric Breast Pumpis intended for a single user. | Same |
| Single/double pump | Single or double | Single or double | Same |
| Media separation(backflowprotection) | Yes | Yes | Same |
| Cycling controlmechanism | Microcontroller | Microcontroller | Same |
| Expression pattern | 2-Phase | 2-Phase | Same |
| Power supply | Li-Ion Battery or mains | Li-Ion Battery or mains | Same |
| Suction levels(massage) | 50-170 ± 25 mmHg | Two in one:75-285 ± 20 mmHg | Different |
Table 1: Comparator Table for Subject and Predicate Devices
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K233136 Page 3 of 4
| Suction levels(expression) | $70-250 \pm 25$ mmHg | Dual frequency:$67.5-277.5 \pm 20$ mmHg$105-285 \pm 20$ mmHg | Different |
|---|---|---|---|
| Suction levels(stimulation) | $70-250 \pm 25$ mmHg | $60-217.5 \pm 20$ mmHg | Different |
| Cycles per minute(massage) | $70-150 \pm 5$ cpm | Two in one:$59-123 \pm 20$ mmHgDual frequency:$39-85 \pm 20$ mmHg | Different |
| Cycles per minute(expression) | $36-136 \pm 5$ cpm | $24-84 \pm 5$ cpm | Different |
| Cycles per minute(stimulation) | $20-33 \pm 5$ cpm | $39-123 \pm 5$ cpm | Different |
| Suction levels | 9 massage, 9 expression, 9stimulation | 5 stimulation, 7 expression, 7two in one, 7 dual frequency, 1stimulation | Different |
| User Interface | On-Off switch, mode changebutton, vacuum adjustmentbuttons, LCD (mode, time,vacuum level, battery) | On-Off switch, mode changebutton, vacuum adjustmentbuttons, LCD (mode, time,vacuum level, battery) | Similar |
| Adjustable SuctionLevels | Yes | Yes | Same |
| Mobile Application | No | No | Same |
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 tabletop/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 suction levels in each mode. 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 Hygeia Express Powered Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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).