Powered Breast Pump (Models 7V and 7X)

K211016 · Haenim Co., Ltd. · HGX · Jun 29, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K211016
• Device Name: Powered Breast Pump (Models 7V and 7X)
• Applicant: Haenim Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Jun 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

Device Story

Powered breast pump (Models 7V and 7X) for single-user, home or professional use. Device consists of motor unit, expression kits (breast shield, diaphragm, pump body, valve), and silicone vacuum tubing. Operates via diaphragm pump mechanism to provide massage and expression modes with user-selectable vacuum and cycle levels. Powered by AC adapter or internal rechargeable lithium-ion battery. User interface includes press-buttons and LED display for mode, vacuum, and speed control. Diaphragm construction provides backflow protection to prevent milk from entering pump mechanism. Device assists lactating women in milk collection; healthcare providers or patients use output to manage lactation needs.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10), electrical safety (AAMI ANSI ES60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and battery safety (IEC 62133-2). Performance testing verified vacuum levels, backflow protection, use-life, and battery functionality.

Technological Characteristics

Diaphragm-based powered breast pump. Materials compliant with 21 CFR 174-179. Power: AC adapter or internal Li-ion battery (3.7V/2600mAh for 7V; 7.4V/2200mAh for 7X). Features LED display, massage/expression modes, and adjustable vacuum/cycle levels. Backflow protection via diaphragm media separation. Non-sterile. Software evaluated per FDA guidance.

Indications for Use

Indicated for lactating women to express and collect breast milk. Single-user device.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Hi bebesuper (Models BT-150S and BT-150L) (K200675)

Submission Summary (Full Text)

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June 29, 2022

Haenim Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt. STE 200 Irvine, CA 92620

Re: K211016

> Trade/Device Name: Powered Breast Pump (Models 7V and 7X) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: Mav 25, 2022 Received: May 31, 2022

Dear Priscilla Chung:

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 (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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For 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) K211016

Device Name Powered Breast Pump (Models 7V and 7X)

Indications for Use (Describe)

The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

Type of Use (Select one or both, as applicable)

| <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|--------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="checked" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(k) Summary K211016

Date: June 28, 2022

### 1. Applicant / Submitter:

| Applicant: | Haenim Co., Ltd. |
|------------|------------------------------------------------------------------|
| Address: | 15, Saryeom-ro 21beon-gil, Seo-gu, Incheon<br>South Korea, 22742 |
| Contact: | Dae Won Kim |
| Tel: | [phone] |

### Submission Correspondent: 2.

| Contact: | Priscilla Chung |
|----------|-----------------------------------------------------------------------------|
| Address: | LK Consulting Group USA, Inc.<br>1150 Roosevelt STE 200,<br>Irvine CA 92620 |
| Phone: | 714-202-5789 |
| Fax: | 714-409-3357 |
| Email: | [e-mail] |

### 3. Subject Device:

| Proprietary Name: | Powered Breast Pump (Models 7V and 7X) |
|-------------------|----------------------------------------|
| Common Name: | Powered breast pump |
| Regulation Name: | Powered breast pump |
| Regulation Number | 21 CFR 884.5160 |
| Product Code: | HGX (pump, breast, powered) |
| Regulatory Class: | Class II |

### Predicate Device: 4.

| Proprietary Name: | Hi bebesuper (Models BT-150S and BT-150L) |
|-------------------|-------------------------------------------|
| 510(k) Number: | K200675 |

The predicate device has not been subject to a design-related recall.

### Device Description: 5.

The Powered Breast Pump (Models 7V and 7X) is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. The device is intended for a single user and can be used in home and professional healthcare environments.

The subject device can be used for single or double breast pumping and consists of the following key components: a motor unit with a press-button user interface, expression kits (NexusFit™ Cap,

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Diaphragm, Pump Body, Breast Shield, and Valve; areola shield; milk collection kit), and a silicone vacuum tube.

The Powered Breast Pump (Models 7V and 7X) has two operational modes (massage and expression), with user-selectable vacuum and cycle levels in each mode (levels are shown in Section 7 of the summary). Both device models are powered by an external AC power supply, while all 7V and select 7X models can be operated using an internal rechargeable lithium-ion battery. The device is provided nonsterile.

All milk contacting components are compliant with 21 CFR 174-179

### 6. Indications for Use:

The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

## Comparison of Intended Use and Technological Characteristics with the 7. Predicate Device

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

| | Powered Breast Pump (Models 7V<br>and 7X)<br>K211016 | Hi bebesuper (Models BT-150S and<br>BT-150L)<br>K200675 | Comparison | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Haenim Co., Ltd. | Bistos Co., Ltd. | | |
| Indications for Use | The Powered Breast Pump (7V and<br>7X) is a single-user, powered breast<br>pump intended to express and collect<br>milk from the breasts of lactating<br>women. | Hi bebesuper (Models BT-150S and<br>BT-150L) is intended to be used by<br>lactating women for expressing and<br>collecting breast milk. It is intended<br>for a single user. | The subject and<br>predicate device<br>indications for use<br>statements are not<br>identical; however,<br>their intended uses<br>are the same (i.e.,<br>for collection of<br>milk from the<br>breasts of lactating<br>women). | |
| Pump Options | Single or Double | Single or Double | Same | |
| Suction Modes | Massage Mode and Expression Mode | Massage Mode and Expression Mode | Same | |
| Pump Type | Diaphragm | Unknown | Different: The<br>pump type of the<br>predicate device is<br>not known;<br>however,<br>differences in the<br>pump type do not<br>raise different | |
| | | | | |
| | | | | questions of safety<br>and effectiveness. |
| Visual<br>Indicator | LED-light display | | Liquid-crystal display | Different: The<br>subject and<br>predicate devices<br>have different<br>display types.<br>Differences in<br>visual indicators do<br>not raise different<br>questions of safety<br>and effectiveness. |
| User Control | Power | | Power | Same |
| | Memory<br>Lamp brightness<br>Mode change<br>Decrease vacuum<br>Increase vacuum<br>Decrease speed<br>Increase speed | | Memory<br>Lamp brightness<br>Mode change<br>Decrease vacuum<br>Increase vacuum<br>Decrease speed<br>Increase speed | |
| Accessories | NexusFitTM Breast Shield<br>Areola shield 21mm<br>Bottle Stand<br>NexusFitTM Cap<br>NexusFitTM Pump Body<br>NexusFitTM Diaphragm<br>NexusFitTM Valve<br>Tubing<br>Nipple<br>Bottle Disk<br>Bottle Cap<br>Bottle<br>Dual Connector<br>Adaptor | | Funnel (21/24/27/32 mm)<br>Funnel Block Funnel cap<br>Diaphragm Top, Diaphragm and<br>Diaphragm Bottom<br>Air tube and air tube connector<br>Nipple<br>Bottle<br>Bottle cap<br>Bottle cover and bottle disc | Different: The<br>subject device has<br>different packaged<br>components than<br>the predicate<br>device. Differences<br>in device<br>components do not<br>raise different<br>questions of safety<br>and effectiveness. |
| Power | 7V:<br>1. AC<br>Adaptor input<br>AC100~240V<br>50/60Hz<br>Adaptor output<br>DC5V 2.0A<br>2. Battery<br>Li-ion 3.7V<br>2600mAh | 7X:<br>1.AC<br>Adaptor input<br>AC100~240V<br>50/60Hz<br>Adaptor output<br>DC12V 2.0A<br>2. Battery<br>Li-ion 7.4V<br>2200mAh | Battery power only:<br>7.4V Li-ion Polymer 2200 mA | Different: The<br>subject device<br>operates under both<br>AC and battery<br>power, while the<br>predicate is only<br>battery powered.<br>Differences in<br>power supply do<br>not raise different<br>questions of safety<br>and effectiveness. |
| Maximum<br>Vacuum<br>Pressure | -290 mmHg | | -290 mmHg | Same |
| Cycle Speed | 7V<br>Expression<br>Mode: 30-50<br>cycle/min | 7X<br>Expression<br>Mode: 34-55<br>cycle/min | Expression Mode: 35/40/45/50/55/60<br>Cycle/Min.<br>Massage Mode: 70/80/90 Cycle/Min | Different: The<br>differences in<br>specifications do<br>not raise different |
| | | | | |
| | Massage Mode:<br>70-90 cycle/min<br><br>Expression<br>Mode: 5 levels | Massage Mode:<br>70-105 cycle/min<br><br>Expression<br>Mode: 6 levels | Expression Mode: 6 levels<br><br>Massage Mode: 3 levels | questions of safety<br>and effectiveness. |
| | Massage Mode: 5 levels | Massage Mode: 5 levels | | |
| Vacuum Range<br>(mmHg) | 7V<br>Single pumping:<br>Massage mode: -50 to -120 mmHg ±<br>20%<br>Expression mode: -50 to -250 mmHg ± 20%<br><br>Double pumping:<br>Massage mode: -30 to -70 mmHg ±<br>20%<br>Expression mode: -40 to -180 mmHg ± 20% | Single pumping:<br>Massage mode: -50 to -140 mmHg ±<br>20% Expression mode: -50 to -250<br>mmHg ± 20%<br><br>Double pumping:<br>Massage mode: -30 to -80 mmHg ±<br>20%<br>Expression mode: -40 to -190 mmHg ± 20% | Single pumping:<br>Massage mode: -50 to -230 mmHg ±<br>20%<br>Expression mode: -50 to -250 mmHg ± 20%<br><br>Double pumping:<br>Massage mode: -30 to -150 mmHg ±<br>20%<br>Expression mode: -30 to -200 mmHg ± 20% | Different: The<br>differences in<br>specifications do<br>not raise different<br>questions of safety<br>and effectiveness. |
| Adjustable<br>Vacuum<br>Levels | 7V<br>12 levels | 7X<br>15 levels | 16 levels | Different: The<br>difference in the<br>number of suction<br>levels do not raise<br>different questions<br>of safety and<br>effectiveness. |
| Backflow<br>Protection | Diaphragm construction acts as a<br>media separation and prevents milk<br>from going into the pump in case of a<br>milk overflow into the vacuum tubes. | | Diaphragm construction acts as a<br>media separation and prevents milk<br>from going into the pump in case of a<br>milk overflow into the vacuum tubes. | Same |
| Nursing Night<br>Lamp | Yes | | Only applicable to BT-150L | Different:<br>Differences in<br>device versions<br>with and without<br>nursing night lamps<br>do not raise<br>different questions<br>of safety and<br>effectiveness. |

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The subject and predicate device do not have identical indications for use statements; however, they do have the same intended use, i.e., for collection of breast milk from the breasts of lactating women.

The subject and predicate device have different technological features, including the user interface, pump, vacuum range, cycle speed/range, and power sources. These technological differences do not raise different questions of safety and effectiveness.

### Summary of Non-Clinical Performance Testing 8.

## Biocompatibility

Biocompatibility testing was performed in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process." Testing included the following:

- Cytotoxicity (ISO 10993-5:2009) ●
- . Sensitization (ISO 10993-10:2010)
- . Irritation (ISO 10993-10:2010)

The testing supports the biocompatibility of the patient-contacting device materials that were shown to be non-cytotoxic, non-irritating, and non-sensitizing.

## Electrical Safety

Testing was conducted in accordance with:

- AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- · 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 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

## 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 in accordance with the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

## Performance Testing

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Performance testing was conducted to demonstrate pump performance met established specifications in the following areas:

- 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.
- . Battery charging testing to demonstrate the duration of time needed to fully recharge the battery.

### Conclusion 9.

The performance testing described above demonstrates that the subject devices are as safe and effective as the predicate device and support a determination of substantial equivalence.