Hi bebe plus

K160274 · Bistos Co., Ltd. · HGX · Sep 1, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K160274
• Device Name: Hi bebe plus
• Applicant: Bistos Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Sep 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Indications for Use

The Hi bebeplus, model BT-100, electric breast pump is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

Device Story

Electrically powered, software-controlled breast pump; intended for single-user, home-use by lactating women. System comprises motor unit, pump kit, and tubing. Operates via 12V DC adapter or rechargeable lithium battery. Provides single or double pumping options. Features basic massage/expression function and memory function to save operating sequences. Vacuum levels range 32-227 mmHg; cycling rates up to 63 cycles per minute. Includes back flow protection. User controls vacuum/cycle settings via interface with LCD display. Output is expressed breast milk collected in pump kit. Benefits include efficient milk expression and collection for breastfeeding mothers.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, -10), electrical safety (IEC 60601-1, -11), EMC (IEC 60601-1-2), and performance testing (cycle speed, suction pressure, battery life, operating life).

Technological Characteristics

Powered breast pump; PP funnel material. Microcontroller-based cycling control. Vacuum range 32-227 mmHg; cycle range 27-63 cpm. Power: 12V DC adapter or Li-Ion battery. Home-use environment. Biocompatibility per ISO 10993; Electrical safety per IEC 60601-1/1-11; EMC per IEC 60601-1-2.

Indications for Use

Indicated for lactating women for expressing and collecting breast milk. Intended for single-user use.

Regulatory Classification

Identification

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

Predicate Devices

• Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty (K150499)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2016

Bistos Co., Ltd. % Dave Kim President Mtech Group 8310 Buffalo Speedway Houston, TX 77025

Re: K160274 Trade/Device Name: Hi Beber1us> model BT-100 Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: July 21, 2016 Received: July 22, 2016

Dear Dave Kim:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

For Division

Douglas Silverstein -S 2016.09.01 16:14:46 -04'00'

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160274

Device Name

Hi bebePlus , model BT-100

Indications for Use (Describe)

The Hi bebertus, model BT-100, electric breast pump is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

Z Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

## K160274

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### Date 510k summary prepared: August 31, 2016

#### I. SUBMITTER

| Submitter's Name | Bistos Co., Ltd. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302<br>Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do,<br>Korea (Zip. 13201) |
| Submitter's Telephone | [phone] |
| Contact person | Jenny Cho ([e-mail]) / RA Manager |
| Official Correspondent | Dave Kim ([e-mail]) |
| Address | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone | [phone] |
| Fax: | [phone] |

#### II. DEVICE

| Trade/proprietary Name | Hi bebeplus |
|------------------------|----------------------------|
| Model No. | BT-100 |
| Common or Usual Name | Electric Breast Pump |
| Regulation Name | Powered Breast Pump |
| Regulation Number | 21 CFR 884.5160 |
| Product Code | HGX: pump, breast, powered |
| Regulatory Class | Class II |
| Over the Counter Use | |

#### III. PREDICATE DEVICE

| Primary Manufacturer | Medela Ag |
|----------------------|-------------------------------------------|
| Device Name | Freestyle Deluxe, Freestyle Solution Set, |
| | Freestyle Basic, Freestyle Motor Warranty |
| 510(k) Number | K150499 |
| Regulation Name | Powered Breast Pump |
| Regulation Number | 21 CFR 884.5160 (Product Code: HGX) |
| Regulatory Class | Class II |
| Over the Counter Use | |

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#### DEVICE DESCRIPTION IV.

The Hi beberths, model BT-100, is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing..

The pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). The Hi beberths, model BT-100 also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery.

The Hi beberths, model BT-100 has two operating functions: basic massage/expression function and memory function to save the operating sequence. The Hi beber™, model BT-100, is capable of providing vacuum levels from 32-227 mmHg with cycling rates up to 63 cycles per minute.

#### V. INDICATIONS FOR USE:

The Hi beberths, model BT-100, electric breast pump is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

| | Hi bebeplus<br>BT-100 | Freestyle® Breast pump<br>(K150499) |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | | |
| Indication for use | The Hi bebeplus, model BT-100,<br>electric breast<br>pump is intended to be used by<br>lactating women for expressing<br>and collecting breast milk. It is<br>intended for a single user. | Freestyle® is a powered<br>breast pump to be used by<br>lactating women to express<br>and collect milk form their<br>breasts. The Freestyle® is<br>intended for a single user |
| Intended Use | Express and collect milk | Express and collect milk |
| Single User | | |
| Device | Yes | Yes |
| Environment of Use | Home | Home |
| Prescription<br>Designation | OTC | OTC |
| User Control | On-off switch Vacuum /Cycle<br>Up Vacuum /Cycle Down<br>Change Operation Mode | On-off switch Vacuum/Cycle<br>adjustment control |
| Visual<br>Indicator | LCD display | LCD display |
| Pumping options | Single or Double pumping | Single or Double pumping |
| Power Supply | Li-Ion battery or<br>AC adaptor provided<br>100V-240V, 50/60 Hz | Li-Ion battery or<br>AC adaptor provided |
| Adjustable<br>Vacuum<br>(expression) | 32 - 227 mmHg ±10% | 45-245 mmHg |
| Maximum Vacuum | 250 mmHg | 270 mmHg |
| Cycles per minute<br>(expression) | 27 - 63 ±5% | 49.8 - 81.6 |
| Suction<br>Settings | 10 | 9 |
| Adjustable<br>Suction Levels | Yes | Yes |
| Mode change | Yes | Yes |
| Cycling Control<br>Mechanism | Microcontroller | Microcontroller |
| Back Flow<br>Protection | Yes | Yes |
| Patient Contact<br>Material | Funnel made of PP | PP |

#### PREDICATE COMPARISON VI.

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The Hi beberths, model BT-100 and the predicate device do not have identical indication for use statements; however, they have the same intended use (expressing and collecting milk from the breasts of lactating women).

In addition, there are differences in the device technological characteristics. The predicate device has 9 adjustable suction levels while the subject device has 10 adjustable suction levels. Also, the predicate device and subject device have different suction strengths and cycle speed ranges. These differences do not raise different questions of safety as compared to the predicate device. The suction levels both allow users to adjust the suction strength.

#### SUMMARY OF NON-CLINICAL TESTS VII.

Hi beber 100 BT-100 complies with voluntary standards for biocompatibility (in vitro cytotoxicity, irritation and sensitization testing), electrical safety, EMC testing, and use in the home healthcare environment. The following data were provided to support the substantial equivalence determination:

### Biocompatibility:

Testing was conducted in accordance with AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices-- Part 5: Tests for In Vitro Cytotoxicity (1.929 Assay) and AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. (Vaginal Irritation and Guinea Pig Maximization Sensitization)

### 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) 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 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests

### Software:

Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)

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FDA Guidance Document, Design Considerations for Devices Intended for Home Use, issued November 24, 2014 was also used to address home-use considerations.

Performance testing was conducted to show that the device meets its design requirements and performs as intended. The specifications were met for:

- Cycle Speed
- . Suction Pressure
- Battery Operating Time
- Battery Recharging Time
- . Operating life

These tests were conducted under conditions of single and double pumping mode and for the varying power sources (e.g., AC/DC power vs. battery power).

#### VIII. SUMMARY OF CLINICAL TESTS

Clinical testing was not required to demonstrate the substantial equivalence of the Hi bebertus, model BT-100 electric breast pump to its predicate device.

#### CONCLUSIONS IX.

Based on the information above, Hi bebert , model BT-100 electrical breast pump is substantially equivalent to the predicate device.