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 Description

The Hi bebeplus, 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 bebeplus, model BT-100 also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery. The Hi bebeplus, model BT-100 has two operating functions: basic massage/expression function and memory function to save the operating sequence. The Hi bebeplus, model BT-100, is capable of providing vacuum levels from 32-227 mmHg with cycling rates up to 63 cycles per minute.

AI/ML Overview

This document is a 510(k) premarket notification for a powered breast pump (Hi bebePlus, model BT-100). The FDA has determined the device is substantially equivalent to a legally marketed predicate device (Medela Ag Freestyle Deluxe, K150499).

Therefore, this document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of clinical performance or diagnostic accuracy, as it is a breast pump, not a diagnostic or AI-powered medical device.

The information provided relates to non-clinical tests conducted to ensure safety and performance equivalence to a predicate device, which are standard for such medical devices seeking market clearance.

Here's an analysis of what is available in relation to your request, adapted for the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications that were tested. While not explicitly called "acceptance criteria" in a table format, these are the parameters against which the device's performance was measured.

Performance Parameter	Acceptance Criteria / Predicate Performance (K150499)	Reported Device Performance (Hi bebePlus BT-100)
Adjustable Vacuum (expression)	45-245 mmHg (predicate)	32-227 mmHg ±10%
Maximum Vacuum	270 mmHg (predicate)	250 mmHg
Cycles per minute (expression)	49.8 - 81.6 (predicate)	27 - 63 ±5%
Suction Settings	9 (predicate)	10
Cycle Speed	Not explicitly stated as a numerical criterion for the new device, but tested for design requirements.	Met specifications
Suction Pressure	Not explicitly stated as a numerical criterion for the new device, but tested for design requirements.	Met specifications
Battery Operating Time	Not explicitly stated as a numerical criterion, but tested for design requirements.	Met specifications
Battery Recharging Time	Not explicitly stated as a numerical criterion, but tested for design requirements.	Met specifications
Operating life	Not explicitly stated as a numerical criterion, but tested for design requirements.	Met specifications

Non-Clinical Acceptance Criteria (Compliance with Standards):

Biocompatibility: In accordance with AAMI / ANSI / ISO 10993-5:2009/(R) 2014 (in vitro cytotoxicity) and AAMI / ANSI / ISO 10993-10:2010 (irritation and skin sensitization).
Electrical Safety: In accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, and IEC 60601-1-11:2015.
Electromagnetic Compatibility (EMC): In accordance with IEC 60601-1-2:2007.
Software Verification and Validation: As recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The performance tests (Cycle Speed, Suction Pressure, Battery Operating Time, Battery Recharging Time, Operating life) are noted as having been conducted "under conditions of single and double pumping mode and for the varying power sources." However, the specific number of units tested or the number of test cycles is not mentioned. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for these engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable or provided. For a breast pump, "ground truth" as it relates to expert consensus for diagnostic accuracy (e.g., radiologist reads) is not relevant. The ground truth for performance characteristics would be direct measurements against engineering specifications.

4. Adjudication method

This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of data by multiple readers to establish a consensus ground truth, which is not relevant for this device.

5. 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

This information is not applicable. An MRMC study is relevant for AI-powered diagnostic devices. This device is a breast pump and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

For the performance tests (Cycle Speed, Suction Pressure, Battery Operating Time, Battery Recharging Time, Operating life), the "ground truth" would be the engineering specifications and direct measurements. For the compliance tests (biocompatibility, electrical safety, EMC, software V&V), the "ground truth" is adherence to published national and international standards.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set, as this device does not utilize machine learning or AI that would require one.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set mentioned for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a wing-like shape extending above them.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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, 302Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do,Korea (Zip. 13201)
Submitter's Telephone	+82 (31) 7500340
Contact person	Jenny Cho (jennycho@bistos.co.kr) / RA Manager
Official Correspondent	Dave Kim (davekim@mtech-inc.net)
Address	8310 Buffalo Speedway, Houston, TX 77025
Telephone	+713-467-2607
Fax:	+713-583-8988

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 bebeplusBT-100	Freestyle® Breast pump(K150499)
Device name
Indication for use	The Hi bebeplus, model BT-100,electric breastpump is intended to be used bylactating women for expressingand collecting breast milk. It isintended for a single user.	Freestyle® is a poweredbreast pump to be used bylactating women to expressand collect milk form theirbreasts. The Freestyle® isintended for a single user
Intended Use	Express and collect milk	Express and collect milk
Single User
Device	Yes	Yes
Environment of Use	Home	Home
PrescriptionDesignation	OTC	OTC
User Control	On-off switch Vacuum /CycleUp Vacuum /Cycle DownChange Operation Mode	On-off switch Vacuum/Cycleadjustment control
VisualIndicator	LCD display	LCD display
Pumping options	Single or Double pumping	Single or Double pumping
Power Supply	Li-Ion battery orAC adaptor provided100V-240V, 50/60 Hz	Li-Ion battery orAC adaptor provided
AdjustableVacuum(expression)	32 - 227 mmHg ±10%	45-245 mmHg
Maximum Vacuum	250 mmHg	270 mmHg
Cycles per minute(expression)	27 - 63 ±5%	49.8 - 81.6
SuctionSettings	10	9
AdjustableSuction Levels	Yes	Yes
Mode change	Yes	Yes
Cycling ControlMechanism	Microcontroller	Microcontroller
Back FlowProtection	Yes	Yes
Patient ContactMaterial	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.

Regulation Number and Section

§ 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).