The MINUET LCD and MINUET LCD eco are portable, multiple-user, powered breast pumps to be used in home or health care settings. These devices are the same, except the MINUET LCD has a rechargeable battery whereas the MINUET LCD eco does not. The devices have two major components: control unit (pump) and breast shield kit (breast shield, diaphragm, tubing, silicone massager, and bottle components). Users have the option of single or double pumping. The devices have two operating modes: massage and expression. The massage mode has seven suction levels whereas the expression mode offers nine suction levels. The vacuum strength range is 50-280 mmHq.

AI/ML Overview

The provided text is a 510(k) summary for the MINUET LCD and MINUET LCD eco powered breast pumps. It describes device information, comparison to a predicate device, and non-clinical performance testing. However, it does not include specific acceptance criteria for the device's performance (such as milk expression rates, user comfort metrics, or quantitative measures of vacuum strength under various conditions beyond its range). It also does not describe a study that details how the device meets such criteria in terms of the output performance of the device.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document. The document focuses on showing substantial equivalence to a predicate device through conformity to general medical device standards and qualitative comparisons of features, rather than quantitative performance against specific acceptance criteria.

Here's what I can extract based on the limitations:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria with quantitative performance metrics for the device's primary function (milk expression) are provided in the document. The document states "Bench tests using internal test protocols to demonstrate device performance, including vacuum level settings, speed settings, backflow/cross-contamination protection, battery operation, and use-life," but does not give the specific criteria or the results of these tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any performance testing related to "device performance" (e.g., milk expression), nor does it mention the data provenance (country of origin, retrospective/prospective). The studies mentioned are primarily engineering and safety tests (biocompatibility, electrical safety, EMC, battery safety, software V&V).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/imaging device requiring expert ground truth establishment in the way a diagnostic tool would. The studies conducted are primarily focused on hardware, software, and material safety and functionality.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here for performance evaluation.

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

Not applicable. This is not an AI-powered diagnostic device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests mentioned, the "ground truth" would be established by validated test methods and reference standards (e.g., ISO for biocompatibility, IEC for electrical safety). For example, for biocompatibility, the ground truth is the pass/fail criteria defined within the ISO standards. The document does not describe specific performance ground truth for milk expression efficacy.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 6, 2018

UNIMOM CO. Sang-Hyun Hong President 110-19 Gajangsaneopseobuk-ro Osan-si, Gyeonggi-do 18102 Korea

Re: K180075

Trade/Device Name: MINUET LCD, MINUET LCD eco Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 27, 2018 Received: July 5, 2018

Dear Sang-Hyun Hong:

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael T. Bailey -S

for 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) K180075

Device Name MINUET LCD, MINUET LCD eco

Indications for Use (Describe)

The MINUET LCD and MINUET LCD eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

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 (K180075)

1. Submitter Information

Submitter:	UNIMOM CO.
Address:	110-19, Gajangsaneopseobuk-ro, Osan-si,Gyeonggi-do, 18102, KOREA
Contact Name:	Hong, Sang-Hyun
Telephone:	+82-70-8798-5577
Fax:	+82-31-372-6782
Email	infounimom@naver.com

2. Date Prepared: August 3, 2018

3. Device Information

Trade/Device Name	MINUET LCD, MINUET LCD eco
Common Name	Powered breast pump
Regulation Number	21 CFR 884.5160
Regulation Name	Powered Breast Pump
Product Code	HGX (Pump, Breast, Powered)
Regulatory Class	II

4. Predicate Device

Spectra S1 Plus and Spectra S2 Plus (K150476) manufactured by Uzinmedicare Co. The predicate device has not been subject to any design related recalls.

5. Device Description

6. Indications for Use

The MINUET LCD and MINUET LCD eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

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

Devices	K180075 (subject devices)	K150476 (predicate device)
Indications for Use	The MINUET LCD and MINUET LCDeco are multiple-user, powered breastpumps intended to express andcollect milk from the breasts oflactating women.	The Spectra S1 Plus and Spectra S2 Plusare single-user, powered breast pumpsintended to express and collect milk fromthe breasts of lactating women.
Pump type	Same as the predicate	Diaphragm
Vacuum strength	Same as the predicate	50-280 mmHg
Suction level	Massage Mode: 7 levels	Massage Mode: 5 levels
Suction level	Expression Mode: 9 Levels	Expression Mode: 12 Levels
Cycle speed	Massage Mode: 23-120 cycles/minExpression Mode: 13-60 cycles/min	38-70 cycles/min
Back flow protection	Same as the predicate	Backflow protector (diaphragm) on the topof milk collection assembly
Visual indicator	Same as the predicate	LCD
Software control	Same as the predicate	Yes
Power supply - Mains	AC/DC adapter with micro USB cable	AC/DC converter
Power supply - Battery	Same as the predicate	Rechargeable lithium ion battery
Pump option	Same as the predicate	Single or double

The subject and predicate devices have intended use – expressing mill from the breasts of lactating women. They also use the same fundamental technoloqy - a microprocessor-controlled diaphragm pump and a solenoid. They have the same vacuum strength range, backflow prevention mechanism, and pump options. They also have comparable power supplies.

The subject and predicate devices have different technological characteristics, as they have different suction levels under each operational mode. Also, the subject devices have high cycle speed up to 120 cycles/min under massage mode. These differences between the subject and predicate devices do not raise different questions of safety and effectiveness.

8. Summary of Non-Clinical Performance Testing

The following studies have been conducted on the subject devices to support substantial equivalence to the predicate device:

Biocompatibility studies on the breast shield, as follows: .
- Cytotoxicity testing per 10993-5:2009 O
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 O
- Irritation testing per ISO 10993-10:2010 O
Electrical safety testing in accordance with: .
- IEC 60601-1:2005+ CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) O
- IEC 60601-1-11:2015 O

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Electromagnetic compatibility testing per IEC 60601-1-2:2014 .
Battery safety testing in accordance with: .
- AAMI/ANSI ES60601-1:2005 o
- IEC 62133:2012 o
. Software verification and validation testing in accordance with FDA quidance: "The content of premarket submissions for software contained in medical devices" dated May 11, 2005
. Bench tests using internal test protocols to demonstrate device performance, including vacuum level settings, speed settings, backflow/cross-contamination protection, battery operation, and use-life

9. Conclusion

The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are 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).