This device is designed to express and collect milk from the breast of a lactating woman. When operated in mode, the device generates the pressure through the interaction of the diaphragm pump and the solenoid electric mechanism. The device adopts the microprocessor that can control the procedure to set and adjust the vacuum levels and cycles of Massage Mode and Express Mode.

Two Modes are pre-programmed with variable vacuum levels and cycle rates (pump speed). The device is capable of providing vacuum levels from 40 to 280 mmHg with cycle rates up to 60 cycles per minute.

The CIMLIRE F1 and S3 are intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user.

The CIMILRE F1 is powered by a 12 VDC adaptor or rechargeable lithium battery. The CIMILRE S3 is powered only by a 12VDC adaptor.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, focusing on the requested information.

The document is a 510(k) Summary for the CIMILRE F1 and CIMILRE S3 powered breast pumps. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies for novel technologies. As such, the information available is limited to performance testing to ensure the device functions as intended and safely, rather than a clinical efficacy study.

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

The document mentions "predefined acceptance criteria" for performance tests, but it does not explicitly list the specific quantitative acceptance criteria for each test. It only states that the devices met these criteria.

Test Performed	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance
Vacuum Strength Test	(Predefined criteria, not detailed)	Met predefined acceptance criteria.
Cycle Range Test	(Predefined criteria, not detailed)	Met predefined acceptance criteria.
Battery Operating Time	(Predefined criteria, not detailed)	Met predefined acceptance criteria.
Electrical Safety	IEC 60601-1:2005/AMD1:2012+ National Deviations for US	Complies with the electrical safety requirements.
Electromagnetic Compatibility	IEC 60601-1-2:2007 (Third Edition)	Complies with the electromagnetic compatibility requirements.
Home Healthcare Environment	IEC 60601-1-11:2010	Complies with requirements for use in home healthcare.
Software Validation	FDA guidance "The content of premarket submissions for software contained in medical devices," issued May 11, 2005.	Software was designed, developed, verified, and validated according to a software development process.
Biocompatibility: Cytotoxicity	ISO 10993-5:2009	Non-cytotoxic.
Biocompatibility: Irritation and Skin Sensitization	ISO 10993-10:2010	Non-irritating and non-skin sensitizing.

2. Sample size 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 the sample size for the performance tests (Vacuum Strength, Cycle Range, Battery Operating Time). It also does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) for a powered breast pump, these tests are typically conducted in a laboratory setting by the manufacturer (Cimilre Co., Ltd., based in Korea) and are prospective.

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)

This information is not applicable to this type of device and submission. The performance tests described (electrical safety, EMC, software, biocompatibility, vacuum/cycle/battery) do not require expert establishment of ground truth in the way medical imaging or diagnostic devices might. Instead, they rely on objective measurements against engineering standards and specifications.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective observations (e.g., reviewing medical images). The tests performed for this breast pump are objective engineering and performance tests.

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

No MRMC comparative effectiveness study was done. This is a powered breast pump, not an AI-powered diagnostic device involving human readers.

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

No standalone algorithm performance study was done. This device is an electromechanical pump and does not involve a diagnostic algorithm. The software validation mentioned pertains to the device's firmware for controlling the pump's functions.

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

The "ground truth" for the performance tests (e.g., Vacuum Strength, Cycle Range, Battery Operating Time) would be engineering specifications and validated measurement methods as defined by the manufacturer and relevant industry standards. For biocompatibility, the ground truth is established by the specified ISO standards. For electrical safety and EMC, it's established by the IEC standards.

8. The sample size for the training set

This information is not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. The "software validation" mentioned refers to traditional software engineering development and testing for firmware.

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

This information is not applicable as there is no training set for an AI/ML algorithm mentioned. The "ground truth" for the software validation (firmware) would be the software requirements specifications and design documents against which the firmware was tested.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

March 7, 2017

Cimilre Co., Ltd. Ko Bong Jae R & D General Manager #201. 202. Sagimakgol-ro 148Jungwon-gu Seongnam-si, Gyeonggi-do 13207 Korea

Re: K162870 Trade/Device Name: CIMILRE F1 and CIMILRE S3 Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: January 23, 2017 Received: January 24, 2017

Dear Ko Bong Jae:

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,

Charles Viviano -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) K162870

Device Name CIMILRE F1 and CIMILRE S3

Indications for Use (Describe)

The CIMILRE F1 and CIMILRE S3 are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K162870 Page 1/7

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

February 17, 2017

Submitter's Information [21 CFR 807.92(a)(1)] 2.

Name of Manufacturer: CIMILRE CO., LTD.
Address: #201, 202, Sagimakgol-ro 148, Jungwon-gu Seongnam-si, ● Gyeonggi-do, Korea (Zip.13207)
Contact Name: Ko Bong Jae / General Manager ●
Telephone No.: ● +82-31-723-0941
Fax No.: +82-31-723-0940
Email Address: bjko@cimilre.kr
Registration No.: In process ●

Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] 3.

Trade/Device Name	CIMILRE F1 and CIMILRE S3
Common Name	Powered breast pump
Regulation Number	21 CFR 884.5160
Regulation Name	Powered breast pump
Regulation Class	Class II
Product Code	HGX
Product Code Name	Pump, Breast, Powered

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K162870 Page 2/7

Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] 4.

The identified predicate devices within this submission are shown as follow;

510(k) Number: K150476 ●
Applicant: Uzinmedicare Co. ●
Trade/Device Name Spectra S1 Plus and Spectra S2 Plus ●
Regulation Number 21 CFR 884. 5160 ●
Regulation Name: Powered breast pump
Regulation Class: Class II
Product Code: HGX ●
Product Code Name: Pump, Breast, Powered .

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

5. Description of the Device [21 CFR 807.92(a)(4)]

The CIMLIRE F1 and S3 are intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user.

The CIMILRE F1 is powered by a 12 VDC adaptor or rechargeable lithium battery. The CIMILRE S3 is powered only by a 12VDC adaptor.

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K162870 Page 3/7

Accessories for CIMILRE F1 and CIMILRE S3 are as follows:

1. Breast Shield Set
  (Tubing, Back-flow Protector, Breast Shield, Silicone Valve, Bottle, Bottle cover, Nipple, Bottle Cap, Disk)

The Breast Shield Set is made of Silicone, Polypropylene and silicone hardness 60 L.S.R

Adaptor (DC 12 V, 2 A)

The CIMILRE F1, CIMILRE S3 pump provides the following user features:

1. Two Modes are provided as follows:
- Massage Mode: suction pattern with fast cycles and low vacuum to start milk flowing
Expression Mode: suction pattern with slower cycles and higher vacuum to express milk.
1. Diaphragm pump design with solenoid electric mechanism.
1. Adjustment of vacuum level/cycles
1. LCD display, for user assistance/device status.
1. Option of either single or double breast pumping.

For a full list of device specifications, please see the Table 1. Comparison of Proposed Device to Predicate Device.

6. Indications for use [21 CFR 807.92(a)(5)]

The CIMILRE F1 and CIMILRE S3 are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

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K162870 Page 4/7

7. Determination of Substantial Equivalence

Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)]

The indications for use of CIMILRE F1 and CIMILRE S3 are the same as the predicate devices. Both the subject and predicate devices have the same intended use.

The subject and the predicate device generate vacuum in a similar manner.

A microprocessor controlled DC motor provides motive force to create volumetric expansion and vacuum. (Pump type: Diaphragm)

The CIMILRE F1 and CIMILRE S3 are substantially equivalent to the legally marketed predicate devices with respect to indications for use and technology characteristics. The table below presents comparisons for each device:

	Proposed Device	Predicate Device
ProductName	CIMILRE F1 and CIMILRE S3	Spectra S1 Plus and Spectra S2 Plus
510(k)Number	K162870	K150476
Manufacturer	CIMILRE Co. Ltd.	Uzinmedicare Co.
Product Code	HGX	HGX
Device Class	II	II
Indicationsfor Use	The CIMILRE F1 and CIMILRE S3 aresingle-user, powered breast pumpsintended to express and collect milkfrom the breasts of lactating women.	The Spectra S1 Plus and Spectra S2Plus are single-user, powered breastpumps intended to express and collectmilk from the breasts of lactatingwomen.
Intended usepopulation	Single-user	Single-user
Intended useenvironment	Home environment	Home environment
Specifications
Power source(Adaptor)	AC/DC Converter(12 VDC)	AC/DC Converter(12 VDC)
Power source(Battery)	Rechargeable Lithium PolymerBattery	Rechargeable Lithium Ion Battery(only for Spectra S1 Plus)

	Proposed Device		Predicate Device
	(only for CIMILRE F1)
Pump type	Diaphragm		Diaphragm
Pump Options		Single or Double	Single or Double
Mode	2 Modes		2 Modes
	(Massage Mode, Expression Mode)		(Massage Mode, Expression Mode)
VacuumLevels	CIMILREF1	Massage Mode:- 5 levelsExpression Mode:- 10 Levels	Massage Mode: 5 levels
	CIMILRES3	Massage Mode:- 5 levelsExpression Mode:- 12 Levels	Expression Mode: 12 Levels
VacuumStrength	40 - 280 mmHg		50 - 280 mmHg
Cycle Range	25 - 60 Cycles/min.(F1)30 - 60 Cycles/min.(S3)		38 - 70 cycles/min
User Interface	Tact switch control- Power, Vacuum/Cycle Up or Down- Mode switchLCD Display		Tact switch control- Power, Vacuum/Cycle Up or Down- Mode switchLCD Display
Accessories	Tubing,Back-flow ProtectorBreast ShieldSilicone ValveBottleBottle coverNippleBottle CapDiskAdaptor		Tubing,Back-flow ProtectorBreast ShieldValveBottleBottle coverNippleBottle CapDiskAdaptor
BackflowProtection	Yes(milk is prevented from entering thetubing.)		Yes(milk is prevented from entering thetubing)
CleaningMethod	- Breast pump:wipe with clean, damp cloth- Breast Shield set: Boiling water		- Breast pump:wipe with clean, damp cloth- Breast Shield set: Boiling water

[Table 1. Comparison of Proposed Device to Predicate Device]

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milre

#201, 202, Sagimakgol-ro 148, Jungwon-gu Seongnam-si, Gyeonggi-do, Korea (Zip.13207) Tel. +82-31-723-0941 / Fax. +82-31-723-0940

K162870 Page 5/7

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The table also provides rationale for a little difference in support of substantial equivalence to the Predicate devices

[Table 2. Little difference with Predicate Device.]

Justification to Support Substantial Equivalence

The subject device has a different user interface,appearance, battery type, vacuum levels and cycle speeds. These differences do not alter the intended use of the device from that of the predicates. In addition, these technological differences do not raise different questions of safety and effectiveness

Non-Clinical Test Summary

The CIMILRE F1 and CIMILRE S3 complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and usability. The following data were provided in support of the substantial equivalence determination:

1. Electrical Safety, Electromagnetic Compatibility and Performance:
  The CIMILRE F1 and CIMILRE S3 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
Electrical Basic Safety and Essential Performance requirements in accordance with IEC ● 60601-1:2005/AMD1:2012+ National Deviations for US
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2007 (Third Edition)
Medical electrical equipment and medical electrical systems used in the home ● healthcare environment in accordance with IEC 60601-1-11:2010
1. Software Validation

The CIMILRE F1 and CIMILRE S3 contain MODERATE level of concern software as firmware. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance:

"The content of premarket submissions for software contained in medical devices," issued May 11, 2005.

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K162870 Page 7/7

3) Biocompatibility

Biocompatibility of the devices was demonstrated by the following testing:

. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: tests for in vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: tests for irritation and skin sensitization

The test results demonstrated that the subject device is non-cytotoxic, non-irritating and non-skin sensitizing.

1. Performance test
  Performance of the devices was demonstrated by the following tests:
Vacuum Strength Test
Cycle Range Test
Battery Operating Time ●

The test results demonstrate that the CIMILRE F1 and CIMILRE S3 met predefined acceptance criteria..

Clinical Test Summary

Clinical testing was not required to demonstrate the substantial equivalence of the CIMILRE F1 and CIMILRE S3 breast pumps to its predicate device.

Conclusion [21 CFR 807.92(b)(3)] 8.

The CIMILRE F1 and CIMILRE S3 have the same intended use and similar technological characteristics to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness. In addition, performance testing conducted demonstrate that the subject devices are as safe and effective as the predicate. Therefore, the subject devices are substantially equivalent to the predicate.

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).