CIMLRE F1 and CIMILRE S3

• K Number: K162870
• Device Name: CIMLRE F1 and CIMILRE S3
• Manufacturer: CIMILRE CO., LTD.
• Date Cleared: 2017-03-07 ( 145 days)
• Product Code: HGX
• Regulation Number: 884.5160

Intended Use

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

Device Description

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.

Predicate Devices

K150476

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a microprocessor controlling pre-programmed modes and vacuum levels, but there is no indication of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No.
The device is a breast pump, which is used to express and collect milk, not to treat or cure a medical condition.

Diagnostic

No
The device is a breast pump intended for expressing and collecting milk, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a diaphragm pump, solenoid electric mechanism, and microprocessor, and mentions power sources (adaptor, battery). It also describes performance testing related to hardware function (vacuum strength, cycle range, battery operating time).

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
• Device Function: The CIMILRE F1 and CIMILRE S3 are breast pumps. Their function is to physically express and collect milk from the breast. They do not analyze any biological samples or provide diagnostic information about the user's health.
• Intended Use: The intended use clearly states that the device is "intended to express and collect milk from the breasts of lactating women." This is a mechanical function, not a diagnostic one.

The information provided in the document confirms that the device is a medical device, but specifically a breast pump, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

HGX

Device Description

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.

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

2. 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.

• 2. Diaphragm pump design with solenoid electric mechanism.
• 3. Adjustment of vacuum level/cycles
• 4. LCD display, for user assistance/device status.
• 5. Option of either single or double breast pumping.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

breasts

Indicated Patient Age Range

lactating women

Intended User / Care Setting

Home environment (or similar environment such as an office) / single user

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Test Summary:

• 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.
• 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.
• Biocompatibility: Tested for in vitro cytotoxicity, irritation and skin sensitization. The test results demonstrated that the subject device is non-cytotoxic, non-irritating and non-skin sensitizing.
• Performance test: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K150476

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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.

1

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,

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

2

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)

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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.: ● [phone]
• Fax No.: [phone]
• Email Address: [e-mail]
• 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)]

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.

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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

2. 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.

• 2. Diaphragm pump design with solenoid electric mechanism.
• 3. Adjustment of vacuum level/cycles
• 4. LCD display, for user assistance/device status.
• 5. 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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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
Product
Name	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
Indications
for Use	The CIMILRE F1 and CIMILRE S3 are
single-user, powered breast pumps
intended to express and collect milk
from the breasts of lactating women.	The Spectra S1 Plus and Spectra S2
Plus are single-user, powered breast
pumps intended to express and collect
milk from the breasts of lactating
women.
Intended use
population	Single-user	Single-user
Intended use
environment	Home environment	Home environment
Specifications
Power source
(Adaptor)	AC/DC Converter
(12 VDC)	AC/DC Converter
(12 VDC)
Power source
(Battery)	Rechargeable Lithium Polymer
Battery	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)
Vacuum
Levels	CIMILRE
F1	Massage Mode:

• 5 levels
  Expression Mode:
• 10 Levels | Massage Mode: 5 levels |
  | | CIMILRE
  S3 | Massage Mode:
• 5 levels
  Expression Mode:
• 12 Levels | Expression Mode: 12 Levels |
  | Vacuum
  Strength | 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 switch
  LCD Display | | Tact switch control
• Power, Vacuum/Cycle Up or Down
• Mode switch
  LCD Display |
  | Accessories | Tubing,
  Back-flow Protector
  Breast Shield
  Silicone Valve
  Bottle
  Bottle cover
  Nipple
  Bottle Cap
  Disk
  Adaptor | | Tubing,
  Back-flow Protector
  Breast Shield
  Valve
  Bottle
  Bottle cover
  Nipple
  Bottle Cap
  Disk
  Adaptor |
  | Backflow
  Protection | Yes
  (milk is prevented from entering the
  tubing.) | | Yes
  (milk is prevented from entering the
  tubing) |
  | Cleaning
  Method | - 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. [phone] / Fax. [phone]

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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

• 2. 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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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.

• 4. 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.