CIMLRE F1 and CIMILRE S3

K162870 · Cimilre Co., Ltd. · HGX · Mar 7, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K162870
• Device Name: CIMLRE F1 and CIMILRE S3
• Applicant: Cimilre Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Mar 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

CIMILRE F1 and S3 are single-user powered breast pumps for home or office use. Device utilizes a diaphragm pump driven by a microprocessor-controlled DC motor and solenoid mechanism to generate vacuum. User interface includes tact switches and LCD display to adjust vacuum levels (40-280 mmHg) and cycle rates (up to 60 cycles/min). Two pre-programmed modes: Massage Mode (fast cycles, low vacuum) to stimulate flow; Expression Mode (slower cycles, higher vacuum) to collect milk. F1 model powered by 12VDC adapter or rechargeable lithium polymer battery; S3 model powered by 12VDC adapter. Accessories include breast shield set with back-flow protection to prevent milk from entering tubing. Healthcare providers or patients use the device to supplement breastfeeding; output is expressed milk collected in a bottle. Device benefits include efficient milk expression and collection for lactating women.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), home healthcare environment standards (IEC 60601-1-11), biocompatibility (ISO 10993-5, ISO 10993-10), and performance testing (vacuum strength, cycle range, battery life).

Technological Characteristics

Diaphragm pump with solenoid mechanism; microprocessor-controlled. Materials: Silicone, Polypropylene, 60 L.S.R. (Breast Shield Set). Power: 12VDC adapter (F1/S3) or Li-Polymer battery (F1). Connectivity: None. Sterilization: Not specified (cleaning via boiling water for accessories). Software: Moderate level of concern firmware.

Indications for Use

Indicated for lactating women requiring a single-user powered breast pump to express and collect breast milk.

Regulatory Classification

Identification

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

Predicate Devices

• Spectra S1 Plus and Spectra S2 Plus (K150476)

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

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 [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

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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)

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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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### 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<br>Name | CIMILRE F1 and CIMILRE S3 | Spectra S1 Plus and Spectra S2 Plus | |
| 510(k)<br>Number | K162870 | K150476 | |
| Manufacturer | CIMILRE Co. Ltd. | Uzinmedicare Co. | |
| Product Code | HGX | HGX | |
| Device Class | II | II | |
| Indications<br>for Use | The CIMILRE F1 and CIMILRE S3 are<br>single-user, powered breast pumps<br>intended to express and collect milk<br>from the breasts of lactating women. | The Spectra S1 Plus and Spectra S2<br>Plus are single-user, powered breast<br>pumps intended to express and collect<br>milk from the breasts of lactating<br>women. | |
| Intended use<br>population | Single-user | Single-user | |
| Intended use<br>environment | Home environment | Home environment | |
| Specifications | | | |
| Power source<br>(Adaptor) | AC/DC Converter<br>(12 VDC) | AC/DC Converter<br>(12 VDC) | |
| Power source<br>(Battery) | Rechargeable Lithium Polymer<br>Battery | Rechargeable Lithium Ion Battery<br>(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<br>Levels | CIMILRE<br>F1 | Massage Mode:<br>- 5 levels<br>Expression Mode:<br>- 10 Levels | Massage Mode: 5 levels |
| | CIMILRE<br>S3 | Massage Mode:<br>- 5 levels<br>Expression Mode:<br>- 12 Levels | Expression Mode: 12 Levels |
| Vacuum<br>Strength | 40 - 280 mmHg | | 50 - 280 mmHg |
| Cycle Range | 25 - 60 Cycles/min.(F1)<br>30 - 60 Cycles/min.(S3) | | 38 - 70 cycles/min |
| User Interface | Tact switch control<br>- Power, Vacuum/Cycle Up or Down<br>- Mode switch<br>LCD Display | | Tact switch control<br>- Power, Vacuum/Cycle Up or Down<br>- Mode switch<br>LCD Display |
| Accessories | Tubing,<br>Back-flow Protector<br>Breast Shield<br>Silicone Valve<br>Bottle<br>Bottle cover<br>Nipple<br>Bottle Cap<br>Disk<br>Adaptor | | Tubing,<br>Back-flow Protector<br>Breast Shield<br>Valve<br>Bottle<br>Bottle cover<br>Nipple<br>Bottle Cap<br>Disk<br>Adaptor |
| Backflow<br>Protection | Yes<br>(milk is prevented from entering the<br>tubing.) | | Yes<br>(milk is prevented from entering the<br>tubing) |
| Cleaning<br>Method | - Breast pump:<br>wipe with clean, damp cloth<br>- Breast Shield set: Boiling water | | - Breast pump:<br>wipe with clean, damp cloth<br>- 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.