DEBP

K092783 · Enko , Ltd. · HGX · Oct 22, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K092783
• Device Name: DEBP
• Applicant: Enko , Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Oct 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The DEBP is intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

Device Story

DEBP is a powered breast pump for single or double breast expression. System utilizes a diaphragm-type vacuum pump driven by a microcontroller-controlled DC electric motor. User interface includes a front panel keypad and LCD display for adjusting cycle speed and vacuum levels (50–250 mmHg). Device operates on 6 AA batteries or AC adapter. Intended for home use by nursing women. Provides stimulation/let-down phase and expression phase. Backflow protection included. Output is collected milk for infant feeding. Healthcare providers do not operate the device; it is an OTC product for patient self-use.

Clinical Evidence

Bench testing only. Performance testing included suction curve analysis and backflow testing to ensure pump integrity. Electrical safety and electromagnetic compatibility testing conducted per IEC 60601-1 and IEC 60601-1-2:2007.

Technological Characteristics

Powered breast pump; diaphragm-type vacuum pump; DC electric motor; microcontroller-controlled. Vacuum range: 50–250 mmHg. Power: 6 AA batteries or AC adapter. User interface: keypad and LCD. Backflow protection integrated. Standards: IEC 60601-1 (safety), IEC 60601-1-2:2007 (EMC).

Indications for Use

Indicated for nursing women to express and collect breast milk for infant feeding.

Regulatory Classification

Identification

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

Predicate Devices

• Medela swing Breastpump (K053052)
• Hollister Inc. Expresse and Premier Powered Breast Pump (Lactaline Personal) (K973501)

Submission Summary (Full Text)

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OCT 2 2 2009

## Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for ENKO Ltd.'s premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the DEBP is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).

Applicant: ENKO Ltd. 10006 sokak, No:64 A.O.S.B. Cigli - Izmir 35620 TURKIYE Tel: [phone] Fax: [phone] www.enkoelektronik.com Attn: Sinan Kazazoglu

Contact: Calley Herzog Biologics Consulting Group, Inc. 13417 Quivas St. Westminster, CO 80234 Ph. 720-883-3633 Fax. [phone]

Date of Submission: 07/01/2009

Proprietary Name: DEBP

Common Name: Powered Breast Pump

Regulatory Class: Class II

Product Codes: HGX

Predicate Device(s): Medela swing Breastpump, By Medela Inc. (K053052) & Hollister Inc. Expresse and Premier Powered Breast Pump (Lactaline Personal) (K973501)

Device Description: The Double Electric Breast Pump (DEBP) is a powered breast pump. The pumping can be performed on one breast or on both breasts at the same time. The Lansinoh

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DEBP can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to control cycle speed and vacuum level. The Lansinoh DEBP is capable of providing vacuum levels from 50 to 250 mmHg, with cycling rates up to 1.85 cycles per second.

The DEBP is intended to express and collect the mother's milk of a Intended Use: nursing woman for the purpose of feeding the collected milk to a baby.

Performance Testing: Suction curves are provided to illustrate the performance of the DEBP. Additionally a backflow test was conducted to ensure satisfactory performance of the pump in the unlikely event that milk were to backflow into the pump unit.

The DEBP will be tested to meet:

- IEC 60601-1, "Medical Electrical Equipment, General Requirements for Safety" .
- IEC 60601-1-2:2007, "Medical electrical equipment. General requirements for basic . safety and essential performance. Collateral standard. Electromagnetic compatibility."

Substantial Equivalence: The Lansinoh DEBP is substantially equivalent to the predicate devices in intended use, technological characteristics and device design. The table below provides a comparison of the DEBP to the predicate devices.

| | New Device | Predicate Device | Predicate Device |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | ENKO Ltd. | Ameda/Hollister | Medela |
| Device Name | DEBP | Expresse & Premeier<br>Breast Pumps | Medela Swing |
| 510(k) # | not yet assigned | K973501 | K053052 |
| Intended Use | The DEBP is<br>intended to express<br>and collect the<br>mother's milk of a<br>nursing woman for<br>the purpose of<br>feeding the collected<br>milk to a baby. | The Lactaline Personal<br>Breast Pumps are<br>intended to express and<br>collect the mother's<br>milk of a nursing<br>woman for the purpose<br>of feeding the collected<br>milk to a baby. | The Swing Breast<br>Pump is a powered<br>breast pump to be used<br>by lactating women to<br>express and collect<br>milk from their<br>breasts. |
| Pumping Suction | 50 - 250 mmHg | <100 - 265 mbar<br>(<75 - 199 mmHg) | 0 - 250 mmHg |

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| Stimulation/Let Down<br>Phase | | | |
|-------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Suction Levels | 50 – 150 mmHg | n/a | 0 - 250 mmHg |
| Cycles per Second | 1.85 (fixed) | n/a | up to 2.17 |
| Expression Phase | | | |
| Suction Levels | 50 – 250 mmHg | <100 - 360 mbar | 0 - 250 mmHg |
| Cycles per Second | 0.51 - 1.0 | 0.5 - 1.0 | up to 2.17 |
| Suction Settings | 8 | 3 | 11 |
| Power Supply | a) 6 AA alkaline<br>batteries<br>b) AC Adapter | a) rechargeable NiCd<br>batteries<br>b) 6 AA alkaline<br>batteries<br>c) AC Adapter<br>d) 12 V adapter for use<br>in motor vehicle | AC Adapter |
| Pumping Option | Single or Double | Single or Double | Single |
| Back Flow Protection | Yes | Yes | No |
| Let Down Function | Yes | No | Yes |
| Cycling/Suction Control | Microcontroller | Microprocessor | Microprocessor |

1000 - 1000 :

and the comments of the comments of the comments of

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## OCT 22 2009

ENKO Ltd. c/o Mr. Ned Devine Sr. Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062-2096

Re: K092783

Trade/Device Name: DEBP Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: October 5, 2009 Received: October 7, 2009

Dear Mr. Devine:

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 for ass attatod in the 2001 - 76, the enactment date of the Medical Device Amendments, or to connineroo print to rialy 2008 reclance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmeter For (110) that 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.

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. You must or any I with all the Act's requirements, including, but not limited to: registration and listing Compry with an the 110 110 1 3 g (21 CFR Part 801); medical device reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4: Indications for Use Statement

Forbeassigned K092783 510(k) Number: Device Name: DEBP

Indications for Use:

The DEBP is intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulkeum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number