LUCINA-MELODI

K112856 · Genadyne Biotechnologies, Inc. · HGX · May 10, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K112856
• Device Name: LUCINA-MELODI
• Applicant: Genadyne Biotechnologies, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: May 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Lucina-Melodi Advance Breast Pump is intended to express and collect milk from the breast of lactating women. This device may be used by more than one user if the collection kit is changed.

Device Story

Battery-powered breast pump; utilizes diaphragm motor to generate suction; features 2-phase suction cycle (Phase 1 high speed, Phase 2 lower speed). Input: user-defined settings via buttons/LCD interface. Output: vacuum pressure for milk expression. Used by lactating women in home or clinical settings. Device includes rechargeable Li-Ion battery and AC adapter. PCB controls motor speed and suction intensity based on user input. Multi-user capability enabled by changing collection kit. Benefits include portability, dual or single breast pumping, and consistent pressure delivery.

Clinical Evidence

Bench testing only. Testing included continuous usage performance to verify pressure consistency within the 50-250 mmHg range, and microbiological tightness validation for the barrier diaphragm membrane in the breast shield set. Electromagnetic compatibility and safety testing performed per IEC 60601-1-2, FCC Part 15 Class B, EN 55011, and IEC 61000-4-2/3.

Technological Characteristics

Powered breast pump; 50-250 mmHg vacuum range; diaphragm motor; rechargeable Li-Ion battery or AC power (19V, 30W). Includes 0.2µm hydrophobic bacteria filter. Dimensions: 6" x 4" x 2.36"; weight: 1.5 lbs. Software-controlled motor speed/suction. Standards: IEC 60601-1-2, FCC Part 15 Class B, EN 55011, IEC 61000-4-2/3.

Indications for Use

Indicated for lactating women to express and collect breast milk. Suitable for multi-user environments provided the collection kit is changed between users.

Regulatory Classification

Identification

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

Predicate Devices

• Medela Symphony Powered Breast Pump (K020518)
• Lucina-Melodi Powered Breast Pump (K102516)

Submission Summary (Full Text)

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K112856 page 1 of 4

## Traditional 510k Summary

## General Information

- 1. Applicant
2. Contact Person

- Trade/Proprietary Name 3. Including Model Number of Device
- Common Name or 4. Classification Name (21 CFR Part 807.87) of Device
- Class in which Device has 5. been placed
- 6. Reason for Premarket Notification
- 7. Identification of Legally Marketed Device Which We Can Claim Substantial Equivalence (Predicate Device)
- Brief Description of Device 8.

# MAY 1-0 2012

Genadyne Biotechnologies, Inc. 16 Midland Ave, Hicksville, NY 11801 (t) 516.487.8787 (f) 516.487.7878

Mr. Chien-Ming GOH (Andrew) Vice President Genadyne Biotechnologies Inc. 16 Midland Ave. Hicksville, NY 11801 (t) 516.487.8787 (f) 516.487.7878

Lucina-Melodi Advance Breast Pump

Powered Breast Pump (21 CFR 884.5160, Product Code HGX)

Class II

Introduction of an already approved device (K102516) with a new indication for use.

Medela Symphony Powered Breast Pump (K020518) Lucina-Melodi Powered Breast Pump (K102516)

The Lucina Melodi Advanced Breast Pump is a battery powered breast pump powered by a smart software. It has a 2 phase suction cycle. Phase 1 runs at a higher speed than phase 2. It is portable and is battery powered, with a rechargeable battery build in the system. It weighs less than 1 kg. it is intended for continuous usage from User A to User B to User C etc. It can be use on both breasts at the same time as well as single breast one at a time.

The device has a build in color LCD screen, and east to use buttons and graphic user interface. The device can be run on battery power and also while

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plugged in to the AC adapter. Internally it gets its suction from a diaphragm motor. The PCB board will control the speed and the suction of the motor to provide optimal suction or based on the settings that the user sets at.

The technology of the Lucina-Melodi Advance Breast Pump is identical to the predicate device (Lucina-Melodi Powered Breast Pump - K102516) and there are no technical differences which would raise new aspects regarding safety and effectiveness. Both employ the same software and hardware architecture.

The Lucina-Melodi Advance Breast Pump is intended to express and collect milk from the breast of lactating women. This device may be used by more than one user if the collection kit is changed.

#### Summary of Technological . Characteristics

#### 10. Intended Use of the Device

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11. Comparison to Predicate Device

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Table of Comparison to Legally Marketed Device

| | Comparative Information | | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device #1 | Predicate Device #2 | New Device |
| Company | Medela Inc. | Genadyne Biotechnologies | Genadyne Biotechnologies |
| Device Name | Medela Symphony Powered Breast<br>Pump | Lucina-Melodi Powered Breast<br>Pump | Lucina-Melodi Advance Breast<br>Pump |
| 510 (K) Number | K020518 | K102516 | |
| | | | |
| Technical Data | | | |
| Vacuum Range | 50-250 mmHg | 50-250 mmHg | 50-250 mmHg |
| Power Requirements | 120V~, 50/60 Hz | 19 V, 30W | 19 V, 30W |
| Battery Type | None | Rechargeable Li-Ion | Rechargeable Li-Ion |
| Dimensions | 8" x 7" x 4" | 6" x 4" x 2.36" | 6" x 4" x 2.36" |
| Weight | ~5 lbs. | 1.5 lbs. | 1.5 lbs. |
| Dual Pumping | Yes | Yes | Yes |
| | | | |
| Accessories | | | |
| Filter | No filter present | 0.2µm hydrophobic bacteria filter | 0.2µm hydrophobic bacteria filter |
| Breast Shields | Yes | Yes | Yes |
| Storage Bag | Yes | Yes | Yes |
| Valve Flanges | Yes | Yes | Yes |
| Tubing | Yes | Yes | Yes |
| Splitter | Yes | Yes | Yes |
| | | | |
| Sterile | Non Sterile | Non Sterile | Non Sterile |
| | | | |
| Indication For Use | The Symphony Powered Breast<br>Pump is intended to express and<br>collect the mother's milk from the<br>breasts of a lactating woman, thus<br>identical to the predicate devices. | Intended use of the powered breast<br>pump is to express and collect milk<br>from the breasts of lactating<br>women. | The Lucina-Melodi Advance Breast<br>Pump is intended to express and<br>collect milk from the breast of<br>lactating women. This device may<br>be used by more than one user if<br>the collection kit is changed. |
| | | | |
| Testing | | | |
| | NA | IEC 60601-1-2 | IEC 60601-1-2 |
| | NA | FCC part 15 Class B | FCC part 15 Class B |
| | NA | EN 55011 | EN 55011 |
| | NA | IEC 61000-4-2 | IEC 61000-4-2 |
| | NA | IEC 61000-4-3 | IEC 61000-4-3 |

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## Discussion of Similarities and Differences Device Similarities

## Indication for use

The Lucina-Melodi Advance Breast Pump, and it's predicate devices are all intended to express and collect milk from the breasts of lactating women.

## Technological characteristics

The software and hardware design for both the Lucina-Melodi Advance Breast Pump and the Lucina-Melodi Powered Breast Pump are exactly identical. The kits and bottles are also exactly identical.

## Device Differences

### Indication for use

Although the basic function and indication for use are the Lucina-Melodi Advance Breast Pump and the Medela Symphony Powered Breast Pump can be used with multiple user, 1 user at a time, whereas the Lucina-Melodi Powered Breast Pump is only intended for single user only.

### Technical Specs

The Lucina-Melodi models are lighter in weight and smaller in size as compared to the Medela Symphony. The Lucina-Melodi models are portable and can be used battery powered or by charging it with the AC adapter, while the Medela Symphony can only be used while it is being plugged in to an AC power source. The Lucina-Melodi models have a rechargeable battery build in, but the Medela Symphony does not.

#### Additional Bench Testing 12.

Bench testing was done on the Lucina-Melodi Advance Breast Pump. Continuous usage test to prove that the machine can withhold strenuous and continuous usage, as well as post testing for consistency to measure pressure over time to ensure that the pressure stays consistent within a defined suction range. A microbiological tightness validation test for the membrane of the barrier diaphragm in the breast shield set was also conducted.

- 13. Conclusion & Determination of Substantial Equivalence
Based upon the information presented above, it is concluded that the proposed Lucina-Melodi Advance Breast Pump is safe and effective for the intended use, and is substantially equivalent to the predicate devices:

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its head turned to the right. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border. The text is in all caps and is oriented to follow the curve of the circle.

# 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

Mr. Chien-Ming (Andrew) GOH Vice President Genadyne Biotechnologies, Inc. 16 Midland Ave HICKSVILLE NY 11801

MAY 1 0 2012

Re: K112856

Trade/Device Name: Lucina-Melodi Advance Breast Pump for multiple users Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: April 30, 2012 Received: May 1, 2012

Dear Mr. GOH:

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. 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH/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.

Sincerély vours.

Benjamin R. Evanko

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):

K112856

Device Name: Lucina-Melodi Advance Breast Pump Indications For Use:

The Lucina-Melodi Advance Breast Pump is intended to express and collect milk from the breast of lactating women. This device may be used by more than one user if the collection kit is changed.

Prescription Use (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (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)

Gaine H. Buys for Benjamin Fisher

ion Sian-Of of Reproductive, Gastro-Renal, 510(k) Number

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