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 Description

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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a breast pump. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific performance metrics like those for diagnostic AI devices. Therefore, many of the requested fields regarding AI performance, expert ground truth, and clinical efficacy studies will not be applicable or directly addressed in this document. The "study that proves the device meets the acceptance criteria" largely refers to bench testing and comparison to predicate devices, not clinical trials for performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from testing standards or predicate comparison)	Reported Device Performance (Lucina-Melodi Advance Breast Pump)
Technical Data:
Vacuum Range: 50-250 mmHg	50-250 mmHg
Power Requirements: 19 V, 30W (matching predicate)	19 V, 30W
Battery Type: Rechargeable Li-Ion (matching predicate)	Rechargeable Li-Ion
Dimensions: 6" x 4" x 2.36" (matching predicate)	6" x 4" x 2.36"
Weight: 1.5 lbs. (matching predicate)	1.5 lbs.
Dual Pumping Capable	Yes
Filter: 0.2µm hydrophobic bacteria filter (matching predicate)	0.2µm hydrophobic bacteria filter
Sterile: Non Sterile	Non Sterile
Testing Standards Compliance:
IEC 60601-1-2 (Electromagnetic compatibility)	Complies
FCC part 15 Class B (Radiated and conducted emissions)	Complies
EN 55011 (Industrial, scientific and medical equipment - RF emission)	Complies
IEC 61000-4-2 (Electrostatic discharge immunity)	Complies
IEC 61000-4-3 (Radiated RF electromagnetic field immunity)	Complies
Functional Performance (Bench Testing):
Withstand strenuous and continuous usage	Demonstrated (Continuous usage test)
Consistent pressure within defined suction range	Demonstrated (Post testing for consistency of pressure over time)
Microbiological tightness of barrier diaphragm	Validated (Microbiological tightness validation test)
Indication for Use:
Express and collect milk from lactating women	Intended to express and collect milk from the breast of lactating women.
Use by more than one user (if collection kit changed)	May be used by more than one user if the collection kit is changed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of a clinical performance study with human subjects or a dataset for AI evaluation. The "testing" mentioned refers to bench tests performed on the device itself.

Sample Size: Not applicable in the context of clinical or AI performance evaluation. Bench testing data volume is not specified beyond "continuous usage test," "post testing for consistency to measure pressure over time," and "microbiological tightness validation test."
Data Provenance: Not applicable. The testing is device-centric bench testing presumably performed by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., disease presence/absence) is not relevant for this breast pump's safety and effectiveness demonstration, which relies on engineering specifications and equivalence to predicate devices. There's no mention of experts establishing a "ground truth" for the bench tests; these tests follow established engineering protocols.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication (like expert consensus on medical images) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

Not applicable. This device is a powered breast pump and is not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established by:

Engineering specifications and regulatory standards: Compliance with standards like IEC 60601-1-2, FCC part 15 Class B, EN 55011, IEC 61000-4-2, IEC 61000-4-3.
Bench test results: Demonstrating the device meets its design requirements (e.g., consistent pressure, durability, microbiological tightness).
Predicate device comparison: The specifications and performance of the predicate devices (Medela Symphony Powered Breast Pump K020518 and Lucina-Melodi Powered Breast Pump K102516) serve as benchmarks for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

Summary

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K112856 page 1 of 4

Traditional 510k Summary

General Information

1. Applicant

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
1. Reason for Premarket Notification
1. 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 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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KII 2856. page. 2 of. 4

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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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 BreastPump	Lucina-Melodi Powered BreastPump	Lucina-Melodi Advance BreastPump
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 BreastPump is intended to express andcollect the mother's milk from thebreasts of a lactating woman, thusidentical to the predicate devices.	Intended use of the powered breastpump is to express and collect milkfrom the breasts of lactatingwomen.	The Lucina-Melodi Advance BreastPump is intended to express andcollect milk from the breast oflactating women. This device maybe used by more than one user ifthe 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

1<112856 page 30f4

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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.

1. 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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Page 2-

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 (800) 638-2041 or (301) 796-7100 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)

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

Page 1 of 1

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).