The Lucina-Melodi Powered Breast Pump is an advanced breast pump powered by a smart software. It has a 2 phase suction cycle. It is portable and is battery powered, with a rechargeable battery build in the system. It weighs less than 1kg. It is intended for single user usage, and can be use on both breasts at the same time. The device has a build in color LCD screen, and easy 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 provided. The device has a smart 2 phase software running which provide 2 different speeds to the user. Phase 1 runs at a higher speed than phase 2. The device has a large color LCD screen, with 6 easy to use buttons.

AI/ML Overview

The requested information described in the acceptance criteria and study proving device performance is not fully present in the provided text for the Lucina-Melodi Powered Breast Pump (K102516). This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report typically associated with AI/software performance.

However, I can extract the relevant information that is available about the "bench testing" that served as the primary evidence for substantial equivalence.

Here's the breakdown of what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a powered breast pump, and the "acceptance criteria" presented are essentially performance characteristics compared to a predicate device. The performance data is from "bench tests" rather than clinical outcomes related to milk expression efficiency in lactating women.

Acceptance Criteria (Implied)	Reported Device Performance (Lucina-Melodi)	Predicate Device (Medela Pump In Style Advance) Performance
Vacuum Range	50-250 MMHG	50-250 MMHG
Pressure Consistency & Stability	Consistent and stable at different levels	(Not explicitly stated for predicate in this context, but implied similar)
Peak Pressure Consistency	Consistent throughout test at several levels	(Not explicitly stated for predicate in this context, but implied similar)
Cycles Per Minute (CPM) Consistency	Consistent over time	(Not explicitly stated for predicate in this context, but implied similar)

Note on "Acceptance Criteria" for a breast pump: For a device like a breast pump, the primary acceptance criteria would revolve around safety and effectiveness in expressing milk. While the 510(k) focuses on substantial equivalence of technical specifications, a full "acceptance criteria" for clinical performance (e.g., milk volume, comfort) would typically involve clinical studies, which are not detailed here. The "reported device performance" in this context refers to the bench test results demonstrating comparable mechanical function.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing" and "data collected," but no specific number of units tested, duration of tests, or number of data points is provided.
Data Provenance: The device was developed by Genadyne Biotechnologies Inc. (Great Neck, NY, USA). The bench tests were conducted to support the 510(k) submission, indicating the data was generated specifically for regulatory purposes. The data is retrospective in the sense that it was collected as part of the device development and testing process prior to submission, not from an ongoing, prospective clinical trial.

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

Number of Experts: Not applicable/not stated. For a mechanical device like a breast pump, "ground truth" is established through engineering and performance testing against specifications and comparison to the predicate device, not typically through expert consensus readings of images or clinical assessments as might be seen with AI/diagnostic tools. The "experts" would be the engineers and technicians involved in the bench testing and design.
Qualifications of Experts: Not stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not stated. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution to establish a ground truth. For a bench test of a mechanical device, performance is measured objectively against predefined parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This type of study is irrelevant for a powered breast pump. MRMC studies are used for diagnostic aids or AI tools that assist human interpreters (e.g., radiologists, pathologists). The Lucina-Melodi is a standalone mechanical device, not an AI-assisted diagnostic tool.
Effect Size: Not applicable.

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

Standalone Performance: Yes, in a sense. The "bench tests" represent the standalone performance of the device's mechanical functions (vacuum, pressure, cycles per minute). The device itself operates "standalone" in terms of its mechanical action. However, it's not an "algorithm only" device in the typical AI sense; it's a mechanical device with "smart software" controlling its function. The provided text describes the electrical and mechanical components and their direct output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The ground truth for the bench tests was based on engineering specifications and direct measurements of mechanical parameters (vacuum range, pressure consistency, CPM consistency). This was then compared to the known specifications and performance characteristics of the legally marketed predicate device (Medela Pump In Style Advance Breast Pump). The goal was to show that the new device performed equivalently in these technical aspects to the predicate.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. For a 510(k) submission of a mechanical device, there isn't typically a "training set" in the context of machine learning. The device's "smart software" likely involves control algorithms that were designed and validated through engineering principles and testing, not by training on a dataset of "cases."

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. Since there's no "training set" in the AI/ML sense, there's no corresponding ground truth to establish for it. The control logic for the pump's "2 phase suction cycle" would have been developed based on scientific understanding of breast pump function and user needs, then validated through testing.

Summary

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K102516 page lots

Traditional 510k Summary

AUG 1 1 2011

General Information

1. Applicant:
  Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 (t) 516.487.8787 (f) 516.487.7878 www.genadyne.com

Contact Person:

Mr. Chien-Ming GOH (Andrew) Vice President Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 Tel: 516-487-8787 Fax: 516-487-7878 Andrew@genadyne.com

3. Trade/Proprietary Name Including Model Number of Device:

Lucina-Melodi Powered Breast Pump

4. Common Name or Classification Name (21 CFR Part 807.87) of Device:

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

5. Class in which Device has been placed:

Class II

6. Reason for Premarket Notification:

Introduction of a new device.

7. Identification of Legally Marketed Device Which We Claim Substantial Equivalence (Predicate Device):

Medela Pump In Style Breast Pump (K950750) Medela Pump In Style Advance Breast Pump (K031614)

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K102516 page 2 of 5

8. Description of the Device

9. Intended use of the Device

The Lucina-Melodi Powered Breast Pump is intended to express and collect milk from the breasts of lactating women.

10. Description of Device

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K102516 page 3 of 5

Comparative Information

11. Comparison to Predicate Device

Table of Comparison to Legally Marketed Device:

Comparative Information
	Predicate Device	New Device
Company	Medela, Inc.	Genadyne Biotechnologies
Device Name	Pump in Style Advance	Lucina-Melodi
510 (K) Number	K031614
Technical Data
Vacuum Range	50-250 MMHG	50-250 MMHG
Power Requirements	60 Hz	19 V, 30W
Battery Type	Non-Rechargeable Ni-MH	Rechargeable Li-Ion
Dimensions	11 5/8 x 7 7/8 x 11 $3\frac{1}{4}$ inches	6 x 4 x 2.36 inches
Weight	9 Lbs	1.5 Lbs
Dual Pumping	Yes	Yes
Accessories
Filter	No	Yes
Breast Shields	Yes	Yes
Storage Bag	Yes	Yes
Baby Bottles	Yes	Yes
Valve flanges	Yes	Yes
Tubing	Yes	Yes
Splitter	No	Yes
Sterile	Non Sterile	Non Sterile

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Indications for Use
	The Pump In Style Advanced Breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. Intended use of the powered breast pump is to express and collect milk from the breasts of lactating women.
Testing
	NA IEC 60601-1-2
	NA FCC part 15 Class B
	NA EN 55011
	NA IEC 61000-4-2
	NA IEC 61000-4-3

Discussion of Similarities and Differences Device Similarities

Indication for use

The Lucina-Melodi Powered Breast Pump and the Medela Pump In Style Advanced Breast Pump are both intended to express and collect milk from the breasts of lactating women. The indication for use is identical.

Technological characteristics

Functional designs are the same, where by the system services as a suction device which is connected to a collection bottles where by breasts shields are use to place onto the breasts to collect milk. All devices are sold non-sterile. Devices are for dual pumping of breasts, and have the same accessories to collect milk.

Basic Product Function

The Lucina-Melodi and the predicate device have the same product function of generating a vacuum to provide general use suction and collection of milk into a bottle.

Device Differences

In comparison to the predicate devices, the Lucina-Melodi has several differences which do not affect the device safety and effectiveness of the intended use. These differences are described in further detail below.

Lucina-Melodi

The Lucina-Melodi is lighter in weight and smaller in dimension. It also have a rechargeable battery so that users could use it without it being plugged onto the wall all the time. In all other aspects, the Lucina-Melodi Powered Breast Pump and the predicate device are substantially equivalent.

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K10z516 page. 5ofs

12. Conclusions:

I believe that the Lucina-Melodi Powered Breast Pump is substantially equivalent to the predicate device. Results from the bench test, proves that the data collected is equally as good as the predicate.

The pressure at different levels was consistent and stable, in both single and double pumping usage. In another pressure vs time test, the peak pressure was consistent throughout the whole test at several pressure levels. Lastly, in the cycles per minute vs time test, the CPM were consistent over time.

13. Determination of Substantial Equivalence

Bench testing were done on the Lucina-Melodi Powered Breast Pump.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three lines forming its body and wings. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002

Mr. Chien-Ming Goh Vice President Genadyne Biotechnologies Inc. 65 Watermill Lane GREAT NECK NY 11021

AUG 1 1 2011

Re: K102516

Trade/Device Name: Lucina-Melodi Powered Breast Pump Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: July 26, 2011 Received: July 27, 2011

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 of medical device-related

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Page 2

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/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/ReportalProblem/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.

Sincerely yours,

Hubert Hennen MD

Herbert P. Lerner, M.D., Director (Acting) 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):

K102516

Device Name: Lucina-Melodi Powered Breast Pump

Indications For Use:

The Lucina-Melodi Powered Breast Pump is intended to express and collect milk from the breasts of lactating women.

Prescription Use (Per 21 CFR 801 Subpart D)

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)

Tomi M. Whay

on Sidn-Off ion of Reproductive, Gastro-Renal, and plogical Devices 510(k) Number KID2516

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).