The powered Melodi Prime Breast Pump is intended to express and collect milk from the breast of a lactating woman. This device is a double pump with a single pumping option; it is intended for a single user.

Device Description

The Melodi Prime breast pump is a battery operated breast pump. It operates with 4 AA size batteries. It comes with a power adapter as it can be used with a power adapter without batteries as well. The power adapter does not charge the batteries.

The Melodi Prime breast pump is designed to be a single patient use device. It consists of a LCD display that allows the user to see the current settings of the device. It is an easy to use device, consist of 5 buttons (On/Off, + , - , Phase 1/ Phase 2, & Single/ Double Pumping).

The breast pump allows for single pumping and double pumping options. The suction hose connections are independent of each other. Inside the device, it consists of a PCB, motor and valve.

The accessories that comes with the device are from Ardo Medical AG. The PumpSets are approved under K141742.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Melodi Prime Breast Pump:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a tabulated format. However, it describes performance characteristics that were tested and deemed acceptable for demonstrating substantial equivalence.

Acceptance Criterion (Inferred)	Reported Device Performance
Consistent Pressure and Cycles	The pressure level and cycles per minute remain consistent throughout the bench test and show a constant and uniform behavior.
Back-flow Prevention (Pump to Tubing)	Back-flow tests confirm that the Melodi Prime Breast Pump can prevent back-flow of the liquid from the Pump Set into the tubing.
Back-flow Prevention (Bottle to Pump)	The Pump Sets are also able to prevent liquid going out from the bottle to the pump.
Durability / Reliability	The system was tested for more than 72 hours without any problems or errors.
Suction Pressure Range	60-250 mmHg (This is a specification, also serving as an implicit criterion. The reported performance implies it meets this range, as it's directly compared to the predicate's 50-250 mmHg, with the subject device's range being within acceptable physiological limits.)
Electrical Safety	Passed electrical safety testing. (Implicit criterion related to the difference in power source from the predicate).
Electromagnetic Compatibility (EMC)	Passed electromagnetic compatibility (EMC) testing. (Implicit criterion related to the difference in power source from the predicate).
Biocompatibility/Food Safety	PumpSets used in the subject device are a cleared device, therefore, no concerns on biocompatibility and food safety. (Implicit criterion, relies on prior clearance of components).

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

Sample Size for Test Set: Not specified. The document refers to "bench tests" and "back flow tests" but does not detail the number of units or test repetitions.
Data Provenance: Not explicitly stated, but the context indicates these were conducted internally by the manufacturer or a contract lab as part of the 510(k) submission process. There is no mention of country of origin for the data or whether it was retrospective or prospective, though bench testing is inherently prospective experimentation.

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

Number of Experts: Not applicable. The "ground truth" for technical performance criteria (like pressure consistency, back-flow prevention, and durability) is typically established through objective measurements and engineering standards, not expert clinical consensus in this context.
Qualifications of Experts: Not applicable for the described tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The tests described are objective bench tests, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a breast pump, and its effectiveness is determined by mechanical performance, safety, and functionality, not by interpretation by human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Standalone Study: Yes, in essence, the "Performance Data" section describes standalone testing of the device's mechanical and functional characteristics without human intervention influencing the fundamental performance results. It's not an "algorithm" in the typical software sense, but the device's inherent operation was tested.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the performance tests was based on objective measurements against engineering specifications and physical principles. For example, pressure levels are measured by sensors, back-flow is visually or mechanically confirmed, and durability is timed.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a mechanical breast pump, not an AI/ML algorithm that requires a "training set" of data in the typical sense.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

Summary

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

April 21, 2015

Genadyne Biotechnologies, Inc. Chien-Ming Goh Vice President, Regulatory Affairs 16 Midland Avenue Hicksville, NY 11801

Re: K143574 Trade/Device Name: Melodi Prime Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: March 27, 2015 Received: March 30, 2015

Dear Chien-Ming 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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) K143574

Device Name Melodi Prime Breast Pump

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510k Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Date Prepared: April 21, 2015

Applicant and official correspondent:

Genadyne Biotechnologies, Inc. 16 Midland Ave, Hicksville, NY 11801 Mr. Chien-Ming GOH (Andrew) Vice President, Regulatory Affairs E-mail: andrew@genadyne.com (t) +1.516.487.8787 (f) +1.516.977-8974

Name of Device

Melodi Prime Breast Pump Classification Name: Powered breast pump (21 CFR 884.5160) Requlation Class: Class II Product Code: HGX

Predicate Device

Lucina-Melodi Powered Breast Pump (K102516)

Device Description

The breast pump allows for single pumping and double pumping options. The suction hose connections are independent of each other. Inside the device, it consists of a PCB, motor and valve.

The accessories that comes with the device are from Ardo Medical AG. The PumpSets are approved under K141742.

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Intended Use / Indications for Use

Performance Data

The pressure level and cycles per minute remains consistent throughout the bench test and shows a constant and uniform behavior. Back flow tests confirm that the Melodi Prime Breast Pump can prevent back flow of the liguid from the Pump Set into the tubing.

The test subject, Melodi Prime Brest Pump and the breast shield set, is able to successfully prevent back flow of the liquid form the Pump Sets into the tubing and into the pump. The Pump Sets are also able to prevent liquid going out from the bottle to the pump.

The system was tested for more than 72 hours without any problems or errors.

Clinical Testing

No clinical data was required.

Predicate Device Comparison

Parameter	Subject device (K142479)	Predicate device (K102516)
Device name	Melodi Prime Breast Pump	Lucina-Melodi Powered Breast Pump
Intended use	Same as the predicate	Intended to express and collect milkfrom the breasts of lactating women.
Pumpingconfiguration	Same as the predicate	Single or double
Anti-backflowmechanism	Same as the predicate	Diaphragm cover
Suction pressure	60-250 mmHg	50-250 mmHg
Suction control	Same as the predicate	Microprocessor
LCD	Same as the predicate	Yes
Power source	6V DC adapter	Adapter output 19V, 30W
	Or four AA batteries	Or rechargeable lithium battery

Substantial Equivalence Discussion

Intended use The subject and predicate devices have the same intended use. .
Technological characteristics Similarities between the subject and predicate devices .
- - They both have single and double pumping options.

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- They both are controlled by the microprocessor.
- They have comparable suction pressures.
- They have the same anti-backflow mechanism.
★ They both have LCD.
Technological characteristics Differences between the subject and predicate devices .
- - The subject device is different from the predicate device in power sources. However, the differences do not raise any concerns, because the subject device has passed electrical safety and electromagnetic compatibility (EMC) testing.
- - The subject and predicate devices may use different materials in user and milk contacting components. However, the PumpSets used in the subject device is a cleared device. Therefore, there are no any concerns on biocompatibility and food safety.

Therefore, the subject device is substantially equivalent to the subject device regarding safety and effectiveness.

Conclusions

Based on the information presented in this submission, it can be concluded that the Melodi Prime Breast Pump is equivalent to its predicate device, the Lucina-Melodi Powered Breast Pump (K102516) with respect to the intended use, materials, design and technological characteristics.

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).