(223 days)
Not Found
No
The description mentions "smart software" and control of speed and suction based on user settings or "optimal suction," but there is no explicit mention of AI, ML, or any learning or adaptive capabilities. The control appears to be based on pre-programmed logic or user input, not on algorithms that learn from data.
No
The device is a breast pump intended to express and collect milk, which is not considered a therapeutic function that prevents, treats, or diagnoses a disease or condition.
No
The device is a breast pump, which is used to express and collect milk. Its intended use and description do not mention diagnosis, detection, or monitoring of any medical condition.
No
The device description explicitly mentions hardware components such as a battery, motor, PCB board, LCD screen, and buttons, indicating it is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Lucina-Melodi Advance Breast Pump's intended use is to "express and collect milk from the breast of lactating women." It is a mechanical device that physically interacts with the body to collect a substance.
- Lack of Diagnostic Function: The device does not analyze the collected milk or any other bodily fluid to provide diagnostic information about the user's health. It simply facilitates the collection process.
The description clearly indicates it's a powered breast pump, which is a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women (implied adult)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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K112856 page 1 of 4
Traditional 510k Summary
General Information
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- 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
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- Reason for Premarket Notification
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- 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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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 Breast | ||
| Pump | Lucina-Melodi Powered Breast | ||
| Pump | Lucina-Melodi Advance Breast | ||
| 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 | ||
| Pump is intended to express and | |||
| collect the mother's milk from the | |||
| breasts of a lactating woman, thus | |||
| identical to the predicate devices. | Intended use of the powered breast | ||
| pump is to express and collect milk | |||
| from the breasts of lactating | |||
| women. | 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. | |||
| 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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