(343 days)
Not Found
No
The description mentions "smart software" and a "smart 2 phase software," but these terms are not synonymous with AI/ML. The software controls pre-defined suction cycles based on user settings, which is standard programmable logic, not adaptive learning or complex pattern recognition characteristic of AI/ML. There is no mention of training data, test data, or algorithms typically associated with AI/ML.
No
A therapeutic device is used to treat or manage a medical condition. A breast pump is used to express milk and does not treat or manage a disease or condition.
No.
The device is described as a breast pump intended to express and collect milk, with no mention of diagnostic capabilities or performing any medical assessments.
No
The device description explicitly mentions hardware components such as a diaphragm motor, PCB board, battery, LCD screen, and buttons, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the Lucina-Melodi Powered Breast Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breasts of lactating women." This is a physical process involving the body, not the analysis of biological samples in vitro (outside the body).
- Device Description: The description details a mechanical device with a motor, software to control suction, a screen, and buttons. It focuses on the physical act of pumping milk.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like milk itself for diagnostic purposes), reagents, or any other components typically associated with IVD devices.
- Bench Testing: The performance studies described are bench tests focused on the mechanical performance of the pump (pressure, cycles per minute), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Lucina-Melodi Powered Breast Pump does not perform this function.
N/A
Intended Use / Indications for Use
The Lucina-Melodi Powered Breast Pump is intended to express and collect milk from the breasts of lactating women.
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.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lactating women
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 were done on the Lucina-Melodi Powered Breast Pump.
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.
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).
0
K102516 page lots
Traditional 510k Summary
AUG 1 1 2011
General Information
-
- Applicant:
Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 (t) 516.487.8787 (f) 516.487.7878 www.genadyne.com
- Applicant:
- 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)
1
K102516 page 2 of 5
8. Description of the Device
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.
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
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.
2
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 |
3
| 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.
4
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.
5
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
6
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
7
Indications for Use
510(k) Number (if known):
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)
OR
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