(173 days)
Not Found
No
The summary describes a standard electrically powered breast pump with digital controls and various models. There is no mention of AI, ML, or any features that would suggest the use of such technologies. The performance studies focus on standard safety and performance metrics for breast pumps.
No.
The device is intended to express and collect milk from the breast of a lactating woman, which is not a therapeutic medical purpose.
No
Explanation: The device is a breast pump intended to express and collect milk, and the provided information focuses on its mechanical and electrical performance, and safety, not on diagnosing any medical condition.
No
The device description explicitly states that the Megna breast pumps are "electrically powered breast pumps" and mentions electrical safety and EMC testing, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breast of a lactating woman." This is a physical process, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details an electrically powered breast pump used to express milk. This aligns with a physical device for collecting a bodily fluid, not a diagnostic tool.
- Lack of Diagnostic Activity: There is no mention of analyzing a sample (like milk, blood, or tissue) to diagnose a condition, monitor a disease, or determine a physiological state.
- Performance Studies: The performance studies focus on the physical and electrical safety and functionality of the pump (biocompatibility, food safety, software validation, electrical safety, EMC, backflow, cleaning validation, suction curves). These are not studies related to diagnostic accuracy or performance.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. The Megna Breast Pump's function is to physically extract milk, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The powered Megna Breast Pumps are intended to express and collect milk from the breast of a lactating woman. The M5 model is a single pump. The M7, M10, and M12 models are double pumps with a single pumping option. All models are intended for single users.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Megna breast pumps are electrically powered breast pumps for over-the-counter use, intended to be used at home to express a nursing mother's breast milk.
The Megna breast pumps are provided in 4 models:
- Model M5 - Megna Digital Single Breast Pump
- Model M7 Megna Digital Double Breast Pump
- Model M10 - Megna Digital Double Breast Pump
- Model M12 - Megna Digital Double Breast Pump
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home healthcare environment
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)
Biocompatibility Testing -
The patient contacting component of all four of the Megna breast pump models is the massage pad on the outer rim of the breast shield. The following biocompatibility testing was conducted on this material:
- Skin irritation test of massage pad ISO 10993-10:2010-0.9% sodium chloride extract
- Skin irritation test of massage pad ISO 10993-10:2010 Sesame oil Extract
- Skin Sensitization Test of massage pad ISO 10993-10:2010 0.9% sodium chloride extract
- Skin Sensitization Test of massage pad ISO 10993-10:2010 0.9% Sesame Oil Extract
- In Vitro Cytotoxicity Test of massage pad ISO 10993-5:2009
Food Safety Testing for all Milk Contacting Materials -
The milk contacting components of all four of the Megna breast pump models are the cylinder, membrane, nipple, silicone sealant, bottle, pump body and sealing cover.
The following food safety testing was conducted on each of the components:
21 CFR 177.2600 - determining the amount of total extractives from rubber articles intended for repeated use:
- Cylinder, Nipple and Silicone Sealant
- Membrane
21 CFR 177.1520 - determining extractable fraction in n-hexane and soluble fraction in xylene for polypropylene used in contact with food: - Pump Body
- Sealing Cover
- Bottle
Not Manufactured with BPA -
The device labeling states that it is not manufactured with BPA.
Software Validation -
The software for each of the 4 models was validated in accordance with FDA guidance and product specifications.
Electrical Safety Testing -
Model M10-
- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1:2012
- IEC 60601-1-11: 60601-1-11 Edition 1.0 2010-04, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Models M5, M7, M12- - IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1: 2012
- IEC 60601-1-11: 60601-1-11 Edition 1.0 2010-04, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EMC Testing -
Model M10 -
- EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007
Models M5, M7, M12 - - EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007
Performance Testing -
The following performance tests were conducted on all four models:
- Backflow testing showed that no milk is able to back flow into the pump.
- Cleaning Validation Testing showed that after cleaning procedures as recommended in the user manual do not affect device performance.
- Suction curves for each mode for each model show that the device performs to suction strength and cycle speed specifications.
Testing Summary:
The non-clinical testing described above show that the Megna Breast Pumps meet their product specifications and relevant safety testing for their intended use. The testing shows that no new issues of safety or effectiveness are raised in comparison to the predicate device and therefore support a decision of substantial equivalence.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2015
Wuxi Xinzhongrui Baby Supplies Co., Ltd. % David Zeng, Ph.D. Consultant Megna, Inc. 1043 Andrew Drive West Chester, PA 19380
Re: K142479
Trade/Device Name: Megna Breast Pumps (Models M5, M7, M10 and M12) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: January 27, 2015 Received: January 28, 2015
Dear Dr. David Zeng,
This letter corrects our substantially equivalent letter of February 24, 2015.
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
1
Page 2 - Dr. David Zeng
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 device-related 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 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" (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 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
2
Indications for Use
510(k) Number (if known) K142479
Device Name
Megna Breast Pumps (Models M5, M7, M10 and M12)
Indications for Use (Describe)
The powered Megna Breast Pumps are intended to express and collect milk from the breast of a lactating woman. The M5 model is a single pump. The M7, M10, and M12 models are double pumps with a single pumping option. All models are intended for single users.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Megna Breast Pumps is provided below.
| Device Common Name: | Powered Breast Pump |
|---|---|
| Device Proprietary Name: | Megna Breast Pumps (Models M5, M7, M10 and M12) |
| Submitter: | Wuxi Xinzhongrui Baby Supplies Co., Ltd. |
| No.117 Xinhua Road, Meicun, New District | |
| Wuxi City, Jiangsu 214000 | |
| China | |
| Phone: +86-510-81155000 | |
| Fax: +86-510-81155898 | |
| Contact: | David Zeng, PhD |
| President | |
| Megna Inc. | |
| 1043 Andrew Drive | |
| West Chester, PA 19380 | |
| Phone (610) 590-1768 | |
| Fax (610) 628-9308 | |
| Email: david.zeng@megnainc.com | |
| Date Prepared: | February 24, 2015 |
| Classification Regulation: | 21 CFR 884.5160 |
| Classification Name: | Powered Breast Pump |
| Panel: | Obstetrics/Gynecology |
| Product Code: | HGX |
| Predicate Device: | K113664, Closer to Nature Electric Breast Pump |
Indication for Use:
The powered Megna Breast Pumps are intended to express and collect milk from the breast of a lactating woman.
The M5 model is a single pump. The M7, M10, and M12 models are double pumps with a single pumping option. All models are intended for single users.
Device Description:
The Megna breast pumps are electrically powered breast pumps for over-the-counter use, intended to be used at home to express a nursing mother's breast milk.
The Megna breast pumps are provided in 4 models:
4
- . Model M5 - Megna Digital Single Breast Pump
- Model M7 Megna Digital Double Breast Pump ●
- . Model M10 - Megna Digital Double Breast Pump
- Model M12 - Megna Digital Double Breast Pump
Summary of Non-Clinical Testing:
Biocompatibility Testing -
The patient contacting component of all four of the Megna breast pump models is the massage pad on the outer rim of the breast shield. The following biocompatibility testing was conducted on this material:
- Skin irritation test of massage pad ISO 10993-10:2010-0.9% sodium chloride . extract
- Skin irritation test of massage pad ISO 10993-10:2010 Sesame oil Extract ●
- Skin Sensitization Test of massage pad ISO 10993-10:2010 0.9% sodium chloride ● extract
- Skin Sensitization Test of massage pad ISO 10993-10:2010 0.9% Sesame Oil . Extract
- In Vitro Cytotoxicity Test of massage pad ISO 10993-5:2009 .
Food Safety Testing for all Milk Contacting Materials -
The milk contacting components of all four of the Megna breast pump models are the cylinder, membrane, nipple, silicone sealant, bottle, pump body and sealing cover.
The following food safety testing was conducted on each of the components:
21 CFR 177.2600 - determining the amount of total extractives from rubber articles intended for repeated use:
- . Cylinder, Nipple and Silicone Sealant
- Membrane .
21 CFR 177.1520 - determining extractable fraction in n-hexane and soluble fraction in xylene for polypropylene used in contact with food:
- Pump Body .
- Sealing Cover .
- . Bottle
Not Manufactured with BPA -
The device labeling states that it is not manufactured with BPA.
5
Software Validation -
The software for each of the 4 models was validated in accordance with FDA guidance and product specifications.
Electrical Safety Testing -
The following electrical safety testing was conducted in each of the models:
Model M10-
- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC ● 60601-1:2012
- IEC 60601-1-11: 60601-1-11 Edition 1.0 2010-04, Medical electrical equipment -. Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Models M5, M7, M12-
- . IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1: 2012
- IEC 60601-1-11: 60601-1-11 Edition 1.0 2010-04, Medical electrical equipment -. Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EMC Testing -
The following electromagnetic compatibility testing was conducted on each of the models:
Model M10 -
-
EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007 .
Models M5, M7, M12 - -
. EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007
Performance Testing -
The following performance tests were conducted on all four models:
- Backflow testing showed that no milk is able to back flow into the pump. ●
- Cleaning Validation Testing showed that after cleaning procedures as recommended in . the user manual do not affect device performance.
- Suction curves for each mode for each model show that the device performs to suction . strength and cycle speed specifications.
Testing Summary:
The non-clinical testing described above show that the Megna Breast Pumps meet their product specifications and relevant safety testing for their intended use. The testing shows that no new
6
issues of safety or effectiveness are raised in comparison to the predicate device and therefore support a decision of substantial equivalence.
Substantial Equivalence:
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | TBD | K113664 |
| Submitter | Megna | Mayborn Group Limited |
| Classification Regulation | 884.5160, Class II | 884.5160, Class II |
| Device Name | Megna Breast Pumps | |
| (Models M5, M7, M10 & | ||
| M12) | Closer to Nature Electric Breast | |
| Pump | ||
| Product Code | HGX | HGX |
| Indication | The Megna Breast Pumps | |
| are intended to express and | ||
| collect milk from the | ||
| breast of a lactating | ||
| woman. | Tommee Tippee Closer to Nature | |
| Double Electric Breast Pump is | ||
| used to express and collect milk | ||
| from the breast of a lactating | ||
| woman. | ||
| Pumping Options | Single or Double | Single or Double |
| Back Flow Protection | Yes | Yes |
| Pump Type | Reciprocating Diaphragm | Reciprocating Diaphragm |
| Power Supply | M5, M7 & M12: 6V DC | |
| Adaptor or 4 1.5V batteries | ||
| M10: 6V DC Adaptor | 9V DC Adaptor or rechargeable 7.4V | |
| lithium polymer battery | ||
| Cycling/Suction Control | ||
| Mechanism | Microprocessor | Microprocessor |
| Number of Suction Levels | M5: 5 | 5 |
| M7: 9 | ||
| M10: 9 | ||
| M12: 9 | ||
| Suction Strength | M5: | |
| Single: 120 - 304mmHg (160 |
- 405 mbar) | Single: 150 - 285 mmHg (200 - 450
mbar)
Double: 97.5 - 210mmHg (130-360
mbar) |
| | M7:
Single & Double:
68 - 300 mmHg (90 - 400
mbar) | |
| | Proposed Device | Predicate Device |
| | M10: | |
| | Single: 60 - 297 mmHg (80 -
395 mbar) | |
| | Double: 60 - 300 mmHg (80 - 400 mbar) | |
| | M12: | |
| | Single: 60- 297 mmHg (80 -
395 mbar) | |
| | Double: 64 - 297 mmHg (85 - 395 mbar) | |
| Cycle Speed | M5: 26-80 cycles / min | |
| | M7: 15-68 cycles / min | |
| | M10: 38 - 139 cycles / min | Fixed: 34 cycles per minute |
| | M12: 13-48 cycles / min | |
| Suction Flow Rate | M5: | |
| | Single: 20 – 80 ml / min | |
| | M7: | |
| | Single: 20 - 99 ml / min | |
| | M10: | Single: 32 - 58 ml / min |
| | Single: 9 - 65 ml / min | Double: 26 - 54 ml / min |
| | Double: 10 - 67 ml / min | |
| | M12: | |
| | Single: 10 - 82 ml / min | |
| | Double: 10 - 83 ml / min | |
Table 1: Device Comparison Table
7
Substantial Equivalence Summary:
As shown above the subject device and the predicate device are similar in both indications for use and technological characteristics. The differences in suction strength, cycle speed and flow rate are not significant and do not raise new questions of safety or effectiveness. The similarities in indications and technological characteristics, combined with the testing summarized above indicate that the Megna breast pumps can be found substantially equivalent to the predicate device as cleared in K113664.