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: 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Megna Breast Pumps (Models M5, M7, M10, and M12), which are powered breast pumps. The document focuses on demonstrating substantial equivalence to a predicate device (K113664, Closer to Nature Electric Breast Pump).

Here's an analysis based on your request:

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating that the Megna Breast Pumps meet various safety and performance standards equivalent to a predicate device, rather than defining specific diagnostic acceptance criteria for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this document is for a breast pump, the "acceptance criteria" are related to safety, electrical performance, biocompatibility, and functional specifications, compared to a predicate device. The "reported device performance" are the results of these tests and comparisons.

Acceptance Criteria Category (implied)	Specific Tests / Performance	Reported Device Performance
Biocompatibility	Skin irritation test (0.9% sodium chloride extract, Sesame oil extract)	Massage pad on outer rim of breast shield passed.
	Skin Sensitization Test (0.9% sodium chloride extract, Sesame Oil extract)	Massage pad on outer rim of breast shield passed.
	In Vitro Cytotoxicity Test	Massage pad on outer rim of breast shield passed.
Food Safety (Milk Contacting Materials)	21 CFR 177.2600 (total extractives from rubber articles)	Cylinder, Nipple and Silicone Sealant, Membrane passed.
	21 CFR 177.1520 (extractable/soluble fraction for polypropylene)	Pump Body, Sealing Cover, Bottle passed.
Material Composition	Not manufactured with BPA	Device labeling states it is not manufactured with BPA.
Software Validation	FDA guidance and product specifications	Software for all 4 models was validated.
Electrical Safety	IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1:2012; IEC 60601-1-11: 2010-04 (Home Healthcare)	All models (M5, M7, M10, M12) passed these standards.
EMC Testing	EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007	All models (M5, M7, M10, M12) passed these standards.
Performance - Backflow	No milk able to back flow into pump	Backflow testing showed that no milk is able to back flow into the pump.
Performance - Cleaning Validation	Cleaning procedures do not affect device performance	Cleaning Validation Testing showed that after cleaning procedures as recommended in the user manual do not affect device performance.
Performance - Suction	Suction strength and cycle speed specifications	Suction curves for each mode for each model show that the device performs to suction strength and cycle speed specifications (specific ranges provided in the "Device Comparison Table" for suction strength and cycle speed across models M5, M7, M10, M12, and compared to predicate). Differences are deemed "not significant."
Indications for Use (Equivalence)	Express and collect milk from the breast of a lactating woman	Proposed device (Megna Breast Pumps) and predicate device (Closer to Nature Electric Breast Pump) have the same indication.
Technological Characteristics (Equivalence)	Pumping Options, Back Flow Protection, Pump Type, Power Supply, Cycling/Suction Control Mechanism, Number of Suction Levels, Suction Strength, Cycle Speed, Suction Flow Rate	Similarities noted (e.g., Reciprocating Diaphragm, Microprocessor control, yes backflow protection, single/double pumping option). Differences in specific values (e.g., suction strength, cycle speed, flow rate) are presented and deemed "not significant" or not raising new safety/effectiveness concerns.

2. Sample size used for the test set and the data provenance:

The document pertains to the regulatory clearance of a physical medical device (breast pump), not an AI/ML algorithm that processes diagnostic images or data. Therefore, the concept of a "test set" in the context of an AI/ML model's performance on patient data is not applicable here. The "tests" mentioned are engineering and material compatibility tests performed on the device components or prototypes. No information on "data provenance" (country of origin, retrospective/prospective) for clinical or diagnostic data is provided because such data is not relevant to this type of device clearance based on the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The device is a breast pump, not an AI/ML diagnostic or predictive tool. "Ground truth" in the context of expert consensus on medical conditions is not relevant here. The "truth" is established by adherence to engineering standards, material safety regulations, and a comparison to the functional specifications of a legally marketed predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for a physical device clearance. Adjudication methods are typically used in clinical studies to resolve disagreements among experts when establishing ground truth for diagnostic AI/ML systems.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a breast pump, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device clearance is adherence to established regulatory standards (e.g., 21 CFR, ISO 10993, IEC 60601, EN 60601), successful completion of specific engineering and material tests, and demonstrable functional equivalence to a legally marketed predicate device. There is no biological or diagnostic "ground truth" in the AI/ML sense.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML model that undergoes training.

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

Not applicable. No AI/ML training set is mentioned or implied.

In summary, the provided document is a 510(k) summary for a powered breast pump. It details the device's compliance with various safety and performance standards and its substantial equivalence to a predicate device, rather than addressing the specific criteria and study design relevant to AI/ML device validation.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K142479

Device Name

Megna Breast Pumps (Models M5, M7, M10 and M12)

Indications for Use (Describe)

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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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 DistrictWuxi City, Jiangsu 214000ChinaPhone: +86-510-81155000Fax: +86-510-81155898
Contact:	David Zeng, PhDPresidentMegna Inc.1043 Andrew DriveWest Chester, PA 19380Phone (610) 590-1768Fax (610) 628-9308Email: 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:

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. 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.

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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

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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 BreastPump
Product Code	HGX	HGX
Indication	The Megna Breast Pumpsare intended to express andcollect milk from thebreast of a lactatingwoman.	Tommee Tippee Closer to NatureDouble Electric Breast Pump isused to express and collect milkfrom the breast of a lactatingwoman.
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 DCAdaptor or 4 1.5V batteriesM10: 6V DC Adaptor	9V DC Adaptor or rechargeable 7.4Vlithium polymer battery
Cycling/Suction ControlMechanism	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 - 450mbar)Double: 97.5 - 210mmHg (130-360mbar)
	M7:Single & Double:68 - 300 mmHg (90 - 400mbar)
	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

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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.

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).