The ExploraMed NC7 Athena Breast Pump is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Device Description

The ExploraMed NC7 Athena Breast Pump (Athena) is a small electric breast pump that is intended for lactating women to express and collect breast milk. The subject device is intended for multiple uses with a single user. Athena may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, she would need to use two (2) Athena devices at the same time, one on each breast.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the Athena Breast Pump (K161266) and states that clinical testing was not required to demonstrate substantial equivalence. Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria, nor does it include details like sample sizes, ground truth establishment, or expert qualifications related to a clinical study.

The performance data listed pertains to bench testing, electrical safety, electromagnetic compatibility, biocompatibility, cleaning validation, and software validation. These tests are typically used to show that the device meets its design specifications and general safety standards, rather than clinical performance criteria.

Here's a breakdown of the requested information based only on the provided document:

A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria for clinical performance or reported clinical device performance. It lists various engineering and safety tests with the implication that the device met the requirements of the listed standards/guidances, but specific acceptance criteria for each test and detailed results are not presented.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No clinical test set data is provided, as clinical testing was not required.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical test set or ground truth derived from expert consensus is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication is mentioned.
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. The device is a breast pump, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a breast pump and does not involve an algorithm for standalone performance evaluation in this context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical ground truth was established for a performance study.
The sample size for the training set:
Not applicable, as no algorithm training set is mentioned for clinical performance.
How the ground truth for the training set was established:
Not applicable, as no algorithm training set is mentioned.

In summary, the provided document clearly states: "Clinical testing was not required to demonstrate substantial equivalence of the Athena to its predicate device." Therefore, the detailed information requested about clinical testing, acceptance criteria, sample sizes, and ground truth is not available within this document. The provided "Performance Data" section solely focuses on non-clinical engineering and safety validations.

Summary

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

August 11, 2016

ExploraMed NC7, Inc. Keri Y. Ng VP Regulatory, Quality, Clinical 201 San Antonio Circle #172 Mountain View, CA 94040

Re: K161266

Trade/Device Name: Athena Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 29, 2016 Received: June 30, 2016

Dear Keri Y. Ng:

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.

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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" (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 vours.

Douglas Silverstein -S 2016.08.11 14:22:47 -04'00'

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) K161266

Device Name Athena Breast Pump

Indications for Use (Describe)

The ExploraMed NC7 Athena Breast Pump is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary – K161266 Athena Breast Pump

Sponsor/Submitter:	ExploraMed NC7, Inc201 San Antonio Circle #172Mountain View, CA 94040
Contact Person:	John ChangVice President, R&DPhone: (650) 559-5805Fax: (650) 284-2552
Date Prepared:	August 11, 2016
Device Trade Name:	Athena Breast Pump
Common Name:	Breast Pump
Device Classification:	Class II
Regulation Number:	21 CFR 884.5160
Classification Name:	Pump, Breast, Powered
Product Code:	HGX
Predicate Device:	Medela Ag Freestyle Breast Pump (K150499)
Device Description:	The ExploraMed NC7 Athena Breast Pump (Athena) is a smallelectric breast pump that is intended for lactating women to expressand collect breast milk. The subject device is intended for multipleuses with a single user. Athena may be operated as a single ordouble pumping system. For a user to pump both breastssimultaneously, she would need to use two (2) Athena devices atthe same time, one on each breast.
Device Operation:	The user turns on the Pump by pressing the “On/Off” button andaligns the nipple in the Flange. Following alignment, the user startthe pumping session by pressing the “Play/Pause” button on thecontrol panel of the Pump. The subject device has two modes:Stimulation and Expression. The Pump starts pumping inStimulation mode at a moderate vacuum level to stimulate milkletdown from the user. After letdown, the Pump changes toExpression mode and increases the vacuum level. The user is ableto increase or decrease the vacuum level. When the pumpingsession ends, the user removes the Pump from the breast; separatesthe Flange from the Pump; and removes the Milk Bag. TheCharger can be inserted into the power port to charge the Pumpwhen not in use.
Indications for Use:	The ExploraMed NC7 Athena Breast Pump is intended to expressmilk from lactating women in order to collect milk from theirbreasts. The device is intended for a single user.
TechnologicalCharacteristics:	Athena generates suction and extracts breast milk. The Flange fitson the breast to create a seal and facilitate the suction. The Pumphas two modes and has user-adjustable suction levels ranging from60mmHg to 245mmHg.

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Substantial Equivalence Comparison

Attribute	Predicate DeviceMedela Ag Freestyle Breast Pump	Subject DeviceExploraMed NC7 Athena Breast Pump
510(k) number	K150499	K161266
Intended Use	Express milk from breast	Same, Express milk from breast
Single User	Yes	Same, Yes
Provided Non-Sterile	Yes	Same, Yes
Re-usable	Yes	Same, Yes
Direct User Contact	Yes	Same, Yes
TechnologicalCharacteristics	Electrical pressure control pumpingsystem to generate suction	Same, Electrical pressure controlpumping system to generate suction
Power Source	AC Adaptor or Li-Ion Battery	Same, Li-Ion Battery
Suction Levels(mmHg)	40-245	Same, 60-245
Adjustable SuctionLevels	Yes	Same, Yes
Suction Settings	9	7
Back Flow Protection	Yes	Same, Yes
Control Mechanism	Microcontroller	Same, Microcontroller
Single or DoublePumping	Single or Double	Same, Single or Double
Mobile	Yes	Same, Yes
Number of ReusableComponents ThatRequire Cleaning	5	2

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The physical characteristics of Athena are similar to the predicate device as demonstrated by the following:

Athena is intended to generate suction to express milk from a lactating mother, which is identical . to the predicate device.
Athena is reusable and provided non-sterile to the customer, which is the same as the predicate device.
The operating suction levels and suction cycles for Athena are within the established range for the predicate device.
. Both devices utilize a closed pumping system.
. Both devices use an electrical pressure control pumping system to generate suction.
. Athena has adjustable suction levels and a backflow protection mechanism, identical to the predicate device.
. Both the predicate device and subject device are intended to be portable.

The differences between the subject device and the predicate device are as follows:

There are seven (7) vacuum levels in Athena and nine (9) vacuum levels in the predicate device. ●
. Athena automatically switches from Stimulation mode to Expression mode. It does not allow the user to manually alternate between modes. The predicate device has a let-down button that allows the user to manually change phases.
Athena is operative via Li Ion battery and the predicate consists of Li Ion battery and AC adaptor.
. There are only two components that require manual cleaning in Athena; whereas, there are five components that require manual cleaning in the predicate.

The differences between the subject device and predicate device do not raise different questions of safety or efficacy.

Performance Data: The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.

Bench Testing
- Reliability testing o
- Vacuum Profile testing O
- O Sound testing
- Cycle Frequency testing O
- Dimensional testing O
- Bag Pressure testing O
- Bag Puncture Verification testing o
Electrical Safety ●
- IEC 60601-1+A1: 2012 O
- IEC 60601-1-11:2015 O
- IEC 60601-1-6: 2010 + A1:2013 O
- IEC 62366:2007 + A1: 2014 o
- IEC 62133:2012 o
Electromagnetic Compatibility ●
- o IEC 60601-1-2:2014
. Biocompatibility (ISO 10993-1)
- O Sensitization
- O Irritation
- Cytotoxicity O

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Cleaning Validation AAMI TIR 12:2010 AAMI TIR 30:2011 FDA Guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” issued March 17, 2015 (UCM253010). Software Validation FDA Guidance: “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” issued May 11, 2005.
Clinical Data:	Clinical testing was not required to demonstrate substantial equivalence of the Athena to its predicate device.
Animal Data:	No animal performance data was required to demonstrate substantial equivalence of the Athena to its predicate device.
Summary of Substantial Equivalence:	The ExploraMed NC7 Athena Breast Pump is substantially equivalent to the predicate device as confirmed through relevant performance tests and device attributes. Therefore, the ExploraMed NC7 Athena Breast Pump is as safe and effective as the predicate device.

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).