Athena Breast Pump

K161266 · Exploramed Nc7, Inc. · HGX · Aug 11, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K161266
• Device Name: Athena Breast Pump
• Applicant: Exploramed Nc7, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Aug 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Indications for Use

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 Story

Athena Breast Pump is a small, portable, electric device for lactating women to express and collect breast milk. User aligns nipple in flange; initiates session via control panel. Device operates in two modes: Stimulation (moderate vacuum for letdown) and Expression (higher vacuum). User adjusts vacuum levels (60-245 mmHg). System uses microcontroller-based electrical pressure control to generate suction. Device is single-user, reusable, and non-sterile. Powered by Li-Ion battery. After use, user separates flange from pump and removes milk bag. Benefits include portable, adjustable milk expression. Healthcare providers do not operate the device; it is for home use by the patient.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was demonstrated through bench testing, including reliability, vacuum profile, sound, cycle frequency, dimensional, bag pressure, and bag puncture verification testing.

Technological Characteristics

Electric breast pump; microcontroller-based pressure control system. Suction range: 60-245 mmHg. Two modes: Stimulation and Expression. Power: Li-Ion battery. Portable form factor. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1, 60601-1-11, 60601-1-6, 62366, 62133. EMC per IEC 60601-1-2.

Indications for Use

Indicated for lactating women to express and collect breast milk. Intended for single-user use.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Medela Ag Freestyle Breast Pump (K150499)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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, Inc<br>201 San Antonio Circle #172<br>Mountain View, CA 94040 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Chang<br>Vice President, R&D<br>Phone: [phone]<br>Fax: [phone] |
| 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 small<br>electric breast pump that is intended for lactating women to express<br>and collect breast milk. The subject device is intended for multiple<br>uses with a single user. Athena may be operated as a single or<br>double pumping system. For a user to pump both breasts<br>simultaneously, she would need to use two (2) Athena devices at<br>the same time, one on each breast. |
| Device Operation: | The user turns on the Pump by pressing the “On/Off” button and<br>aligns the nipple in the Flange. Following alignment, the user start<br>the pumping session by pressing the “Play/Pause” button on the<br>control panel of the Pump. The subject device has two modes:<br>Stimulation and Expression. The Pump starts pumping in<br>Stimulation mode at a moderate vacuum level to stimulate milk<br>letdown from the user. After letdown, the Pump changes to<br>Expression mode and increases the vacuum level. The user is able<br>to increase or decrease the vacuum level. When the pumping<br>session ends, the user removes the Pump from the breast; separates<br>the Flange from the Pump; and removes the Milk Bag. The<br>Charger can be inserted into the power port to charge the Pump<br>when not in use. |
| Indications for Use: | The ExploraMed NC7 Athena Breast Pump is intended to express<br>milk from lactating women in order to collect milk from their<br>breasts. The device is intended for a single user. |
| Technological<br>Characteristics: | Athena generates suction and extracts breast milk. The Flange fits<br>on the breast to create a seal and facilitate the suction. The Pump<br>has two modes and has user-adjustable suction levels ranging from<br>60mmHg to 245mmHg. |

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### Substantial Equivalence Comparison

| Attribute | Predicate Device<br>Medela Ag Freestyle Breast Pump | Subject Device<br>ExploraMed 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 |
| Technological<br>Characteristics | Electrical pressure control pumping<br>system to generate suction | Same, Electrical pressure control<br>pumping system to generate suction |
| Power Source | AC Adaptor or Li-Ion Battery | Same, Li-Ion Battery |
| Suction Levels<br>(mmHg) | 40-245 | Same, 60-245 |
| Adjustable Suction<br>Levels | Yes | Same, Yes |
| Suction Settings | 9 | 7 |
| Back Flow Protection | Yes | Same, Yes |
| Control Mechanism | Microcontroller | Same, Microcontroller |
| Single or Double<br>Pumping | Single or Double | Same, Single or Double |
| Mobile | Yes | Same, Yes |
| Number of Reusable<br>Components That<br>Require 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. |