(98 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description and performance studies focus on standard electrical and mechanical aspects of a breast pump.
No
The device is intended to express and collect breast milk, and does not claim to treat or alleviate a disease or condition.
No.
The device's intended use is to express and collect milk from lactating women, which is a collection/assistive function, not a diagnostic one.
No
The device description explicitly states it is a "small electric breast pump," indicating it is a hardware device with electrical components. The performance studies also include bench testing, electrical safety, and electromagnetic compatibility, which are typical for hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express milk from lactating women in order to collect milk from their breasts." This is a physical process performed on the body, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description confirms it's a "small electric breast pump" used to "express and collect breast milk." This aligns with a physical device for external use.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
The ExploraMed NC7 Athena Breast Pump is a medical device, but it falls under the category of devices used for physical intervention or support, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HGX
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.
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
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)
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
- Vacuum Profile testing
- Sound testing
- Cycle Frequency testing
- Dimensional testing
- Bag Pressure testing
- Bag Puncture Verification testing
- Electrical Safety
- IEC 60601-1+A1: 2012
- IEC 60601-1-11:2015
- IEC 60601-1-6: 2010 + A1:2013
- IEC 62366:2007 + A1: 2014
- IEC 62133:2012
- Electromagnetic Compatibility
- IEC 60601-1-2:2014
- Biocompatibility (ISO 10993-1)
- Sensitization
- Irritation
- Cytotoxicity
- 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 testing was not required to demonstrate substantial equivalence of the Athena to its predicate device.
No animal performance data was required to demonstrate substantial equivalence of the Athena to its predicate device.
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.
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines beneath them.
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.
1
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
2
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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3
510(K) Summary – K161266 Athena Breast Pump
| Sponsor/Submitter: | ExploraMed NC7, Inc
201 San Antonio Circle #172
Mountain View, CA 94040 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Chang
Vice President, R&D
Phone: (650) 559-5805
Fax: (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 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. |
| Device Operation: | The user turns on the Pump by pressing the “On/Off” button and
aligns the nipple in the Flange. Following alignment, the user start
the pumping session by pressing the “Play/Pause” button on the
control panel of the Pump. The subject device has two modes:
Stimulation and Expression. The Pump starts pumping in
Stimulation mode at a moderate vacuum level to stimulate milk
letdown from the user. After letdown, the Pump changes to
Expression mode and increases the vacuum level. The user is able
to increase or decrease the vacuum level. When the pumping
session ends, the user removes the Pump from the breast; separates
the Flange from the Pump; and removes the Milk Bag. The
Charger can be inserted into the power port to charge the Pump
when not in use. |
| 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. |
| Technological
Characteristics: | Athena generates suction and extracts breast milk. The Flange fits
on the breast to create a seal and facilitate the suction. The Pump
has two modes and has user-adjustable suction levels ranging from
60mmHg to 245mmHg. |
4
Substantial Equivalence Comparison
| Attribute | Predicate Device
Medela Ag Freestyle Breast Pump | Subject Device
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
Characteristics | Electrical pressure control pumping
system to generate suction | Same, Electrical pressure control
pumping 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 Suction
Levels | Yes | Same, Yes |
| Suction Settings | 9 | 7 |
| Back Flow Protection | Yes | Same, Yes |
| Control Mechanism | Microcontroller | Same, Microcontroller |
| Single or Double
Pumping | Single or Double | Same, Single or Double |
| Mobile | Yes | Same, Yes |
| Number of Reusable
Components That
Require Cleaning | 5 | 2 |
5
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
6
| 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. |