(121 days)
Not Found
No
The description focuses on standard electronic and mechanical components (microprocessor, vacuum pump, battery) and a mobile app that replicates the physical controls. There is no mention of adaptive algorithms, learning from user data, or any other characteristics typically associated with AI/ML in medical devices.
No.
A breast pump, while assisting in a physiological process, is not typically classified as a therapeutic device. Therapeutic devices are generally intended to treat or alleviate a disease, injury, or medical condition. Breast pumps facilitate milk expression but do not treat a medical condition.
No
The device is a breast pump, used to express and collect milk. It does not diagnose any medical condition.
No
The device description clearly states it is an "electric breast pump" with physical components like a vacuum pump, battery, power button, mode button, and touch wheel. While it has a mobile app that replicates the controls, the core functionality and milk expression are performed by the physical hardware.
Based on the provided information, the Naya Breast Pump System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "express and 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.
- Device Description: The description details a mechanical pump that generates suction to extract milk. It does not mention any analysis or testing of biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information about a person's health or condition. The Naya Breast Pump System does not perform this function.
The device is a medical device, specifically a powered breast pump, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Naya Breast Pump System is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Naya Breast Pump System is a personal use electric breast pump capable of single or double pumping. The device is electrically powered from either an internal rechargeable battery or an external supply. The external supply also charges the battery. The device can also connect to an iPhone (iOS 8.0+) application (Mobile App) that replicates the front panel controls and indicators on the pump.
The Naya Breast Pump System may be used in the hospital or home setting. The Pump may be used by different users, but one person at a time. The Distal Breast Assembly (DBA) is intended as a single user component.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 260 mmHg. The Naya Breast Pump System is powered by a rechargeable battery or from mains.
The User Interface with the pump is:
- Power Button
- Mode Button
- Touch Wheel
The Mobile App looks identical to the pump user interface in that the same three interface points are present.
The device has two modes of operation:
- Stimulation Mode: Suction pattern with fast cycles and low vacuum to start milk flowing
- Flow Mode: Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lactating women in the hospital or home setting
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)
We have performed a number of bench tests to demonstrate the Naya Breast Pump System performs within its specifications. These tests included:
- Breast Shield Assembly (BSA) Concentrated Cleaning
- Biocompatibility Test
- Software Verification
- ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 Test
- Pump Drive Systems (PDS)
- User Interface pre- and post- conditioning
- Battery pre- and post- aging
- Breast Shield Assembly (BSA)
- Fluid Isolation & Drainage
- Functional pre- and post- aging
- Conditioning Test
- Lifetime Cycling
The materials were tested as Surface contact, Intact skin, and Limited duration (
§ 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 features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
Naya Health Inc. % Paul Dryden Consultant 390 Bridge Pkwy. Suite C Redwood City, CA 94065
Re: K160511 Trade/Device Name: Naya Breast Pump System Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: Class II Product Code: HGX Dated: May 20, 2016 Received: Mav 23, 2016
Dear Paul Dryden,
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 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
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160511
Device Name
Nava Breast Pump System
Indications for Use (Describe)
The Naya Breast Pump System is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts.
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14
Page 1 of 1
SC Publishing Services (301) 443-6740
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510(k) Summary Page 1 of 4
| Date of Preparation: | 21-Jun-16 |
|---|---|
| Naya Health, Inc. | |
| 390 Bridge Pkwy, Suite C | |
| Redwood City, CA 94065 | Tel - 650-346-6271 |
| Fax - 847-680-6269 | |
| Official Contact: | Janica B. Alvarez - Co-founder and CEO |
| Proprietary or Trade Name: | Naya Breast Pump System |
| Common/Usual Name: | Powered breast pump |
| Classification Name: | Powered breast pump |
| HGX - CFR 884.5760 | |
| Class II - OTC | |
| Predicate Devices: | K151632 - Medela - Symphony |
Device Description:
The Naya Breast Pump System is a personal use electric breast pump capable of single or double pumping. The device is electrically powered from either an internal rechargeable battery or an external supply. The external supply also charges the battery. The device can also connect to an iPhone (iOS 8.0+) application (Mobile App) that replicates the front panel controls and indicators on the pump.
The Naya Breast Pump System may be used in the hospital or home setting. The Pump may be used by different users, but one person at a time. The Distal Breast Assembly (DBA) is intended as a single user component.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 260 mmHg. The Naya Breast Pump System is powered by a rechargeable battery or from mains.
The User Interface with the pump is:
- Power Button
- . Mode Button
- . Touch Wheel
The Mobile App looks identical to the pump user interface in that the same three interface points are present.
The device has two modes of operation:
- Stimulation Mode: Suction pattern with fast cycles and low vacuum to start milk ● flowing
- . Flow Mode: Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
4
510(k) Summary Page 2 of 4 21-Jun-16
Indications for Use:
The Naya Breast Pump System is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts.
| Patient Population: | Lactating women |
|---|---|
| Environment of use: | Home and / or hospital settings |
| Contraindications: | None |
Table 1 below presents a comparison between the proposed device and the predicate.
Substantial Equivalence Discussion of Comparison to Predicates
The Naya Breast Pump System is viewed as substantially equivalent to the predicate device because:
Indications -
Indications for use are to express milk of lactating women ● Discussion - These are the identical indications for use of the predicate - Medela -Symphony - K151632.
Technology -
- The technology of a reciprocating diaphragm vacuum pump to express milk and the ● flange and collection bottle system are similar to the predicate. The power source, user controls, ability to adjust vacuum level and pump mode are similar to the predicate.
Discussion - The technology and performance specifications for the proposed device are similar to the predicate - Medela - Symphony - K151632.
Materials -
- The materials which are in contact with the user and the expressed milk are considered by ● ISO 10993-1 as having the following classification:
- . Surface contact, Intact skin, Limited duration (