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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Naya Breast Pump System. It focuses on demonstrating substantial equivalence to a predicate device (Medela Symphony) rather than presenting a study proving that the device meets specific acceptance criteria related to an AI's performance, as the request implies. The device in question is a physical breast pump, not an AI-powered diagnostic or predictive tool.

Therefore, most of the information requested (AI acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone AI performance, training set details) is not applicable to this document.

However, I can extract information related to the device's functional performance and equivalence to its predicate, as outlined in the document.

Here's a breakdown of what can be extracted and what cannot:

Information NOT APPLICABLE / NOT FOUND in the document:

1. A table of acceptance criteria and the reported device performance (for AI-specific metrics): This document does not describe AI-specific acceptance criteria or performance metrics. It describes the device's functional attributes and compares them to a predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned in the context of an AI study. The document mentions "bench tests" and "non-clinical performance testing," which are engineering validations, not clinical studies with patient data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What can be inferred or extracted from the document regarding the device's performance and validation:

The document focuses on demonstrating substantial equivalence to an existing predicate device (Medela Symphony) based on similarities in:

Intended Use
Technology
Materials
Environment of Use
Patient Population
Non-Clinical Performance Testing

Table of Device Attributes vs. Predicate:

The document provides a "Comparison of the Proposed Device to the Predicate" (Table 1 on page 6). This isn't "acceptance criteria" in the AI sense, but rather a comparison of specifications to show equivalence.

Attribute	Proposed Naya Breast Pump System	Medela Symphony (Predicate) K151632	Note (Acceptance "Proxy")
Intended Use	A powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts.	A powered breast pump to be used by lactating women to express and collect milk from their breast.	Identical. This is a critical point for substantial equivalence. "Acceptance" is that it performs the same fundamental function.
Patient population	Lactating women	Lactating women	Identical.
Environment of use	Home and Hospital	Home and Hospital	Identical.
OTC	Yes	Yes	Identical.
Power Source	Input: 100-240 VAC, 50/60Hz, 2.1A; 1 x 14.8V / 3200 mAh Rechargeable Li-ion Battery	Input: 100-240 VAC, 50/60Hz, 0.3A; 2 x 6V / 1.2 Ah Rechargeable Pb batteries	Different specifications but similar function. The acceptance is that the proposed power source is safe and effective for its purpose, as validated by electrical safety tests (ES60601-1, IEC 60601-1-2, IEC 60601-1-11).
Pump Style	Reciprocating Pump	Diaphragm pump	Similar function, different mechanism. Both use a vacuum pump (the predicate is a diaphragm pump, the proposed is a reciprocating diaphragm vacuum pump). The acceptance is that the new mechanism achieves comparable performance.
Single/double Pumping	Both	Both	Identical.
Adjustable Suction Levels	10 levels	16 levels	Different number of levels, but both offer adjustability. The acceptance is that 10 levels are sufficient for the intended use and performance.
Cycle Speed	34 - 120	45 - 120	Overlapping range. The proposed device has a slightly wider range. The acceptance is that this range is safe and effective.
Overflow Protection	Yes (diaphragm)	Yes (diaphragm)	Identical. Critical safety feature.
Vacuum range - double (mmHg)	50-250	75-200	Overlapping ranges. Wider range for the proposed device, particularly on the lower end. Accepted if demonstrably safe and effective.
Vacuum range - single (mmHg)	50-260	75-270	Overlapping ranges. Wider range for the proposed device on the lower end, similar on the higher end. Accepted if demonstrably safe and effective.
Cycling/Suction Control Mechanism	Microprocessor	Microprocessor	Identical.
Accessories	Flange (Breast Shield Assembly), including tubing, check valve and puck diaphragm; Bottle (Collection Cup)	Flange / Soft Flange; Tubing; Check valve; Diaphragm; Bottle	Similar components. The acceptance is that these components work effectively and safely with the proposed pump.
Software	Yes (with Mobile App that replicates pump UI)	Yes	Similar functionality with added mobile app control. Acceptance is that the mobile app does not introduce new safety concerns and functions identically to the physical interface.
Cleaning method for Accessories	Soap and warm water	Soap and warm water; Boiling water	Similar cleaning methods. The predicate allows for boiling. Acceptance is that the stated cleaning method for the Naya system is adequate for hygiene and material integrity.
Materials in contact with user and expressed milk tested per ISO 10993-1	Cytotoxicity, Sensitization, Intracutaneous (No natural latex, certified for food-contact per 21 CFR 174-179)	(Not explicitly detailed for predicate in this table, but assumed to meet standards)	Compliance with ISO 10993-1. This indicates biological safety acceptance.
Electrical Safety	ES60601-1, IEC 60601-1-2, IEC 60601-1-11 home use	UL 1431	Compliance with recognized electrical safety standards. The acceptance is meeting these standards for safe operation.
Flange offered in multiple sizes	Yes	Yes	Identical.

Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" is a collection of Non-Clinical Performance Testing and a comparison ("Substantial Equivalence Discussion") to the predicate device.

Bench Tests/Non-Clinical Performance Testing Summary:
- Breast Shield Assembly (BSA) Concentrated Cleaning
- Biocompatibility Test (meets ISO 10993 requirements: Cytotoxicity, Intracutaneous reactivity, Sensitization for Surface contact, Intact skin, Limited duration (< 24 hours); no natural latex, food-contact certified per 21 CFR 174-179).
- Software Verification (for the mobile app, ensuring it "look[s] and perform[s] exactly like the interface on the pump").
- Electrical Safety/EMC/Home Use Tests: ES 60601-1, IEC 60601-1-2, IEC 60601-1-11.
- Pump Drive Systems (PDS) testing: User Interface pre- and post-conditioning; Battery pre- and post-aging.
- Breast Shield Assembly (BSA) testing: Fluid Isolation & Drainage; Functional pre- and post-aging; Conditioning Test; Lifetime Cycling.
Methodology: The document states "We have performed a number of bench tests to demonstrate the Naya Breast Pump System performs within its specifications." These tests are implicitly the "proof" that the device is safe and effective and/or performs comparably to the predicate.
Ground Truth: For a physical device, the "ground truth" and "acceptance criteria" are typically defined by engineering specifications, validated safety standards (e.g., ISO, IEC), and functional performance expected from such a device (e.g., ability to generate vacuum, withstand use, biocompatibility). The study aims to demonstrate that the Naya pump meets these established engineering and safety standards, and its performance is at least equivalent to the predicate.

In summary, this document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the criteria for "acceptance" and "proof" differ significantly from what would be expected for an AI system. The key here is "substantial equivalence" based on engineering and safety testing, not AI performance metrics or human-in-the-loop studies.

Summary

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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

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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

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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

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510(k) Summary Page 1 of 4

Date of Preparation:	21-Jun-16

Naya Health, Inc.390 Bridge Pkwy, Suite CRedwood City, CA 94065	Tel - 650-346-6271Fax - 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 pumpHGX - CFR 884.5760Class II - OTC
Predicate Devices:	K151632 - Medela - Symphony

Device Description:

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.

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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 (< 24 hours) tests performed included: Cytotoxicity, Intracutaneous reactivity, and Sensitization.

Discussion - The materials are similar and have been found to meet ISO 10993 requirements and thus can be substantially equivalent for safety as the predicate - Medela - Symphony -K151632.

Environment of Use -

The environment of use, home and / or hospital is identical to the predicate. ● Discussion - The environment of use is identical to the predicate - Medela - Symphony -K151632.

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510(k) Summary Page 3 of 4 21-Jun-16

Patient Population -

The patient population is lactating women is identical to the predicate. ● Discussion - The user population is identical to the predicate - Medela - Symphony -K151632.

Non-Clinical Performance Testing Summary

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) ●
- O User Interface pre- and post- conditioning
- O Battery pre- and post- aging
. Breast Shield Assembly (BSA)
- Fluid Isolation & Drainage o
- Functional pre- and post- aging O
- Conditioning Test o
- o Lifetime Cycling

Materials -

The materials were tested as Surface contact, Intact skin, and Limited duration (< 24 hours): Cytotoxicity, Intracutaneous reactivity, and Sensitization. In addition the material contains no natural latex and are certified for food-contact in accordance with 21 CFR 174-179.

Discussion of Differences

The basic design, performance and features of the Naya Breast Pump System are similar to the predicate. The notable differences are:

. The ability to also control the device via a mobile App.
- o We have evaluated this App and it is configured to look and perform exactly like the interface on the pump.

These differences do not raise any new safety concerns and supports substantially equivalence.

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510(k) Summary Page 4 of 4 21-Jun-16

Attribute	ProposedNaya Breast Pump System	MedelaSymphonyK151632
Intended Use	The Naya Breast Pump System isa powered breast pump to be usedby lactating women in thehospital or home setting toexpress and collect milk fromtheir breasts.	The Symphony breast pump is apowered breast pump to be used bylactating women to express andcollect milk from their breast.
Patient population	Lactating women	Lactating women
Environment of use	Home and Hospital	Home and Hospital
OTC	Yes	Yes
Power Source	Input: 100-240 VAC, 50/60Hz,2.1A1 x 14.8V / 3200 mAhRechargeable Li-ion Battery	Input: 100-240 VAC, 50/60Hz0.3A2 x 6V / 1.2 AhRechargeable Pb batteries
Pump Style	Reciprocating Pump	Diaphragm pump
Single/double Pumping	Both	Both
Adjustable Suction Levels	10 levels	16 levels
Cycle Speed	34 - 120	45 - 120
Overflow Protection	Yes (diaphragm)	Yes (diaphragm)
Vacuum range - double (mmHg)	50-250	75-200
Vacuum range - single (mmHg)	50-260	75-270
Cycling/Suction Control Mechanism	Microprocessor	Microprocessor
Accessories	Flange (Breast Shield Assembly),including tubing, check valve andpuck diaphragmBottle (Collection Cup)	Flange / Soft FlangeTubingCheck valveDiaphragmBottle
Software	Yes	Yes
Cleaning method for Accessories	Soap and warm water	Soap and warm waterBoiling water
Materials in contact with user andexpressed milk tested per ISO 10993-1	CytotoxicitySensitizationIntracutaneous
Electrical Safety	ES60601-1IEC 60601-1-2IEC 60601-1-11 home use	UL 1431
Flange offered in multiple sizes	Yes	Yes

Table 1 – Comaprison of the Proposed Device ot the Predicate

Substantial Equivalence Conclusion

The Naya Breast Pump System is substantially equivalent to the above listed predicate and we have determined that there are no significant differences which would affect safety and efficacy for the patient population. This has been demonstrated through performance testing, design, and features, and non-clinical testing.

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).