The Pump by Babyation 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. The Pump by Babyation can be used by multiple users.

Device Description

The Pump by Babyation is a multiple-user powered breast pump system that allows lactating women to discreetly express and collect milk. It is powered by a rechargeable lithium ion battery. Users have the option of single or double pumping. The device has two phases of pumping, stimulation and expression. Stimulation phase is characterized by faster cycle times and lower suction levels and is used to initiate milk letdown. Expression phase is characterized by slower cycle times and higher suction levels and is used after milk letdown has occurred. The device consists of a main enclosure which houses all of the electrical components that control the system and the pneumatic components that generate suction at vacuum levels up to 250mmHg. The main enclosure also provides an insulated storage area for one ice pack, milk collection bottles, breast shields, and the necessary tubing for the system. The device also includes a mobile app that connects to the device via Bluetooth and allows the user to control the pump.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "The Pump by Babyation," a powered breast pump. While it details non-clinical testing performed to demonstrate device safety and performance, it explicitly states "CLINICAL PERFORMANCE DATA - Not Applicable." This means the submission did not rely on clinical studies for demonstrating substantial equivalence.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and human reader performance are not present in this document because a clinical study, as typically understood for AI/ML devices or diagnostic accuracy, was not conducted or required for this particular regulatory submission.

However, based on the information provided, I can construct a table for the non-clinical acceptance criteria and summarize the non-clinical tests that "prove" the device meets these criteria.

Here's a breakdown of the information available and what is not applicable (N/A) given the context (a 510(k) for a breast pump, not a diagnostic AI/ML device):

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for a physical medical device (a breast pump), the "acceptance criteria" are related to its functional performance, safety, and compliance with general medical device standards, rather than the accuracy of a diagnostic algorithm. The acceptance criteria are implicitly tied to the performance parameters of the predicate device and the relevant standards.

Acceptance Criteria Category	Reported Device Performance (Summary from Non-Clinical Testing)
Cleaning & Reprocessing	Reusable components subjected to cleaning and reprocessing per AAMI TIR30.
Biocompatibility	Patient-contacting material tested per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10).
Software Verification	Software development and testing considered IEC 62304; documentation per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Electromagnetic Compatibility (EMC), Electrical Safety, Battery Safety	Tested per ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 62133-2.
Wireless Coexistence	Tested per ANSI C63.27 and KDB 447498.
Performance Testing	Bench testing conducted for: - Vacuum performance: 50-250 mmHg (double/single pumping) - Speed verification: 30-120 cycles/min - Milk collection in worst-case scenario - Battery performance - Backflow control - Cross-contamination. (Tested using internal test protocols, specific numerical results not provided in this summary but implied to meet internal specifications for substantial equivalence.)
Usability	Usability testing performed per IEC 62366 and IEC 60601-1-6.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of a clinical study for a diagnostic device. For the non-clinical bench testing, the "sample size" would refer to the number of devices or components tested. This is not explicitly stated but implies sufficient units to meet testing requirements (e.g., durability, electrical safety tests often involve a small number of units).
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable as this is not a clinical study involving patient data. All testing appears to be lab-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth as understood for diagnostic accuracy (e.g., radiologist reads) is not relevant here. The "ground truth" for this device's performance would be the specifications and requirements derived from engineering standards and the predicate device's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are typically for clinical studies where expert consensus is needed to establish ground truth or resolve discrepancies in human reader performance. This was a non-clinical submission.

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

N/A. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a breast pump, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

While the device has software and a mobile app, it's not an AI algorithm performing a diagnostic task. Its "performance" is mechanical and electronic (suction, cycle speed, battery life, safety features). Bench testing (performance testing, software verification) serves as the "standalone" evaluation of its functional components. The specifics of these tests are outlined in point 1 and 2 above (e.g., vacuum performance, speed verification).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ISO, IEC, AAMI), and the performance characteristics of the legally marketed predicate device. For instance, the vacuum range (50-250 mmHg) and cycle speed (30-120 cycles/min) are direct performance metrics that were verified against design specifications.

8. The sample size for the training set

N/A. This refers to a machine learning context. The "training" for this device would be its design and manufacturing processes, not data training.

9. How the ground truth for the training set was established

N/A. Not applicable as this is not an AI/ML device requiring a training set with established ground truth.

In summary, the provided document is a regulatory submission for a physical medical device (breast pump), not an AI/ML diagnostic or prognostic tool. Therefore, the "acceptance criteria" and "proof" of meeting those criteria are based on extensive non-clinical laboratory testing and compliance with recognized medical device standards, rather than clinical studies involving patient data or human reader performance.

Summary

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April 4, 2018

Babyation, LLC % Allison Komiyama Principal Consultant Acknowledge Regulatory Strategies, LLC 2834 Hawthorn Street San Diego, California 92104

Re: K173699 Trade/Device Name: The Pump by Babyation Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: Class II Product Code: HGX Dated: March 1, 2018 Received: March 5, 2018

Dear Allison Komiyama:

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 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);

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Page 2 - Allison Komiyama

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joyce M. Whang -S

for

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) K173699

Device Name The Pump by Babyation

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 K173699

DATE PREPARED

March 14, 2018

MANUFACTURER AND 510(k) OWNER

Babyation LLC 911 Washington Avenue, Suite 427 St. Louis, MO 63101, USA Telephone: +1 (844) 744-7867 Official Contact: Jared Miller, CTO/COO

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	The Pump by Babyation
Common Name:	Powered breast pump
Regulation Number:	21 CFR 884.5160
Class:	II
Product Code:	HGX (pump, breast, powered)
Review Panel:	Obstetrics/Gynecology

PREDICATE DEVICE IDENTIFICATION

510(k) Number:	K160511
Device Name:	Naya Breast Pump System
Manufacturer:	Naya Health, Inc.

The predicate device has not been subject to a design related recall.

DEVICE DESCRIPTION

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The device consists of a main enclosure which houses all of the electrical components that control the system and the pneumatic components that generate suction at vacuum levels up to 250mmHg. The main enclosure also provides an insulated storage area for one ice pack, milk collection bottles, breast shields, and the necessary tubing for the system. The device also includes a mobile app that connects to the device via Bluetooth and allows the user to control the pump.

INDICATIONS FOR USE

PREDICATE COMPARISON

The following table compares The Pump by Babyation to the predicate device with respect to the indications for use and technological characteristics:

Device &Predicate Device	Subject DeviceBabyation LLC / The Pump by Babyation(K173699)	Predicate DeviceNaya Health Inc. / Naya Breast Pump System(K160511)
Indications forUse	The Pump by Babyation is a powered breastpump to be used by lactating women in thehospital or home setting to express and collectmilk from their breasts. The Pump byBabyation can be used by multiple users.	The Naya Breast Pump System is a poweredbreast pump to be used by lactating women in thehospital or home setting to express and collectmilk from their breasts.
Single/Multiple	Multiple users	Multiple users
Environment ofUse	Hospital, Home	Hospital, Home
Power Source	Input: 100-240 VAC, 50/60Hz, 0.7-0.35ARechargeable Li-Ion Battery (7.2 V / 2200 mAh)	Input: 100-240 VAC, 50/60Hz, 2.1ARechargeable Li-ion Battery (1 x 14.8V / 3200 mAh)
Pump Type	Reciprocating diaphragm pump	Reciprocating diaphragm pump
User Interface	Hardware interface, mobile app	Hardware interface, mobile app
User Control	Power ButtonControl Wheel / Button Mobile App	Power ButtonTouch Wheel / Button Mobile App
Software	Yes	Yes
Mobile App	Yes	Yes
Single/double	Both	Both
AdjustableSuction Levels	10 levels	10 levels
Cycle Speed(cycles /min)	30 - 120	34 - 120

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Device &Predicate Device	Subject DeviceBabyation LLC / The Pump by Babyation(K173699)	Predicate DeviceNaya Health Inc. / Naya Breast Pump System(K160511)
BackflowProtection(prevention ofbackflow ofliquid intopump/tubing)	Yes (filter, sensor)	Yes (diaphragm)
OverflowProtection (stopspumping whenthe bottle is fullto preventoverflow)	Yes (sensor)
Vacuum range -double / single(mmHg)	50-250 / 50-250	50-250 / 50-260
Cycling/SuctionControlMechanism	Microprocessor	Microprocessor
Design Features	Reciprocating diaphragm vacuum pumpPortable, battery poweredPump controlled by interface on unit or by mobile appAir-based silicone flange (i.e., breast shield)Expressed milk flows from the flanges to the bottles through tubing	Reciprocating diaphragm vacuum pumpPortable, battery poweredPump controlled by interface on unit or by mobile appWater-based silicone flangeMilk expressed directly in collection cups attached to the flanges

The Pump by Babyation has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.

SUMMARY OF NON-CLINICAL TESTING

Non-clinical testing was conducted to verify that The Pump by Babyation met all design specifications, demonstrated safety based on current industry standards, and is substantially equivalent to the predicate. The following tests were performed:

A. Cleaning: The reusable components were subjected to cleaning and reprocessing using methods outlined in AAMI TIR30 A compendium of processes, materials, test methods, and acceptance criteria/or cleaning reusable medical devices.

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B. Biocompatibility: Patient contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
C. Software Verification: The software development and testing was executed with consideration to IEC 62304 Medical device software - Software life cycle processes. Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
D. Electromagnetic Compatibility, Electrical Safety, and Battery Safety: The subject device was tested in compliance with the following:
- i. ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ii. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Medical electrical equipment Part 1-11: General requirements iii. for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid İV. electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
E. Wireless Coexistence: The subject device was tested in compliance with ANSI C63.27 American National Standard for Evaluation of Wireless Coexistence, KDB 447498 RF Exposure Procedures and Equipment Authorization Policies for Mobile and Portable Devices
F. Performance Testing: Bench testing was conducted to demonstrate pump performance (vacuum performance, speed verification, milk collection in the worst case scenario), battery performance, backflow control, and cross contamination were tested using internal test protocols.

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G. Usability: Usability testing was performed in compliance with IEC 62366 Medical devices - Part 1: Application of usability engineering to medical devices and IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.

CLINICAL PERFORMANCE DATA

Not Applicable

CONCLUSION

Based on the comparison and analysis above, The Pump by Babyation is substantially equivalent to 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).