The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

Device Description

The Rumble Tuff electrically powered breast pumps (models PA219DM and PA210DM) are intended for multi-user use to extract milk from lactating breasts. The PA209DM model is powered by a 9V AC/DC Power Adaptor and/or built-in 7.4V Li-lon battery. The PA210DM model is powered by a 12V AC/DC Power Adaptor and does not have a batter powered option. Pumping can be performed on one breast (single pumping) or on both breasts (double pumping). The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontrolled DC electric motor. The controlling program consists of 3 phases of speed control (Reflex, Swift, and Natural) and various suction settings. The subject devices utilize an LCD screen as a user interface. All patient-contacting and breast milk-contacting materials are identical to the predicate device.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Rumble Tuff Electric Breast Pump (models PA209DM and PA210DM). It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device (Rumble Tuff Electric Breast Pump K113315).

Let's break down the information to address your specific points about acceptance criteria and the study proving the device meets them.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria for a novel AI/software medical device. Therefore, many of your requested points regarding AI/algorithm performance, ground truth establishment, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a breast pump.

Instead, the "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate, and that any technological differences do not raise new questions of safety or effectiveness. The "study" proving this largely relies on non-clinical tests comparing the new devices to the predicate and compliance with relevant voluntary standards.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical device (breast pump), the "acceptance criteria" are primarily related to meeting performance specifications similar to the predicate and complying with relevant safety and performance standards. There isn't a table of specific AI algorithm acceptance criteria and reported AI performance as one might expect for a software-as-a-medical-device (SaMD) submission.

However, we can infer some comparative performance points:

Acceptance Criteria (Inferred from Predicate Comparison & Standards)	Reported Device Performance (Rumble Tuff PA209DM, PA210DM)
Intended Use (Equivalent to predicate)	"The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user." (Expanded use compared to predicate's "home use" only)
Environmental Use (Equivalent or expanded to predicate)	Hospital, Home (Expanded from predicate's "Home" only)
Vacuum Range (Comparable to predicate)	75 – 250 mmHg (Predicate: 85 – 250 mmHg, showing comparable range) Detailed breakdown for new devices: AC/DC Adaptor: Reflex (80-211 mmHg), Swift (80-176 mmHg), Natural (81-247 mmHg) Battery (PA209DM): Reflex (78-206 mmHg), Swift (80-172 mmHg), Natural (79-242 mmHg)
Cycle Speed (Comparable to predicate)	Reflex: 20 cycles in 15 seconds Swift: 82 – 115 cycles/min Natural: 30 – 76 cycles/min (Predicate: Stimulation mode: 168-100 cycles/min, Expression mode: 42-74 cycles/min, showing comparable functionality despite different modes)
Backflow Protection (Equivalent to predicate)	Silicone Diaphragm (Same as predicate)
Material in Contact with User's Body (Equivalent to predicate)	Polypropylene for Breast shield; Silicone for Breast shield cover (Same as predicate)
Electrical Safety (Compliance with IEC 60601-1)	Compliance demonstrated.
Electromagnetic Compatibility (Compliance with IEC 60601-1-2)	Compliance demonstrated.
Safety for Home Setting (Compliance with IEC 60601-1-11)	Compliance demonstrated.
Software Verification and Validation (Compliance with FDA guidance)	Compliance demonstrated.
Backflow Protection Performance	Testing performed.
Vacuum Performance	Testing performed.
Use Life	Testing performed.
Risk Management (Compliance with EN ISO 14971)	Compliance demonstrated.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in the context of a clinical test set with human subjects for performance evaluation like an AI model would have. For physical devices, "testing" usually refers to bench testing, engineering validation, and compliance verification. The tests listed are non-clinical (e.g., electrical safety, vacuum performance, use life).
Data Provenance: Not applicable in the context of clinical data for an AI/algorithm system. The "data" here would be test results from physical device measurements. No explicit mention of country of origin or retrospective/prospective for these non-clinical tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission does not involve AI model performance evaluation requiring expert-established ground truth from medical images or clinical data. The tests are for the physical and functional aspects of a breast pump.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication process described as it's not a clinical study involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This 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

Not applicable. This device is a physical breast pump. While it has a "microcontrolled DC electric motor" and a "controlling program," the submission focuses on its overall functional safety and equivalence, not on the standalone performance of its internal software/algorithm in the way one would evaluate a diagnostic AI.

7. The Type of Ground Truth Used

Not applicable / Engineering and Regulatory Standards. The "ground truth" for this device's performance would be defined by engineering specifications, validated test methods, and compliance with the limits set by voluntary standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management). For comparison to the predicate, the predicate's established performance serves as a reference.

8. The Sample Size for the Training Set

Not applicable. This refers to machine learning models. This document describes a physical medical device.

9. How the Ground Truth for the Training Set was Established

Not applicable. This refers to machine learning models.

Summary of the "Study that Proves the Device Meets the Acceptance Criteria"

The "study" in this context is a series of non-clinical tests and demonstrations of compliance with voluntary standards that support the claim of substantial equivalence.

These include:

Risk Analysis: Developed in accordance with EN ISO 14971:2012.
Electrical Safety Testing: In accordance with IEC 60601-1:2005-1:2005+CORR.2.2007+AM1:2012.
Electromagnetic Compatibility Testing (EMC): In accordance with IEC 60601-1-2:2014.
Safety Testing for Home Setting Use: In accordance with IEC 60601-1-11:2015.
Software Verification and Validation Testing: Adhering to FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
Backflow Protection Testing
Vacuum Performance Testing
Use Life Testing

The conclusion (Section 8) explicitly states: "The performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence." This statement is the qualitative proof that the device meets the implicit acceptance criteria for substantial equivalence to its predicate.

Summary

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April 17, 2020

A Cute Baby, Inc. Matthew Kho Director 865 N 1430 W Orem, UT 84057

Re: K200712

Trade/Device Name: Rumble Tuff Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 20, 2020 Received: March 18, 2020

Dear Matthew Kho:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200712

Device Name Rumble Tuff Electric Breast Pump

Indications for Use (Describe)

The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating Women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

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)

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K200712 Page 1 of 4

510(k) Summary — K200712

1. Submitter Information: A Cute Baby, Inc. 865 N 1430 W Orem, UT 84057 USA Tel: 1-801-609-8168 Fax: 1-801-769-2688
  Contact: Mr. Matthew Kho Director matthew.kho@acutebaby.com

Date of 510(k) Summary prepared: April 16, 2020

1. Device Information:

Proprietary Name:	Rumble Tuff Electric Breast Pump
Model Numbers:	PA209DM and PA210DM
Common Name:	Powered Breast Pump
Regulation name:	Powered Breast Pump
Regulation Number:	21 CFR 884.5160
Regulatory Class:	Class II
Product Code:	HGX (Pump, Breast, Powered)
Classification Panel:	Obstetrics/Gynecology

3. Predicate Device Information:

Predicate Device:

Rumble Tuff Electric Breast Pump (K113315) The predicate device has not been subject to design-related recall.

4. Device Description:

1. Indication for Use:

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	Rumble Tuff PA209DM, PA210DM(K200712) (New Devices)	Rumble Tuff PA201D(K113315) (Predicate Device)
Device Name	Rumble Tuff Electric Breast Pumps(PA209DM, PA210DM)	Rumble Tuff Electric Breast Pump –PA201D
Indication for Use	The Rumble Tuff Electric BreastPump is intended to express andcollect milk from the breasts oflactating women. The Rumble TuffElectric Breast Pump is intendedfor multiple users in a hospitalsetting. It is also intended forhome use by a single user.	The Rumble Tuff Electric BreastPump is a personal use, electricallypowered device used to expressmilk from the breasts of lactatingwomen. This device is not intendedfor hospital use.
Environment of Use	Hospital, Home	Home
Vacuum Range	75 – 250 mmHg	85 – 250 mmHg
Power Supply	PA209DM - 9V AC/DC Adapter,7.4V Li-Ion Rechargeable battery,PA210DM - 12V AC/DC Adapter	12V AC/DC Adapter7.4V Li-ion Rechargeable battery
Pumping Option	Single/double	Single/double
Cycling/Suction ControlMechanism	Microcontroller	Microcontroller
BackflowProtection	Silicone Diaphragm	Silicone Diaphragm
User control	PA209DM:- Expression Button- Vacuum Adjusting Knob- M Button (memory)- Power (on vs. off)PA210DM:- Vacuum Adjusting Buttons (upand down)- Expression Button- M Button (memory)	Vacuum Adjusting WheelLet-down ButtonM buttonPower (on vs. off)
	- Power (on vs. off)
Solenoid valve	PA209DM: 1PA210DM: 2	1
Vacuum range	AC/DC adaptor poweredReflex (8 levels): 80 – 211 mmHgSwift (8 levels): 80 – 176 mmHgNatural (10 levels): 81 – 247 mmHgBattery powered (PA209DM)Reflex (8 levels): 78 – 206 mmHgSwift (8 levels): 80 – 172 mmHgNatural (10 levels): 79 – 242 mmHg	80 – 250 mmHg
Cycle speed	Reflex: 20 cycles in 15 secondsSwift: 82 – 115 cycles/minNatural: 30 – 76 cycles/min	Stimulation mode: 168 – 100 cycles/minExpression mode: 42 – 74 cycles/min
Material (that maycome in contactwith the user'sbody)	Polypropylene for Breast shield;Silicone for Breast shield cover	Polypropylene for Breast shield;Silicone for Breast shield cover
Sterilization	Non-sterile	Non-sterile
Vacuum chamber	2	1
AmbientTemperature range	+10°C to 40°C (50°F to 104°F)	+10°C to 40°C (50°F to 104°F)
Transportation /StorageEnvironment	Temperature: -10 to 50°cRelative Humidity:20 ~ 90%	Temperature: -10 to 50°cRelative Humidity:20 ~ 80%

6. Comparison of Intended Use and Technological Characteristics:

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The subject and predicate device have similar indications for use and have the same intended use.

The subject and predicate device have different technological features, including a different design, user interface, number of vacuum chambers, number of solenoid valves, number of operation modes, number of vacuum levels, cycle speed/range, and power sources. These technological differences do not raise different questions of

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safety and effectiveness.

7. Summary of Non-Clinical Tests:

The subject devices comply with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and powered suction pumps. The following data were provided in support of the substantial equivalence determination:

Risk Analysis developed in accordance with EN ISO 14971:2012. ●
Electrical Safety Testing in accordance with IEC 60601-1:2005-1:2005+CORR.2.2007+AM1:2012.
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014. ●
Safety testing for use in a home setting in accordance with IEC 60601-1-11:2015.
Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
Backflow protection testing ●
Vacuum performance testing ●
Use life testing

8. Conclusion:

The performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence.

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).