Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a "microcontrolled DC electric motor" and a "controlling program" with predefined phases and suction settings. There is no mention of learning, adaptation, or data-driven decision making, which are characteristic of AI/ML. The software validation is standard for medical device software and doesn't indicate AI/ML.

Therapeutic

No.
A therapeutic device is typically involved in the treatment or prevention of a disease, injury, or other medical condition. A breast pump, while a medical device, is used to express and collect milk, which is a supportive function rather than a direct therapeutic intervention for a medical condition.

Diagnostic

No

The device description indicates its purpose is to "express and collect milk from the breasts of lactating women," which is a functional purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components including a vacuum pump, electric motor, power adaptors, battery, and LCD screen. While it mentions a "controlling program," the device is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Rumble Tuff Electric Breast Pump is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "express and collect milk from the breasts of lactating women." 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 creates vacuum to extract milk. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Rumble Tuff Electric Breast Pump's function is purely mechanical extraction of a bodily fluid, not analysis of that fluid or any other biological sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

HGX

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.

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

Home use by a single user, or multiple users in a hospital 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)

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K113315

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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:

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.

1. Indication for Use:

4

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.

| | 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 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. | The Rumble Tuff Electric Breast
Pump is a personal use, electrically
powered device used to express
milk from the breasts of lactating
women. This device is not intended
for 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 Adapter
7.4V Li-ion Rechargeable battery |
| Pumping Option | Single/double | Single/double |
| Cycling/
Suction Control
Mechanism | Microcontroller | Microcontroller |
| Backflow
Protection | Silicone Diaphragm | Silicone Diaphragm |
| User control | PA209DM:

Expression Button
Vacuum Adjusting Knob
M Button (memory)
Power (on vs. off)
PA210DM:
Vacuum Adjusting Buttons (up
and down)
Expression Button
M Button (memory) | Vacuum Adjusting Wheel
Let-down Button
M button
Power (on vs. off) |
| | - Power (on vs. off) | |
| Solenoid valve | PA209DM: 1
PA210DM: 2 | 1 |
| Vacuum range | AC/DC adaptor powered
Reflex (8 levels): 80 – 211 mmHg
Swift (8 levels): 80 – 176 mmHg
Natural (10 levels): 81 – 247 mmHg

6. Comparison of Intended Use and Technological Characteristics:

5

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

6

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.