Rumble Tuff Electric Breast Pump

K200712 · A Cute Baby, Inc. · HGX · Apr 17, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K200712
• Device Name: Rumble Tuff Electric Breast Pump
• Applicant: A Cute Baby, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Apr 17, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended 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.

Device Story

Electrically powered breast pump (models PA209DM, PA210DM) for milk expression; single or double pumping. System uses diaphragm-type vacuum pump driven by microcontrolled DC electric motor. User interface includes LCD screen and controls for expression, vacuum adjustment, and memory. PA209DM powered by 9V AC/DC adapter or 7.4V Li-ion battery; PA210DM powered by 12V AC/DC adapter. Used in hospital or home settings by lactating women. Device provides adjustable suction and cycle speeds via three programmed phases (Reflex, Swift, Natural). Output is expressed breast milk collected in containers. Healthcare providers or patients use device to facilitate lactation; output allows for infant feeding when direct breastfeeding is not possible or as a supplement.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including risk analysis (EN ISO 14971:2012), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment safety (IEC 60601-1-11), software verification/validation, backflow protection, vacuum performance, and use life testing.

Technological Characteristics

Diaphragm-type vacuum pump; microcontrolled DC electric motor. Materials: Polypropylene (breast shield), Silicone (breast shield cover). Power: 9V/12V AC/DC adapter or 7.4V Li-ion battery. Vacuum range: 75–250 mmHg. Connectivity: None. Sterilization: Non-sterile. Software: Microcontroller-based speed/suction control.

Indications for Use

Indicated for lactating women requiring breast milk expression and collection. Suitable for single-user home use and multi-user hospital settings.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Rumble Tuff Electric Breast Pump (K113315)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]
Contact: Mr. Matthew Kho Director [e-mail]

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

- 2. 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.

- 5. Indication for Use:

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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<br>(K200712) (New Devices) | Rumble Tuff PA201D<br>(K113315) (Predicate Device) |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Rumble Tuff Electric Breast Pumps<br>(PA209DM, PA210DM) | Rumble Tuff Electric Breast Pump –<br>PA201D |
| Indication for Use | The Rumble Tuff Electric Breast<br>Pump is intended to express and<br>collect milk from the breasts of<br>lactating women. The Rumble Tuff<br>Electric Breast Pump is intended<br>for multiple users in a hospital<br>setting. It is also intended for<br>home use by a single user. | The Rumble Tuff Electric Breast<br>Pump is a personal use, electrically<br>powered device used to express<br>milk from the breasts of lactating<br>women. This device is not intended<br>for hospital use. |
| Environment of Use | Hospital, Home | Home |
| Vacuum Range | 75 – 250 mmHg | 85 – 250 mmHg |
| Power Supply | PA209DM - 9V AC/DC Adapter,<br>7.4V Li-Ion Rechargeable battery,<br>PA210DM - 12V AC/DC Adapter | 12V AC/DC Adapter<br>7.4V Li-ion Rechargeable battery |
| Pumping Option | Single/double | Single/double |
| Cycling/<br>Suction Control<br>Mechanism | Microcontroller | Microcontroller |
| Backflow<br>Protection | Silicone Diaphragm | Silicone Diaphragm |
| User control | PA209DM:<br>- Expression Button<br>- Vacuum Adjusting Knob<br>- M Button (memory)<br>- Power (on vs. off)<br>PA210DM:<br>- Vacuum Adjusting Buttons (up<br>and down)<br>- Expression Button<br>- M Button (memory) | Vacuum Adjusting Wheel<br>Let-down Button<br>M button<br>Power (on vs. off) |
| | - Power (on vs. off) | |
| Solenoid valve | PA209DM: 1<br>PA210DM: 2 | 1 |
| Vacuum range | AC/DC adaptor powered<br>Reflex (8 levels): 80 – 211 mmHg<br>Swift (8 levels): 80 – 176 mmHg<br>Natural (10 levels): 81 – 247 mmHg<br><br>Battery powered (PA209DM)<br>Reflex (8 levels): 78 – 206 mmHg<br>Swift (8 levels): 80 – 172 mmHg<br>Natural (10 levels): 79 – 242 mmHg | 80 – 250 mmHg |
| Cycle speed | Reflex: 20 cycles in 15 seconds<br>Swift: 82 – 115 cycles/min<br>Natural: 30 – 76 cycles/min | Stimulation mode: 168 – 100 cycles/min<br>Expression mode: 42 – 74 cycles/min |
| Material (that may<br>come in contact<br>with the user's<br>body) | Polypropylene for Breast shield;<br>Silicone for Breast shield cover | Polypropylene for Breast shield;<br>Silicone for Breast shield cover |
| Sterilization | Non-sterile | Non-sterile |
| Vacuum chamber | 2 | 1 |
| Ambient<br>Temperature range | +10°C to 40°C (50°F to 104°F) | +10°C to 40°C (50°F to 104°F) |
| Transportation /<br>Storage<br>Environment | Temperature: -10 to 50°c<br>Relative Humidity:<br>20 ~ 90% | Temperature: -10 to 50°c<br>Relative Humidity:<br>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.