RUMBLE TUFF

K113315 · Acute Ideas Co. , Ltd. · HGX · Nov 20, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K113315
• Device Name: RUMBLE TUFF
• Applicant: Acute Ideas Co. , Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Rumble Tuff Electric Breast Pump is an electrically powered single-user device to express and collect milk from the breasts of lactating women. The device is not intended for hospital use.

Device Story

The Rumble Tuff Electric Breast Pump is a powered, single-user device for expressing and collecting breast milk. It utilizes a diaphragm-type vacuum pump driven by a microcontroller-controlled DC electric motor. The system includes a vacuum relief valve operated by a solenoid to regulate suction. Users control cycle speed and vacuum levels via a roller-type adjuster. Models feature either LED indicators or an LCD screen for displaying pumping information. Power options include AA batteries, a 7.4V Li-ion battery, or an AC adapter. The device is intended for home use by the lactating woman. By providing adjustable suction and cycle speeds, the device facilitates milk expression, potentially benefiting the user by supporting breastfeeding goals. Patient-contacting components are made of polypropylene and silicone.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included vacuum level and cycle speed verification. Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin sensitization and irritation). Safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Materials: Polypropylene and silicone. Principle: Diaphragm-type vacuum pump with solenoid-driven vacuum relief valve. Energy: 4 AA batteries, 7.4V Li-ion battery, or 12V AC/DC adapter. Connectivity: None. Software: Microcontroller-based control of motor and vacuum. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for lactating women requiring an electrically powered, single-user device to express and collect breast milk. Not for hospital use.

Regulatory Classification

Identification

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

Predicate Devices

• Swing Breastpump (K053052)
• Lansinoh Affinity Double Electric Breast Pump (DEBP) (K092783)

Submission Summary (Full Text)

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# Acute Ideas Co., Ltd.
3F, No.11, Lane 35, Jihu Road, Neihu Dist., Taipei, Taiwan
3F, No.11, Lane 35, Jihu Road, Neihu Dist., Taipei, Taiwan

Sr, No.11, Lane 35, Jihu Road, Neihu Dist., Taipei, Taiwan
TEL: [phone] FAX: [phone]

# NOV 2 0 2012

.

# 510(K) Summary

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:

| Applicant: | Acute Ideas Co., Ltd. |
|----------------------|----------------------------------------------------------------------|
| | 3F, No. 11, Lane 35, Jihu Road, |
| | Neihu Dist, Taipei, Taiwan, 114, R.O.C. |
| | Tel: [phone] |
| | Fax: [phone] |
| | www.acuteideas.com |
| | Attn: Jessica Wang |
| Contact: | Matthew Kho |
| | A Cute Baby, Inc. |
| | 865 N 1430 W |
| | Orem UT 84057 USA |
| | Tel: [phone] |
| | Fax: [phone] |
| | |
| Date of Submission: | 11/01/2012 |
| Proprietary Name: | Rumble Tuff Electric Breast Pump |
| | (Models: PA200S, PA201S, PA201D, PA203S and PA203D) |
| Common Name: | Electric Breast Pump |
| Classification name: | Pump, Breast, Powered |
| Regulatory Class: | Class II |
| Product Codes: | HGX |
| Indication for Use: | The Rumble Tuff Electric Breast Pump is an electrically powered |
| | single-user device used to express and collect milk from the breasts |
| | of lactating women. The device is not intended for hospital use. |
| | |
| Predicate Device(s): | Swing Breastpump (K053052) By Medela, Inc. and Lansinoh |
| | Affinity Double Electric Breast Pump (DEBP) (K092783) By |
| | ENKO Ltd. |
| | 1 of 5 |

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Acute Ideas Co., Ltd 3F, No.11, Lane 35, Jihu Road, Neihu Dist., Taipei, Taiwan TEL: [phone] FAX: [phone]

The Rumble Tuff Electric Breast Pump is a powered Breast Device Description: Pump. With different models, the Pumping can be performed on one breast or on both breasts at the same time; the Rumble Tuff Electric Breast Pump can be powered by 4 AA batteries, one 7.4V Li batteries or an AC Adapter provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. Rumble Tuff Electric Breast Pump has five models; PA200S, PA201S, PA201D, PA203S, and PA203D. The suffix "S" stands for the model with single collection kit, and "D" stands for the model with dual collection kits. The user interface of PA200S uses 4 LEDs for indicating pumping cycle and uses a roller type adjuster for pumping level adjustment and indicating pumping level. Models PA201S, PA201D, PA203S, and PA203D all use the same user interface, a LCD screen for showing the pumping information; it also uses a roller type adjuster for pumping level adjustment. For all models, the user is able to control the cycle speed and vacuum level. The summary of the 5 models are as follows:

| Model | PA200S | PA201S | PA203S |
|----------------------|----------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| Pumping Suction | 125 - 250 mmHg | 115 - 250 mmHg | 115 - 250 mmHg |
| Suction Settings | 7 Levels | a) Stimulation (8 Levels)<br>b) Expression (8 Levels) | a) Stimulation (8 Levels)<br>b) Expression (8 Levels) |
| Power Supply | a) 4 AA Alkaline Batteries<br>b) 12V AC/DC Adapter | a) 7.4V Li-ion Battery<br>b) 12V AC/DC Adapter | a) 4 AA Alkaline Batteries<br>b) 12V AC/DC Adapter |
| Pumping Option | Single | Single | Single |
| Back Flow Protection | Yes | Yes | Yes |
| Interface (display) | LED indicators | LCD Screen | LCD Screen |
| Pumping Cycles | up to 1.67/sec | Up to 1.83/sec | Up to 1.11/sec |

#### Single Pumping Models

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## Acute Ideas Co., Ltd

3F, No.11, Lane 35, Jihu Road, Neihu Dist., Taipei, Taiwan TEL: [phone] FAX: [phone]

| Model | PA201D | PA203D |
|----------------------|---------------------------|----------------------------|
| Pumping Suction | 85 – 250 mmHg | 85 – 250 mmHg |
| Suction Settings | a) Stimulation (8 levels) | a) Stimulation (8 levels) |
| | b) Expression (8 levels) | b) Expression (8 levels) |
| Power Supply | a) 7.4V Li-Ion Battery | a) 4 AA Alkaline Batteries |
| | b) 12V AC/DC Adapter | b) 12V AC/DC Adapter |
| Pumping Option | Single or Double | Single or Double |
| Back Flow Protection | Yes | Yes |
| Interface (display) | LCD Screen | LCD Screen |
| Pumping Cycles | Up to 1.23/sec | Up to 1.23/sec |

#### Double Pumping Models

The patient-contacting portions of the Rumble Tuff Electric Breast Materials Used: Pump are composed of polypropylene and silicone. The patientcontacting portions of the predicate devices also included polypropylene. The polypropylene and silicone in the Rumble Tuff were evaluated for biocompatibility per ISO 10993 (see testing description in the "Testing" section) and deemed biocompatible. Testing: The Rumble Tuff Electric Breast Pump is tested to meet: . IEC 60601-1:2005, "Medical Electrical Equipment, General Requirements for Safety" ● IEC 60601-1-2:2007, "Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. " ● ISO 10993-5: 2009, "In Vitro Cytotoxicity Test of Expression collection Kit"

- ISO 10993-10: 2010, "Skin Sensitization Test of Expression collection Kit (polar and non-polar)"
- ISO 10993-10: 2010, "Skin irritation Test of Expression collection Kit {polar and non-polar}"
- Additionally, the tests of vacuum levels and cycle speeds conducted by Acute Ideas are provided to demonstrate the performance of Rumble Tuff Electric Breast Pump.

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#

TEL: [phone] FAX: [phone]

## Comparison to Predicate Devices:

The following table summarizes the basic similarities and differences between Rumble Tuff Electric Breast Pump and predicate devices.

#### For single pumping models:

| | New Device | New Device | New Device | Predicate Device |
|-----------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------|
| Device Name | Rumble Tuff Electric<br>Breast Pump -<br>PA200S | Rumble Tuff Electric<br>Breast Pump -<br>PA2015 | Rumble Tuff Electric<br>Breast Pump -<br>PA203S | Medela Swing |
| 510(k) # | K113315 | K113315 | K113315 | K053052 |
| Product Code | HGX | HGX | HGX | HGX |
| Classification | 2 | 2 | 2 | 2 |
| Intended use | to express milk | to express milk | to express milk | to express milk |
| Power Source | a) 4 AA alkaline<br>batteries<br>b) 12V AC/DC<br>Adapter | a) 7.4V Li-Ion<br>Rechargeable<br>Battery<br>b) 12V AC/DC<br>Adapter | a) 4 AA Alkaline<br>Batteries<br>b) 12V AC/DC<br>Adapter | a) 4 AA alkaline<br>batteries<br>b) 4.8V DC<br>Adapter |
| Pump type | Diaphragm type | Diaphragm type | Diaphragm type | Diaphragm type |
| Pumping<br>Suction | 125 – 250 mmHg | 115 - 250 mmHg | 115 – 250 mmHg | 0 - 250 mmHg |
| Adjustable<br>suction level | Yes | Yes | Yes | Yes |
| Pumping Option | Single | Single | Single | Single |
| Back Flow<br>Protection | Yes | Yes | Yes | No |
| Let Down<br>Function | Yes | Yes | Yes | Yes |
| Cycling /<br>Suction Control<br>Mechanism | Microcontroller | Microcontroller | Microcontroller | Microcontroller |
| Design of<br>vacuum relief | Using a vacuum<br>relief valve driven<br>by a solenoid | Using a vacuum<br>relief valve driven<br>by a solenoid | Using a vacuum<br>relief valve driven<br>by a solenoid | Using a vacuum<br>relief valve driven<br>by a solenoid |
| Material (that<br>may contact<br>user's body) | PP for Breastshield;<br>Silicone for<br>Breastshield cover | PP for Breastshield;<br>Silicone for<br>Breastshield cover | PP for Breastshield;<br>Silicone for<br>Breastshield cover | PP for Breast Shield |

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# Acute Ideas Co., Ltd.

3F, No.11, Lane 35, Jihu Road, Neihu Dist., Taipei, Taiwan

| | New Device | New Device | Predicate Device |
|-----------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------|
| Device Name | Rumble Tuff Electric Breast<br>Pump - PA201D | Rumble Tuff Electric Breast<br>Pump - PA203D | Lansinoh DEBP |
| 510(k) # | K113315 | K113315 | K092783 |
| Product Code | HGX | HGX | HGX |
| Classification | 2 | 2 | 2 |
| Intended use | to express milk | to express milk | to express milk |
| Power Source | a) 7.4V Li-Ion<br>Rechargeable Battery<br>b) 12V AC/DC Adapter | a) 4 AA Alkaline Batteries<br>b) 12V AC/DC Adapter | a) 6 AA alkaline batteries<br>b) 9V DC Adapter |
| Pump type | Diaphragm type | Diaphragm type | Diaphragm type |
| Pumping Suction | 85 - 250 mmHg | 85 - 250 mmHg | 50 - 250 mmHg |
| Adjustable<br>suction level | Yes | Yes | Yes |
| Pumping Option | Single or Double | Single or Double | Single or Double |
| Back Flow<br>Protection | Yes | Yes | Yes |
| Let Down<br>Function | Yes | Yes | Yes |
| Cycling/Suction<br>Control<br>Mechanism | Microcontroller | Microcontroller | Microcontroller |
| Design of vacuum<br>relief | Using a vacuum relief valve<br>driven by a solenoid | Using a vacuum relief valve<br>driven by a solenoid | Using a vacuum relief valve<br>driven by a solenoid |
| Material (that<br>may contact user's<br>body) | PP for Breastshield;<br>Silicone for Breastshield<br>cover | PP for Breastshield;<br>Silicone for Breastshield<br>cover | PP + TPR for Breast Shield |

#### For double pumping models:

#### Conclusion:

The Rumble Tuff Electric Breast Pumps are substantially equivalent to the predicate devices. Based upon the test data submitted, the devices provide sufficient vacuum pressure to safely and effectively express and collect milk from lactating women.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### November 20, 2012

Acute Ideas Co., Ltd. % Mr. Matthew Kho Director A Cute Baby, Inc. 865 N 1430 W OREM UT 84057

Re: K113315

Trade/Device Name: Rumble Tuff® Electric Breast Pump (Models: PA200S, PA201S, PA201D, PA203S and PA203D) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: November 6, 2012 Received: November 6, 2012

Dear Mr. 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. 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.

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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 I va must compy "Harth labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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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#### 510(k) Number: K113315

Device Name: Rumble Tuff® Electric Breast Pump (Models: PA200S, PA201S, PA201D, PA203S and PA203D)

Indication for Use:

The Rumble Tuff Electric Breast Pump is an electrically powered single-user device to express and collect milk from the breasts of lactating women. The device is not intended for hospital use.

Prescription Use ___

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2012.11.20 15:05:38 -05'00'

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K113315 510(k) Number