Yooeehouse Breast Pump

K163183 · Nantong Poly Technology Co., Ltd. · HGX · Oct 2, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K163183
• Device Name: Yooeehouse Breast Pump
• Applicant: Nantong Poly Technology Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Oct 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Yooeehouse breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. The Yooeehouse pumpset should be used in combination with Yooeehouse breast pump and is intended to be used by lactating women to express and collect milk from their breast. The pumpset can be used both as a single pumpset and as a double pumpset.

Device Story

Powered breast pump for lactating women; home use. Device consists of pump unit, non-sterile pumpset (silicone, polypropylene, ABS, polyphenylene sulfone), and USB power adapter. Microcomputer-controlled negative pressure module creates vacuum to extract milk. User selects mode (massage or expression), velocity, and intensity. Solenoid valve provides variable vacuum cycling (24-110 cycles/min). Massage mode: 30 mmHg; expression mode: 60-220 mmHg. Models S08/S10 feature LED indicators; L08/L10 feature LCD. Device provides single or double pumping. Healthcare provider does not operate; patient self-use. Output is expressed milk collected in containers. Benefits include assistance with milk expression for breastfeeding.

Clinical Evidence

Bench testing only. Testing included backflow protection, vacuum profile (min/max levels, cycle rates), and durability. Electrical safety (AAMI/ANSI ES60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10) were verified. Software validation performed per FDA guidance.

Technological Characteristics

Powered breast pump; micro air pump mechanism. Materials: silicone, polypropylene, ABS, polyphenylene sulfone. Power: USB adapter. Vacuum: 60-220 mmHg (expression), 30 mmHg (massage). Cycling: 24-110 cycles/min. Interface: LED or LCD. Backflow protection via valve. Microcomputer-controlled.

Indications for Use

Indicated for lactating women to express and collect breast milk. Intended for single-user, indoor use; supports single or double pumping.

Regulatory Classification

Identification

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

Predicate Devices

• Ardo Carum and Calypso Powered Breast Pumps (K141742)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 2, 2017

Nantong Poly Technology Co., Ltd. % Jonathan Hu Technical Manager Medwheat (Shanghai) Medical Technology Co.,Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No.33 Room 303 Shanghai, 200093 China

Re: K163183

Trade/Device Name: Yooeehouse Breast Pump (Models: S08, S10, L08, L10) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: August 15, 2017 Received: August 22, 2017

Dear Jonathan Hu:

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.

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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 (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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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) K163183

Device Name

Yooeehouse Breast Pump (Models: S08, S10, L08, L10)

Indications for Use (Describe)

The Yooeehouse breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.

The Yooeehouse pumpset should be used in combination with Yooeehouse breast pump and is intended to be used by lactating women to express and collect milk from their breast. The pumpset can be used both as a single pumpset and as a double pumpset.

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

| | Investor/Insider Use (See SEC Rule 144 & Section 16) |
|--|------------------------------------------------------|
| | Issuer Use: Compensation and/or SEC Rule 10b5-1 Plan |

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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## K163183 Page 1 of 4

# 510(k) Summary

### Submitter's Information

Name of Sponsor:

Contact Name: Telephone No .: Fax No .: Email Address:

### Date Prepared

September 28, 2017

### Correspondent's Information

Company Name: Address:

Correspondent Name: Telephone No .: Email Address:

## Medwheat ( Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang, First Suite No, 33, Room 303, Shanghai, China Jonathan Hu 86-021-65181421 [e-mail]

### Device Name and Classification

Trade Name: Model Names: Common Name: Classification Number: Classification Name: Product Code: Regulatory Class:

Yooeehouse Breast Pump S08. S10. L08. L10 Powered Breast Pump 21 CFR 884.5160 Powered Breast Pump HGX (Pump, Breast, Powered) II

### Identification of Predicate Device(s)

K141742 - Ardo Carum and Calypso Powered Breast Pumps

The predicate devices have not been subject to a design-related recall.

### Description of the Device

The subject device is a breast pump that is intended to be a single patient reusable device. The device is used in a home environment and is capable of single and dual pumping. The submission includes four different breast pumps: L08, L10, S08, and S10.

The breast pump uses a USB adapter. The breast pump consists of a pump, a non-sterile pumpset (composed of silicone, polypropylene, acrylonitrile butadiene styrene, and polyphenylene sulfone), and a power adapter. The breast pump has a negative pressure

Nantong Poly Technology Co., Ltd. No.332, Xinxing Road, Development Zone, Nantong, Jiangsu, China Rongmin Lin 86-0513 81528229 86-0513 81528229 [e-mail]

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module that utilizes a microcomputer-controlled system to set and adjust the mode (massage or expression), velocity and intensity of stimulation and suction. The vacuum pump component of the device creates the negative pressure used to extract milk from the breast. The vacuum pump is connected to a solenoid valve that provides variable vacuum cycling rates ranging from 24-110 cycles/minutes. In the massage mode, there is single vacuum pressure of 30 mmHg, while the expression mode has vacuum pressures ranging from 60 to 220 mmHg depending on the expression setting selected. A light-emitting diode indicator (Models S08 and S10) or liquid-crystal display (models L08 and L10) indicate the status of operation.

### Indication for Use

The Yooeehouse breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.

The Yooeehouse pumpset should be used in combination with Yooeehouse powered breast pumps and is intended to be used by lactating women to express and collect milk from their breast. The pumpset can be used both as a single pumpset and as a double pumpset.

| | K 163183 | K141742 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Yooeehouse breast pump is<br>intended to be used by lactating women<br>to express and collect milk from their<br>breast. It can be used as a single pump<br>and as a double pump. The unit is<br>intended for indoor use only and is<br>intended for single users.<br><br>The Yooeehouse pumpset should be<br>used in combination with Yooeehouse<br>powered breast pumps and is intended<br>to be used by lactating women to<br>express and collect milk from their<br>breast. The pumpset can be used both as<br>a single pumpset and as a double<br>pumpset. | The ARDO Carum powered breast<br>pump is intended to be used by<br>lactating women to express and collect<br>milk from their breast. It can be used as<br>a single pump and as a double pump.<br>The unit is intended for indoor use only<br>and is intended for multiple users.<br><br>The ARDO Calypso breast pump is<br>intended to be used by lactating women<br>to express and collect milk from their<br>breast. It can be used as a single pump<br>and as a double pump. The unit is<br>intended for indoor use only and is<br>intended for single users.<br><br>The ARDO Pumpset should be used in<br>combination with ARDO breast pumps<br>and is intended to be used by lactating<br>women to express and collect milk<br>from their breast. The Pumpset can be<br>used both as a single pumpset and as a<br>double pumpset |

Comparison of Indication for Use with Predicate Device

The subject device's indication for use statement is not identical to the predicate device. The predicate device has separate indication for use statements for each version included in the predicate submission; however, both the subject and predicate device have the same intended use to express and collect milk from lactating women for breast feeding.

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| Device & Predicate Device(s): | K163183 | | | K141742 | | | |
|----------------------------------------|---------------------|---------------------|---------------------|---------------------|------------------------------------------------------------|--|--|
| General Device Characteristics | | | | | | | |
| Models | S08 | S10 | L08 | L10 | | | |
| Code | HGX | HGX | HGX | HGX | | | |
| Single User | Yes | Yes | Yes | Yes | Carum : multiuser<br>Calypso: single user | | |
| Single/double pump | Single or<br>double | Single or<br>double | Single or<br>double | Single or<br>double | Single or double | | |
| Pump Type | Micro air<br>pump | Micro air<br>pump | Micro air<br>pump | Micro air<br>pump | Micro air pump | | |
| Media separation (backflow protection) | Valve | Valve | Valve | Valve | Valve | | |
| Expression pattern | 2- phase | 2- phase | 2- phase | 2- phase | 2- phase | | |
| Specifications | | | | | | | |
| Power supply | Micro USB | Micro USB | Micro<br>USB | Micro USB | Carum: AC or rechargeable<br>Calypso: Rechargeable battery | | |
| Suction levels (massage/stimulation) | 1 | 1 | 1 | 1 | 7 (Carum) | | |
| Suction levels (expression) | 9 | 9 | 9 | 9 | 8 | | |
| Suction Strength (expression) | 60- 220<br>mmHg | 60- 220<br>mmHg | 60- 220<br>mmHg | 60- 220<br>mmHg | Carum: 22-250 mmHg<br>Calypso: 37-250 mmHg | | |
| Suction levels (Expression) | 9 | 9 | 9 | 9 | 8 | | |
| Cycles per minutes (expression) | 24-65 | 24-65 | 24-65 | 24-65 | 30-60 | | |
| Visual indicator | LED | LED | LCD | LCD | LCD | | |

### Comparison of Technological Characteristics with Predicate Device

The subject device and the predicate device do not have the same technological characteristics. The maximum vacuum pressure, suction levels, cycle speed, and power supply are different between the subject device and the predicate device. These differences do not raise different questions of safety and effectiveness, and can be addressed through performance testing.

### Non-Clinical Performance Test Summary

The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination:

- Bench Testing
- Backflow Protection Testing: Performance testing was conducted to assess backflow . protection of the subject device (i.e., prevention of milk ingress into the pump tubing or pump).
- . Vacuum Profile Testing: Performance testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection. Testing was conducted under single and double pumping conditions with appropriate power sources.
- . Durability testing: performance testing was conducted to assess use-life of the device.
- Electrical Safety
- AAMI / ANSI ES60601-1:2005/ (R) 2012 and A1:2012, C1:2009/(R) 2012 and .

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K163183 Page 4 of 4

- A2:2010/(R) 2012
- . IEC 60601-1-11:2015
- Electromagnetic Compatibility
- IEC 60601-1-2:2014 ●
- . Biocompatibility
- Sensitization ISO 10993-10:2010 •
- . Irritation - ISO 10993-10:2010
- . Cytotoxicity - ISO10993-5:2009
- Software Validation ●
- FDA Guidance: "Guidance for the Content of Premarket Submissions for Software • Contained in Medical Devices" issued May 11, 2005.

### Conclusion

Based on the comparison and analysis above, the Yooeehouse Breast Pump is substantially equivalent to the predicate device.