(322 days)
Not Found
No
The description mentions a "microcomputer-controlled system" for setting and adjusting modes, velocity, and intensity, but this is typical for electronic devices and does not indicate the use of AI or ML. There is no mention of learning, adaptation, or data-driven decision making.
No.
The device is a breast pump intended to express and collect milk, which is not considered a therapeutic function based on the provided information.
No
The device is a breast pump, intended to express and collect milk, not to diagnose any medical condition.
No
The device description explicitly states the device consists of a pump, a pumpset, and a power adapter, which are all hardware components. While it mentions a microcomputer-controlled system, this system controls the hardware components of the breast pump.
Based on the provided information, the Yooeehouse 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 their breast." This is a physical process involving the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical pump that creates negative pressure to extract milk. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the mechanical and electrical aspects of the device (backflow protection, vacuum profile, durability, electrical safety, EMC, biocompatibility, software validation). There are no studies related to the analysis of biological samples or diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Yooeehouse breast pump does not perform this function.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lactating women, home environment
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)
- 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 . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a large, sans-serif font. The text is black and appears to be the main subject of the image. The background is plain white, which makes the text stand out clearly. There is a faint watermark in the background.
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
2
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 Jonathan.hu@medwheat.com
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 lin_11000@126.com
4
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 | ||
| 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. | The ARDO Carum powered 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 multiple users.
The ARDO Calypso 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 ARDO Pumpset should be used in
combination with ARDO 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 |
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.
5
| 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 | ||
| Calypso: single user | |||||||
| Single/double pump | Single or | ||||||
| double | Single or | ||||||
| double | Single or | ||||||
| double | Single or | ||||||
| double | Single or double | ||||||
| Pump Type | Micro air | ||||||
| pump | Micro air | ||||||
| pump | Micro air | ||||||
| pump | Micro air | ||||||
| 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 | ||||
| USB | Micro USB | Carum: AC or rechargeable | |||||
| 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 | ||||||
| mmHg | 60- 220 | ||||||
| mmHg | 60- 220 | ||||||
| mmHg | 60- 220 | ||||||
| mmHg | Carum: 22-250 mmHg | ||||||
| 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 .
6
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.