(322 days)
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.
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.
This document K163183 is a 510(k) premarket notification for a breast pump, which is a Class II medical device. The information provided outlines the device's characteristics, intended use, and the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.
The prompt asks for details related to acceptance criteria and studies proving the device meets those criteria, specifically in the context of an AI/ML medical device. However, the provided document does not describe an AI/ML medical device. It details a physical medical device (a breast pump) and its mechanical and electrical performance. Therefore, many of the specific questions about AI/ML study design (like sample size for training/test sets, expert adjudication, MRMC studies, ground truth establishment, etc.) are not applicable to the content of this document.
I will address the parts of your request that are relevant to the provided content.
1. A table of acceptance criteria and the reported device performance
The document summarizes performance tests and states that specifications were met. It does not provide a specific table of acceptance criteria with corresponding numerical results for each one. Instead, it lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Bench Testing | |
| Backflow Protection | Performance testing conducted to assess prevention of milk ingress into pump tubing or pump. (Implied: Met expectations) |
| Vacuum Profile | Performance testing conducted at minimum and maximum vacuum settings to determine min & max vacuum levels. Specifications were met for vacuum level, cycle rate, and backflow protection. Testing conducted under single and double pumping conditions with appropriate power sources. |
| Durability | Performance testing conducted to assess use-life of the device. (Implied: Met expectations) |
| Electrical Safety | |
| AAMI / ANSI ES60601-1:2005/ (R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 | Complied (Implied by inclusion in non-clinical performance test summary) |
| IEC 60601-1-11:2015 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Electromagnetic Compatibility | |
| IEC 60601-1-2:2014 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Biocompatibility | |
| Sensitization ISO 10993-10:2010 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Irritation - ISO 10993-10:2010 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Cytotoxicity - ISO10993-5:2009 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Software Validation | |
| FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005. | Complied (Implied by inclusion in non-clinical performance test summary) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes (e.g., number of devices tested for durability, or number of cycles for vacuum testing). It also does not mention data provenance in terms of country of origin or retrospective/prospective nature, as the testing described is standard laboratory bench testing for a physical device, not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical device, not an AI/ML algorithm requiring expert ground truth for interpretation of medical images or data. Ground truth for a breast pump would be based on engineering specifications and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to expert review and consensus for AI/ML performance evaluation, not to the bench testing of a physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for performance testing is established by engineering specifications, physical measurement standards, and regulatory requirements (e.g., IEC standards, ISO standards). For example, a vacuum pressure measurement is compared against a specified range (e.g., 60-220 mmHg).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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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 (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
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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 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
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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 | |
|---|---|---|
| Indicationsfor Use | The Yooeehouse breast pump isintended to be used by lactating womento express and collect milk from theirbreast. It can be used as a single pumpand as a double pump. The unit isintended for indoor use only and isintended for single users.The Yooeehouse pumpset should beused in combination with Yooeehousepowered breast pumps and is intendedto be used by lactating women toexpress and collect milk from theirbreast. The pumpset can be used both asa single pumpset and as a doublepumpset. | The ARDO Carum powered breastpump is intended to be used bylactating women to express and collectmilk from their breast. It can be used asa single pump and as a double pump.The unit is intended for indoor use onlyand is intended for multiple users.The ARDO Calypso breast pump isintended to be used by lactating womento express and collect milk from theirbreast. It can be used as a single pumpand as a double pump. The unit isintended for indoor use only and isintended for single users.The ARDO Pumpset should be used incombination with ARDO breast pumpsand is intended to be used by lactatingwomen to express and collect milkfrom their breast. The Pumpset can beused both as a single pumpset and as adouble 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 : multiuserCalypso: single user | ||
| Single/double pump | Single ordouble | Single ordouble | Single ordouble | Single ordouble | Single or double | ||
| Pump Type | Micro airpump | Micro airpump | Micro airpump | Micro airpump | 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 | MicroUSB | Micro USB | Carum: AC or rechargeableCalypso: Rechargeable battery | ||
| Suction levels (massage/stimulation) | 1 | 1 | 1 | 1 | 7 (Carum) | ||
| Suction levels (expression) | 9 | 9 | 9 | 9 | 8 | ||
| Suction Strength (expression) | 60- 220mmHg | 60- 220mmHg | 60- 220mmHg | 60- 220mmHg | Carum: 22-250 mmHgCalypso: 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.
§ 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).