(190 days)
The Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The Wearable Breast Pump (model: 1203) is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout, and bra adjuster. All components (minus the pump) are reusable and may be manually cleaned. The Wearable Breast Pump includes rotary electric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes. The Wearable Breast Pump is a battery-powered electro-mechanical device that can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed, and pumping history information. All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.
The Wearable Breast Pump has undergone non-clinical testing to demonstrate that it meets design specifications and is substantially equivalent to the predicate device (Elvie Pump, K181863).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety, Electromagnetic Compatibility, and Wireless Technology | Compliance with: | Non-clinical tests were conducted and demonstrate compliance: |
| - IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | - Device meets basic safety and essential performance requirements. | |
| - IEC 60601-1-2:2014 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests) | - Device meets electromagnetic disturbance requirements. | |
| - IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020 (second edition) (Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance-Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environments) | - Device meets requirements for use in home healthcare environments. | |
| - IEC 62133:2012 (Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications) | - Device's battery components meet safety requirements. | |
| - Compliance with FDA Guidance document, "Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013 | - Documentation demonstrating compliance with wireless technology guidance was provided. | |
| Biocompatibility | User-contacting materials must be non-cytotoxic, non-irritating, and non-sensitizing, in accordance with ISO 10993. | Biocompatibility testing demonstrated that user-contacting materials are non-cytotoxic, non-irritating, and non-sensitizing, per ISO 10993-5:2009 and ISO 10993-10:2010. |
| Software Validation | Software validation for a "moderate level of concern" as per FDA guidance (2005 guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). | Software validation testing was conducted for a "moderate level of concern" and deemed compliant. |
| Performance Testing | - Vacuum pressure and cycle rate must meet device specifications at all settings. | - Vacuum pressure and cycle rate testing demonstrated that the device met its specifications. |
| - No backflow of liquid into the tubing/pump. | - Backflow testing confirmed that liquid does not backflow into the tubing/pump. | |
| - Device maintains specifications throughout its proposed use life. | - Use life testing demonstrated that the device maintains its specifications throughout its proposed use life. | |
| - Battery remains functional during its stated use-life. | - Battery performance testing demonstrated that the battery remains functional during its stated battery use-life. | |
| - Battery status indicator remains functional during its stated battery life. | - Battery status indicator testing demonstrated that the battery status indicator remains functional during its stated battery life. |
2. Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" in the context of clinical data for the Wearable Breast Pump. The testing appears to be primarily non-clinical, focusing on engineering, safety, and performance standards. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not provided. The testing conducted falls more under product validation and verification based on regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the "ground truth" for the non-clinical tests described is based on established engineering and safety standards (e.g., IEC, ISO) and the device's own design specifications, rather than expert interpretation of clinical data.
4. Adjudication method for the test set:
Not applicable, as this refers to a clinical adjudication process. The non-clinical testing relies on objective measurements against predefined standards.
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 device is a powered breast pump, not an AI-assisted diagnostic or interpretative system that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical-electronic device, not an algorithm, so standalone algorithm performance is not a relevant concept here.
7. The type of ground truth used:
The ground truth for the non-clinical testing is based on:
- International Standards: e.g., IEC 60601 series for electrical safety and EMC, ISO 10993 for biocompatibility.
- FDA Guidance Documents: e.g., for wireless technology and software validation.
- Device Specifications: Internal design requirements for vacuum pressure, cycle rate, backflow prevention, use life, and battery performance.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML product that utilizes a training set for algorithm development.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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December 9, 2022
Mayborn (UK) Limited % Shelley Li Offical Correspondent Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, 555 West Guangzhong Road Shanghai, 200072 China
K221598 Trade/Device Name: Wearable Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: October 31, 2022 Received: October 31, 2022
Dear Shellev Li:
Re:
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.
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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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Monica D. Garcia -S
Monica D. Garcia, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221598
Device Name Wearable Breast Pump
Indications for Use (Describe)
The Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. It is intended for 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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510(k) summary - K221598
l. Submitter
MAYBORN (UK) LIMITED MAYBORN HOUSE BALLIOL BUSINESS PARK, NEWCASTLE UPON TYNE NE12 8EW UNITED KINGDOM
Manufacturer:
Jiangsu Xinbei Electrical Appliances Co., Ltd. No. 115 Xinjin Road, Xinwu District, Wuxi City, Jiangsu Province
Contact person
Sean Neasham Group Quality Manager Phone: +44 191 250 4509 E-mail: sneasham@mayborngroup.com
Date of preparation: December 7, 2022
II. Proposed Device
| Trade Name: | Wearable Breast Pump |
|---|---|
| Common name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name | Powered breast pump |
| Regulatory Class: | Class II |
| Product code: | HGX (Pump, Breast, Powered |
| Review Panel | Obstetrics/Gynecology |
III. Predicate Device
| 510(k) Number: | K181863 |
|---|---|
| Trade name: | Elvie Pump |
| Common name: | Powered breast pump |
| Classification: | Class II |
| Product Code: | HGX |
| Manufacturer | Jabil Circuit (Shanghai) LTD |
The predicate device has not been subject to a design related recall.
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IV. Device description
The Wearable Breast Pump (model: 1203) is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout, and bra adjuster. All components (minus the pump) are reusable and may be manually cleaned.
The Wearable Breast Pump includes rotary electric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes.
The Wearable Breast Pump is a battery-powered electro-mechanical device that can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed, and pumping history information.
All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179..
V. Indications for use
The Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect mills from their breasts. It is intended for a single user.
VI. Comparison of technological characteristics with the predicate device
The intended use and key technological characteristics of the subject and predicate device are compared in the table below.
| Item | Proposed device | Predicate device(K181863) | Comparison |
|---|---|---|---|
| Trade name | Wearable BreastPump | Elvie Pump | NA |
| Product Code | HGX | HGX | Same |
| RegulationNo. | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Classification | Class II | Class II | Same |
| Indicationsfor use | The Wearable BreastPump is a poweredbreast pump to beused by lactating | The Elvie Pump is apowered breast pumpto be used bylactating women to | Same |
| women to expressand collect milk fromtheir breasts. It isintended for a singleuser. | express and collectmilk from theirbreasts.The Elvie Pump isintended for a singleuser. | ||
| Intended Use | Express milk frombreast | Express milk frombreast | Same |
| Environmentsof Use | Home | Home | Same |
| Single Userdevice | Yes | Yes | Same |
| Single /DoublePumping | Both | Both | Same |
| PatientPopulation | Lactating women | Lactating women | Same |
| Over theCounter | Yes | Yes | Same |
| PowerSource | Power adapter(battery charger) andLi-Ion Battery | USB cable (batterycharger) and Li-IonBattery | Similar |
| AdjustableSuctionLevels | Yes | Yes | Same |
| BackflowProtection | Yes | Yes | Same |
| SuctionStrength | 12-253 mmHg | 40-220 mmHg | Different |
| MaximumSuctionStrength | 253 mmHg | 220 mmHg | Different |
| Expressionlevels | 8 | 7 | Different |
| Pump type | Rotary Electric Pump | Piezoelectric Pump | Same |
| Two-phaseExpression | Yes | Yes | Same |
| User Controls | On pump body and/orthrough app | On pump body and/orthrough app | Same |
| ControlMechanism | Microcontroller | Microcontroller | Same |
| Mobile App | Yes | Yes | Same |
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The subject and predicate device have identical indications for use statements and have the same intended use. The subject and predicate device have different technological characteristics, including different pump types, suction specifications, maximum suction pressure specifications, and power sources. However, the different technological characteristics do not raise different safety and effectiveness questions.
VII. Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications and that the subject device is substantially equivalent to the predicate device, as follows.
- Electrical Safety, Electromagnetic Compatibility, and Wireless Technology a)
- IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical . equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020 (second edition) ● Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance-Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home
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healthcare environments
- . IEC 62133:2012 – Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- Documentation provided in accordance with the FDA Guidance document, . " Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013.
b) Biocompatibility
Biocompatibility testing in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments:
- Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices -. Part 5: Tests for in vitro cytotoxicity
- Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices -. Part 10: Tests for irritation and skin sensitization
- Irritation per ISO 10993-10:2010 Biological evaluation of medical devices Part . 10: Tests for irritation and skin sensitization
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
c) Software Validation
Software validation testing was conducted for a "moderate level of concern" as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
d) Performance Testing
- Vacuum pressure and cycle rate testing was conducted at all settings and . demonstrated that the device met its specifications.
- Backflow testing was conducted to demonstrate that liquid does not backflow . into the tubing/pump.
- Use life testing was conducted to demonstrate that the device maintains its . specifications throughout its proposed use life.
- Battery performance testing was conducted to demonstrate that the battery ●
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remains functional during its stated battery use-life.
- . Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
IX. Conclusion
The performance testing described above demonstrates that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence 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).