(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on electro-mechanical and software control for basic functions like monitoring and history. There is no mention of learning, adaptation, or complex pattern recognition.
No.
A therapeutic device is intended to treat or alleviate a medical condition. This device is a breast pump used to express milk, which is a collection device rather than a treatment.
No
The Elvie Pump is described as a powered breast pump intended to express and collect milk. Its description details its mechanical function (generating negative pressure to express milk) and features related to milk collection and user convenience (hands-free, rechargeable battery, mobile app for monitoring milk volume). There is no mention of the device being used to identify, diagnose, or monitor any disease, condition, or physiological state beyond basic milk collection parameters.
No
The device description explicitly states it is a "battery-powered electro-mechanical device that contains software" and lists multiple hardware components like a pump (motor unit), breast shield, bottle, etc. It also details electrical safety and electromagnetic compatibility testing, which are relevant to hardware.
Based on the provided information, the Elvie Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breasts." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a mechanical pump that applies negative pressure to the nipple to extract milk. It collects the milk, but it doesn't analyze or test the milk itself for diagnostic purposes.
- Lack of Diagnostic Testing: There is no mention of the device performing any kind of test on the milk or the user to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical and electrical performance of the pump, software validation (including a milk measurement algorithm, but this is for monitoring volume, not diagnostic analysis), biocompatibility, and usability. There are no studies related to diagnostic accuracy, sensitivity, specificity, etc., which are typical for IVD devices.
- Predicate Device: The predicate device is another breast pump (Medela Freestyle), which is also not an IVD.
IVD devices are designed to perform tests on samples (like blood, urine, tissue, etc.) outside of the body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Elvie Pump's function is purely mechanical and related to milk expression and collection.
N/A
Intended Use / Indications for Use
The Elvie Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Pump is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Elvie Pump 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 adjustor. All components (minus the pump) are reusable and may be manually cleaned. The kit components may be purchased separately and are available in different sizes and configurations.
The Elvie Pump includes piezoelectric 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 Elvie Pump is a battery-powered electro-mechanical device that contains software. It 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Home
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)
The following performance tests were conducted on the Elvie Pump device:
- Biocompatibility testing demonstrating that the patient contacting device components are biocompatibility, including the following specific tests:
- Cytotoxicity per ISO 10993-5 O
- Irritation per ISO 10993-10 O
- o Sensitization per ISO 10993-10
- Software validation for a minor level of concern per the FDA guidance document "Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, including cybersecurity assessment and validation of the milk measurement algorithm
- Simulated use testing (usability study) per IEC 62366-1 Application of Usability Engineering to Medical Devices
- Use life testing to support the proposed use life
- Electrical safety testing per IEC 60601-1 and IEC 60601-1-11
- Electromagnetic compatibility testing per and IEC 60601-1-2
- Cleaning validation on the reprocessing instructions included in the labeling
- Device performance testing including evaluation of vacuum performance and backflow demonstrating that the subject device meets its specifications
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.
Medela Freestyle (K150499)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 10, 2018
Chiaro Technology Limited % Marc C. Sanchez, Esq. Regulatory Attorney Contract In-House Counsel and Consultants, LLC 53516 Bickett Chapel Hill, NC 27517
Re: K181863 Trade/Device Name: Elvie Pump Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: July 11, 2018 Received: July 12, 2018
Dear Marc C. Sanchez:
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.
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael T. Bailey -S
for 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) K181863
Device Name Elvie Pump
Indications for Use (Describe)
The Elvie Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Pump is intended for a single user.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Traditional 510k Submission Elvie Pump
510(K) Summary - K181863
The following information is provided as required by 21 CFR 807.87 for the Elvie Pump 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence is based.
| Sponsor: | Chiaro Technology Limited
63-66 Hatton Garden
London EC1N 8LE United Kingdom
Establishment Registration: 3012098706 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Jabil Circuit (Shanghai) LTD.
600 Tian Lin Road, Shanghain, China 200233
Establishment Registration: 3005210579 |
| Contact: | Marc C. Sanchez, Esq.
Contract In-House Counsel and Consultants, LLC
53516 Bickett Chapel Hill NC 27517
Ph: 202.765.4491
E-mail: msanchez@fdaatty.com |
| Date Prepared: | October 9, 2018 |
| Proprietary Name: | Elvie Pump |
| Common Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160, Powered breast pump |
| Regulatory Class: | Class II |
| Product Code: | HGX (pump, breast, powered) |
| Predicate Device(s): | Medela Freestyle (K150499) |
The predicate device has not been subject to a design related recall.
Device Description:
The Elvie Pump 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 adjustor. All components (minus the pump) are reusable and may be manually cleaned. The kit components may be purchased separately and are available in different sizes and configurations.
4
Traditional 510k Submission Elvie Pump
The Elvie Pump includes piezoelectric 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 Elvie Pump is a battery-powered electro-mechanical device that contains software. It 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.
Indications for Use:
The Elvie Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Pump is intended for a single user.
The subject and predicate device have the same intended use.
Comparison of Technological Characteristics:
The Elvie Pump uses the same fundamental technology and mode of action as the predicate device, the Medela Freestyle powered electric breast pump (K150499). The table below summarizes the key specifications of the Elvie Pump and the predicate.
| Attribute | Predicate Device
Medela Freestyle | Subject Device
Elvie Pump |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K150499 | K181863 |
| Product code | HGX | HGX |
| Classification Name | Pump, Breast, Powered | Pump, Breast, Powered |
| Indications for Use | The Freestyle is a powered breast pump
to be used by lactating women to
express and collect milk from their
breasts. The Freestyle is intended for a
single user. | The Elvie Pump is a powered breast
pump to be used by lactating women
to express and collect milk from their
breasts. The Elvie Pump is intended
for a single user. |
| Intended Use | Express milk from breast | Express milk from breast |
5
Traditional 510k Submission
| Yes | Elvie Pump | |
|---|---|---|
| Single User Device | Yes | Yes |
| Single / Double | ||
| Pumping | Both | Both |
| Patient Population | Lactating women | Lactating women |
| Environment of | ||
| Use | Home | Home |
| Over the Counter | ||
| (OTC) | Yes | Yes |
| Power Source | AC adaptor or Rechargeable Li-Ion | |
| Battery | Rechargeable Li-Polymer Battery | |
| Adjustable Suction | ||
| Levels | Yes | Yes |
| Backflow | ||
| Protection | Yes | Yes |
| Suction Level | ||
| (mmHg) | 40-245 | 40-220 |
| Cycles per | ||
| Second | 1.7-1.93 | 1.1-2.0 |
| Cycles per | ||
| Second | 0.83-1.36 | 0.6-1.0 |
| Two-phase | ||
| Expression | Yes | Yes |
| User Interface | Pump body | Pump body and/or mobile app |
| Software | Yes | Yes |
| Control | ||
| Mechanism | Microcontroller | Microcontroller |
| Portable | Yes | Yes |
| Milk Quantity | ||
| Measurement | No | Yes |
As evidenced by the table above, there are differences in technological characteristics between the subject and predicate device. These differences in technological characteristics do not raise different questions of safety or effectiveness.
6
Summary of Non-Clinical Test Reports:
The following performance tests were conducted on the Elvie Pump device:
- . Biocompatibility testing demonstrating that the patient contacting device components are biocompatibility, including the following specific tests:
- Cytotoxicity per ISO 10993-5 O
- Irritation per ISO 10993-10 O
- o Sensitization per ISO 10993-10
- . Software validation for a minor level of concern per the FDA guidance document "Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, including cybersecurity assessment and validation of the milk measurement algorithm
- Simulated use testing (usability study) per IEC 62366-1 Application of Usability Engineering to Medical Devices
- . Use life testing to support the proposed use life
- Electrical safety testing per IEC 60601-1 and IEC 60601-1-11 ●
- Electromagnetic compatibility testing per and IEC 60601-1-2
- Cleaning validation on the reprocessing instructions included in the labeling
- . Device performance testing including evaluation of vacuum performance and backflow demonstrating that the subject device meets its specifications
Conclusion:
The Elvie Pump is substantially equivalent to the predicate device.