(136 days)
Not Found
No
The description details electronic control of a motor and solenoid based on user-selectable settings, with no mention of adaptive learning, pattern recognition, or other AI/ML characteristics. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is intended to express and collect milk from the breasts of lactating women, which is a supportive function, not a treatment for a disease or condition.
No
The device is a breast pump intended to express and collect milk, not diagnose any medical condition.
No
The device description clearly outlines hardware components such as a motor, vacuum pump, solenoid, LCD display, buttons, and a rechargeable battery, indicating it is a physical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ameda Mya Joy PLUS breast pump is used to express and collect milk from the breasts of lactating women. It is a mechanical device that applies suction to the breast.
- Lack of Specimen Analysis: The device does not analyze or test the breast milk itself. It simply facilitates its collection.
The description clearly outlines the device's function as a mechanical pump for milk expression, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Ameda Mya Joy PLUS breast pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
Product codes
HGX
Device Description
The Mya Joy PLUS Breast Pump is an electric breast pump powered by an external AC-DC power supply or by an internal rechargeable lithium ion battery. The device is provided non-sterile.
The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping).
The Mya Joy PLUS Breast Pump utilizes a DC-powered motor driving a diaphragm-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels at various pre-determined cycle frequencies.
The Mya Joy PLUS Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes and control vacuum strength within each mode, 6 levels of vacuum strength in stimulation and 12 levels in expression.
The Mya Joy PLUS Breast Pump is intended for a single user in the home environment. When properly connected, the Ameda Hygienikit pumping kit transfers the vacuum generated by the powered pump to the breast enabling expression and collection of milk. A diaphragm in the breast flange assembly physically isolates pump and tubing from the space where milk is expressed, flows and is collected, effectively protecting the breast milk from contamination.
The pump allows lactating women to express milk at their own convenience and maintain their milk supply.
The base model of the Mya Joy PLUS Breast Pump contains a pump, pumping kit, AC adapter with detachable USB-C cable, and a lanyard. Optional accessories, such as a carrying bag or spare parts for the pumping kit, may be included in the packaging of other product offerings.
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
single user in the 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
Testing involved measurement of vacuum at user-selectable settings in both stimulation and expression modes for pumping at a single breast (single pumping) or both breasts simultaneously (double pumping). Testing was conducted separately under two states of power: (1) externally supplied by an AC/DC adapter and (2) internally supplied from a rechargeable lithium ion battery. Specifications were met under all conditions.
Testing was also performed to characterize noise emitted from the pump during operation, the ability of the pump to operate within stated operating and storage conditions, and the ability of packaging to withstand simulated transportation conditions.
Testing also confirmed device life and battery operating time.
Test results demonstrated that the Ameda Mya Joy PLUS breast pump met predetermined acceptance criteria.
Clinical testing was not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 22, 2021
Ameda, Inc. Sean GM Pettibone Coo 485 Half Day Road; Suite 320 Buffalo Grove, IL 60089
Re: K203570
Trade/Device Name: Mya Joy PLUS Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: March 22, 2021 Received: March 23, 2021
Dear Sean GM Pettibone:
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/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 mediation-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,
For 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 Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K203570
Device Name Mya Joy PLUS Breast Pump
Indications for Use (Describe)
The Ameda Mya Joy PLUS breast pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
In accordance with 21 CFR 807.92(a) the following summary is provided:
PREPARED: April 16, 2021
SUBMITTER:
Ameda, Inc. 485 Half Day Road, Suite 320 Buffalo Grove, IL 60089 Phone: 847-964-2620
PRIMARY CONTACT PERSON:
Carolin Archibald President and CEO Ameda, Inc. 847-964-2620
Device information
Trade Name: Mya Joy PLUS Breast Pump Common name: Powered Breast Pump Classification Name: PUMP, BREAST, POWERED Classification Panel: Obstetrics/Gynecology Classification Regulation: 21 CFR 884.5160 Regulatory Class: II Product Code: HGX
Predicate Device Information
Cimilre F1: K162870
The predicate device has not been subject to a design-related recall.
Device Description
The Mya Joy PLUS Breast Pump is an electric breast pump powered by an external AC-DC power supply or by an internal rechargeable lithium ion battery. The device is provided non-sterile.
4
The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping).
The Mya Joy PLUS Breast Pump utilizes a DC-powered motor driving a diaphragm-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels at various pre-determined cycle frequencies.
The Mya Joy PLUS Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes and control vacuum strength within each mode, 6 levels of vacuum strength in stimulation and 12 levels in expression.
The Mya Joy PLUS Breast Pump is intended for a single user in the home environment. When properly connected, the Ameda Hygienikit pumping kit transfers the vacuum generated by the powered pump to the breast enabling expression and collection of milk. A diaphragm in the breast flange assembly physically isolates pump and tubing from the space where milk is expressed, flows and is collected, effectively protecting the breast milk from contamination.
The pump allows lactating women to express milk at their own convenience and maintain their milk supply.
The base model of the Mya Joy PLUS Breast Pump contains a pump, pumping kit, AC adapter with detachable USB-C cable, and a lanyard. Optional accessories, such as a carrying bag or spare parts for the pumping kit, may be included in the packaging of other product offerings.
Indications for Use
The Ameda Mya Joy PLUS breast pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
Comparison of Technological Characteristics
The indications for use of the Ameda Mya Joy PLUS breast pump and the intended use are the same as those of the predicate device, the Cimilre F1 powered breast pump (K162870). It has a nearly identical external shape, user interface, similar vacuum motor, including noise dampening material.
5
Key technological characteristics of the Ameda Mya Joy PLUS breast pump and the predicate device are compared side-by-side in the table below.
| Proposed Device | Predicate Device | |
|---|---|---|
| Device name | Mya Joy PLUS | F1 |
| 510(k) Number | TBD | K162870 |
| Manufacturer | Ameda, Inc. | Cimilre |
| Product Code | HGX | HGX |
| Device Class | 2 | 2 |
| Indications for | ||
| Use | The Ameda Mya Joy PLUS | |
| breast pump is a single- | ||
| user, powered breast pump | ||
| intended to express and | ||
| collect milk from the | ||
| breasts of lactating women. | The CIMILRE F1 is a single- | |
| user, powered breast | ||
| pumps intended to express | ||
| and collect milk from the | ||
| breasts of lactating women | ||
| Intended Use | ||
| Environment | Home Environment | Home Environment |
| POWER | ||
| Power Source | ||
| (external) | AC/DC adapter; 5VDC | AC/DC adapter: 12 VDC |
| Power Source | ||
| (internal) | rechargeable lithium-ion | |
| battery | ||
| 3.7V, 1500 mAh | rechargeable lithium | |
| polymer battery | ||
| 7.4V, 900 mAh | ||
| Battery | ||
| performance | at least 2 hours on full | |
| charge | 2 hours on full charge | |
| Auto Power-off | After 45 minutes in | |
| expression mode | After 30 minutes in | |
| expression mode | ||
| VACUUM | ||
| PERFORMANCE | ||
| Pump Type | Diaphragm | Diaphragm |
| Pump Options | Single or Double | Single or Double |
| Modes | Stimulation and Expression | Massage and Expression |
| Vacuum levels | 6 (stimulation) | |
| 12 (expression) | 5 (massage) | |
| 10 (expression) | ||
| Vacuum range | 40 - 350 mm Hg | 40 - 300 mm Hg |
| Proposed Device | Predicate Device | |
| Cycle range | 80 - 120 cycles/minute | |
| (stimulation) | ||
| 25 - 63 cycles/minute | ||
| (expression) | 25 - 60 cycles/minute | |
| (CPM) | ||
| Cycle speed | Pre-programmed | Pre-programmed |
| Noise level | 43dB |