(133 days)
The Ameda Pearl Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ameda Pearl Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
The Ameda Pearl Electric Breast Pump is an electric breast pump powered by an external AC-DC power supply or its 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 Ameda Pearl Electric 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 and pumping (cycle) speeds. Vacuum is monitored continuously by a sensor mounted on an internal printed circuit board. The Ameda Pearl Electric Breast Pump has a backlit LCD display, which shows pumping mode, suction level, cycle speed level, timer, and battery charge level. Surrounding the front panel display are eight soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes, control vacuum strength and cycle speed, and adjust the lighting intensity of the LCD display and of a nightlight which shines from the underside of the pump handle. There are 6 levels of suction strength in stimulation mode and 12 levels in expression mode. While the user can select any of 6 available cycle speeds at each of the 12 vacuum levels in expression mode, the cycle speed in stimulation mode is pre-set at each of the 6 vacuum levels available in that mode. At minimum vacuum, level 1, the cycle speed is highest, 120 CPM (cycles per minute). Medium vacuum levels 2 and 3 are cycled at 100 CPM, and the highest 3 vacuum levels are delivered at 80 CPM. The Ameda Pearl Electric Breast Pump is primarily intended for multiple users in a hospital environment. Use is also expected 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 air space where milk is expressed and collected, protecting the breast milk from contamination. The Ameda Pearl Electric Breast Pump is supplied with an AC adapter. HygieniKit is not included.
The Ameda Pearl Electric Breast Pump is a powered breast pump intended for lactating women to express and collect milk. It is designed for multiple users in a hospital setting and single-user home use.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics (like vacuum pressure accuracy or cycle speed consistency) with their corresponding reported device performance values. Instead, it states that "Specifications were met under all conditions" for vacuum pressure and cycle speed.
However, a comparison table with the predicate device (Spectra S3 Plus Breast Pump) provides insights into the operational characteristics and implicit performance expectations. While not formal 'acceptance criteria' in the strict sense, these values reflect the operational range and expected performance of the device.
| Feature | Acceptance Criteria (Implicit from design/comparison) | Reported Device Performance (from summary) | Notes |
|---|---|---|---|
| Power Source (External) | AC/DC adapter supporting 15V, 2A DC operation | AC/DC adapter 15V, 2A DC | Meets its own designed power input. |
| Power Source (Internal) | Rechargeable lithium-ion battery, 10.8V, 2600 mAh | Rechargeable lithium-ion battery, 10.8V, 2600 mAh | Matches its own design specifications. |
| Battery Performance | ≥ 4 hours on full charge | 4 hours on full charge | Meets specified battery life. This is an improvement over the predicate device (3 hours). |
| Auto Power-off | After 60 minutes in expression mode | After 60 minutes in expression mode | Meets specified auto-off duration. This is a longer duration than the predicate (30 minutes), indicating a design choice. |
| Pump Type | Diaphragm | Diaphragm | Matches its own design. |
| Modes | Stimulation and Expression | Stimulation and Expression | Matches its own design. |
| Vacuum Levels | 6 in stimulation mode, 12 in expression mode | 6 in stimulation mode, 12 in expression mode | Matches its own design. The predicate has 5 in massage mode and 12 in expression mode, suggesting a slight difference in stimulation/massage phase granularity. |
| Vacuum Range | 30 – 250 mm Hg | 30 – 250 mm Hg | Matches its own design specifications. The predicate device has a slightly different range (50 – 270 mm Hg), indicating a different operational characteristic that the submission implicitly argues does not raise new safety/effectiveness questions. |
| Cycle Speed Range (Stimulation) | 80, 100, 120 cycles/minute | 80, 100, 120 cycles/minute | Matches its own design. The predicate has a fixed 70 cycles/minute in massage mode. The difference here is a key technological characteristic that was assessed for safety and effectiveness during the substantial equivalence determination. |
| Cycle Speed Range (Expression) | 30 – 48 cycles/minute | 30 – 48 cycles/minute | Matches its own design. The predicate has 38 – 54 cycles/minute in expression mode. Similar to vacuum range, this difference was assessed for substantial equivalence. |
| LCD Display | Mode, Time, Vacuum Level, Battery Status, Cycle speed | Mode, Time, Vacuum Level, Battery Status, Cycle speed | Matches essential display elements of the predicate. |
| LCD Brightness | 3-level adjustable | 3-level adjustable | This is an improvement over the predicate (non-adjustable). |
| Night Light Brightness | 3-level adjustable | 3-level adjustable | This is an improvement over the predicate (2-level adjustable). |
| Button Controls | 8 buttons (Power, Mode, Suction, Cycle Speed, LCD, Night light) | 8: Power, Mode, Suction increase and decrease, Cycle Speed increase and decrease, LCD brightness, Night light brightness | More granular control options compared to the predicate (7 buttons) by including a dedicated LCD brightness control. |
| Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Risk Analysis in accordance with ISO 14971:2019, Electrical safety testing per IEC 60601-1, Electromagnetic compatibility testing per IEC 60601-1-2, Use in home healthcare per IEC 60601-1-11 | Fully compliant with relevant safety standards. This is a critical component of establishing safety for substantial equivalence. |
| Software | Verification and validation per FDA guidance | Software verification and validation conducted; Moderate level of concern. | Complies with FDA guidance for software in medical devices. |
| Backflow/Overflow Protection | Adequate protection demonstrated | Testing confirmed device life and battery operating time, battery indicator accuracy, and protection against backflow and overflow. | This is a critical safety feature for breast pumps. The confirmation of its efficacy is a key performance criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of subject data (e.g., lactating women). The testing described is bench performance testing and non-clinical engineering tests. Therefore, specific sample sizes for human subjects or data provenance (country of origin, retrospective/prospective) are not applicable or provided in this context. The testing involved the device units themselves.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The study primarily describes non-clinical engineering and bench performance testing. There is no mention of human expert-established ground truth related to clinical outcomes or interpretation of data in the provided text, as this is a device performance test, not a diagnostic or interpretative AI study.
4. Adjudication Method for the Test Set
Not applicable, as the testing described is non-clinical bench testing and does not involve human interpretation or subjective assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, often with and without AI assistance, to assess performance and impact on human decision-making. The Ameda Pearl Electric Breast Pump is a mechanical device, and its evaluation focuses on physical performance parameters and safety, not diagnostic interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, in a sense. The bench performance testing evaluates the device's inherent mechanical and electrical performance (e.g., vacuum pressure generation, cycle speed consistency) without human interaction or interpretation as part of the primary outcome. This type of testing is analogous to "standalone" performance for mechanical devices, demonstrating the device's capabilities on its own.
7. The Type of Ground Truth Used
The ground truth for the non-clinical testing was based on:
- Engineering Specifications: The device's designed vacuum pressure range, cycle speeds, battery life, and other operational parameters.
- International Standards: Compliance with recognized standards such as ISO 14971 (Risk Analysis), IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and IEC 60601-1-11 (Home Healthcare).
- FDA Guidance: Software verification and validation followed the 2005 FDA guidance document.
- Functional Verification: Confirmation of features like backflow/overflow protection and battery indicator accuracy.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical medical device, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for an AI/ML algorithm mentioned in the context of this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 12, 2022
Ameda, Inc. Sean Pettibone Coo 485 Half Day Road; Suite 320 Buffalo Grove. Illinois 60089
Re: K221576
Trade/Device Name: Ameda Pearl Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: May 30, 2022 Received: June 1, 2022
Dear Sean 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. You must comply with all the Act's
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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-regulatory-information/postmarketing-safety-reportingcombination-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,
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
Enclosure
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Indications for Use
510(k) Number (if known) K221576
Device Name Ameda Pearl Electric Breast Pump
Indications for Use (Describe)
The Ameda Pearl Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ameda Pearl Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by 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 - K221576
In accordance with 21 CFR 807.92(a) the following summary is provided:
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 carolin.archibald@ameda.com
DATE PREPARED: October 12, 2022
Device information
Trade Name: Ameda Pearl Electric Breast Pump Common Name: Powered breast pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Product Code: HGX (Pump, Breast, Powered) Classification Panel: Obstetrics/Gynecology Regulatory Class: II
Predicate Device Information
Spectra S3 Plus: K181784
The predicate device has not been subject to a design-related recall.
Device Description
The Ameda Pearl Electric Breast Pump is an electric breast pump powered by an external AC-DC power supply or its internal rechargeable lithium-ion battery. The device is provided non-sterile.
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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 Ameda Pearl Electric 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 and pumping (cycle) speeds. Vacuum is monitored continuously by a sensor mounted on an internal printed circuit board.
The Ameda Pearl Electric Breast Pump has a backlit LCD display, which shows pumping mode, suction level, cycle speed level, timer, and battery charge level. Surrounding the front panel display are eight soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes, control vacuum strength and cycle speed, and adjust the lighting intensity of the LCD display and of a nightlight which shines from the underside of the pump handle.
There are 6 levels of suction strength in stimulation mode and 12 levels in expression mode. While the user can select any of 6 available cycle speeds at each of the 12 vacuum levels in expression mode, the cycle speed in stimulation mode is pre-set at each of the 6 vacuum levels available in that mode. At minimum vacuum, level 1, the cycle speed is highest, 120 CPM (cycles per minute). Medium vacuum levels 2 and 3 are cycled at 100 CPM, and the highest 3 vacuum levels are delivered at 80 CPM.
The Ameda Pearl Electric Breast Pump is primarily intended for multiple users in a hospital environment. Use is also expected 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 air space where milk is expressed and collected, protecting the breast milk from contamination.
The Ameda Pearl Electric Breast Pump is supplied with an AC adapter. HygieniKit is not included.
Indications for Use
The Ameda Pearl Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ameda Pearl Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
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Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Device
The intended use and key technological characteristics of the Ameda Pearl Electric Breast Pump and the predicate device are compared side-by-side in the table below.
| Subject Device | Predicate Device | |
|---|---|---|
| Device name | Ameda Pearl Electric Breast Pump | Spectra S3 Plus Breast Pump |
| 510(k) Number | K221576 | K181784 |
| Manufacturer | Ameda, Inc. | Uzinmedicare Co. |
| Product Code | HGX | HGX |
| Device Class | 2 | 2 |
| Indications forUse | The Ameda Pearl Electric Breast Pumpis a powered breast pump to be usedby lactating women to express andcollect milk from their breasts. TheAmeda Pearl Electric Breast Pump isintended for multiple users in ahospital setting. It is also intended forhome use by a single user. | The Spectra 3 Plus Breast Pump is apowered breast pump to be used bylactating women to express and collectmilk from their breast. The Spectra 3Plus Breast Pump is intended formultiple users in a hospital setting. It isalso intended for home use by a singleuser. |
| Intended UseEnvironment | Hospital and Home Healthcare | Hospital and Home Healthcare |
| POWER | ||
| Power Source(external) | AC/DC adapter 15V, 2A DC | AC/DC adapter 12V, 2A DC |
| Power Source(internal) | Rechargeable lithium-ion battery,10.8V, 2600 mAh | Rechargeable lithium-ion battery,11.1V, 2000 mAh |
| Batteryperformance | 4 hours on full charge | 3 hours on full charge |
| Auto Power-off | After 60 minutes in expression mode | After 30 minutes in expression mode |
| VACUUMPERFORMANCE | ||
| Pump Type | Diaphragm | Diaphragm |
| Modes | Stimulation and Expression | Massage and Expression |
| Vacuum levels | 6 in stimulation mode12 in expression mode | 5 in massage mode12 in expression mode |
| Vacuum range | 30 – 250 mm Hg | 50 – 270 mm Hg |
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| Subject Device | Predicate Device | |
|---|---|---|
| Cycle speedrange | 80, 100, 120 cycles/minute(stimulation mode) | 70 cycles/minute (massage mode) |
| 30 – 48 cycles/minute (expression mode) | 38 – 54 cycles/minute (expression mode) | |
| USER INTERFACE | ||
| LCD Display | Mode, Time, Vacuum Level, Battery Status, Cycle speed | Mode, Time, Vacuum Level, Battery Status, Cycle speed |
| LCD brightness | 3-level adjustable | Non-adjustable |
| Night lightbrightness | 3-level adjustable | 2-level adjustable |
| Button controls | 8: Power, Mode, Suction increase and decrease, Cycle Speed increase and decrease, LCD brightness, Night light brightness | 7: Power, Mode, Suction increase and decrease, Cycle Speed increase and decrease, Night light brightness |
The subject and predicate device have identical indications for use statement and have the same intended use. The subject and predicate device have different technological features, including the user interface, vacuum range, cycle speed range, and power sources. These technological differences do not raise different questions of safety or effectiveness.
Summary Of Non-Clinical Testing
The following data were provided in support of the substantial equivalence determination.
Risk Analysis in accordance with ISO 14971:2019
Electrical safety testing per IEC 60601-1:2005 (3rd Edition) with US deviations per AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012
Electromagnetic compatibility testing per IEC 60601-1-2: 2014+AMD1:2020, edition 4.1
Use in the home healthcare environment per IEC 60601-1-11:2015
Software verification and validation was conducted in accordance with the 2005 FDA quidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered a Moderate level of concern.
Bench Performance Testing
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The Ameda Pearl Electric Breast Pump was tested to demonstrate it meets stated performance specifications (vacuum pressure and cycle speed). 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 lithiumion battery. Specifications were met under all conditions.
Testing confirmed device life and battery operating time, battery indicator accuracy, and protection against backflow and overflow.
Conclusion
The results of the performance testing described above demonstrate that the Ameda Pearl Electric Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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).