(227 days)
No
The summary describes a standard powered breast pump with adjustable settings, memory function, and app control. There is no mention of AI or ML in the device description, performance studies, or key metrics.
No.
A breast pump, while used for a health-related purpose (collecting breast milk), is generally not classified as a therapeutic device. Therapeutic devices are typically intended to treat, cure, mitigate, or prevent disease, or affect the structure or any function of the body for a therapeutic purpose. A breast pump facilitates milk expression and collection, which is a physiological process, rather than treating a medical condition.
No
Explanation: The device is a powered breast pump intended to express and collect milk from lactating women, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "powered breast pump" and details hardware components like an ON/OFF button, +/- buttons, a power adapter, and an integrated rechargeable battery. While it mentions a mobile app for operation, the core device is a physical, powered pump.
Based on the provided information, the Ardo Alyssa 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 a condition.
- Device Description: The description details a powered breast pump that generates negative pressure. This aligns with a mechanical device for extracting a bodily fluid, not a device for analyzing a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like milk itself for diagnostic purposes), reagents, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies focus on the mechanical and electrical functionality of the pump (vacuum pressure, cycle rate, backflow, battery life), not on the accuracy or reliability of a diagnostic test.
In summary, the Ardo Alyssa is a medical device, specifically a powered breast pump, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ardo Alyssa is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Alyssa is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Ardo Alyssa is a powered breast pump that generates negative pressure to express millt from the breasts of lactating women. It is intended for a single user and can be used in professional healthcare and home environments. The pump can be used for single or double breast pumping. To operate as a single or double pumping system, the pump needs to be connected to a single or double pump sets to be provided with the Ardo Alyssa are identical to those cleared in K141742 for the Ardo Calypso Powered Breast Pump.
The Ardo Alyssa has two operational modes (stimulation and expression), with eight vacuum levels in each mode. The device comprises an ON/OFF button and two +/- buttons for independently adjusting (increasing or decreasing) vacuum and cycle. The user also has an option to operate the device via the mobile app, MyArdoApp. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. The pump can be powered using the supplied power adapter or by an integrated rechargeable battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lactating women / professional healthcare and home environments
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)
Non-clinical tests were conducted to verify that the Ardo Alyssa met all design specifications and that it is substantially equivalent to the predicate device. The testing performed is summarized below:
- a. Biocompatibility testing on the patient-contacting materials of the device was not provided in this submission, as all of the patient-contacting materials are identical to those cleared in K141742 for the Ardo Calypso Powered Breast Pump. Therefore, this submission relied on the biocompatibility information from the Ardo Calypso Powered Breast Pump to support the patient-contacting materials of the subject device.
- b. Electrical Safety, Electromagnetic Compatibility, and Wireless Technology
- 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 with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- . IEC 60601-1-11:2015. 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 environment.
- . IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
- IEC 62133-2:2017 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
- UL 1642 Standard for Safety: Lithium batteries ●
- . Documentation provided in accordance with the FDA guidance document, "Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013.
- Software verification and validation in accordance with the FDA quidance document. C. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
- d. Cybersecurity information was provided in accordance with the FDA quidance document, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" dated October 2, 2014.
- e. Performance testing was conducted to confirm that the subject device meets all performance specifications and operates as intended. The following were evaluated with passing results:
- . 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 remains . functional during its stated battery use-life.
- . Battery status indicator testing was conducted to demonstrate that the battery status indicator displays the correct remaining battery operation time.
Key Results: The subject and predicate device have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the Ardo Alyssa is as safe and effective as the Medela Freestyle Flex™ and supports a determination of substantial equivalence.
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.
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15, 2022
ARDO Medical AG % Kristin Zielinski Duggan Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004
Re: K212773
Trade/Device Name: Ardo Alyssa Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: March 14, 2022 Received: March 14, 2022
Dear Kristin Zielinski Duggan:
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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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,
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecologv 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
2
Indications for Use
510(k) Number (if known) K212773
Device Name Ardo Alyssa
Indications for Use (Describe)
The Ardo Alyssa is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Alyssa 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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3
510(k) Summary K212773
Submitter Information:
| Sponsor: | ARDO Medical AG
Gewerbestrasse 19
CH-6314 Unterägeri
Switzerland |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Thomas Schlieper
Phone: +41 41 754 70 62
Email: thomas.schlieper@ardo.ch |
| Submission Correspondent: | Hogan Lovells US LLP
Kristin Zielinski Duggan
Columbia Square 555 Thirteenth Street, NW
Washington, DC 20004-1109 |
| Tel: | +1 202 637 5600 |
| Direct: | +1 202 637 8894 |
| Fax: | +1 202 637 5910 |
Date 510(k) Summary Prepared: April 14, 2022
Device Information:
| Name of Device: | Ardo Alyssa |
|---|---|
| Common or Usual Name: | Powered breast pump |
| Regulation Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulatory Class: | Class II |
| Product Code: | HGX (Pump, Breast, Powered) |
| Review Panel: | Obstetrics/Gynecology |
Predicate Device:
| 510(k) Number: | K191653 |
|---|---|
| Manufacturer: | Medela AG |
| Device Name: | Freestyle Flex™ |
The predicate device has not been subject to a design-related recall.
Device Description:
The Ardo Alyssa is a powered breast pump that generates negative pressure to express millt from the breasts of lactating women. It is intended for a single user and can be used in professional healthcare and home environments. The pump can be used for single or double breast pumping. To operate as a single or double pumping system, the pump needs to be connected to a single or
4
double pump sets to be provided with the Ardo Alyssa are identical to those cleared in K141742 for the Ardo Calypso Powered Breast Pump.
The Ardo Alyssa has two operational modes (stimulation and expression), with eight vacuum levels in each mode. The device comprises an ON/OFF button and two +/- buttons for independently adjusting (increasing or decreasing) vacuum and cycle. The user also has an option to operate the device via the mobile app, MyArdoApp. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. The pump can be powered using the supplied power adapter or by an integrated rechargeable battery.
Indications for Use:
The Ardo Alyssa is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Alyssa is intended for a single user.
Comparison of Intended Use and Technological Characteristics:
The following table compares the subject device to the predicate device with respect to the indications for use and technological characteristics:
| Device & Predicate
Device: | Subject Device
Ardo Alyssa
K212773 | Predicate Device
Freestyle Flex™
K191653 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Ardo Alyssa is a powered breast
pump to be used by lactating women
to express and collect milk from their
breasts. The Ardo Alyssa is intended
for a single user. | The Freestyle Flex™ breast pump
is a powered breast pump to be
used by lactating women to
express and collect milk
from their breasts.
The Freestyle Flex™ breast pump
is intended for a single user.
The breast pump is intended to be
used in a home environment. |
| Intended Use | Single-user | Single-user |
| Modes of operation | Stimulation mode, Expression mode | Stimulation mode, Expression
mode |
| Pumping options | Single and double | Single and double |
| Vacuum strength and
levels | Stimulation mode: 23 – 113 mmHg, 8
levels
Expression mode: 23 - 248 mmHg, 8
levels | Stimulation mode: 45 - 140
mmHg, 9 levels
Expression mode: 45 - 245
mmHg, 9 levels |
| Cycle speed | Stimulation mode: 72 - 120
cycles/min
Expression mode: 20 – 50 cycles/min | Stimulation mode: 111 cycles/min
Expression mode: 45 - 75
cycles/min |
| Power source | AC adaptor: 100 – 240 V, 50/60 Hz,
400 mA (Output: 5VDC, 2A)
Li-ion battery (3.7 V, 2600mAh) | AC adaptor: 100 – 240 V, 50/60
Hz, 400 mA (Output: 5VDC, 2A)
Li-ion battery (3.7 V, 2750mAh) |
| Backflow protection | Diaphragm | Diaphragm |
| Device control
through an app | Yes | Yes |
5
The subject and predicate device do not have identical indications for use statements but do have the same intended use – to express and collect milk from the breasts of lactating women. The subject and predicate device have different technological characteristics, including vacuum pressures, cycle speeds, and battery specifications. These differences do not raise different questions of safety or effectiveness.
Performance Testing:
Non-clinical tests were conducted to verify that the Ardo Alyssa met all design specifications and that it is substantially equivalent to the predicate device. The testing performed is summarized below:
- a. Biocompatibility testing on the patient-contacting materials of the device was not provided in this submission, as all of the patient-contacting materials are identical to those cleared in K141742 for the Ardo Calypso Powered Breast Pump. Therefore, this submission relied on the biocompatibility information from the Ardo Calypso Powered Breast Pump to support the patient-contacting materials of the subject device.
- b. Electrical Safety, Electromagnetic Compatibility, and Wireless Technology
- 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 with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- . IEC 60601-1-11:2015. 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 environment.
- . IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
- IEC 62133-2:2017 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
- UL 1642 Standard for Safety: Lithium batteries ●
- . Documentation provided in accordance with the FDA guidance document, "Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013.
- Software verification and validation in accordance with the FDA quidance document. C. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
- d. Cybersecurity information was provided in accordance with the FDA quidance document, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" dated October 2, 2014.
- e. Performance testing was conducted to confirm that the subject device meets all performance specifications and operates as intended. The following were evaluated with passing results:
- . 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
6
K212773 Page 4 of 4
specifications throughout its proposed use-life.
- Battery performance testing was conducted to demonstrate that the battery remains . functional during its stated battery use-life.
- . Battery status indicator testing was conducted to demonstrate that the battery status indicator displays the correct remaining battery operation time.
Conclusion:
The subject and predicate device have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the Ardo Alyssa is as safe and effective as the Medela Freestyle Flex™ and supports a determination of substantial equivalence.