ARDO Alyssa

K212773 · Ardo Medical AG · HGX · Apr 15, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K212773
• Device Name: ARDO Alyssa
• Applicant: Ardo Medical AG
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Apr 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

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.

Device Story

Ardo Alyssa is a powered breast pump generating negative pressure to express milk from lactating women. Device supports single or double pumping; used in professional healthcare or home environments. Operated by user via device buttons or MyArdoApp mobile application. Features include stimulation and expression modes, eight vacuum levels per mode, memory function for session replay, and power pumping button for predefined pump-pause programs. Powered by AC adapter or integrated rechargeable Li-ion battery. Backflow protection provided by diaphragm. Output is expressed milk collected in pump sets. Device assists in milk expression for lactating women.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included vacuum pressure/cycle rate verification, backflow prevention, use-life, battery performance, electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and battery safety (IEC 62133-2, UL 1642). Biocompatibility relied on predicate Ardo Calypso (K141742).

Technological Characteristics

Powered breast pump; negative pressure generation. Materials: identical to Ardo Calypso (K141742). Power: AC adapter (100-240V) or Li-ion battery (3.7V, 2600mAh). Connectivity: Bluetooth/Wireless for MyArdoApp. Backflow protection: diaphragm. Modes: stimulation/expression. Vacuum: 23-248 mmHg. Cycle: 20-120 cycles/min. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62133-2, UL 1642.

Indications for Use

Indicated for lactating women to express and collect breast milk. Intended for single-user use.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Freestyle Flex™ (K191653)

Reference Devices

• Ardo Calypso Powered Breast Pump (K141742)

Submission Summary (Full Text)

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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

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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 [phone] 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

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# 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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# 510(k) Summary K212773

#### Submitter Information:

| Sponsor: | ARDO Medical AG<br>Gewerbestrasse 19<br>CH-6314 Unterägeri<br>Switzerland |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Thomas Schlieper<br>Phone: [phone]<br>Email: [e-mail] |
| Submission Correspondent: | Hogan Lovells US LLP<br>Kristin Zielinski Duggan<br>Columbia Square 555 Thirteenth Street, NW<br>Washington, DC 20004-1109 |
| Tel: | [phone] |
| Direct: | [phone] |
| Fax: | [phone] |

# 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

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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<br>Device: | Subject Device<br>Ardo Alyssa<br>K212773 | Predicate Device<br>Freestyle Flex™<br>K191653 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Ardo Alyssa is a powered breast<br>pump to be used by lactating women<br>to express and collect milk from their<br>breasts. The Ardo Alyssa is intended<br>for a single user. | The Freestyle Flex™ breast pump<br>is a powered breast pump to be<br>used by lactating women to<br>express and collect milk<br>from their breasts.<br>The Freestyle Flex™ breast pump<br>is intended for a single user.<br>The breast pump is intended to be<br>used in a home environment. |
| Intended Use | Single-user | Single-user |
| Modes of operation | Stimulation mode, Expression mode | Stimulation mode, Expression<br>mode |
| Pumping options | Single and double | Single and double |
| Vacuum strength and<br>levels | Stimulation mode: 23 – 113 mmHg, 8<br>levels<br>Expression mode: 23 - 248 mmHg, 8<br>levels | Stimulation mode: 45 - 140<br>mmHg, 9 levels<br>Expression mode: 45 - 245<br>mmHg, 9 levels |
| Cycle speed | Stimulation mode: 72 - 120<br>cycles/min<br>Expression mode: 20 – 50 cycles/min | Stimulation mode: 111 cycles/min<br>Expression mode: 45 - 75<br>cycles/min |
| Power source | AC adaptor: 100 – 240 V, 50/60 Hz,<br>400 mA (Output: 5VDC, 2A)<br>Li-ion battery (3.7 V, 2600mAh) | AC adaptor: 100 – 240 V, 50/60<br>Hz, 400 mA (Output: 5VDC, 2A)<br>Li-ion battery (3.7 V, 2750mAh) |
| Backflow protection | Diaphragm | Diaphragm |
| Device control<br>through an app | Yes | Yes |

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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

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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.