ARDO Calypso Pro Powered Breast Pump

K150721 · Ardo Medical AG · HGX · Jun 17, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150721
• Device Name: ARDO Calypso Pro Powered Breast Pump
• Applicant: Ardo Medical AG
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Jun 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Indications for Use

The ARDO Calypso Pro breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.

Device Story

Ardo Calypso Pro is a single-piston powered breast pump for hospital, rental, and personal use. Device operates via AC outlet, car battery, or optional battery pack. User interface includes keyboard and LCD display for independent adjustment of vacuum (50–330 mbar) and cycle frequency (30–60 cycles/min). Vacuum and cycle settings remain stable when adjusted independently. Device connects to single or double pumpsets via suction connection. Intended for multiple-user environments. Provides milk expression for lactating women; assists in collection for feeding or storage. Healthcare providers or patients operate device; settings customized by user. Error codes displayed on LCD for troubleshooting.

Clinical Evidence

No clinical data. Bench testing only; device is identical to the previously cleared predicate device.

Technological Characteristics

Single-piston pump; plastic housing; LCD display; keyboard controls. Power: 100-240V AC, car battery, or 6x1.5V battery. Vacuum: 50-330 mbar (37-250 mmHg). Cycles: 30-60/min. Patient-contact materials: Bormed HD810MO and ELASTOSIL LR 3003/50 A/B. Electrical safety: IEC 60601-1. EMC: IEC 60601-1-2. Noise level: < 55 dBA.

Indications for Use

Indicated for lactating women to express and collect breast milk. Suitable for single or double pumping. Intended for multiple-user, indoor settings.

Regulatory Classification

Identification

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

Predicate Devices

• Calypso Powered Breast Pump (K141742)

Submission Summary (Full Text)

{0}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2015

Ardo Medical Ag % Yarmela Pavlovic Partner Hogan Lovells US LLP 3 Embarcadero Center, Suite 1500 San Francisco, CA 94111

Re: K150721

> Trade/Device Name: Ardo Calypso Pro Powered Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: March 19, 2015 Received: March 19, 2015

Dear Yarmela Pavlovic,

This letter corrects our substantially equivalent letter of June 17, 2015.

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. 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.

{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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Benjamin R. Fisher -S

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) K150721

Device Name

ARDO Calypso Pro Powered Breast Pump

#### Indications for Use (Describe)

The ARDO Calypso Pro breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> Residential Use (Part 201, CERCLA, Select One) |
|--------------------------------------------------------------------------------------------------------|
| <input checked="checked" type="checkbox"/> Commercial or Industrial Use (Part 201, CERCLA, Select One) |

| | 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 [e-mail]

"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 ARDO'S CALYPSO PRO POWERED BREAST PUMP

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Ardo medical AG Gewerbestrasse 19 6314 Unteraegeri Switzerland E-mail: [e-mail] Phone: ++41 41 / 754 70 70 Facsimile: ++41 41 / 754 70 71

Contact Person: Roger Dubach

Date Prepared: March 19, 2015

## Name of Device

CALYPSO PRO, POWERED BREAST PUMP

## Name/Address of Correspondent

Yarmela Pavlovic, Partner Hogan Lovells US LLP 3 Embarcadero Center. Suite 1500 San Francisco, CA 94111 Telephone [phone] Facsimile [phone] E-mail: [e-mail]

#### Common or Usual Name

Powered breast pump

#### Classification Name

HGX, Powered breast pump 21 C.F.R. § 884.5160

#### Predicate Device

Calypso Powered Breast Pump (K141742)

#### Device Description

The ARDO Calypso Pro Powered Breast Pump is a single piston pump for hospital, rental and personal use. The unit is equipped with a robust plastic housing and a simplified, logically-organized keyboard with an LCD display readout.

The electrical equipment is designed for outlet and for car battery-operation, or for (optional) battery The controls allow each mother to customize the settings through a flexible system for use.

{4}------------------------------------------------

adjusting vacuum and cycles. The ARDO Calypso Pro breast pump's vacuum level remains stable when the user changes the cycle setting. Likewise, the cycle level remains stable when the user changes the vacuum setting.

Accessories for Calypso Pro include:

- Pumpset (single or double)
- Power cord; .
- Bottle holder;
- Nylon bags for accessories and for the PumpSet;
- . EasyFreeze bag;
- Breastfeeding bag (Shoulder Bag consisting of cold bag, cooling elements, Calypso bag and Pumpset bag); and
- . Pumpsets.

## Intended Use / Indications for Use

The ARDO Calypso Pro breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.

## Technological Characteristics

The ARDO Calypso Pro breast pump is a single piston pump for hospital, rental and personal use. The unit is equipped with a robust plastic housing and a simplified, logically organized keyboard with an LCD display readout. The electrical equipment is designed for outlet or car battery-operation, or for (optional) battery use. The controls allow each mother to choose customized vacuum and cycle settings. The ARDO Calypso Pro breast pump includes a battery compartment and outlet adapter. The device is identical to the predicate device previously cleared by FDA.

The accessories for the ARDO Calypso Pro breast pump are the same as the accessories for the previously cleared ARDO Calypso breast pump. The accessories were previously cleared under K141742, along with the predicate Calypso breast pump. Accessories for Calypso Pro breast pump include:

- Power cord; ●
- Bottle holder;
- Nylon bags for accessories and for the PumpSet; ●
- EasyFreeze bag; ●
- Breastfeeding bag (Shoulder Bag consisting of cold bag, cooling elements, Calypso bag ● and Pumpset bag); and
- . Pumpsets.

## Performance Data

The ARDO Calypso Pro breast pump is identical to the previously cleared ARDO Calypso breast pump, except for a minor difference in the indications for use. There have been no device changes since the last 510(k) notification. Thus, further performance testing was not necessary.

{5}------------------------------------------------

## Substantial Equivalence

The ARDO Calypso Pro breast pump is substantially equivalent to the ARDO Calypso breast pump. The ARDO Calypso Pro breast pump is identical to the predicate device except for a minor difference in the indications for use. The minor difference in the indications for use between the ARDO Calypso Pro breast pump and the ARDO Calypso breast pump does not raise new issues of safety or effectiveness. There have been no device changes since the last 510(k) notification. Thus, the ARDO Calypso Pro breast pump is substantially equivalent to the predicate.

## Conclusions

Based upon the information above, the ARDO Calypso Pro breast pump is substantially equivalent to the predicate device.

{6}------------------------------------------------

## ARDO MEDICAL AG'S Calypso Pro Powered Breast Pump Substantial Equivalence Chart

| Feature | New Device | Predicate Device |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ardo medical AG | Ardo medical AG, |
| | Powered Breast Pump | Powered Breast Pumps |
| | Calypso Pro Breast Pump | Calypso Breast Pump |
| Indication for use | The ARDO Calypso Pro breast pump<br>is intended to be used by lactating<br>women to express and collect milk<br>from their breast. It can be used as<br>a single pump and as a double<br>pump. The unit is intended for indoor<br>use only and is intended for multiple<br>users. | The ARDO Calypso breast pump is<br>intended to be used by lactating women to<br>express and collect milk from their breast.<br>It can be used as a single pump and as a<br>double pump. The unit is intended for<br>indoor use only and is intended for single<br>users. |
| Suction Connection | 1 suction connection, suitable for<br>double pumping mode via Y<br>connector | same |
| Power Supply | Adaptor:<br>100 V - 240 V<br>50/60 Hz | same |
| Electrical Safety | IEC 60601-1 | same |
| EMC Emitted<br>Interference | Complies with<br>IEC 60601-1-2 | same |
| EMC Interference<br>Resistance | Complies with<br>IEC 60601-1-2 | same |
| Battery | Battery 6 x 1,5 V; 9 V, 1200 mA | same |
| Noise Level | < 55 dBA | same |
| Weight | Pump weight 0.545 kg | same |
| Vacuum range in<br>stimulation mode | no stimulation mode available | same |
| Vacuum range in<br>suction (expression)<br>mode | 50 – 330 mbar<br>37 – 250 mmHg | same |
| Cycle range in<br>stimulation mode<br>(cycles per minute) | no Stimulation mode available | same |
| Cycle range in<br>suction (expression)<br>mode (cycles per<br>minute) | 30 – 60 / min | same |
| Programs / Features | Suction Mode<br>Vacuum and Cycle Frequency can<br>be set independently | same |
| Alarms | Error Code in Display | same |
| Accessories | Pumpset with non-sterile Plastic<br>Bottles | same |
| Patient Contacting<br>Materials | Bormed HD810MO &<br>ELASTOSIL LR 3003/50 A/B | same |
| Life Cycle | Warranty: 400 operating hours | same |