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 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 use. The controls allow each mother to customize the settings through a flexible system for 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.

AI/ML Overview

The provided text is a 510(k) summary for a breast pump, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study for acceptance criteria. As such, it does not contain the information requested for acceptance criteria and a study proving a device meets those criteria.

Specifically, the document states:
"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." and "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."

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: No specific performance acceptance criteria or study results are presented. The document relies on the predicate device's performance.
Sample sized used for the test set and the data provenance: No test set was used as no further performance testing was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was used.
Adjudication method for the test set: Not applicable as no test set was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a breast pump, not an AI-powered diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a breast pump, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth was established for performance testing.
The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable as this is not an AI/machine learning device requiring a training set.

The document primarily provides a Substantial Equivalence Chart comparing the new device (Calypso Pro) to its predicate device (Calypso) based on technological characteristics. This chart indicates that the new device is identical to the predicate device across all listed features except for a minor difference in the "Indication for use" (specifically, the predicate indicated "single users" for indoor use, while the new device indicates "multiple users").

The relevant comparative information from the provided text is included below, but it does not represent acceptance criteria and performance data from a specific study of the new device.

Substantial Equivalence Chart (Modified to reflect acceptance criteria focus, though not explicitly stated as such in the original document):

Feature	Predicate Device Performance (Implied Acceptance Criteria for New Device)	Reported New Device Performance
Indication for use	The ARDO Calypso 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 single users.	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.
Suction Connection	1 suction connection, suitable for double pumping mode via Y connector	same
Power Supply	Adaptor: 100 V - 240 V, 50/60 Hz	same
Electrical Safety	IEC 60601-1	same
EMC Emitted Interference	Complies with IEC 60601-1-2	same
EMC Interference Resistance	Complies with 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 suction (expression) mode	50 – 330 mbar / 37 – 250 mmHg	same
Cycle range in suction (expression) mode	30 – 60 / min	same
Programs / Features	Suction Mode, Vacuum and Cycle Frequency can be set independently	same
Alarms	Error Code in Display	same
Accessories	Pumpset with non-sterile Plastic Bottles	same
Patient Contacting Materials	Bormed HD810MO & ELASTOSIL LR 3003/50 A/B	same
Life Cycle	Warranty: 400 operating hours	same

Summary

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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.

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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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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Indications for Use

510(k) Number (if known) K150721

Device Name

ARDO Calypso Pro Powered Breast Pump

Indications for Use (Describe)

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

Residential Use (Part 201, CERCLA, Select One)
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)

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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: info@ardo.ch 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 +1 415 374 2336 Facsimile +1 415 374 2499 E-mail: yarmela.pavlovic@hoganlovells.com

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 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.

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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

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.

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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.

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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 pumpis intended to be used by lactatingwomen to express and collect milkfrom their breast. It can be used asa single pump and as a doublepump. The unit is intended for indooruse only and is intended for multipleusers.	The ARDO Calypso breast pump isintended to be used by lactating women toexpress and collect milk from their breast.It can be used as a single pump and as adouble pump. The unit is intended forindoor use only and is intended for singleusers.
Suction Connection	1 suction connection, suitable fordouble pumping mode via Yconnector	same
Power Supply	Adaptor:100 V - 240 V50/60 Hz	same
Electrical Safety	IEC 60601-1	same
EMC EmittedInterference	Complies withIEC 60601-1-2	same
EMC InterferenceResistance	Complies withIEC 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 instimulation mode	no stimulation mode available	same
Vacuum range insuction (expression)mode	50 – 330 mbar37 – 250 mmHg	same
Cycle range instimulation mode(cycles per minute)	no Stimulation mode available	same
Cycle range insuction (expression)mode (cycles perminute)	30 – 60 / min	same
Programs / Features	Suction ModeVacuum and Cycle Frequency canbe set independently	same
Alarms	Error Code in Display	same
Accessories	Pumpset with non-sterile PlasticBottles	same
Patient ContactingMaterials	Bormed HD810MO &ELASTOSIL LR 3003/50 A/B	same
Life Cycle	Warranty: 400 operating hours	same

Regulation Number and Section

§ 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).