The ARDO Carum powered 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.

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 Pumpset should be used in combination with ARDO breast pumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset.

Device Description

ARDO Carum and Calypso Powered Breast Pumps consist of the breast milk pump and a pump set (single or double pump set). They are double piston or reciprocating pumps for hospital, rental and personal use. The units are 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. For both the Carum and Calypso breast pumps, the vacuum level remains stable when the user changes the cycle setting. Likewise, the cycle level remains stable when the user changes the vacuum setting. A non-sterile pump set is included for collection and storage of milk.

Three models of ARDO Powered Breast Pumps are available:

-Calvpso with battery compartment and outlet adapter:
-Carum with outlet cord: and
-Carum with built in rechargeable battery and outlet cord.

Accessories for Carum include:

-Power cord:
-Protective carrying case;
Car adapter (12VDC); -
-Trolley;
Bottle holder: -
-EasvFreeze holder:
EasyFreeze bag; and -
-PumpSets.

Accessories for Calvpso 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, Calvpso bag and Pumpset bag); and
-Pumpsets.

AI/ML Overview

The provided text is a 510(k) summary for the ARDO Carum and Calypso Powered Breast Pumps. It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device. However, it does not describe an AI/ML powered device, nor does it detail acceptance criteria and a study proving an AI device meets those criteria in the typical sense of diagnostic performance metrics like sensitivity or specificity.

Therefore, many of the requested points are not applicable as they relate to AI/ML device performance studies. I will address the points that can be inferred from the document regarding the performance tests conducted on the breast pumps.

Here's an analysis based on the provided text, with "N/A" for sections not applicable to this document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, but it doesn't explicitly define "acceptance criteria" as pass/fail thresholds with numerical targets for each. Instead, it states that the devices "functioned as intended" or that testing "support[s] the safety profile and performance."

Performance Test Category	Acceptance Criteria (Inferred)	Reported Device Performance
Safety & Biocompatibility	Compliance with relevant ISO and IEC standards; no adverse findings.	- Microbiological Tightness (ISO 11737-1:2006): Performed.
		- Biocompatibility:
		- Cytotoxicity (ISO 10993-5:2009/(R)2014): Performed.
		- Irritation (ISO 10993-10:2010): Performed.
		- Sensitization (ISO 10993-10:2010): Performed.
		- Acute systemic toxicity (ISO 10993-11:2006/(R)2010): Performed.
		Conclusion: Device materials were demonstrated to be biocompatible for intended use.
Electrical & Mechanical Functionality	Compliance with relevant IEC standards; device functions as specified.	- Electromagnetic Safety (IEC 60601-1-2:2007): Performed.
		- Electrical Safety (IEC 60601-1:2005): Performed.
		- Battery Safety (IEC 62133:2003, EN 60068-2-27:2009, EN 60068-2-6:2008): Performed.
	- Max vacuum pressure during a simulated 20-min session meets specifications.	- Vacuum Pressure over Time: Evaluation conducted to determine max vacuum pressure during a simulated 20-minute pumping session.
		Conclusion: In all instances, the ARDO Carum and Calypso Powered Breast Pumps functioned as intended.
Software Performance	Software verified and validated.	- Software: Verified and validated.
Overall Performance & Substantial Equivalence	Performs as intended, safe, and effective, demonstrating substantial equivalence to predicate.	Conclusion: Performed as intended and in a manner substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/ML model's performance. The "tests" mentioned are engineering and safety tests on the physical breast pump devices. The sample size for these engineering tests is not explicitly stated but would typically involve a certain number of manufactured units or material samples. The data provenance is not described in terms of country of origin or retrospective/prospective for typical medical device performance studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This information is relevant for AI/ML diagnostic or prognostic studies, not for the physical device performance testing described.

4. Adjudication method for the test set

N/A. Not applicable to the type of device and testing described.

5. 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

N/A. This is a breast pump, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A. This is a physical medical device (breast pump), not an algorithm.

7. The type of ground truth used

For the safety and performance tests:

Safety & Biocompatibility: Ground truth is established by the specified ISO and IEC standards and their defined methodologies for evaluation.
Electrical & Mechanical Functionality: Ground truth is established by the defined specifications of the device (e.g., intended vacuum pressure range, cycle range) and compliance with IEC standards for electrical and battery safety. "Functioned as intended" implies comparison against design specifications.
Software Performance: "Verified and validated" against software requirements and design specifications.

8. The sample size for the training set

N/A. There is no AI/ML model training discussed in this document.

9. How the ground truth for the training set was established

N/A. There is no AI/ML model training discussed in this document.

Summary

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

October 17, 2014

Ardo Medical AG % Yarmela Pavlovic Regulatory Counsel Hogan Lovells, LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103

Re: K141742

Trade/Device Name: Ardo Carum and Calypso Powered Breast Pumps Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: Class II Product Code: HGX Dated: September 2, 2014 Received: September 2, 2014

Dear Yarmela Pavlovic,

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.

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

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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" (21 CFR 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 yours,

Herbert P.
Lerner -S

for Benjamin 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)

K141742

Device Name

ARDO Carum and Calypso Powered Breast Pumps

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

ARDO'S CARUM AND CALYPSO POWERED BREAST PUMPS

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: October 9, 2014

Name of Device

CARUM and CALYPSO, POWERED BREAST PUMPS

Name/Address of Correspondent

Yarmela Pavlovic, Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 Telephone +1 267 675 4600 FAX +1 267 675 4601 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

Medela Symphony Breast Pump Model 024 (K020518).

Device Description

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organized keyboard with an LCD display readout.

Three models of ARDO Powered Breast Pumps are available:

-Calvpso with battery compartment and outlet adapter:
-Carum with outlet cord: and
-Carum with built in rechargeable battery and outlet cord.

Accessories for Carum include:

-Power cord:
-Protective carrying case;
Car adapter (12VDC); -
-Trolley;
Bottle holder: -
-EasvFreeze holder:
EasyFreeze bag; and -
-PumpSets.

Accessories for Calvpso 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, Calvpso bag and Pumpset bag); and
-Pumpsets.

Intended Use / Indications for Use

The ARDO Calvpso 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.

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Technological Characteristics

The Carum and Calypso Powered Breast Pumps have similar technological characteristics compared to the predicate device. Each features a pump with suctions and variable vacuum and cycle ranges. All devices provide a pump set with plastic bottlerences between the devices include slight variation in the vacuum range, 30/50-330 mbar for the subject devices compared to 50-250 mbar for the predicate device. In addition, the range of cycles per minute differs slightly between the devices. These minor technological differences do not raise any new types of safety or effectiveness questions because the kev questions of effective milk collection and user comfort are common to all devices. Further, differences in patient-contacting materials were evaluated in testing and device materials were demonstrated to be biocompatible for its Therefore, the Carum and Calypso Pumps present similar technological intended use. characteristics compared to the predicate device in support of substantial equivalence.

Performance Data

The following performance tests were conducted:

Microbiological Tightness (ISO 11737-1:2006);
. Biocompatibility:
- o Cvtotoxicity (ISO 10993-5:2009/(R)2014):
- Irritation (ISO 10993-10:2010); o
- Sensitization (ISO 10993-10:2010); O
- Acute systemic toxicity (ISO 10993-11:2006/(R)2010); O
Electromagnetic Safety (IEC 60601-1-2:2007); ●
. Electrical Safety (IEC 60601-1:2005); and
Battery Safety (IEC 62133:2003, EN 60068-2-27:2009, EN 60068-2-6:2008). ●

In addition, the software was verified and validated. Evaluation of the vacuum pressure over time was conducted to determine the maximum vacuum pressure during a simulated, 20-minute pumping session. In all instances, the ARDO Carum and Calypso Powered Breast Pumps functioned as intended.

Conclusions

Based upon the information above, the ARDO Carum and Calypso powered breast pumps perform as intended and in a manner that is substantially equivalent to the predicate device. The Carum and Calypso Powered Breast Pumps are substantially equivalent to the Medela Symphony Powered Breast Pump. The Carum and Calvoso Powered Breast Pumps have the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Carum and Calypso Powered Breast Pumps and their predicate device raise no new issues of safety or effectiveness. The testing data support the safety profile and performance of the device and demonstrate that the devices perform as intended in the specified use conditions. Thus, the Carum and Calypso Powered Breast Pumps are substantially equivalent.

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).