(112 days)
Not Found
No
The summary describes a standard powered breast pump with adjustable vacuum and cycle settings. There is no mention of AI, ML, or any features that would suggest the use of such technologies for optimizing pumping patterns, analyzing milk flow, or providing personalized recommendations based on data. The "flexible system for adjusting vacuum and cycles" appears to be a manual user control feature.
No
The device is a breast pump used to express and collect milk, which is a supportive function rather than a therapeutic treatment for a medical condition.
No
Explanation: The device is a breast pump, intended to express and collect milk. It does not provide any diagnosis or information about a patient's medical condition.
No
The device description explicitly details physical hardware components such as a pump, housing, keyboard, LCD display, power cords, battery compartments, and accessories like carrying cases and bottle holders. The performance studies also include tests related to electrical and battery safety, which are relevant to hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The ARDO breast pumps are designed to physically express and collect breast milk from a lactating woman. They do not perform any diagnostic tests on the milk or the woman's body.
- Intended Use: The stated intended use is "to express and collect milk from their breast." This is a mechanical function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of the pump (double piston, vacuum and cycle adjustments, power options) and accessories for milk collection and storage. There is no mention of analyzing or testing the milk.
Therefore, the ARDO Carum and Calypso breast pumps are medical devices, but they fall under a different category than In Vitro Diagnostics. They are devices used for a physiological process (milk expression) rather than for diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
HGX
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:
- -Calypso 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: -
- -EasyFreeze holder:
- EasyFreeze bag; and -
- -PumpSets.
Accessories for Calypso 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, rental and personal use / indoor use only
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
Performance tests were conducted:
- Microbiological Tightness (ISO 11737-1:2006);
- Biocompatibility:
- Cytotoxicity (ISO 10993-5:2009/(R)2014):
- Irritation (ISO 10993-10:2010);
- Sensitization (ISO 10993-10:2010);
- Acute systemic toxicity (ISO 10993-11:2006/(R)2010);
- 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.
Key Metrics
Not Found
Predicate Device(s)
Medela Symphony Breast Pump Model 024 (K020518).
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing ribbon-like shape.
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
ARDO Carum and Calypso Powered Breast Pumps
Indications for Use (Describe)
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.
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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3
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
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
4
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.
Intended Use / Indications for Use
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 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.
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.
5
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.