(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical and electrical controls, not data-driven algorithms.
No
Explanation: This device is a breast pump, which is used to express and collect milk. It is not designed to treat or diagnose any medical condition, nor does it restore, modify, or replace any physiological function. It is a device for collecting a bodily fluid.
No
Explanation: The device is a breast pump, intended for expressing and collecting milk. Its function is not to diagnose any condition.
No
The device description clearly states it is a "single piston pump" with "robust plastic housing," "keyboard," "LCD display," and electrical equipment for various power sources, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breast." This is a physical process involving the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a mechanical pump designed to extract milk. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The ARDO Calypso Pro breast pump is a medical device, but it falls under a different category than IVDs. It's a device used to physically interact with the body for a specific purpose (milk expression).
N/A
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.
Product codes
HGX
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.
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.
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
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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 (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)
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)
| 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 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 | |
| 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. | ||
| 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 |