(27 days)
No
The description focuses on standard breast pump functionality, including vacuum/cycle adjustment, memory function, power pumping, and mobile app control, without mentioning any AI/ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
A therapeutic device is typically intended to treat or alleviate a medical condition. This device is a breast pump used by lactating women to express and collect milk, which is a physiological process, not a medical treatment.
No
The device is described as a powered breast pump used by lactating women to express and collect milk. Its function involves applying vacuum and adjusting cycle speed to facilitate milk collection, not to diagnose any medical condition.
No
The device description clearly states it is a "powered breast pump" with physical components like a pump unit, buttons, and an integrated battery, indicating it is a hardware device with accompanying software.
Based on the provided information, the Ardo Bellis is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breasts." This is a physical process involving the body, not the analysis of biological samples outside the body.
- Device Description: The description details a mechanical pump that applies vacuum and frequency to the breast. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description 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 based on sample analysis.
The Ardo Bellis is clearly described as a powered breast pump, which is a medical device used for a physical function, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Ardo Bellis is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Bellis is intended for a single user and multiple users.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Ardo Bellis is a breast pump unit for collecting breast milk by application of a defined vacuum with a defined frequency on a woman's breast. The pump needs to be connected to a single or double pump set (Carum and Calypso Powered Breast Pumps, cleared under K141742) to be used on one or two breasts. The case and controls of the pump unit have limited contact with the user and are intended only to control the activities of the device parts that contact the user's breast. The device is comprised of an ON/OFF button and two +/- buttons for adjusting (increasing or decreasing) the vacuum and cycle speed. The pump can also be operated using the accompanying mobile application. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. An integrated battery allows for portable use of the device. With the supplied power adapter, the device can be recharged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Ardo Bellis can be used indoors in professional as well as home care environments.
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 changes made to the design and indications for use of the subject device do not raise different questions of safety and effectiveness. Therefore, the performance testing included in K212773 can be leveraged to support the safety and effectiveness of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 30, 2023
ARDO Medical AG % Thomas Reichthalhammer Partner Medtech360 Am Wasser 14 Polling, Bavaria 84570 Germany
Re: K230590 Trade/Device Name: Ardo Bellis Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: February 27, 2023 Received: March 3, 2023
Dear Thomas Reichthalhammer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230590
Device Name Ardo Bellis
Indications for Use (Describe)
The Ardo Bellis is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Bellis is intended for a single user and multiple users.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY - K230590
Submitter:
ARDO Medical AG Gewerbestrasse 19 CH-6314 Unterägeri Switzerland
Primary Contact:
MEDTECH360 Dr. Thomas Reichthalhammer Am Wasser 14 84570 Polling Tel: +49-8631-9869-101 email: tr@medtech360.de
Date Prepared: March 29, 2023
Device Information:
Device/Trade Name: Ardo Bellis Common or Usual Name: Powered breast pump Regulation Number: 21 CFR 884.5160 Requlation Name: Powered breast pump Regulatory Class: II Product Code: HGX (Pump, Breast, Powered) Review Panel: Obstetrics/Gynecology
Predicate Device: ARDO Medical AG, Alyssa, K212773
The predicate device has not been subject to a design-related recall.
Device Description
The Ardo Bellis is a breast pump unit for collecting breast milk by application of a defined vacuum with a defined frequency on a woman's breast. The pump needs to be connected to a single or double pump set (Carum and Calypso Powered Breast Pumps, cleared under K141742) to be used on one or two breasts. The case and controls of the pump unit have limited contact with the user and are intended only to control the activities of the device parts that contact the user's breast. The device is comprised of an ON/OFF button and two +/- buttons for adjusting (increasing or decreasing) the vacuum and cycle speed. The pump can also be operated using the accompanying mobile application. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. An integrated battery allows for portable use of the device. With the supplied power adapter, the device can be recharged.
Ardo Bellis can be used indoors in professional as well as home care environments.
4
Indications for Use
The Ardo Bellis is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Bellis is intended for a single user and multiple users.
Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
| | Subject Device
Ardo Bellis
K230590 | Predicate Device
Ardo Alyssa
K212773 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Ardo Bellis is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Bellis is intended for a single user and multiple users. | The Ardo Alyssa is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Alyssa is intended for a single user. |
| Intended Use | Multiple users | Single-user |
| Modes of operation | Same as predicate | Stimulation and expression mode |
| Pumping options | Same as predicate | Single and double |
| Vacuum strength and levels | Same as predicate | Stimulation mode: 23-113 mmHg, 8 levels
Expression mode: 23-248 mmHg, 8 levels |
| Cycle speed | Same as predicate | Stimulation mode: 72-120 cycles/min
Expression mode: 20-50 cycles/min |
| Power source | Same as predicate | AC adapter: 100-240 V, 50/60 Hz, 400 mA (Output: 5VDC, 2A)
Li-ion battery (3.7 V, 2600 mAh) |
| Device control through an app | Same as predicate | Yes |
Table 1. Comparison of indications for use and technological characteristics
The purpose of this Special 510(k) submission is to modify the indications for use statement for the subject device to include multiple users. As shown in the table above, the subject and predicate devices have different indications for use statements; however, intended uses of the predicate and subject devices are the same (i.e., to express and collect milk from the breasts of lactating women).
5
The only technological difference between the subject and predicate devices is the case design (difference in shape, size, and weight), as shown in the table below. This difference does not raise different questions of safety or effectiveness.
Image /page/5/Picture/2 description: The image shows two different breast pumps. The breast pump on the left is labeled "Case of Ardo Bellis subject of this 510k application". The breast pump on the right is labeled "Case of Ardo Alyssa predicate device K212773". Both breast pumps are white and have a digital display.
Performance Data
The changes made to the design and indications for use of the subject device do not raise different questions of safety and effectiveness. Therefore, the performance testing included in K212773 can be leveraged to support the safety and effectiveness of the subject device.
Conclusions
The information described above demonstrate that the Ardo Bellis is as safe and effective as the predicate device and supports a determination of substantial equivalence.