(145 days)
Not Found
No
The summary describes a sterile pumpset accessory for breast pumps and focuses on its physical components, sterilization, and biocompatibility. There is no mention of AI or ML technology.
No
The device is a pumpset accessory used to express and collect milk, which is not considered a therapeutic function.
No
The device is a breast pump accessory used for expressing and collecting milk, not for diagnosing any medical condition.
No
The device description explicitly states it consists of multiple physical components including a bottle, bottle cap, breast shell, and tubing kit, which are hardware.
Based on the provided information, 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 diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The device is a "sterile pumpset accessory" that connects to a breast pump for "removal, collection, and storage of the mother's breast milk." This aligns with its intended use as a milk collection system, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (like milk, blood, etc.) to diagnose a condition, monitor a disease, or determine compatibility.
- Performance Studies: The performance studies focus on biocompatibility, sterilization validation, and packaging/shelf life. These are relevant to a medical device that comes into contact with the body and handles a biological fluid, but not to the performance of a diagnostic test.
In summary, the One Mum Pumpset is a medical device used for the physical process of breast milk expression and collection, not for performing a diagnostic test.
N/A
Intended Use / Indications for Use
The One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The One Mum Pumpset can be used both as a single pumpset and as a double pumpset and is intended for single users only.
Product codes
HGX
Device Description
The One Mum Pumpset is a sterile pumpset accessory used by a single user in conjunction with the Ardo breastpumps. The Pumpset has nearly identical technological characteristics and identical principles of operation as the non-sterile pumpset previously cleared in the Ardo Carum and Calypso Powered Breast Pumps (K141742), with the minor difference being that the Pumpset is sterilized using an ethylene oxide gas cycle. Like the predicate device non-sterile pumpset, the One Mum Pumpset consists of multiple components including a bottle, bottle cap, polypropylene breast shell, and silicon tubing kit that connects to the breast pump for the removal, collection, and storage of the mother's breast milk. The Pumpset can be used both as a single pumpset and as a double pumpset and may be used in indoor settings including hospital and home.
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
Home, hospital, single 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)
Biocompatibility: The biocompatibility of the One Mum Pumpset has been established per ISO 10993 guidelines:
- Cytotoxicity Study Using the Elution Method per ISO 10993-5:2009
- Maximization Sensitization Study per ISO 10993-10:2010
- Intracutaneous Reactivity Study per ISO 10993-10:2010
- Systemic Toxicity Study per ISO 10993-11:2006
Test results demonstrate the One Mum Pumpset is not cytotoxic, non-irritating and not systemically toxic.
Sterilization Validation: Sterilization was completed to assure a sterility assurance level of level (SAL) of 10-6 per ISO 11135-1:2007. Residual testing was also conducted per ISO 10993-7:2008. Results demonstrate the sterilization process is valid and that the residual values are within appropriate limits.
Packaging and Shelf Life Validation: Accelerated and real-time aging studies have been conducted per ISO 11607-1:2009 on finished, sterilized devices and all performance specifications post-aging have been met. Packaging validation was completed to ensure packaging integrity.
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.
Not Found
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 29, 2017
Ardo Medical AG % Yarmela Pavlovic Regulatory Counsel Hogan Lovells US LLP 3 Embarcadero Center, Suite 1500 San Francisco, CA 94111
Re: K172067
Trade/Device Name: One Mum Pumpset Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: November 20, 2017 Received: November 20, 2017
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.
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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); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for 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) K172067
Device Name One Mum Pumpset
Indications for Use (Describe)
The One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The One Mum Pumpset can be used both as a single pumpset and as a double pumpset and is intended for single users only.
| 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)
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510(k) SUMMARY
Ardo medical AG's One Mum Pumpset
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
- Roger Dubach, Head of R&D Ardo medical AG Gewerbestrasse 19 6314 Unteraegeri Switzerland E-mail: roger.dubach@ardo.ch Phone: +41 41 / 754 70 70 Facsimile: +41 41 / 754 70 71 Date Prepared: November 29, 2017
Name of Device
One Mum Pumpset
Common or Usual Name
Pumpset
Classification
21 CFR 884.5160 (powered breast pump), Class II, product code HGX (pump, breast, powered)
Predicate Devices
Ardo Carum and Calypso Powered Breast Pumps (K141742). This predicate device has not been subject to a design-related recall.
Intended Use / Indications for Use
The One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The One Mum Pumpset can be used both as a single pumpset and as a double pumpset and is intended for single users only.
Device Description
The One Mum Pumpset is a sterile pumpset accessory used by a single user in conjunction with the Ardo breastpumps. The Pumpset has nearly identical technological characteristics and identical principles of operation as the non-sterile pumpset previously cleared in the Ardo Carum and Calypso Powered Breast Pumps (K141742), with the minor difference being that the Pumpset is sterilized using an ethylene oxide gas cycle.
4
Like the predicate device non-sterile pumpset, the One Mum Pumpset consists of multiple components including a bottle, bottle cap, polypropylene breast shell, and silicon tubing kit that connects to the breast pump for the removal, collection, and storage of the mother's breast milk.
The Pumpset can be used both as a single pumpset and as a double pumpset and may be used in indoor settings including hospital and home.
Comparison of Technological Characteristics
The One Mum Pumpset is a sterilized version of the non-sterile pumpset previously cleared in the Ardo Carum and Calypso Powered Breast Pumps (K141742). The reason for this Special 510(k) is to describe the sterilization process and demonstrate adequate sterility validation of the proposed One Mum Pumpset. These changes do not raise different questions of safety and effectiveness.
Performance Data
Biocompatibility: The biocompatibility of the One Mum Pumpset has been established per ISO 10993 guidelines:
- Cytotoxicity Study Using the Elution Method per ISO 10993-5:2009
- Maximization Sensitization Study per ISO 10993-10:2010
- . Intracutaneous Reactivity Study per ISO 10993-10:2010
- . Systemic Toxicity Study per ISO 10993-11:2006
Test results demonstrate the One Mum Pumpset is not cytotoxic, non-irritating and not systemically toxic.
Sterilization Validation: Sterilization was completed to assure a sterility assurance level of level (SAL) of 10 °per ISO 11135-1:2007. Residual testing was also conducted per ISO 10993-7:2008. Results demonstrate the sterilization process is valid and that the residual values are within appropriate limits.
Packaging and Shelf Life Validation: Accelerated and real-time aging studies have been conducted per ISO 11607-1:2009 on finished, sterilized devices and all performance specifications post-aging have been met. Packaging validation was completed to ensure packaging integrity.
In all instances, the One Mum Pumpset functioned as intended and met all the same acceptance criteria as the predicate.
Conclusion
The One Mum Pumpset is as safe and effective as the non-sterile pumpset (K141742). The One Mum Pumpset has the same intended use and the same principles of operation as its predicate device. The change in technological characteristics of sterilizing the device does not raise different questions of safety or effectiveness. Performance data demonstrate that the One Mum Pumpset is as safe and effective as the non-sterile pumpset. Therefore, the
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One Mum Pumpset is substantially equivalent to the predicate.