← Product Code [HGX](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX) · K172067 # One Mum Pumpset (K172067) _Ardo Medical AG · HGX · Nov 29, 2017 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K172067 ## Device Facts - **Applicant:** Ardo Medical AG - **Product Code:** [HGX](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX.md) - **Decision Date:** Nov 29, 2017 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 884.5160 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## 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 Story One Mum Pumpset is a sterile accessory for Ardo powered breast pumps; used by lactating women to express and collect milk. Components include bottle, bottle cap, polypropylene breast shell, and silicon tubing kit. Device connects to breast pump to facilitate milk removal, collection, and storage. Used in home or hospital settings by the mother. Provides a sterile, single-user solution for milk expression. Benefits include hygienic milk collection and compatibility with existing Ardo pump systems. ## Clinical Evidence No clinical data. Bench testing only. Biocompatibility established per ISO 10993-5, -10, and -11. Sterilization validated to SAL 10^-6 per ISO 11135-1:2007 with residual testing per ISO 10993-7:2008. Packaging and shelf-life validated per ISO 11607-1:2009. ## Technological Characteristics Materials: polypropylene breast shell, silicon tubing, plastic bottle. Sterilization: Ethylene oxide gas cycle. Standards: ISO 10993 (biocompatibility), ISO 11135-1:2007 (sterilization), ISO 10993-7:2008 (residuals), ISO 11607-1:2009 (packaging). Configuration: single or double pumpset. No software or electronic components. ## Regulatory Identification A powered breast pump in an electrically powered suction device used to express milk from the breast. ## Predicate Devices - Ardo Carum and Calypso Powered Breast Pumps ([K141742](/device/K141742.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {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); 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 {2}------------------------------------------------ ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 {5}------------------------------------------------ One Mum Pumpset is substantially equivalent to the predicate. --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K172067](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K172067) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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