(145 days)
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.
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.
The provided text is a 510(k) summary for the Ardo Medical AG's One Mum Pumpset. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device. This document does not describe the acceptance criteria of an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.
The information provided pertains to a physical medical device (a breast pump accessory) and its sterilization and biocompatibility testing. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document.
However, based on the content related to the One Mum Pumpset, I can extract information relevant to its performance testing, which serves a similar purpose to acceptance criteria for a physical device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) | Not cytotoxic |
| ISO 10993-10:2010 (Sensitization) | Non-sensitizing | |
| ISO 10993-10:2010 (Intracutaneous) | Non-irritating | |
| ISO 10993-11:2006 (Systemic Toxicity) | Not systemically toxic | |
| Sterilization Validation | ISO 11135-1:2007 (SAL) | Achieved SAL of 10^-6 |
| Residual Testing | ISO 10993-7:2008 | Residual values within appropriate limits |
| Packaging & Shelf Life | ISO 11607-1:2009 (Aging Studies) | All performance specifications post-aging met; Packaging integrity ensured |
| Overall Functionality | Same as predicate device (K141742) | Functioned as intended; Met all same acceptance criteria as predicate |
Regarding the other requested points (2-9), these are entirely focused on AI/ML device studies and are not applicable to the submitted document as it discusses a physical breast pump accessory:
- No AI/ML device is mentioned.
- No test set for an algorithm is described.
- No experts for ground truth establishment for an AI algorithm are mentioned.
- No adjudication method for an AI test set is discussed.
- No multi-reader/multi-case comparative effectiveness study for AI assistance is mentioned.
- No standalone AI algorithm performance is discussed.
- No AI ground truth type is mentioned.
- No training set size or ground truth establishment for a training set is relevant to this document.
§ 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).