(66 days)
Tommee Tippee® Closer to Nature® Double Electric Breast Pump is used to express and collect milk from the breast of a lactating woman.
This Double Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 5 alternate settings of suction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz or 4oz pod, which fits into "Closer to Nature" bottles for feeding. The product is designed to use, one pod size per 5oz bottle and 2 pod sizes for a 9oz bottle for expressing, storing and feeding. This device is mains or battery powered.
Included with the double electric breast pump motor unit and vacuum system are:
- 1 off Carry Bag to hold pump and accessories
- 2 off Feeding bottles 5oz with teats as per Mayborn Single Electric Breast Pump K110343
- 2 off Feeding bottles 9oz without teats
- 4 off Milk storage lids as per Mayborn Single Electric Breast Pump K110343
- 2 off 4oz Milk storage pods
- 4 off 2oz Milk storage pods as per Mayborn Single Electric Breast Pump K110343
- 1 off Milk storage pod tray
- 1 off Bottle bag for feeding bottles with milk storage lid
- 6 off Disposable Breast pads as per Mayborn Single Electric Breast Pump K110343
- 2 off Spare valves
- 2 off Spare Diaphragms
2 off - Hygiene cover - as per Mayborn Single Electric Breast Pump - K110343
The provided text describes the 510(k) summary for the Tommee Tippee Closer to Nature Double Electric Breast Pump (K113664), demonstrating substantial equivalence to a predicate device, the Ameda Purely Yours Ultra (K973501).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as pass/fail thresholds in the document. Instead, the study focuses on demonstrating substantial equivalence to the predicate device by comparing key performance parameters. The "acceptance" can be inferred as showing "no significant difference" or comparable performance to the predicate.
| Performance Characteristic | Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (Tommee Tippee Closer to Nature) | Predicate Device Performance (Ameda Purely Yours Ultra) |
|---|---|---|---|
| Vacuum - Double Pumping | No significant difference from predicate | Setting 1: 160mbar | |
| Setting 3: 260mbar | |||
| Setting 5: 330mbar | Setting 1: 120mbar | ||
| Setting 3: 180mbar | |||
| Setting 5: 220mbar | |||
| Vacuum - Single Pumping | No significant difference from predicate | Setting 1: 240mbar | |
| Setting 3: 380mbar | |||
| Setting 5: 450mbar | Setting 1: 200mbar | ||
| Setting 3: 280mbars | |||
| Setting 5: 330mbar | |||
| Suction Flow Rate - Single Pump (ml, 2 min 30 sec) | No significant difference from predicate | Setting 1: 80ml | |
| Setting 3: 115ml | |||
| Setting 5: 145ml | Setting 1: 108ml | ||
| Setting 3: 147ml | |||
| Setting 5: 160ml | |||
| Suction Flow Rate - Double Pump (ml, 2 min 30 sec) | No significant difference from predicate | Setting 1: LH 73ml, RH 65ml | |
| Setting 3: LH 105ml, RH 95ml | |||
| Setting 5: LH 135ml, RH 125ml | Setting 1: LH 75ml, RH 80ml | ||
| Setting 3: LH 88ml, RH 103ml | |||
| Setting 5: LH 120ml, RH 135ml | |||
| Noise Level (dB) | No significant difference from predicate | Setting 1: 64.3db | |
| Setting 3: 63.4db | |||
| Setting 5: 63.7db | Setting 1: 62.6db | ||
| Setting 3: 62.5db | |||
| Setting 5: 63db | |||
| Materials | Meets FDA food additive criteria and biocompatibility | All milk/human contact components meet FDA 21 CFR 176, 177, 178. Skin contact materials satisfy ISO 10993 parts 5 and 10. | (Implicit: Predicate also meets these standards) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for the test set. The data appears to be from a retrospective comparison as part of the 510(k) submission process, comparing the newly developed device against a legally marketed predicate device. The provenance of the data is not explicitly stated beyond being measurements taken for the "Tommee Tippee Closer to Nature" device and the "Ameda Purely Yours Ultra" predicate. It is likely that the measurements for the Tommee Tippee device were performed by Mayborn Group Limited (United Kingdom) or a contracted lab. The source of the predicate device's performance data is not detailed but would typically come from publicly available specifications or testing by the submitter of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information (number of experts, their qualifications, and ground truth establishment) is not applicable to this submission. The study is a physical and technical comparison of device performance characteristics (vacuum, flow rate, noise, materials) against a predicate, not clinical performance based on expert interpretation of results (e.g., image analysis, diagnostic accuracy).
4. Adjudication Method for the Test Set
This is not applicable as the comparisons are based on objective physical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. This is a medical device comparison based on physical performance and material safety, not a study involving human readers, AI assistance, or clinical effectiveness in that context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. There is no algorithm or AI component in this breast pump.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the measured physical properties and characteristics of both the new device and the predicate device. For the materials, the ground truth is defined by FDA regulations for food contact and ISO 10993 standards for biocompatibility. These are objective, measurable standards, not subject to expert consensus or pathology.
8. The Sample Size for the Training Set
This is not applicable. There is no training set as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
§ 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).