(29 days)
Tommee Tippee® Closer to Nature® Single Electric Breast Pump is personnel use item for lactating women and is intended for one user to express and collect milk from the breast.
This Single Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 4 alternate settings of sucction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz pod, which fits into "Closer to Nature" lottles 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.
The provided text is a 510(k) Summary for the Tommee Tippee Closer to Nature Single Electric Breast Pump, aiming to prove substantial equivalence to predicate devices (K110343 and K113664), not to meet acceptance criteria in the sense of a clinical trial for a new medical device with performance endpoints. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is largely not applicable to this type of document.
This submission focuses on comparing the new device against existing, legally marketed predicate devices to demonstrate that it operates in a similar manner and does not raise new questions of safety or effectiveness. The "studies" conducted are comparative performance tests rather than clinical trials with patient outcomes.
However, I can extract the comparative data and present it in a table format, interpreting the "acceptance criteria" as the performance of the predicate device, and the "reported device performance" as the new product's performance.
Here's the information derived from the provided text, addressing your points where applicable:
1. Table of Acceptance Criteria (Predicate Device Performance) and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are not explicitly stated as numerical thresholds that must be met. Instead, the new device's performance is compared directly to its predicate device (Tommee Tippee Closer to Nature Single Electric Breast Pump, K110343, and in some cases, K113664 for the backflow). The goal is to show "no significant difference" or "significant improvement" where relevant.
| Performance Area | Predicate Device (K110343) Performance (Acceptance Criteria) | New Product (K121322) Reported Performance | Conclusion (as per submission) |
|---|---|---|---|
| Vacuum (Single Pumping) | |||
| Setting 1 | Stimulation | Stimulation | No significant difference |
| Setting 2 | 135mmHg | 150mmHg | No significant difference |
| Setting 3 | 205mmHg | 220mmHg | No significant difference |
| Setting 4 | 269mmHg (REF 510K) | 233mmHg | No significant difference |
| Suction Flow Rate | |||
| Setting 2 | 87ml/min | 88ml/min | No significant difference |
| Setting 3 | 122ml/min | 118ml/min | No significant difference |
| Setting 4 | 131ml/min | 131ml/min | No significant difference |
| Noise Level | |||
| Setting 4 (highest suction) | 68dba | 68dba | No significant difference |
| Materials | Predicate materials met FDA food additive criteria and biocompatibility (ISO 10993 parts 5 & 10 for skin contact). | New product materials meet FDA food additive criteria and biocompatibility (ISO 10993 parts 5 & 10 for skin contact). | No significant difference (both meet standards) |
| Electrical Safety | Predicate tested to IEC 60601-1:1988+A1:1991+A2:1995, UL 60601-1, and IEC 60601-1-2:2001+A1:2004. | New product (unit and adaptor) has the same electrical construction as predicate and is tested to the same applicable standards. | No significant difference (both meet standards) |
| Backflow Protection | No explicit backflow protection mechanism mentioned, implied that it could occur based on the new device's improvement. | New diaphragm system created a physical barrier stopping all backflow into the vacuum tube (same as K113664). | Significant improvement over K110343 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of devices tested for each performance characteristic. The tests appear to be conducted on "the new product" and "the predicate" (singular), implying a single unit or a small, unspecified number of units for engineering characterization.
- Data Provenance: The tests were conducted internally by Mayborn Baby and Child during product development. This is non-clinical, in-house testing. The country of origin of the data is not explicitly stated beyond Mayborn Group Limited being based in the United Kingdom. Given the nature of a 510(k) for a breast pump, this would be prospective laboratory/bench testing, not retrospective human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" in the context of clinical expert consensus (as with medical imaging or diagnostic devices) is not relevant here. The "ground truth" for these tests is the physical measurement of performance parameters (vacuum, flow rate, noise, material properties, electrical safety, backflow) of the devices themselves, performed using standard engineering and laboratory methods.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process for these physical performance tests. The results are direct measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for diagnostic devices where multiple human readers interpret medical cases. This submission is for a breast pump, and the "studies" are engineering performance comparisons, not human clinical effectiveness studies. Therefore, there is no effect size related to human readers improving with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
Not applicable. This is not an AI/algorithm-based device. The device's performance is its inherent physical function.
7. The Type of Ground Truth Used
The "ground truth" for the performance comparisons was based on:
- Physical measurements of vacuum, flow rate, and noise.
- Material testing against FDA regulations and ISO 10993 standards (biocompatibility).
- Electrical safety testing against IEC and UL standards.
- Observational testing for backflow protection.
These are objective, quantifiable engineering and regulatory compliance assessments, not clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 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).