(141 days)
The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.
The Symphony breast pump is intended to be used by lactating women to express and collect milk from their breasts. The pumping can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). The Symphony breast pump is a multi-user breast pump and therefore, designed for a safe and hygienic use by different mothers. The Symphony breast pump employs a control knob for the user to adjust the applied vacuum. The suction patterns are programmed with either constant or variable cycles (pump speed). The Symphony breast pump is capable of providing vacuum levels from -50 to -250 mmHg with cycling rates up to 120 cycles per minute.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medela Symphony Breast Pump. Please note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria against a clinical outcome. Therefore, some requested information, particularly around clinical acceptance criteria and related study details, may not be explicitly present or not applicable in the same way it would be for a novel device.
Acceptance Criteria and Device Performance for Medela Symphony Breast Pump (K151632)
The provided document (510(k) summary) focuses on demonstrating substantial equivalence of the Medela Symphony Breast Pump (current version) to a legally marketed predicate device (K020518). The "acceptance criteria" are primarily based on meeting the same performance specifications as the predicate device or demonstrating that modifications do not adversely affect safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance (Symphony Current Version) |
|---|---|
| Indications for Use: To be used by lactating women to express and collect milk from their breast. (Identical to predicate) | The device has identical indications for use compared to the predicate (K020518). |
| Environment of Use: Hospital, Home (Identical to predicate) | Hospital, Home. |
| Power Source: 100-240 Vac, 50/60Hz, 0.3A. (Identical to predicate) | 100-240 Vac, 50/60Hz, 0.3A. |
| Batteries: 2 x 6V/1.2Ah Rechargeable Pb Batteries. (Identical to predicate) | 2 x 6V/1.2Ah Rechargeable Pb Batteries. |
| Battery charge/discharge: Operation time: approx. 1 hour; Charging time: approx. 4 hours (80%), approx. 8 hours (100%). (Identical to predicate) | Operation time: approx. 1 hour; Charging time: approx. 4 hours (80%), approx. 8 hours (100%). Performance testing demonstrated that the specification for battery operation time is met. |
| Maximum vacuum mmHg/kPa: Approx. -290 mmHg / -40 kPa. (Identical to predicate) | Approx. -290 mmHg / -40 kPa. |
| Vacuum range - double pumping (Standard Program and 24 mm / size M PersonalFit breastshield): -50 to -250 mmHg ± 20 mmHg / -7 to -33 kPa ± 3 kPa. (Identical to predicate) | Performance testing at minimum and maximum vacuum settings demonstrated that the specification for vacuum level is met. |
| Vacuum range - double pumping (Preemie+ Program and 24 mm / size M PersonalFit breastshield): -70 to -250 mmHg ± 20 mmHg / -7 to -33 kPa ± 3 kPa. (New program, compared against specified range). | Performance testing at minimum and maximum vacuum settings demonstrated that the specification for vacuum level is met. |
| Vacuum range - single pumping (Standard Program and 24 mm / size M PersonalFit breastshield): -50 to -250 mmHg ± 20 mmHg / -7 to -33 kPa ± 3 kPa. (Identical to predicate) | Performance testing demonstrated that the specification for vacuum level is met in single pumping mode. |
| Vacuum range - single pumping (Preemie+ Program and 24 mm / size M PersonalFit breastshield): -70 to -250 mmHg ± 20 mmHg / -7 to -33 kPa ± 3 kPa. (New program, compared against specified range). | Performance testing demonstrated that the specification for vacuum level is met in single pumping mode. |
| Adjustable Suction Levels: 16 levels. (Identical to predicate) | 16 levels. |
| Cycle Speed (Standard Program): 54 – 120 Cycles/Minute. (Identical to predicate) | Performance testing demonstrated that the specification for cycle rate is met. |
| Cycle Speed (Preemie+ Program): 35 – 120 Cycles/Minute. (New program, compared against specified range). | Performance testing demonstrated that the specification for cycle rate is met. |
| Overflow protection: A Protection Membrane on the pump side acts as a media separation and prevents milk from going into the pump in case of a milk overflow into the vacuum tubes. (Identical to predicate) | Present and functions as described. Demonstrated not to impact safety/effectiveness negatively. |
| Safety and Effectiveness: No new issues of safety and effectiveness introduced by modifications. | "Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended." Complies with ISO 14971, FDA guidance on sterility and biocompatibility, IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use), and EN ISO 10079-1 (suction equipment). |
| Software: Software changes (including Preemie+ program) are verified and validated according to FDA guidance for "moderate" level of concern. No failures leading to minor injury (pain or engorgement) should occur. | Software verification and validation testing were conducted, and documentation provided as recommended by FDA guidance. The software was deemed "moderate" level of concern. |
| Sterilization (for sterile items): Compliance with FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." Accelerated aging per ASTM F1980 (07) to support shelf life. | Sterilization information provided in accordance with FDA guidance. Accelerated aging tests conducted per ASTM F1980 (07) to support labeled shelf life. |
| Cleaning Validation: Validation of manual cleaning, dishwasher cleaning, and sanitation (boiling water & micro-steam™ bags) to reduce organisms from human breast milk solution containing organisms. Protocol based on AAMI TIR30-2003. | Validation of cleaning methods (manual, dishwasher, and sanitation) conducted using a selection of reusable breast pump kit components challenged with human breast milk solution containing organisms. Evaluated for presence of surviving organisms post-cleaning/sanitizing. Protocol based on AAMI TIR30-2003. |
| Biocompatibility: Compliant with FDA guidance "Use of International Standard ISO-10993..." No new testing required as patient contacting materials are identical to predicate. | Biocompatibility evaluation completed; concluded no new testing required as all patient contacting materials are identical to those used in the predicate. |
| Drive Unit Lifespan: Verification of drive unit life time in support of breast pump service life specification. | Testing conducted to verify drive unit life time in support of the breast pump service life specification. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing primarily to demonstrate physical and functional specifications.
- Sample Size for Performance Testing:
- For testing with the Standard 2.0 program card: Six pumps were used (three with each of the two approved motor types).
- For testing with the Preemie+ program card: One pump of each motor type was used (total of 2 pumps).
- Additional tests (battery operation, varying input voltages, different breast shield sizes, single pumping) were conducted, but specific sample sizes for these sub-tests are not explicitly stated beyond implying they were performed on the tested pumps.
- Data Provenance: The tests are non-clinical, laboratory-based performance tests, likely conducted at the manufacturer's facilities in Switzerland (Medela AG is based in Baar, Switzerland). The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate compliance with specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) summary for a powered breast pump. The "ground truth" for the performance tests (e.g., vacuum levels, cycle rates, battery life) is established by direct measurement against engineering specifications and industry standards, not by expert consensus or interpretation of complex medical imagery/data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for diagnostic devices where human reader interpretations are being assessed against a consensus ground truth. For performance testing of a physical device like a breast pump, measurements are objective and directly compared to specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Symphony breast pump to its predicate device." Therefore, there is no mention of human readers, AI assistance, or effect size improvements related to such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The Medela Symphony Breast Pump is a mechanical device with integrated software for controlling its operation (e.g., 2-Phase Expression, Preemie+ program). It does not involve "algorithms only" or "AI" in the sense of a standalone diagnostic or predictive algorithm being evaluated independently. The software is integral to the device's function, and its performance is assessed as part of the overall device performance (e.g., ensuring correct vacuum and cycle rates as programmed).
7. The Type of Ground Truth Used
The "ground truth" for the device's technical performance is based on:
- Engineering Specifications: Defined vacuum ranges, cycle speeds, and battery life.
- Voluntary Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), home use safety (IEC 60601-1-11), and suction equipment performance (EN ISO 10079-1).
- Regulatory Guidance: Adherence to FDA guidance for sterility, biocompatibility, and software validation.
8. The Sample Size for the Training Set
This information is not applicable. The Medela Symphony Breast Pump is a traditional electromechanical medical device. It does not use "training sets" in the context of machine learning or artificial intelligence. Its software is programmed based on predefined algorithms and fixed parameters and validated through traditional software verification and validation, not through learning from data like an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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).