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510(k) Data Aggregation
(198 days)
Spectra 9Plus
The Spectra 9Plus is a single user, powered breast pump intended to express and collect milk from the breasts of lactating women.
The Spectra 9Plus is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended to be a single patient reusable device. The device is capable of single and dual pumping.
The Spectra 9Plus is powered by a 9V DC adaptor or rechargeable Lithium ion battery. It is composed of materials commonly found in medical devices such as polypropylene, ABS, and silicone. All milk-contacting components are constructed out of food-grade materials that are compliant with 21 C.F.R. parts 174-179.
The Spectra 9Plus is considered a skin-contacting device with a limited (≤24 hours) contact duration.
The user employs buttons to switch from massage mode to expression mode and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed, while expression mode has 10 suction levels and 10 cycling speeds. The Spectra 9Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute.
The provided text is a 510(k) Summary for a breast pump, not a diagnostic AI device. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, expert ground truth, or MRMC studies for an AI device.
However, I can extract the relevant information about the non-clinical tests performed to demonstrate substantial equivalence for the Spectra 9Plus breast pump.
Here's a summary of the non-clinical tests conducted, which serve as the "studies" to prove the device meets acceptance criteria related to safety and performance:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the non-clinical tests):
| Acceptance Criteria (Standard/Test Objective) | Reported Device Performance (Compliance/Result) |
|---|---|
| Electrical Safety (IEC 60601-1:2005 with US deviations) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | Complies |
| Safety for Home Use (IEC 60601-1-11:2010) | Complies |
| Biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010 for cytotoxicity, sensitization, irritation) | Complies |
| Software Validation (IEC 62304, FDA Guidance for Software in Medical Devices) | Complies |
| Risk Analysis (ISO 14971:2007) | Developed in accordance with the standard |
| Vacuum Profile Test | Performance met specifications (implied by "support of the substantial equivalence determination") |
| Backflow Protection Test | Performance met specifications (implied) |
| Pump Use-Life Test | Performance met specifications (implied) |
| Suction Strength (Expression Mode) (50-270 mmHg) | Achieved 50-270 mmHg |
| Suction Strength (Massage Mode) (50-150 mmHg) | Achieved 50-150 mmHg |
| Cycle Speed (Expression Mode) (26-60 cycles/min) | Achieved 26-60 cycles/min |
| Cycle Speed (Massage Mode) (70 cycles/min) | Achieved 70 cycles/min |
The following information is NOT available in the provided document, as it pertains specifically to AI device evaluation, which is not relevant to this breast pump 510(k) summary:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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