(143 days)
The intended use of this electrically powered (diaphragm-type) suction device is to express milk from the breast.
The Luxmatic 12-15 ISC Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm Hg and 220mm Hg) which includes a soft silicone tube and plastic tubing. An accessory kit includes overflow safety bottles, plastic breast shields and a collection cup. The device is battery and line-powered for 12V DC by a transformer or utilizes a 12V battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The overflow bottle contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the overflow. The pump can be used with Single Breast Pump Kit #281100 or Double Breast Pump Kit #281102. Dimensions are 7 X 12 X 7 inches and the weight is 4.5 lbs. Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the overflow bottle, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. A bacterial filter may be used between the overflow bottle and the pump to prevent cross infection when more than one patient is using the pump. Bacterial filters should be changed regularly.
Here's an analysis of the provided information regarding acceptance criteria and studies for the Luxmatic 12-15 ISC Portable Electric Breast Pump:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria in the traditional sense of a performance study. However, we can infer some "acceptance criteria" based on the comparisons made and the nature of the non-clinical tests.
| Acceptance Criteria (Inferred) | Reported Device Performance (Luxmatic 12-15 ISC) | Original Predicate Device Performance (White River K#850705) |
|---|---|---|
| Functional Equivalence | ||
| Pump Type: Diaphragm | Diaphragm | Same (Diaphragm) |
| Vacuum Control Cycle | Yes | Same (Yes) |
| Overflow Bottle | Yes | Same (Yes) |
| Overflow Shutoff | Yes | Same (Yes) |
| Collection Bottles | Yes | Same (Yes) |
| Single Patient Use | Yes | Yes |
| Indications for Use | Same (to express milk from the breast) | Same (to express milk from the breast) |
| Performance Parameters | ||
| Adjustable Suction Range | 150-220 mm Hg | Not Available (implies the Luxmatic offers a specific range which is a differentiator but still acceptable for safe and effective use) |
| Vacuum Gauge | Yes | Same (Yes) |
| Bacteria Filter | Yes | Not Available (implies an added safety feature) |
| Safety and Compliance | ||
| Electrical Isolation | Met IEC-601-1-2 (1993) | Not explicitly stated, but assumed compliant with relevant standards for a marketed device. |
| Electrical/Mechanical/Environmental Performance | Met FDA November 1993 Draft "Reviewer Guidance" & TÜV GS Germany requirements | Not explicitly stated, but assumed compliant with relevant standards. |
| Patient-contacting Material (Skin & Milk) Approval | Approved for food contact per 21 CFR Parts 176, 177, 178 | Not explicitly stated, but assumed compliant. |
| No design characteristics violating Reviewer Guidance or safety hazards | Confirmed no violations/hazards during testing. | Not explicitly stated, but assumed compliant. |
| Weight (Comparative, not absolute 'acceptance') | 4.5 lbs. | 10 lbs. (Luxmatic is significantly lighter, which is a design difference but not a safety/effectiveness issue) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that "The breastpumps were manufactured in series production and checked with TÜV GS approved samples." It doesn't specify a numerical sample size for the non-clinical tests, but it implies that production samples were used for testing. It doesn't mention specific unit numbers.
- Data Provenance: The testing was conducted internally by KaWeCo GmbH in Germany, or by a testing body contracted by them, to meet FDA and German (TÜV GS) standards. The report itself is a "Summary of 510(k) safety and effectiveness information," indicating it's a submission to the FDA. The nature of the tests (electrical, mechanical, material compatibility) means they are inherently prospective (testing the device before market release).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. This device is a medical device (breast pump) and the assessment of its safety and effectiveness relies on engineering and materials testing, not diagnostic accuracy requiring expert interpretation of medical images or symptoms. Therefore, the concept of "ground truth" established by medical experts for a test set is not relevant in this context. The "ground truth" here is compliance with technical standards and material regulations.
4. Adjudication Method for the Test Set:
- Not Applicable. As explained above, the assessment is based on objective measurements against engineering and material standards, not subjective expert judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) and their performance with and without AI assistance is compared. This breast pump is not a diagnostic device, so an MRMC study was not performed. The "comparison" is not about reader improvement but about device features and safety/effectiveness equivalence to a predicate.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not Applicable. This is not a software algorithm or AI device. The device itself (the breast pump) is the "standalone" entity whose performance is being evaluated against safety and effectiveness standards without a "human-in-the-loop" component in the sense of a diagnostic interpretation task.
7. Type of Ground Truth Used:
- The "ground truth" for this device's safety and effectiveness assessment is based on:
- Engineering Standards Compliance: Meeting requirements outlined in IEC-601-1-2 (1993) and IEC 601-1-1-2 (1993), as well as TÜV GS Germany requirements and the FDA's November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions."
- Material Compatibility Regulations: Compliance with 21 CFR Parts 176, 177, and 178 for food-contacting materials.
- Functional Equivalence: Demonstrating that the device performs its intended function (expressing milk) in a similar manner to the predicate device, despite some design differences.
8. Sample Size for the Training Set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As no training set was used, this question is irrelevant.
§ 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).