(172 days)
The intended use of the electrically powered (diaphragm-type) suction device is to express milk from the breast of lactating women.
pj.s comfort® Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm unity oontaine a clapmelling a filter, soft silicone tube and plastic tubing. An accessory kit includes silicone breast cups and a collection cup. The device is battery and line-powered for 12V DC by an external transformer or utilizes a 12V-battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The bacterial filter contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the bacterial. The pump can be used with the Single Breast Pump Kit #6166-3 or the Double Breast Pump Kit #6166-0. Dimensions are 7 x 12 x 3 .5 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 bacterial filter, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. The bacterial filter should be changed regularly.
Here's an analysis of the provided information, focusing on the acceptance criteria and study details for the pj.s comfort® Portable Electric Breast Pump:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in the traditional sense of specific performance metrics or thresholds. Instead, the approach taken is a demonstration of substantial equivalence to predicate devices. This means the device is considered acceptable if it performs similarly to, and raises no new safety or effectiveness concerns compared to, established devices already legally marketed.
Therefore, the "acceptance criteria" are implicitly met by demonstrating that the device's characteristics and performance are comparable to the identified predicate devices: White River Portable Electric Breast Pump (K#850705) and Luxmatic 12-15 ISC Portable Electric Breast Pump (K#971543).
Here's a table based on the comparison provided in the 510(k) summary, which outlines the similarities and differences, implicitly forming the basis for acceptance:
| Parameter | Predicate Device (White River/Luxmatic) Performance (implicitly "Acceptance Criteria") | pj.s comfort® Performance (Reported Device Performance) | Notes on Equivalence/Difference |
|---|---|---|---|
| Pump Type | Diaphragm | Diaphragm | Same |
| Vacuum Control Cycle | Yes | Yes | Same |
| Adjustable Suction Range | Not available (White River) / 150-220 mm Hg (Luxmatic) | 150-220 mm Hg | Equivalent to Luxmatic, improved on White River |
| Vacuum Gauge | Yes | Yes | Same |
| Bacteria Filter | Not available (White River) / Yes (Luxmatic) | Yes | Equivalent to Luxmatic, improved on White River |
| Collection Bottles | Yes | Yes | Same |
| Single Patient Use | Yes | Yes | Same |
| Indications For Use | To express milk from the breast | To express milk from the breast | Same |
| Timer | Not available | Yes | New Feature, considered not raising new safety/effectiveness questions |
| Weight | 10 lbs. (White River) / 4.5 lbs. (Luxmatic) | 4.5 lbs. | Equivalent to Luxmatic, lighter than White River |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission is for a medical device (breast pump) and does not involve clinical data with a "test set" in the context of biological data or performance against a specific disease. The "testing" referred to is non-clinical engineering and materials testing.
- Data Provenance: The "testing information" referenced for safety and effectiveness was "conducted in accordance with the FDA November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions', DCRND, which outlined Electrical, Mechanical and Environmental Performance Requirements." This indicates the data is likely prospective as it was generated specifically for this submission, following FDA guidance for non-clinical testing. The country of origin for the data is implicitly the United States, as it's a US company submitting to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As this device does not involve a diagnostic or prognostic claim that requires expert interpretation of images or patient data, "ground truth" established by experts in a clinical sense is not relevant. The "truth" here is established by engineering and materials science standards.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical "test set" 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
- Not applicable. This device is a breast pump, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on engineering standards and material science specifications. This includes:
- Demonstrating the pump's electrical, mechanical, and environmental performance meets established safety and functionality requirements.
- Confirming that patient-contacting materials (breast cups, milk-contacting internal parts) comply with 21 CFR Parts 176, 177, and 178 for materials approved for food contact.
8. The sample size for the training set
- Not applicable. This device does not utilize machine learning or AI, and therefore does not have 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).