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The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

The Philips Avent Manual Breast Pump expresses and collects milk from the breast of a lactating woman. The device is designed to be reusable by a single user. The pump diaphragm is activated by a manual pivoting handle. The duckbill valve closes to prevent backflow and seal the device under negative pressure as the handle is depressed. The valve then relaxes to allow milk flow into the bottle between pump actuations. Pumping can only be performed on one breast at a time. The vacuum level can be adjusted to comfort by varying the speed and travel of the manual handle. The device is comprised of the manual breast pump parts and feeding bottle. The Philips Avent Manual Breast Pump operates in one mode - manual. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

This document is a 510(k) summary for the Philips Avent Manual Breast Pump, seeking to establish substantial equivalence to predicate devices. The study conducted is a performance test comparing the subject device to existing predicate devices, focusing on vacuum pressure levels.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • For vacuum pressure testing: Not explicitly stated as a number of devices tested, but it mentions "All devices were tested" for the subject device and the two predicate devices. This implies at least one of each device was tested, but more details like replicates are not provided.
  • For biocompatibility: Not specified in terms of sample size of materials or tests.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be a prospective performance test specifically conducted for this 510(k) submission, comparing the new device against existing ones under controlled conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable. This study is a technical performance test (measuring vacuum pressure and biocompatibility), not a study requiring expert interpretation of diagnostic images or clinical outcomes to establish ground truth. The "ground truth" here is the physical measurement of pressure and the results of standardized biocompatibility tests.

4. Adjudication Method for the Test Set

• This information is not applicable. As this is a technical performance test rather than a clinical trial requiring subjective assessments, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This device is a manual breast pump, and the study focuses on its physical performance characteristics (vacuum pressure and biocompatibility) compared to predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• This information is not applicable. This device is a physical, non-electronic medical device (a manual breast pump) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• Vacuum Pressure: The ground truth used was direct physical measurement of vacuum pressure (in mmHg) under specified operating conditions (recommended use and worse-case use).
• Biocompatibility: The ground truth was established by standardized laboratory tests for cytotoxicity, irritation, and dermal sensitization, which provide objective results based on established protocols (e.g., ISO10993).

8. The Sample Size for the Training Set

• This information is not applicable. This is not an AI/ML device, so there is no training set in the typical sense.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable. As there is no training set, there is no ground truth established for one.

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Non-powered Breast Pump to express milk from the breast.

Easy Comfort ™ Deluxe Manual Breast Pump

This document is a 510(k) premarket notification letter from the FDA for a nonpowered breast pump. It does not include information about acceptance criteria or a study proving device performance in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth).

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Device Identification: Easy Comfort™ Deluxe Manual Breast Pump, Regulation Number 21 CFR 884.5150 (Nonpowered breast pump).
• Regulatory Determination: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• General Controls: Reference to general controls provisions of the Act (registration, labeling, good manufacturing practice, etc.).
• FDA Contact Information: For questions regarding labeling, promotion, and general responsibilities.
• Indications for Use: "Non-powered Breast Pump to express milk from the breast."

There is no mention of "acceptance criteria" for performance, specific metrics like sensitivity or specificity, or details of any clinical or performance study conducted to establish these.

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Like the predicate device, the proposed Eventlo Comfort East Pump . Like the predicate device to the latest of and one been a manage of any and is a non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.

non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.

The provided document is a 510(k) premarket notification approval letter for the Evenflo Comfort Ease Manual Breast Pump Kit from the FDA, dated December 2, 2001. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) summary typically includes a section on "Substantial Equivalence Discussion" which would reference performance data comparing the new device to a predicate device. However, this document is merely the FDA's approval letter, not the 510(k) summary itself. The letter states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the FDA determined that the Evenflo breast pump performs as safely and effectively as existing breast pumps already on the market, based on the information provided in the original 510(k) submission.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval and contact information for further inquiries.

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The White River Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.

Not Found

I am sorry, but this document contains no information about acceptance criteria or a study that proves a device meets acceptance criteria. It is a letter from the FDA regarding a 510(k) premarket notification for a "Mini Manual Breast Pump" and an "Indications for Use" statement for the same device.

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