(84 days)
The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.
The Electric Breast Pump is a personal use electric breast pump capable of single pumping. The device is electrically powered from either internal batteries or an external AC powered supply and is provided non-sterile.
The Electric Breast Pump consists of the motor, breast shields, tubing, bottle and valve. The materials used are silicone (breast shield) and polypropylene (Pump body and bottle).
The electric breast pump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release).
The device has two modes of operation:
- Stimulation mode: Suction patterns with fast cycles and low vacuum to start milk flowing
- Expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.
The provided document details the 510(k) summary for the Joytech Healthcare Co., Ltd. Electric Breast Pump (Models LD-202 and LD-213). It focuses on demonstrating substantial equivalence to a predicate device, the Medela Swing Breast Pump (K053052).
While the document describes performance tests conducted, it does not provide a table of specific acceptance criteria and detailed reported device performance for functional aspects (like vacuum pressure, battery life, or backflow leakage) that would be expected to demonstrate clinical effectiveness. Instead, it refers generally to "all requirements of the applicable standards" and lists the types of tests performed.
Therefore, for the information requested regarding acceptance criteria and detailed performance, I can only extract general statements and the types of tests, not specific numerical criteria or results.
Here's a summary of the information available, addressing your points as much as possible:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Performance testing was conducted to validate and verify that the Electric Breast Pump met all requirements of the applicable standards." However, it does not provide a table with specific numerical acceptance criteria for functional performance (e.g., a specific vacuum range and the measured performance) nor the detailed reported device performance directly. It only lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (General Statement/Test Type) |
|---|---|
| Electrical Safety | Compliance to AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 "Medical Electrical Equipment" |
| Home-used Medical Equipment | Compliance to IEC 60601-1-11:2015 "General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment" |
| Electromagnetic Compatibility (EMC) | Compliance to IEC 60601-1-2:2014 "Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" |
| Biocompatibility - Cytotoxicity | Compliance to ISO 10993-5:2009 "Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity" |
| Biocompatibility - Sensitization | Compliance to ISO10993-10:2010 "Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization" |
| Biocompatibility - Irritation | Compliance to ISO10993-10:2010 "Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization" |
| Software Validation | Verification and validation in accordance with FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. |
| Bench Performance - Vacuum pressure | Testing conducted for "Vacuum pressure range (suction)" and "Maximum vacuum pressure." Specific numerical results or acceptance criteria are not provided. |
| Bench Performance - Backflow-leakage | Testing conducted for "Backflow-leakage testing." Specific numerical results or acceptance criteria are not provided. |
| Bench Performance - Battery life | Testing conducted for "Battery life testing." The comparison table indicates "Approx. 1.5h for pumping time" for both the subject and predicate devices, suggesting this is the expected performance. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any of the performance tests. The tests appear to be bench testing (laboratory-based) rather than clinical studies involving human subjects for performance evaluation, as indicated by the "Bench Performance Testing" section. Therefore, there is no mention of data provenance in terms of country of origin or retrospective/prospective nature for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance testing described is bench testing against established engineering and biocompatibility standards, not evaluation by clinical experts establishing ground truth for a diagnostic output.
4. Adjudication method for the test set
Not applicable. This is not a study involving human reader interpretation or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is an electric breast pump, a mechanical and electrical device, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The performance tests are for the device's physical and electrical functions.
7. The type of ground truth used
For the safety and performance tests, the "ground truth" would be established by the specifications and requirements outlined in the referenced international standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993 series) and the internal design specifications for the vacuum pressure, cycling, and battery life. There's no clinical "ground truth" like pathology or outcomes data needed for this type of device submission.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device. The performance data comes from testing the physical device.
9. How the ground truth for the training set was established
Not applicable, as 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).