(70 days)
The powered Simplicity Breast Pump is designed to express milk from the breast.
The Simplicity Breast Pump uses a mechanical pumping system to generate suction. It is powered either by two (2) standard C batteries (not included with kit) or powered electrically by utilizing the AC adapter which is provided in the kit and can be plugged into any standard wall outlet. The powered motor activates movement of a rubber dlaphragm inside a pumping chamber which provides suction to express breast milk.
This document describes the premarket notification (510(k)) for the Simplicity Electric/Battery Breast Pump Kit. It seeks to demonstrate substantial equivalence to a predicate device, the Evenflo Sof-Touch Ultra Breast Pump.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense of a target performance metric. Instead, the acceptance criterion for the Simplicity Breast Pump was to demonstrate substantial equivalence to the Predicate device (Evenflo Sof-Touch Ultra Breast Pump) in terms of vacuum pressure as a function of time.
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Demonstrate substantial equivalence to the predicate device in terms of vacuum pressure as a function of time. | "The test data demonstrates that the performance of the Simplicity Breast Pump in terms of vacuum pressure as a function of time is suitable for its intended use, and the device is substantially equivalent to the Predicate (Evenflo)." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Laboratory bench testing was performed to assess the effects of the new characteristics of the proposed Simplicity Breast Pump. These tests compared the proposed Simplicity Breast Pump against the Predicate [Evenflo]."
- Sample Size for the test set: Not specified. The document only mentions "relatively simple experimental methods for determination of vacuum pressures as a function of time" and "laboratory bench testing." It does not provide the number of devices tested or the number of measurements taken.
- Data Provenance: The testing was "Laboratory bench testing," implying it was conducted in a controlled environment by the manufacturer or a designated facility. The country of origin is not explicitly stated for the testing, but the submitter, The First Years, Inc., is based in Avon, MA, USA. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a bench test evaluating physical performance characteristics (vacuum pressure), not a human-interpreted diagnostic outcome. Therefore, there was no "ground truth" established by human experts in the medical sense. The "ground truth" or reference was the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. As this was a bench test comparing a physical property (vacuum pressure), there was no human adjudication of diagnostic outcomes. The comparison was based on objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focused on the physical performance characteristics of a breast pump, not the diagnostic efficacy or interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the context of a breast pump. There is no "algorithm" in the sense of AI or a diagnostic tool that would have a standalone performance. The "device" itself is a mechanical and electrical system whose performance was evaluated in isolation (standalone) from a user, by measuring its physical output.
7. The Type of Ground Truth Used
The "ground truth" for the comparison was the performance of the predicate device (Evenflo Sof-Touch Ultra Breast Pump) in terms of vacuum pressure as a function of time. This is a form of empirical data from an established, legally marketed device used as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical breast pump, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows a logo for "the first years" along with the date "JAN 13 1997". The image also contains the text "Simplicity ™ Electric/Battery Breast Pump Kit Section VII". The text indicates that the image is related to a breast pump kit and a specific section of a document.
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510(k) Summary of Safety and Effectiveness Information
Submitter Information A.
Submitter's Name: Address:
Telephone No. Fax No. Contact Person: Date of Preparation: Anthony Paolo The First Years, Inc. One Kiddie Drive Avon. MA 02322-1171 508-588-1220, Ext. 234 508-583-9067 Anthony Paolo October 31, 1996
Device Name B.
Trade Name: Common/Usual Name: Classification Name:
Simplicity Electric/Battery Breast Pump Kit Powered Breast Pump Powered Breast Pump
C. Predicate Device Name
Trade Name:
Evenflo Sof-Touch Ultra Breast Pump
D. Device Description
The Simplicity Breast Pump uses a mechanical pumping system to generate suction. It is powered either by two (2) standard C batteries (not included with kit) or powered electrically by utilizing the AC adapter which is provided in the kit and can be plugged into any standard wall outlet. The powered motor activates movement of a rubber dlaphragm inside a pumping chamber which provides suction to express breast milk.
Intended Use of the Device E.
The powered Simplicity Breast Pump is designed to express milk from the breast.
Summary of Similarities and Differences ய்
The 510(k) Substantial Equivalence Decision-Making Process (Detailed) decision tree (ODE Guidance Memo #K86-3) was utilized to make a determination of substantial equivalence (see Exhibit VII-I). The answers to the following questions from this decision tree lead to a determination of substantial equivalence:
The First Years Inc.
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Corporate Headquarters One Kiddie Drive, Avon, MA 02322-1171 Tel 508-588-1220 Fax 508-583-9067 Offices and Warehouses Fontana, California · Mississauga, Canada · Cirencester, UK · Gent, Belgium · Paris, France
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Does New Device have Same Indication Statements? 1.
Yes. Although the unit labels from both the Simplicity Breast Pump and the Predicate [Evenflo] do not specifically set out its intended use, it is clear from the description of each that the intended use of both devices are to express milk from the breast and, therefore, are identical.
Does New Device Have the Same Technological Characteristics, e.g., 2. Design, Materials, etc.
No. Though the two systems have the same basic components (i.e., power source, pump, breast shields), the design of these components may vary. However, both systems are provided non-sterile and have been designed to contain a powered breast pump for reusable use.
Both the Predicate [Evenflo] and the proposed Simplicity Breast Pump are powered by either electricity or batteries. However, the materials of manufacture may be different and some of the internal pumping components may differ. The Simplicity Breast Pump is designed for either dual sided action or single-sided pumping action.
3. Could the New Characteristics Affect Safety or Effectiveness?
Yes. The differences between the proposed Simplicity Breast Pump and the Predicate [Evenflo] could affect both safety and effectiveness.
4. Do the New Characteristics raise New Types of Safety or Effectiveness Questions?
No. Powered breast pumps, such as the proposed Simplicity Breast Pump and the Predicate [Evenflo] are generally intended to provide a means to express breast milk. The safety and effectiveness questions are not new and include questions concerning vacuum pressure as a function of time.
5. Do Accepted Scientific Methods Exist for Assessing Effects of the New Characteristics?
Yes. The assessment of the effects of the characteristics of the proposed Simplicity Breast Pump can be determined using relatively simple experimental methods for determination of vacuum pressures as a function of time.
6. Are Performance Data Available to Assess Effects of New Characteristics?
Yes. Laboratory bench testing was performed to assess the effects of the new characteristics of the proposed Simplicity Breast Pump. These tests compared the proposed Simplicity Breast Pump against the Predicate [Evenflo]. The objective of the laboratory testing was to determine substantial equivalence
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of the performance characteristics between the Simplicity Breast Pump and the Predicate [Evenflo]. Specific performance characteristics evaluated included assessment of the vacuum pressure as a function of time.
Does Performance Data Demonstrate Equivalence? 7.
Yes. The test data demonstrates that the performance of the Simplicity Breast Pump in terms of vacuum pressure as a function of time is suitable for its intended use, and the device is substantially equivalent to the Predicate (Evenflo).
Conclusion:
Based on the FDA's decision tree, the subject device, the Simplicity Breast Pump, is substantially equivalent to the Predicate [Evenflo].
Contact Person:
Anthony La Porta
Anthony Padlo Director-Quality Assurance
Dated: 10/31/96
§ 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).