K Number
K964403
Device Name
SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
Date Cleared
1997-01-13

(70 days)

Product Code
Regulation Number
884.5160
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The powered Simplicity Breast Pump is designed to express milk from the breast.
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.
More Information

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No
The description focuses on a mechanical pumping system and electrical power source, with no mention of AI or ML.

No
Explanation: A therapeutic device is used to treat a disease, injury, or other medical condition. A breast pump is used to express milk, which is a supportive function rather than a direct treatment for a medical condition.

No.
The device's stated intended use is to "express milk from the breast," and its operation involves generating suction for this purpose, not for diagnosing any medical condition.

No

The device description explicitly states it uses a "mechanical pumping system" and is powered by batteries or an AC adapter, indicating it is a hardware device with mechanical components, not software-only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "express milk from the breast." This is a physical process performed on the body, not a test performed on a sample taken from the body.
  • Device Description: The description details a mechanical pumping system to generate suction for expressing milk. This is a mechanical device for a physical action.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing a biological sample (blood, urine, tissue, etc.)
    • Detecting or measuring substances in a sample
    • Providing information for diagnosis, monitoring, or screening of a disease or condition

In summary, the Simplicity Breast Pump is a medical device used for a physical function (expressing breast milk), not for performing diagnostic tests on biological samples.

N/A

Intended Use / Indications for Use

The powered Simplicity Breast Pump is designed to express milk from the breast.

Product codes

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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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

breast

Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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 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.

Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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).

0

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.

Ka64403

pi73

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.

Page -22-

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

1

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

2

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