EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

• K Number: K022933
• Device Name: EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
• Manufacturer: EVENFLO COMPANY, INC.
• Date Cleared: 2002-12-02 ( 89 days)
• Product Code: HGX
• Regulation Number: 884.5160

Intended Use

The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast. The Evenflo Comfort Select Breast Pump and Comfort Select Dual Breast Pump are battery/electric powered suction device used to express milk from the breast of lactating women.

Device Description

The Evenflo Comfort Select Auto-cycle Breast Pump is an electrically powered breast pump that uses the principle of negative suction to express milk from the breast. The Evenflo pump is sold in single and dual models. The dual model allows the user to pump one or both breasts at a time, and is designed with ergonomics in mind so as to be comfortable for the user. The single model applies the same ergonomics but is used to pump only one breast at a time.

Predicate Devices

None

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the mechanical function of the device.

Therapeutic

No
The device is described as an electrically operated suction device used to express milk from the breast, which is not typically classified as a therapeutic device. It is a pump for milk expression, not for treating a disease or condition.

Diagnostic

No
Explanation: The device is described as an "electrically operated suction device used to express milk from the breast," which is a functional purpose, not a diagnostic one. There is no indication that it identifies, detects, or monitors a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "electrically powered breast pump" and a "suction device," indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
• Evenflo Comfort Select Breast Pump Function: The Evenflo Comfort Select Breast Pump is a device that physically extracts milk from the breast. It does not analyze any biological specimens to provide diagnostic information.

The provided information clearly describes a device for expressing breast milk, which is a mechanical process, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast.

The Evenflo Comfort Select Breast Pump and Comfort Select Dual Breast Pump are The Evelifie Battery/electric powered suction device used to express milk from the breast of lactating women.

Product codes

85 HGX

Device Description

The Evenflo Comfort Select Auto-cycle Breast Pump is an electrically powered breast pump that uses the principle of negative suction to express milk from the breast. The Evenflo pump is sold in single and dual models. The dual model allows the user to pump one or both breasts at a time, and is designed with ergonomics in mind so as to be comfortable for the user. The single model applies the same ergonomics but is used to pump only one breast at a time. Evenflo believes its Comfort Select Auto-cycle Breast Pump is substantially equivalent to lawfully marketed breast pumps.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Breast

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image shows the word "evenflo" in a bold, sans-serif font. The word is black and appears to be slightly stylized. There is a black shape in the upper left corner of the image, partially obscuring the word. The background is white.

Eventlo Company, Inc.
707 Crossroads Court
Vandalia, Ohio 45377
[phone]

DEC_022002

510(K) PREMARKET NOTIFICATION EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

1. Name of the Device

• Proprietary Name Evenflo Comfort Select Auto-cycle Breast Pump a. Kit
• Classification Name Powered Breast Pump b.

Intended Use 2.

The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast.

3. Device Description

The Evenflo Comfort Select Auto-cycle Breast Pump is an electrically powered breast pump that uses the principle of negative suction to express milk from the breast. The Evenflo pump is sold in single and dual models. The dual model allows the user to pump one or both breasts at a time, and is designed with ergonomics in mind so as to be comfortable for the user. The single model applies the same ergonomics but is used to pump only one breast at a time. Evenflo believes its Comfort Select Auto-cycle Breast Pump is substantially equivalent to lawfully marketed breast pumps.

Establishment Registration Number 4.

The Evenflo establishment registration number is 1519363. The company address is:

Evenflo Company, Inc. 1000 Evenflo Dr. P.O. Box 709 Canton, GA 30114

770-704-2000 Fax: [phone]

న్ Classification of the Device

21 CFR §884.5160 states that powered breast pumps are class II medical devices.

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KO22A33 page 2

rossroads Cour

Performance Standards for the Device

The Food and Drug Administration has established no performance standards for breast pumps.

Proposed Product Labeling 7.

An initial copy of Evenflo Breast Pump product labeling is included in this notification (Appendix B).

Predicate Product(s) 8.

The Evenflo Comfort Select Auto-cycle Breast Pump is substantially equivalent to the following powered breast pumps currently marketed:

Manufacturer

Medela The First Years Evenflo

Breast Pump Trade Name

Double Pumping Mini-Electric Natural Comfort Personal Comfort Dual Breast Pump

510(k) statement 9.

Evenflo's 510(k) statement is attached.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes.

Public Health Service

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

DEC 02 2002

Mr. Matthew G. McCarty Product Safety Engineer Evenflo Company, Inc. 707 Crossroads Court VANDALIA OH 45377

Re: K022933

Trade/Device Name: Evenflo Comfort Select Auto-Cycle Breast Pump kit Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: 85 HGX Dated: August 30, 2002 Received: September 4, 2002

Dear Mr. McCarty:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Henry C. Broglin

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known): YO3QQ33

Evenflo Comfort Select Breast Pump Device Name: Evenflo Comfort Select Dual Breast Pump

Indications for Use:

The Evenflo Comfort Select Breast Pump and Comfort Select Dual Breast Pump are The Evelifie Bottery/electric powered suction device used to express milk from the breast of lactating women. :

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Offic

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(Division Sign-Division of Reproductio and Radiological Devi 510(k) Number

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