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.

AI/ML Overview

This document is a 510(k) premarket notification for the Evenflo Comfort Select Auto-cycle Breast Pump Kit. It focuses on establishing substantial equivalence to legally marketed predicate devices rather than detailing a specific performance study with acceptance criteria.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design, sample sizes for test/training, expert adjudication, MRMC studies, standalone performance, type of ground truth, etc.) are not available in this document.

Here's what can be extracted and inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as specific performance metrics. The underlying acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This typically means showing that the device is as safe and effective as a predicate device and performs as intended.
Reported Device Performance: The document states the device "uses the principle of negative suction to express milk from the breast" and is "designed with ergonomics in mind so as to be comfortable for the user." However, no quantitative performance data (e.g., suction pressure, efficiency, comfort ratings) are provided in support of these claims in this submission.

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (as stated or implied in the document)
Substantial equivalence to predicate devices in terms of safety and effectiveness, and intended use.	"Uses the principle of negative suction to express milk from the breast."
Device functions as an electrically operated suction device to express milk.	The device is an "electrically operated suction device used to express milk from the breast."
Ergonomic design for user comfort.	"designed with ergonomics in mind so as to be comfortable for the user."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable / Not provided. This document does not describe a performance study with a test set of data or subjects. The submission relies on a comparison to predicate devices and a description of the device.
Data Provenance: Not applicable / Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable / Not provided. No test set or ground truth establishment process is described.
Qualifications of Experts: Not applicable / Not provided.

4. Adjudication method for the test set

Adjudication Method: Not applicable / Not provided. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This is a breast pump, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: No. This is not an algorithm, but a physical medical device (breast pump). The 510(k) process for such devices typically involves demonstrating mechanical functions, biocompatibility, electrical safety, and often comparisons to existing devices, but not "standalone algorithm performance."

7. The type of ground truth used

Type of Ground Truth: Not applicable / Not provided. The submission focuses on substantial equivalence based on device description and comparison to predicates, not on validating a diagnostic or predictive performance against a "ground truth."

8. The sample size for the training set

Sample Size for Training Set: Not applicable / Not provided. There is no AI component or training set involved in this 510(k) submission.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable / Not provided. There is no AI component or training set involved in this 510(k) submission.

Summary of available information related to the device's "study":

The "study" in this context is the 510(k) premarket notification process itself, which aims to demonstrate that the Evenflo Comfort Select Auto-cycle Breast Pump Kit is substantially equivalent to legally marketed predicate devices.

Predicate Products:
- Medela Double Pumping Mini-Electric Breast Pump
- The First Years Natural Comfort Breast Pump
- Evenflo Personal Comfort Dual Breast Pump
Basis for Equivalence: The document states, "Evenflo believes its Comfort Select Auto-cycle Breast Pump is substantially equivalent to lawfully marketed breast pumps." The specific evidence for this equivalence (e.g., technical specifications comparison, performance testing data) is not detailed in the provided text, but would have been included in the full 510(k) submission.
FDA Determination: The FDA reviewed the submission (K022933) and determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This determination allows the device to be marketed.
Performance Standards: The FDA has established no specific performance standards for breast pumps (as stated in Section 6, page 2).
Intended Use: "The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast." (Page 1, Section 2) The "Indications for Use" from the enclosure (Page 4) specifies it's "a battery/electric powered suction device used to express milk from the breast of lactating women."

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
(937) 415-3300

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

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: 770-704-2002

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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. :

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Concurrence of CDRH, Offic

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

0012

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).