The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use battery/electric powered suction devices used to express milk from the breast of lactating women. These devices are not intended for hospital use.

Device Description

The Evenflo Comfort Control Adjustable Speed Breast Pump with Automatic Cycling, and the Evenflo Comfort Control Dual Adjustable Speed Breast Pump with Automatic Cycling are diaphragm type pumps, driven by small DC motors, that create cycling negative pressure. The negative pressure generated by the pump is sufficient to overcome the resistance to the outflow of milk that is created by the muscles, yet gentle enough to prevent tissue damage to the user. The cycling speed and the strength of the negative pressure are controlled by individual rotary controls located on the pump unit. The combination of cycling speed and negative pressure control allow for a range of pressures to be selected. When used as a single collection pump, the maximum negative pressure ranges from 173 mm Hg to 56 mm Hg, and when used in the dual mode, it ranges from 173 mm Hg to 43 mm Hg.

AI/ML Overview

The provided text describes a 510(k) submission for the Evenflo Comfort Control Breast Pump and Evenflo Comfort Control Dual Breast Pump. As such, the "acceptance criteria" and "device performance" are framed in terms of substantial equivalence to predicate devices, rather than strict quantitative performance metrics against a defined standard typical of a new device's clinical trial.

Here's the information extracted and organized as requested:

Acceptance Criteria and Device Performance for Evenflo Comfort Control Breast Pump

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are implicitly defined by the performance characteristics of the predicate devices. The Evenflo Comfort Control Breast Pump aims to demonstrate substantial equivalence by matching or exceeding the performance of these predicates in key areas.

Performance Characteristic	Acceptance Criteria (Predicate Range/Value)	Evenflo Comfort Control Performance (Reported Value)
Intended Use	To Express Milk	To Express Milk
Power Source	AC Adapter / Batteries	AC Adapter or 2 C Batteries
Single or Double Pumping	Yes / Single Only	Yes (for Dual model)
Adjustable Suction Levels	Yes	Yes
Adjustable Cycle Speed	Yes / No	Yes
Overflow Protection	Yes	Yes, valve in horn
Highest Vacuum Setting (mm Hg)	165 - 185 mm Hg	173 mm Hg
Lowest Vacuum Setting (mm Hg)	30 - 109 mm Hg	43 mm Hg
Range of Cycle Speeds (Cycles/Minute)	29 - 60 Cycles/Minute	36 - 54 Cycles/Minute
Nipple Adapter	Yes	Yes
Time to 75% Initial Vacuum on Batteries (hours)	1 - 20 hours	7 hours
Time to 0% Initial Vacuum on Batteries (hours)	5 - 37 hours	10 hours

Note: The acceptance criteria are derived from the range of performance observed across the predicate devices listed. The Evenflo device's reported performance falls within, or is comparable to, these ranges, supporting its claim of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific performance tests. The testing was conducted on "its Comfort Control Pumps and each of the predicate devices" implying at least one unit of each model.
Data Provenance: Not specified, but likely internal testing conducted by Evenflo Company, Inc. It is not mentioned whether it was retrospective or prospective, or the country of origin of the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. The "ground truth" for this device's performance is objective physical measurements (vacuum pressure, cycle speed, battery life), not expert consensus on medical outcomes.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Performance was measured objectively, not interpreted by adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic or imaging devices where human interpretation is a key factor.
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the performance testing described as "Non-Clinical Testing" on the Evenflo Comfort Control Pumps and predicate devices would be considered standalone performance, as it involves objective measurement of device parameters (negative pressure, cycle speed, battery life) without a human operator's influence on the outcome beyond operating the device for the test.

7. The Type of Ground Truth Used

Type of Ground Truth: Objective physical measurements and specifications. The "ground truth" for this device's performance evaluation is based on direct measurements of mechanical parameters such as vacuum pressure (mm Hg), cycle speed (cycles/minute), and battery life (hours).

8. The Sample Size for the Training Set

Sample Size: Not applicable. This device is a mechanical breast pump, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and engineering would be based on general principles and regulatory requirements, not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable, as there is no "training set" for a mechanical device like this. The device design and safety would be established through engineering principles, material science, and regulatory standards for medical devices.

Summary

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510(k) Summary

Submitter: Evenflo Company, Inc. 797 Crossroads Court Northwoods Business Center II Vandalia, Ohio 45377

Phone: (937) 415-3300 Fax: (937) 415-3112

Contact Name: Westly Hetrick

Date Prepared: October 9, 1998

Common Name: Breast Pump

Trade Name: Evenflo Comfort Control Breast Pump Evenflo Comfort Control Dual Breast Pump

Classification Name: Powered Breast Pump
Class II Device - 21 C.F.R. § 884.5160

Substantial Equivalence:

Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pumps are substantially equivalent to the following currently marketed breast pumps:

Company	Product Name	510(k) Clearance Number
Medela, Inc.	Little Hearts Deluxe Battery Breast Pump	[Unknown]
Medela, Inc.	Mini-Electric Breast Pump	K901344
Medela, Inc.	Pump In Style	K950750
Ameda Egnell	Express and Premiere (Sold as: Purely Yours Breast Pump)	K973501

General Description:

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Evenflo Comfort Control Breast Pump 510(k) Summary Page 2

Design and Materials:

All food or human contact components are manufactured from material that meets FDA food additive criteria as set forth in 21 Code of Federal Regulations Parts 176, 177 and 178.

Intended Use:

The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use batterv/electric powered suction devices used to express mills from the breast of lactating women. These devices are not intended for hospital use.

Technology Considerations:

The following is a chart showing the similarities and difference between the Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump and its predicate devices:

	Evenflo ComfortControl	MedelaPump In Style	Ameda Egnell	MedelaLittle Hearts	MedelaMini Electric
Intended Use	To Express Milk	To Express Milk	To Express Milk	To Express Milk	To Express Milk
Power Source	AC Adapter or 2 CBatteries	AC Adapter	AC Adapter or 6 AABatteries	AC Adapter or 2 DBatteries	AC Adapter or 2 AABatteries
Single or Double Pumping	Yes	Yes	Yes	Single Only	Single Only
Adjustable Suction Levels	Yes	Yes	Yes	Yes	Yes
Adjustable Cycle Speed	Yes	No	Yes	No	No
Overflow Protection	Yes, valve in horn	Yes, reservoirtype	Yes, reservoir type	Yes, non-woven fiber	No
Highest Vacuum Setting (in Hg)	6.8	7.3	6.7	6.5	6.8
Highest Vacuum Setting (mm Hg)	173	185	170	165	173
Lowest Vacuum Setting (in Hg)	1.7	3.7	1.2	3.7	4.3
Lowest Vacuum Setting (mm Hg)	43	94	30	94	109
Range of Cycle Speeds(Cycles/Minute)	54~36	49	60~29	33	31
Nipple Adapter	Yes	Yes	Yes	Yes	Yes
Time to 75% Initial Vacuum onBatteries (hours)	7	NA	1	20	3
Time to 0% Initial Vacuum onBatteries (hours)	10	NA	5	37	13

Non-Clinical Testing:

Evenflo conducted performance testing on its Comfort Control Pumps and each of the predicate devices. These tests measured the negative pressure generated by each pump and plotted the result as a function of time. Through these tests, a comparison of vacuum pressure and cycle speed could be determined. Tests were also conducted to determine the expected useful life of the battery for each pump.

Conclusion:

It is Evenflo Inc.'s conclusion that the Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are substantially equivalent to its predicate devices. Based upon the test data submitted, the Comfort Control provides sufficient vacuum pressure to effectively express and collect milk from lactating women.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 1903

Donald E. Segal Akin. Gump. Strauss. Hauer & Feld 1333 New Hampshire Avenue, NW Suite 400 Washington, DC 20036

Re:

K983776 Evenflo Comfort Control Dual Breast Pump Dated: April 15, 1999 Received: April 15, 1999 Regulatory Class: II 21 CFR 884.5160/Procode: 85 HGX

Dear Mr. Segal:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrts/dsmaldsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K983776

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

Indications For Use: The Evenflo Comfort Control Breast Pump and Comfort Control Dual
Breast Pump are personal use battery/electric powered suction devices
used to express milk from the breast of lactating women. These devices
are not intended for hospital use.

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…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Segerson

on Sign-Off ivision of Reproductive. Abdominal, El and Radiological Dev 510(k) Number

Prescription Use

Over -The-Counter Use OR

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

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).