The Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.

Device Description

The Evenflo Advanced Double Electric Breast Pump is an electrically powered breast pump that uses negative pressure to express milk from a lactating woman's breasts. A reciprocating vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels between 25 and 254 mmHg. The flange system is convertible between single and double pumping. Four buttons on the user interface allow the user to select one of 32 settings (eight vacuum levels and four cycle rates for each vacuum level) and the LED interface displays the selected setting. Additionally, there are three different flange sizes that allow the user to select the size that best fits their breasts. These features allow the user to customize the device, improving the comfort of their pumping experience. The device can be powered by six "AA" batteries or the provided mains adapter.

AI/ML Overview

The provided 510(k) summary for the Evenflo Advanced Double Electric Breast Pump (K131153) describes the acceptance criteria and the study that proves the device meets those criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria	Reported Device Performance
Vacuum Range (double pumping)	Within performance specification ranges of predicate devices (K973501: 75-200 mmHg)	25-254 mmHg
Vacuum Range (single pumping)	Within performance specification ranges of predicate devices (K973501: 75-270 mmHg, K102600: 3-254 mmHg)	25-270 mmHg
Cycle Speed	Within performance specification ranges of predicate devices (K973501: 30-60, K102600: 46 fixed)	30 - 80 cycles/minute (Note: This is broader than the primary predicate K973501 but overlaps and is consistent with the general concept of variable cycle speed in predicate devices)
Electrical Safety	UL 1431, FCC 15A, CISPR 11:2009 compliant	Demonstrated compliance with UL 1431, FCC 15A, CISPR 11:2009 (Implied by "General Electrical Safety UL 1431, FCC 15A, CISPR 11:2009" and the conclusion of substantial equivalence based on non-clinical testing).
Sound Pressure	Within specifications	No specific quantitative acceptance criteria or performance values are provided beyond "Sound Pressure" being part of the non-clinical testing.
Operational Forces	Within specifications for assembly/disassembly	No specific quantitative acceptance criteria or performance values are provided beyond "Operational Forces to assemble and disassemble components" being part of the non-clinical testing.
Check Valve Functionality	Within specifications	No specific quantitative acceptance criteria or performance values are provided beyond "Check Valve" being part of the non-clinical testing.
Battery Life	Within specifications	No specific quantitative acceptance criteria or performance values are provided beyond "Battery Life" being part of the non-clinical testing.
Comparative Vacuum and Cycle Testing	Proposed device is substantially equivalent to predicate devices	"It was demonstrated that the proposed device is substantially equivalent to the predicate device" in these areas. This implies the performance fell within acceptable ranges relative to the predicates, even if exact numerical criteria aren't explicitly stated for all aspects.
Indications for Use	To express milk from lactating women for a single user (consistent with predicates)	"Indications for use are to express milk of lactating women. This is for a single user." (Stated as not identical to predicates, but the intended use is the same).
Technology/Principle of Operation	Identical to predicates (reciprocating vacuum pump, flange/collection system)	"The technology and principle of operation for the proposed device is identical to the predicates."
Materials (milk/user contact)	Identical to predicate K102600 and ISO 10993 Compliant (for materials not identical)	"The materials which are in contact with the user and the expressed milk are identical to the predicate." and "ISO 10993 Compliant" (for predicate K102600, implying the new device also needs to be).
Environment of Use	Identical to predicates (Home)	"The environment of use, home, is identical to the predicates."
Patient Population	Identical to predicates (Lactating women)	"The patient population is lactating women which is identical to the predicates."
Sterilization Method for Accessories	Boiling water (identical to predicate K102600)	"Boiling water" (stated as "Identical to Predicate K102600").

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a sample size for any specific "test set" in the context of clinical or user performance data analysis. The studies described are bench tests (non-clinical testing). Therefore, concepts like country of origin or retrospective/prospective data generation are not applicable here.

The "studies" are laboratory-based bench testing and comparative measurements against predicate devices.

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

N/A. As the studies are bench tests, there is no "ground truth" to be established by experts in the sense of clinical image interpretation or diagnosis. The "ground truth" for bench tests is typically derived from calibrated measurement equipment and engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. This submission focuses on engineering performance bench tests.

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

No. This device is a breast pump, not an AI-powered diagnostic device necessitating an MRMC study.

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

N/A. This device is a mechanical/electrical product, not an algorithm. Standalone performance refers to the output of an algorithm itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench tests would be:

Instrumental measurements: Calibrated devices measuring vacuum, cycle speed, sound pressure, electrical parameters, operational forces, and battery life.
Engineering specifications/standards: Compliance with UL 1431, FCC 15A, CISPR 11:2009, and ISO 10993 implied for material biocompatibility.
Predicate device performance: The performance of the legally marketed predicate devices (K973501 and K102600) served as a benchmark for comparison to demonstrate substantial equivalence.

8. The sample size for the training set

N/A. This product does not involve machine learning or AI models that require a "training set."

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

N/A. Not applicable due to the nature of the device.

Summary

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K131153

510(k) Summary
Page 1 of 4

JUN 1 8 2013

Date of Preparation:	17-Jun-2013
Evenflo Feeding, Inc.9277 Centre Pointe Dr., Suite 160West Chester, OH 45069	Tel - 513-870-1629Fax - 513-870-1646
Official Contact:	Mr. Wade HalmaProduct Integrity Engineering Manager
Proprietary or Trade Name:	Evenflo Advanced Double Electric Breast Pump
Common/Usual Name:	Powered breast pump
Classification Name:	Powered breast pumpHGX - CFR 884.5160Class 2 - OTC
Predicate Devices:	K973501 - Ameda - Purely YoursK102600 - Evenflo - SimplyGo

Device Description:

Four buttons on the user interface allow the user to select one of 32 settings (eight vacuum levels and four cycle rates for each vacuum level) and the LED interface displays the selected setting. Additionally, there are three different flange sizes that allow the user to select the size that best fits their breasts. These features allow the user to customize the device, improving the comfort of their pumping experience.

The device can be powered by six "AA" batteries or the provided mains adapter.

Indications for Use:

The Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from lactating woman's breasts. This is for a single user.

Patient Population:	Lactating women
Environment of use:	Home
Contraindications:	None

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K131153

Attribute	New deviceAdvanced DoubleElectrical Breast Pump	AmedaPurely YoursK973501	EvenFloSimplyGoK102600
Intended Use	Express milk	Express milk	Express milk
Patient population	Lactating women	Lactating women	Lactating women
Environment of use	Home	Home	Home
OTC	Yes	Yes	Yes
Power Source	AC / Battery	AC / Battery	AC / Battery
Pump Style	Reciprocating Vacuum Pump	Single-Stroke ReciprocatingVacuum Pump	Reciprocating Vacuum Pump
Single/double Pumping	Both	Both	Single
Adjustable Suction Levels	Yes	Yes	Yes
Cycle Speed	30 - 80	30 - 60	46 (fixed)
Overflow Protection	Yes (diaphragm)	Yes (diaphragm)	Yes (float)
Vacuum range - double (mmHg)	25-254	75-200	N/A
Vacuum range - single (mmHg)	25-270	75-270	3-254
Cycling/Suction Control Mechanism	Microprocessor	Microprocessor	Mechanical cycling with suction regulator
Accessories	FlangeSoft FlangeBottleTubingCheck valveDiaphragm	FlangeSoft FlangeBottleTubingCheck valveDiaphragm	Flange (horn)Soft Flange (horn insert)BottleCheck valveOverflow Valve
Flanges and Inserts come in multiple sizes	Yes	Yes	No
Software	Boiling water	Boiling water	Boiling water
Cleaning method for Accessories	Identical to PredicateK102600	N/A	ISO 10993 Compliant
Materials	UL 1431	UL 1431	UL 1431
Electrical Safety

: : .

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

・

510(k) Summary

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510(k) Summary Page 3 of 4 17-Jun-2013

The Evenflo Advanced Double Electric Breast Pump is viewed as substantially equivalent to the predicate devices because:

Indications -

Indications for use are to express milk of lactating women. This is for a single user. . Discussion - Indications for Use statements between the subject device and the predicate device are not identical, but the intended use of the three devices-to express milk from the breasts of lactating women-is the same.

Technology -

The technology of a reciprocating vacuum pump to express milk and the flange and . collection bottle system are identical to the predicate. The power source, user controls, ability to adjust vacuum and frequency settings and performance specifications are identical to the predicates.
Discussion - The technology and principle of operation for the proposed device is identical to the predicates - Evenflo SimplyGo - K102600 and the Ameda Purely Yours - K973501.

Materials -

The materials which are in contact with the user and the expressed milk are identical to . the predicate.
Discussion - The materials are identical to the predicate - Evenflo SimplyGo - K102600.

Environment of Use -

The environment of use, home, is identical to the predicates.

Discussion - The environment of use is identical to the predicates - Evenflo SimplyGo -K102600 and the Ameda Purely Yours - K973501.

Patient Population -

The patient population is lactating women which is identical to the predicates. . Discussion - The user population is identical to the predicates - Evenflo SimplyGo -K102600 and the Ameda Purely Yours - K973501.

Non-clinical Testing Summary -

We have performed a number of bench tests to demonstrate the Evenflo Advanced Dual Electric Breast Pump performs within its specifications and within the performance specification ranges of the predicate devices. These tests included:

Vacuum testing ●
General Electrical Safety UL 1431, FCC 15A, CISPR 11:2009 .
Sound Pressure .
Operational Forces to assemble and disassemble components .
Check Valve .
Battery Life

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510(k) Summary Page 4 of 4 17-Jun-2013

In addition, we performed comparative vacuum and cycle testing with the proposed device and the predicates. It was demonstrated that the proposed device is substantially equivalent to the predicate device.

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 18, 2013

Evenflo Feeding, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K131153

Trade/Device Name: Evenflo Advanced Double Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: May 26, 2013 Received: June 4, 2013

Dear Mr. Job:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Mr. Mark Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely,

Image /page/5/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black against a white background. The letters "P.L" are stylized with a circular design inside the letters.

for Benjamin R. Fisher, Ph.D. Director™ Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number:

K131153

Device Name:

Evenflo Advanced Double Electric Breast Pump

Indications for Use:

The Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.

Prescription Use (Part 21 CFR 801 Subpart D) Over-the-counter use XX (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert - R. Merner - S

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).