An electrically powered breast pump with adjustable vacuum and massage settings and 2 funnels for expressing milk from the breasts of a lactating woman.

Device Description

The Gerber Double Electric Breast Pump is a simple and effective system for expressing milk from a lactating women's breast(s). The device includes the following components: a pump base, flexible tubing, a funnel assembly, a carrying bag, and accessories (e.g. bottles, nipples, and disposable nursing pads). The device is powered by a variable speed power supply that drives a diaphragm pump creates the negative pressure required to extract breast milk. The breast pump is capable of providing a variable vacuum and massage like motion. A maximum vacuum of 240 mm Hg can be applied to one or both breasts.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Gerber Double Electric Breast Pump, seeking substantial equivalence to existing predicate devices. It does not contain information about the acceptance criteria and a study proving device performance in the context of an AI/ML medical device.

The document discusses "non-clinical tests" as "Bench testing of the device has demonstrated that the Gerber Double Electric Breast pump meets established requirements when used in the manner and environment specified in product labeling." It explicitly states, "No clinical tests have been conducted on this device."

Therefore, I cannot provide the requested information as it pertains to a medical device that is not an AI/ML product and does not involve the types of studies described in your request. The device is a traditional medical device (breast pump), and its clearance is based on substantial equivalence to predicate devices rather than complex performance studies against specific acceptance criteria for an AI/ML algorithm.

Summary

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K043098

Image /page/0/Picture/1 description: The image shows the Gerber logo. The logo features a drawing of a baby's face inside a black circle. Below the circle is the word "Gerber" in a bold, sans-serif font, and below that is the text "GERBER PRODUCTS COMPANY A NON-THING OMPAN".

DEC 1 5 2004

SURE CO. DEARON L. ARRINGAN, 1971 - 198 2006 - 100 - 100 - 100 - 2004 - 100 - 100 - 100 - 100 - 100 - 100 - 100

510(k) Summary September 20, 2004

Submitter:	Gerber Products Company445, State StreetFremont, MI 49413-0001Phone: 231 928 2831Fax: 231 928 2964
Contact Name:	Dr. Nicholas HetherDirector, Product Safety & Regulatory Sciences
Trade Name:	Gerber Double Electric Breast Pump
Common Name:	Electric Breast Pump
Classification Name:	Powered Breast Pump21 CFR 884.5160 (85 HGX) Class-II
Substantial Equivalence:	The Gerber Double Electric Breast Pump is substantiallyequivalent to the following legally marketed predicate devices:

Company	Product Name	510(k) clearance#
Medela	Pump-in-Style	K031614
Ameda Egnell	Purely Yours	K973501
Playtex	Breast Pump	K022594

General Description:

Device Description:

The device is powered by a variable speed power supply that drives a diaphragm pump creates the negative pressure required to extract breast milk. The breast pump is capable of providing a variable vacuum and massage like motion. A maximum vacuum of 240 mm Hg can be applied to one or both breasts.

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Design and materials:

All components that may come in contact with the milk are manufactured from materials that meet FDA food contact criteria. The materials that contact the breast have been tested for biocompatibility.

Intended Use:

An electrically powered breast pump with settings, for expressing milk from the breasts of a lactating woman.

Technological Characteristics of the Device:

The Gerber Double Electric Breast Pump is substantially equivalent to other powered breast pumps that are available for commercial distribution. A chart showing the similarities and differences of the proposed powered breast pump and the predicate powered breast pumps follows:

Comparison of Predicate Devices
	New device	K031614	K022594	K973501
	GerberDoubleElectricBreast Pump	MedelaPump-in-Style	Playtex BreastPump	Ameda EgnellPurely Yours
Intended Use:	Express milk	Express milk	Express milk	Express milk
Power Source:	DC	DC	DC	DC
Pump Style:	Diaphragm	Diaphragm	ReciprocatingPiston	ReciprocatingPiston
Single/double Pumping:	Both	Both	Both	Both
Adjustable SuctionLevels:	Yes	Yes	Yes	Yes
Cycle Speed:	Fixed	Variable	Variable	Variable
Overflow Protection:	No	No	Yes	Yes
Highest Vacuum Setting- (mmHg):	240	250	229	170
Lowest Vacuum Setting	0	0	64	31
Active Breast Massage:	Yes	No	Yes	No
Software (microchip)	Yes	Yes	Yes	Yes

Discussion of Non-clinical Tests:

Bench testing of the device has demonstrated that the Gerber Double Electric Breast pump meets established requirements when used in the manner and environment specified in product labeling.

Discussion of clinical tests performed:

No clinical tests have been conducted on this device.

Conclusion:

The Gerber Double Electric Breast Pump is safe and effective for its intended use of milk expression and is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2004

Gerber Products Company % Ms. Chantel Carson Manager Underwriters Laboratories, Inc. Northbrook Division 333 Pfingsten Road NORTHBROOK IL 60062-2096 Re: K043098

Trade/Device Name: Gerber Double Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: November 24, 2004 Received: November 30, 2004

Dear Ms. Carson:

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 (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 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 (QS) 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 Section 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:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmadsmamain.html

Sincerely yours,

Nancy C. brogdon

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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Indications for Use

510(k) Number:

K_043098 ___ (To be assigned)

Device Name:

Gerber Double Electric Breast Pump

Indications for Use:

An electrically powered breast pump with adjustable vacuum and massage settings and 2 funnels for expressing milk from the breasts of a lactating woman.

Prescription Use (Per CFR 801.109)

Over-the-counter use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leymann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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).