EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187

K032845 · The First Years, Inc. · HGY · Apr 5, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K032845
• Device Name: EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
• Applicant: The First Years, Inc.
• Product Code: HGY · Obstetrics/Gynecology
• Decision Date: Apr 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5150
• Device Class: Class 1

Intended Use

Non-powered Breast Pump to express milk from the breast.

Device Story

Easy Comfort™ Deluxe Manual Breast Pump is a non-powered, manually operated device designed for milk expression. User operates pump mechanism to create suction at breast interface; milk is collected in attached container. Intended for home use by lactating women. Device facilitates milk removal for feeding or storage. Simple mechanical design; no electronic components or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Non-powered manual breast pump. Mechanical suction generation. Materials and dimensions not specified. No energy source, connectivity, or software.

Indications for Use

Indicated for lactating women to express milk from the breast. No specific age or contraindications listed.

Regulatory Classification

Identification

A nonpowered breast pump is a manual suction device used to express milk from the breast.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 5 2004

Mr. Robin C. Conner Quality Assurance Manager The First Years, Inc. Corporate Headquarters One Kiddie Drive AVON MA 02322-1171

Re: K032845

Trade/Device Name: Easy Comfort™ Deluxe Manual Breast Pump Regulation Number: 21 CFR 884.5150 Regulation Name: Nonpowered breast pump Regulatory Class: II Product Code: 85 HGY Dated: January 22, 2004 Received: January 23, 2004

Dear Mr. Conner:

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 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 CFF) 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 the 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" (21CFR Part 807.97) you may obtain. 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.

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

Page 2

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## ATTACHMENT 3

## INDICATIONS FOR USE STATEMENT

022845 510(k) Number (if known): _

Easy Comfort ™ Deluxe Manual Breast Pump Device Name:

Indications for Use:

Non-powered Breast Pump to express milk from the breast.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. brogdon
(Division Sign-Off)

*Over-The-Counter Use*

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032845

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