← Product Code [HGX](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX) · K022140

# WHISPER WEAR BREAST PUMP (K022140)

_Whisper Wear · HGX · Sep 30, 2002 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K022140

## Device Facts

- **Applicant:** Whisper Wear
- **Product Code:** [HGX](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX.md)
- **Decision Date:** Sep 30, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5160
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for Use

The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

## Device Story

The Whisper Wear Breast Pump is a self-contained, battery-operated device worn under clothing. It utilizes a DC motor to actuate a silicone diaphragm, generating negative pressure to express milk into a collection bag. The device is intended for use by lactating women. It functions as a mechanical pump to assist in milk collection.

## Clinical Evidence

Bench testing only. Performance data included vacuum and cycle rate testing, and compliance with ISO 10993 (biological evaluation) and UL safety standards.

## Technological Characteristics

Battery-operated powered breast pump; DC motor; silicone diaphragm; collection bags. Complies with ISO 10993-1, 10993-5, 10993-10, UL 1431, and UL 2601-1. Mechanical operation.

## Regulatory Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

## Predicate Devices

- Medela Mini Electric® Breastpump ([K901344](/device/K901344.md))

## Submission Summary (Full Text)

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>
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# Summary of Safety and Effectiveness for the Whisper Wear Breast Pump

submitted by Whisper Wear, Inc. 2221 Newmarket Parkway, Suite 136 Marietta, GA 30067 Phone: (770) 984-0905

| Contact Person:      | Al Weisenborn                             |
|----------------------|-------------------------------------------|
| Device Trade Name:   | Whisper Wear Breast Pump                  |
| Common Name:         | Breast Pump                               |
| Classification Name: | Powered Breast Pump per 21 CFR § 884.5160 |

## Identification of a Legally Marketed Predicate Device

The Whisper Wear, Inc. Breast Pump is substantially equivalent to the Medela Mini Electric® Breastpump, which is legally marketed and distributed by Medela, Inc. pursuant to 510(k) K901344.

### Device Description

The Whisper Wear Breast Pump is a self-contained, battery-operated device that is worn under and held in place by everyday clothing. A DC motor imparts motion to a silicone diaphragm that develops a negative pressure that expresses milk from the breast to a collection bag.

### Intended Use

The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

# Summary of Technological Characteristics

Thirteen (13) technological characteristics of the Whisper Wear, Inc. Breast Pump were compared to those of predicate device and found to be equivalent.

# Summary of Performance Data

The Whisper Wear, Inc. Breast Pump complies with the following standards, practices, and guidances:

- 10993-1, Biological Evaluation-Part 1: Guidance on Selection of Tests
- 10993-5, Biological Evaluation-Part 5: Tests for Cytotoxicity: In Vitro Methods

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- 10993-10, Biological Evaluation-Part 10: Tests for irritation and sensi-● tization
- UL 1431, Personal Hygiene and Health Care Appliances ●
- UL 2601-1, Medical Electrical Equipment, Part 1: General Requirements ● for Safety

The Whisper Wear, Inc. Breast Pump is substantially equivalent to the Medela Mini Electric® Breastpump, which is legally marketed and distributed by Medela, Inc. pursuant to 510(k) K901344. This has been demonstrated through a series of bench tests including vacuum and cycle rate performance.

The tissue contact and milk contact materials used to fabricate the Whisper Wear Breast Pump and Collection Bags have a long history of safe usage. Since the Whisper Wear Breast Pump and Collection Bags meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Whisper Wear Breast Pump and Collection Bags will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 3 0 2002

Whisper Wear Incorporated c/o Mr. Al Weisenborn Certified Quality Engineer 19526 East Lake Drive MIAMI FL 33015

Re: K022140

Trade /Device Name: Whisper Wear Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: July 1, 2002 Received: July 2, 2002

Dear Mr. Weisenborn:

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 10 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 (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 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,

Nancy Chroydon

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

Page 1 of 1

510(k) Number (if known): __ KO22

Device Name: Breast Pump

Indications for Use:

The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use __________ | OR |
|-----------------------------|----|
| (Per 21 CFR 801.109)        |    |
| (Optional Format 1-2-96)    |    |

Over-The-Counter Use__X_

David G. Dyson

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

Whisper Wear, Inc.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K022140](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K022140)

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