PLAYTEX BREAST PUMP

K022594 · Playtex Products, Inc. · HGX · Nov 1, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022594
• Device Name: PLAYTEX BREAST PUMP
• Applicant: Playtex Products, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

An electrically powered breast pump used to express milk from the breast of a lactating woman.

Device Story

Electric breast pump for milk expression; utilizes reciprocating piston mechanism; powered by 12V DC supply. System components: pump assembly, breast cup assembly, carry bag, and collection bottles/liners. User interface: button pad for selecting 5 pre-set suction levels and 5 pre-set speed settings. Features active breast massage and overflow protection. Designed for use by lactating women in home or clinical settings. Device provides vacuum pressure to express and collect milk; adjustable settings allow user to customize suction and cycle speed for comfort and efficacy.

Clinical Evidence

No clinical tests have been conducted on this device. Substantial equivalence is supported by non-clinical bench testing demonstrating the device meets established requirements for vacuum pressure and performance.

Technological Characteristics

Powered reciprocating piston pump; 12V DC energy source. Materials: FDA-compliant food-grade components; silicone breast cup insert (biocompatibility tested). Features: 5 suction levels (2.5-9.0 in Hg), 5 speed settings (45-75 cycles/min), overflow protection, active breast massage. Form factor: portable, usable on tabletop or in carry bag. Connectivity: None.

Indications for Use

Indicated for lactating women to express milk from the breast.

Regulatory Classification

Identification

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

Predicate Devices

• Ameda Egnell Express and Premier (K973501)
• Ameda Egnell Elite (K950531)
• Medela Pump-in-Style (K950750)

Submission Summary (Full Text)

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Premarket Notification 510(k) Playtex® Breast Pump Playtex Products, Inc.

K022594

Playtex

Technical Center 75 Commerce Drive Allendale, New Jersey 07401-1600 201 785-8000

Playtex Products, Inc.

# 510(k) Summary of Safety and Effectiveness

July 9, 2002

| Submitter: | Playtex Products, Inc.<br>75 Commerce Drive<br>Allendale, NJ 07401<br>Phone: [phone] | | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--|
| Contact Name: | Dr. Paul A. Siracusa<br>Senior Vice President, Research & Development | | |
| Trade name: | Playtex Breast Pump | | |
| Common name: | Powered Breast Pump for Mother's Milk | | |
| Classification name: | Powered Breast Pump, 21 CFR 884.5160 (85 HGX) Class II | | |
| | Substantial Equivalence: Playtex Breast Pump is substantially equivalent to the following<br>currently marketed breast pumps: | | |
| Company | Product Name | 510(k) Clearance Number | |
| Ameda Eqnell<br>Ameda Egnell<br>Medela | Express and Premier<br>Elite<br>Pump-in-Style. | K973501<br>K950531<br>K950750 | |

# General Description:

The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 4 major assemblies: a pump assembly, a breast cup assembly, a carry bag, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 5 pre-set suction levels and 5 pre-set speed settings, which are selectable by the user via a button pad. The device is powered by a 12V DC power supply, which is included with the package.

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# Design and Materials:

All milk and human contact components are manufactured from materials that meets FDA food additive criteria as set forth in Part 21 Code of Federal Regulations Parts 176, 177 and 178. In addition, the silicone breast cup insert has been tested for biocompatibility per established guidelines.

### Intended Use:

The intended use of the Playtex Breast Pump is to express milk from the breast of lactating women.

## Comparison to Predicate Devices

The following is a chart showing the similarities and differences between the Playtex Breast Pump and the Predicate Devices:

| | Playtex<br>Breast Pump | Medela Pump-<br>in-Style | Ameda Purely<br>Yours | Ameda Elite |
|---------------------------------------|-------------------------|----------------------------|--------------------------------------------------------|-------------------------|
| 510(k) Number | N/A | K950750 | K973501 | K950531 |
| Intended Use | To Express<br>Milk | To Express Milk | To Express Milk | To Express<br>Milk |
| Power Source | DC Power<br>Supply | DC Power<br>Supply | DC Power Supply<br>or 6 AA Batteries | DC Power<br>Supply |
| Pump Type | Reciprocating<br>Piston | Reciprocating<br>Diaphragm | Reciprocating<br>Piston | Reciprocating<br>Piston |
| Single or Double Pumping | Both | Both | Both | Both |
| Adjustable Suction Levels | Yes | Yes | Yes | Yes |
| Adjustable Cycle Speed | Yes | No | Yes | Yes |
| Overflow Protection | Yes | No | Yes | Yes |
| Highest Vacuum Setting (in<br>Hg) | 9.0 | 7.3 | 6.7 | 9.8 |
| Lowest Vacuum Setting (in<br>Hg) | 2.5 | 3.7 | 1.2 | 0.0 |
| Range of Cycle Speeds<br>(Cycles/min) | 75 - 45 | 49 | 60 - 29 | 60 - 30 |
| Breast Cup-to-Breast<br>Interface | Soft Silicone | Rigid Plastic | Rigid Plastic<br>(partial silicone<br>covering avail.) | Rigid Plastic |
| Active Breast Massage | Yes | No | No | No |
| Hospital Grade System | Yes | No | Yes | Yes |
| Usable on Tabletop<br>or Inside Bag | Both | Inside | Tabletop | Tabletop |

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KO22594 p.3

## Discussion of Non-Clinical Tests:

Testing of the device has demonstrated that the Playtex 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:

In conclusion, the Playtex Breast Pump is substantially equivalent to its predicate devices. Based upon the test data submitted, the device provides sufficient vacuum pressure to effectively express and collect milk from lactating women.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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 symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2002

Paul A. Siracusa, D. En. Sc. Senior Vice President Research and Development Playtex Products, Inc. 75 Commerce Drive ALLENDALE NJ 07401

Re: · K022594

Trade/Device Name: Playtex Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: 85 HGX Dated: July 26, 2002 Received: August 5, 2002

Dear Dr. Siracusa:

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. Iisting 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 (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 | [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy 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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Premarket Notification 510(k) Playtex® Breast Pump Playtex Products, Inc. March 22, 2002

# Indications for Use Statement

| Applicant: | Playtex Products, Inc. |
|---------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | KC22544 |
| Device Name: | Playtex® Breast Pump |
| Indications for Use: | An electrically powered breast pump used to express<br>milk from the breast of a lactating woman. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use or

(Optional format 1-26-99)

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David M. Simpson

(Division Sign-C Division of Repro and Radio 510(k) Nun