LACTATION TECHNIQUES MODEL B

K981549 · Lactation Techniques, Inc. · HGX · May 24, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K981549
• Device Name: LACTATION TECHNIQUES MODEL B
• Applicant: Lactation Techniques, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: May 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Lactation Techniques™ Model B auto cycling breast pump is to aid nursing mothers at home with the extraction of breast milk in the absence of the nursing child due to illness or other situations causing temporary separation.

Device Story

Lactation Techniques™ Model B is an auto-cycling powered breast pump; designed for home use by nursing mothers. Device functions by creating suction to extract breast milk when the nursing child is absent. Operation is mechanical/electromechanical; intended to assist mothers during temporary separation. Output is expressed breast milk collected in a container. Device aids in maintaining lactation and providing nutrition for the infant in the mother's absence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered breast pump; auto-cycling mechanism; intended for home use. Class II device (21 CFR 884.5160, Product Code: HGX).

Indications for Use

Indicated for nursing mothers at home requiring breast milk extraction during temporary separation from the nursing child due to illness or other situations.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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## MAY 2 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark Leloudis President Lactation Techniques, Inc, 1252 West 50 South Centerville, Utah 84014

Re: K981549/S1 Lactation Techniques™Model B Powered Breast Pump Regulatory Class: II 21 CFR 884.5160/Product Code: 85 HGX Dated: March 26, 1999 Received: March 29, 1999

Dear Mr. Leloudis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indication 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission

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Page 2 - Mr. Leloudis

does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

David A. Szymanski, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Lactation Techniques TM Model B

Device Name:

Indications For Use:

The Lactation Techniques TM Model B auto cycling breast pump is to aid nursing mothers at home with the extraction of breast milk in the absence of the nursing child due to illness or other situations causing temporary separation.

(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Jarid br. Slayton

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 1981549 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)