MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B

K082802 · Learning Curve Brands Inc. the First Years · HGX · Oct 9, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K082802
• Device Name: MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
• Applicant: Learning Curve Brands Inc. the First Years
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Oct 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Powered Breast Pump to express milk from the breast.

Device Story

The miPump is an electric/battery-powered breast pump designed for home use by lactating women to express breast milk. The device utilizes an electrical pressure control system to generate suction, which is applied to the breast via a silicone shield. Users operate the device by selecting from eight suction levels using a button interface; suction intensity is indicated by green lights. The pump is powered by four AA batteries or an AC adapter. The system includes a pump assembly, tubing, flapper valves, and collection bottles. By creating rhythmic suction, the device facilitates milk expression, which can assist in maintaining milk supply or providing stored milk for infant feeding. The device is intended for over-the-counter use.

Clinical Evidence

No clinical data. The device relies on bench testing and material safety compliance to demonstrate substantial equivalence.

Technological Characteristics

Powered breast pump; 8-level suction control; electrical pressure-controlled pump; powered by 4 AA batteries or 6V AC adapter. Materials: ABS (pump assembly), polypropylene (adapters, bottles, collars), silicone (flapper valve, shield), PVC non-phthalate (hose), LDPE (storage bags). Materials meet FDA 21 CFR 175-178 food additive criteria. Form factor: portable, handheld/tabletop. No software/firmware algorithm; manual user-controlled suction adjustment.

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.

Submission Summary (Full Text)

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K082802

510(k) Summary of Safety and Effectiveness August 8, 2008

## 1. Submitter Information

| a. Address: | Learning Curve Brands<br>100 Technology Drive Suite 2A<br>Stoughton, MA 02072<br>Tel. [phone] |
|--------------------|----------------------------------------------------------------------------------------------------|
| b. Contact Person: | Supravan Khongkruaphan<br>Product Integrity Manager |

# 2. Name of the Device

- a. Trade Name : miPump TM
- b. Classification Name : Power Breast Pump
- c. Common/Usual Name
- miPump Single Electric / Battery Breast Pump Y4612 1.
- miPump Double Electric / Battery Breast Pump Y4613 2.
- miPump Deluxe Double Electric / Battery Breast Pump Y4614 3.

## 3. Classification of the Device

Per 21 CFR 884.5160 states that power breast pump are class II medical devices.

#### 4. General Device Description

The miPump Electric / Battery Breast Pump are quiet, small, safety and effective system for express milk from the breast. It has electrical pressure control pumping system to generate suction. This device is designed with eight suction levels, which are selectable by the user via pressing the suction button. It is powered either by four (4) AA batteries (not included with package) or powered electrically by utilizing the AC adaptor (6V) which is provided in the package and can be plugged into any standard wall outlet.

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Image /page/1/Picture/0 description: The image shows the Underwriters Laboratories Inc. logo. The logo consists of a circle with the letters UL inside. To the right of the circle is the text "Underwriters Laboratories Inc."

Subject Device:

miPump Single Electric/Battery Breast Pump & miPι
Double Electric/Battery Breast Pump

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| No. | Item | |
|-----|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3. | Location in 510(k): | Device Description – Section 11 |
| | Finding/Question Noted: | The Device Description does not identify all of the accessories of the device. Please refer to the device labeling and describe each accessory in the device description (i.e. pads, milk storage, handle, etc).<br><br>These accessories should also include a reference if they are currently cleared devices, are part of another device that is cleared, or other. If they are currently cleared device, please provide the manufacturer and FDA K number for each accessory.<br><br>If any of these are part of a Kit, please provide a Kit Certification. (http://www.fda.gov/cdrh/ode/odecl874.html) |
| | Sponsor's Response: | Revised Device Description section to include all of the accessories and kit of the device (page 24), also provide kit certification (Attachment 3). Addition, describe how the kit and accessory are packed in package. |
| | Third Party Summary: | |

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## Device Description

The miPump Electric / Battery Breast Pump is a quiet, small, safe and effective system to express milk from the breast. It has electrical pressure control pumping system to generate suction. This device is designed with eight suction levels, which are selectable by the user via pressing the suction button. It is powered either by four (4) AA batteries (not included with package) or powered electrically by utilizing the AC adaptor (6V) which is provided in the package and can be plugged into any standard wall outlet. (See Attachment I for Drawing, Label and Instruction for use).

The principle of operation of the miPump Electric / Battery Pump is as follows:

- 1. Turn pump on by pressing and holding power button down for three seconds. Power light will illuminate indicating pump is on. The pump always powers on at lowest level.
- 2. To pump sit upright, Grasp the bottle by 3-way adaptor and insert breast into the Flexi-Fit shield. Your breast should completely fill shield.
- 3. To increase suction, press the "+" button. There are eight suction levels. The green suction indicator lights illuminate as suction is increased. When the last light is illuminated, the highest suction setting has been reached.
- 4. To reduce suction, press the "-" button. To immediately reduce suction, turn pump off and remove shield from breast.

Learning Curve Brands intends to market the miPump Electric / Battery Breast Pump with following components as Table below. Materials for all components used in the manufacture of the miPump Electric / Battery Pump that come in contact with the user's skin and breast milk are manufactured from materials that meet FDA food additive criteria per Title 21, CFR, sections 175-178. There is no information suggesting that there have been any tissue irritation, sensitization, or cell damage response with these materials. See section 15 for supportive information concerning material testing.

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| Kit of miPump Electric / Battery Breast Pump | | |
|------------------------------------------------------------|----------------------------------------------------------------------|--------------------------|
| Parts List | Material | For SKU # |
| Pump Assembly***/* | Injection Molded ABS | Y4612 / Y4613<br>/ Y4614 |
| AC/DC Adapter | Class2Transformer;InputAC120V60Hz<br>9W output Color Black and White | Y4612 / Y4613<br>/ Y4614 |
| Drip edge 3-way bottle<br>adapter***/* | Injection Molded polypropylene Color<br>Clear | Y4612 / Y4613<br>/ Y4614 |
| Basic One-way Angled<br>9ml Flapper Valve<br>Assembly***/* | Injection Molded PP ;with Silicone,<br>Flapper Color Natural | Y4612 / Y4613<br>/ Y4614 |
| Flexi-Fit Breast Pump<br>Shield***/* | Liquid Injection Molded Silicone Color<br>Clear/Natural | Y4612 / Y4613<br>/ Y4614 |
| Pump Hose***/* | PVC non Phthalate | Y4612 / Y4613<br>/ Y4614 |
| Accessories of miPump Electric / Battery Breast Pump | | |
| Parts List | Material | For SKU # |
| 5 oz Soothie Bottle | PP | Y4612 / Y4613<br>/ Y4614 |
| Soothie Bottle Nipple | Silicone, Stage 1 | Y4612 / Y4613<br>/ Y4614 |
| Soothie Bottle Collar | Injection Molded PP | Y4612 / Y4613<br>/ Y4614 |
| Soothie Bottle Hood | PP | Y4612 / Y4613<br>/ Y4614 |
| 2pk Milk Storage Bags | LDPE | Y4612 / Y4613<br>/ Y4614 |
| Milk Storage wide<br>closure covers | Injection Molded PP Color White | Y4612 / Y4613<br>/ Y4614 |
| Tote | PMS 462U(brown) and PMS<br>291C(blue) | Y4612 / Y4613<br>/ Y4614 |
| Instruction Booklet | Color White | Y4612 / Y4613<br>/ Y4614 |
| Slip Sheet | Color PMS Yellow | Y4612 / Y4613<br>/ Y4614 |
| 2 pk Lanolin pads | Layer of Thermo-bond Polypropylene<br>non-woven fabric | Y4613 , Y4614<br>only |
| Pump Handle | ABS | Y4613 , Y4614<br>only |
| Bottle Adaptors | PP | Y4614 only |
| Insulated Bottle Carrier | Micro Fiber | Y4614 only |
| Reusable Cold Packs | PE cover | Y4614 only |

:

:

:

*** Components come in contact with the user's skin and breast milk

* Complied with FDA 21 CFR 175-178 Indirect Food Additive in BV test Report (5108 196-0003)

:

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 9 2008

Learning Curve Brands/The First Years % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747

Re: K082802

> Trade Name: miPump Electric/Battery Breast Pump: miPump Single Electric/ Battery Breast Pump Y4612, miPump Double Electric/Battery Breast Pump Y4613, and miPump Deluxe Double Electric/Battery Breast Pump Y464

Regulation Number: 21 CFR §884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 18, 2008 Received: September 24, 2008

Dear Mr. Conry:

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.

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#### Page 2

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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

loque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use

#### K082802 510(k) Number (if known):

Device Name: miPump Electric / Battery Breast Pump

- miPump Single Electric / Battery Breast Pump Y4612 -
- miPump Double Electric / Battery Breast Pump Y4613 -
- miPump Deluxe Double Electric / Battery Breast Pump Y4614 -

Indication For Use: Powered Breast Pump to express milk from the breast.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) =

-10-

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K082802