LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP

K051926 · Limerick, Inc. · HGX · Dec 12, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051926
• Device Name: LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
• Applicant: Limerick, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Dec 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The intended use of the electrically powered suction device is to express milk from the breast.

Device Story

The pj's comfort jr.® is a portable electric breast pump designed for lactating women to express milk. It utilizes a variable speed DC motor to generate negative pressure, which is applied to the breast via flexible tubing and breast cups. The device is operated by the user via a control panel featuring two knobs: one for adjusting vacuum levels (90-270 mm Hg) and one for adjusting cycle speed (16-70 cycles per minute). A PIC 16F872 microprocessor manages the vacuum cycling and solenoid valve operation. The device can be powered by an AC/DC wall converter, a 12-Volt battery pack, or a 12-volt motor vehicle adapter. Indicator lights on the control panel display session time and provide alerts for pump failure, excess vacuum, or overheating. The device is intended for over-the-counter use.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Powered by a variable speed DC motor controlled by a PIC 16F872 microprocessor. Suction range: 40-270 mm Hg. Cycle range: 16-70 cycles per minute. Power sources: AC/DC adapter, 12V battery, or 12V vehicle adapter. Includes a filter between the kit and pump. Materials are biocompatible per FDA requirements. Form factor: portable electric unit.

Indications for Use

Indicated for lactating women to express breast milk.

Regulatory Classification

Identification

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

Predicate Devices

• pj's comfort® Portable Breast Pump (K012275)
• Medela Pump In Style Breast Pump (510(k) not known)
• Ameda Expresse (K973501)
• Ameda Premier (K973501)

Submission Summary (Full Text)

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Name of Company: Limerick Inc. Premarket Notification - 510(k) # K051926 Fremarket Notifoution - onfort jr.® Portable Electric Breast Pump

### EXHIBIT #1 Page 1 Of 4

### 510(K) SUMMARY

This summary of 510 (k) safety and effectiveness information is being submitted This summary of 510 (K) Safety and Sheet. SMDA 1990 and 21 CFR 807.92.
in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K051926

#### Submitter's Identification: 1.

Limerick Inc. 2150 North Glenoaks Boulevard Burbank, CA 91504

Date Summary Revised: December 7, 2005

#### Name of the Device: 2.

pj's comfort jr.® Portable Electric Breast Pump

# Predicate Devices Information:

pj's comfort ® Portable Breast Pump K012275 Medela Pump In Style Breast Pump (510 (k) not known) Medela Pump in Style Breast Pamp (616 (4) 1133 - 113 (1) 1133 - 11 Premier Powered Breast pump K973501

#### Device Description: ను

The pj's comfort jr® Portable Electric Breast Pump is powered by a The pJ s comfort fre Portable Elocalle Discussion pump similar variable speed DC motor that drivos a high op that has 510(k) approval #
to that used in the pj's comfort® breast pump that has 510(k) approval # to that used in the pro creates the negative pressure required to KUTZZ7J. The vaouall partip article the vacuum pump is extract breast milk. In the presont upplied on controller circuit, and a
interconnected with a PIC 16F872 microprocessor controller circuit, and a interconnected with a PTO-101 or an also pacuum cycling rates, from 16
solenoid valve that provide variable speed vacuum charather control panol solehold valve that provide vanable opera vacating your of the control panel.

A second knob located on the front panel provides for user selection of A second Kriob located on the from levels from 90 to 270 mm Hg. infinitely vanable maximum vaodam is always 40 mm Hg. The vacuum is the same for single and double pumping.

When the cycle knob and the vacuum knob are both set at maximum the vinen the cycle Rhob and the rate rated in the cycle speed is 16 cycles per minute.

When the cycle knob is set at maximum and the vacuum knob is set at vinen the cycle knob is sot at mapproximately 90 mm Hg. and the cycle speed is 70 cycles per minute.

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Name of Company: Limerick Inc. Name of Sotification -- 510(k) # K051926 Premarket Notification = STo(it) if Roo rozle Electric Breast Pump

# EXHIBIT #1 Page 2 of 4

When the cycle knob is set at minimum, and the vacuum knob is set at When the cycle Knob is set at minimam, and the volume.
maximum, the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute.

oyole opeod is the vacuum knob are both set at minimum, the When the cycle knob and the vacuality the back only and the cycle speed is 36 cycles per minute.

The controller contains firmware, loaded at the factory in non-volatile The controller contains limitware, to be loaded at each startup. The pj's
memory, and requires no software to be loaded at each startup. The pj's memory, and requires no sonward to sortwall # K012275 uses a comfort ® bleast pump with o ro(it) approvide components to carry out similar control functions.

out Simillar Sentrel for for the pj's confort the pj's confort jr.® to mimic
The above controls allow the user of the information movimize The above controls allow the uccling of their infant, and to maximize the speed and strength of Subking of the Hg. is applied to one or both comfort. A maximum vacuum of 276 mm . Ignes applied by way of flexible tubing to the breast cup(s).

The pj's comfort jr® front control panel also has a set of indicator lights also The pJ's comfort IN® front control particular ression. These lights also
that show the time remaining in the pumping session. These lights also of that show the time remaining in the pamping outtern in case of pump failure.

- Top three lights flashing: Excess vacuum level; not user repairable, 1. return to factory for repair.
- tubing or replace filter.
- tubing of replace litter.
3. Bottom three lights flashing: Pump overheated: turn pump off and Bottom three lights hashing. T ump overnounce, If this happens often, return pump to factory for repair.

The pi's comfort jr® Portable Electric Breast Pump can be operated by l he pJ's comfort JN® Portable Liecthe Broad. Punp .
use of either an AC/DC wall converter, a 12-Volt battery pack or a 12 volt motor vehicle adapter.

All materials used in the manufacturing of this device that have contact All matehals used in the manafacturements of the FDA and with food or numan tissue mect requirements of and or biocompatability.

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Name of Company: Limerick Inc. Name of Company - 510(k) # K051926 Premarket Notification = 310(K) # R001620
Name of Device: pj's comfort jr.® Portable Electric Breast Pump

### EXHIBIT #1 Page 3 of 4

#### Intended Use: 4.

The intended use of the electrically powered suction device is to express milk from the breast.

### Comparison to Predicate Devices: 5.

Table of Comparison to Legally Marketed Devices:

Below is a comparison chart outlining differences and similarities between the Below is a comparison crart outlining unterences ails comfort(@Rortable Electric
pj's comfort jr® Portable Electric Breast Pump, pji's comfort @ Portable Electric pj's comfort JR® Portable Electric Breast Pump, pJ 0 Common Collection
Breast Pump, the Medela Pump In Style, and the Ameda Expresse and Premier breast pumps:

| | Current<br>device | Predicate devices | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Character-<br>istics | Limerick<br>pj's comfort jr® | Limerick<br>pj's comfort® | Medela Pump In<br>Style-K unknown | Ameda Expresse<br>K973501 | Ameda Premier<br>K973501 |
| Intended Use | As described in 21<br>CFR 884.5160 | As described in 21<br>CFR 884.5160 | As described in 21<br>CFR 884.5160 | As described in 21<br>CFR 884.5160 | As described in 21<br>CFR 884.5160 |
| Suction<br>Levels | 40-270 mm Hg. | 20-240 mm Hg. | 80-240 mm Hg. | <100-265mbar | <100-265mbar |
| Suction Cycle | 16 to 70 cycles<br>per minute | 20 to 60 cycles<br>per minute | 48 cycles per<br>minute | 30-60 cycles per<br>minute | 30-60 cycles per<br>minute |
| Filter between<br>kit and pump | Yes | Yes | No | No | No |
| Power Supply | 1. rechargeable<br>NiMH battery<br>2. AC adapter<br>3. 12 V adapter<br>for use in<br>motor vehicle | 1. rechargeable<br>NiMH battery<br>2. AC adapter<br>3. 12 V adapter<br>for use in<br>motor vehicle | 1. rechargeable<br>battery<br>2. AC adapter<br>3. 12 V adapter<br>for use in<br>motor vehicle | 1. rechargeable<br>NiCd<br>batteries<br>2. 5 AA alkaline<br>batteries<br>3. AC Adapter<br>4. 12V adapter<br>for use in<br>motor vehicle | 1. rechargeable<br>NiCd<br>batteries<br>2. 5 AA alkaline<br>batteries<br>3. AC Adapter<br>4. 12V adapter<br>for use in<br>motor vehicle |
| Cycle/Suction<br>Control<br>mechanism | Microprocessor | Discrete electronic<br>component<br>circuitry | Mechanical<br>cycling suction<br>regulator | Microprocessor | Microprocessor |
| Weight | 1.5 pounds | 4.5 pounds | 7 pounds | 1.1 pounds | 1.1 pounds |

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Name of Company: Limerick Inc. Name of Sompany - 510(k) # K051926 Premarket Notification = 516(K) # Roo Fortable Electric Breast Pump

EXHIBIT #1 Page 4 of 4

#### Conclusions: 6.

Limerick pj's comfort jr Portable Electric Breast Pump has the same intended
ited in the same in and comfort the pile comfort ® Portable Flectric Limerick pj's comfort Jr Portable Liection Droad Portable Electric
use, similar design and technology as the pj's comfort ® Portable Electric use, similar design and technology as the Ameda Expresse and Premier.
Breast Pump, the Medela Pump In Style, and the Ameda Expresse and Premier.
Breast Pump, the Medela Pump Breast Pump, the Medela Puinp in Style, and testing data, Limerick pi's
As our comparison chart indicates, as well as our testing data, Limetick pit safet As our comparison chart moreales, as well as our con and , and , and , and , and comfort jr® Portable Elective Breast forms and reviews , Limerick pirs
effectiveness. Thus, when compared to the predicated devices, Limench pic effectiveness. Thus, when continued to the production cornorate any significant
comfort jr ® Portable Electric Breast Pump does normation mestage of that could comfort jr ® Portable Electric Breast Fump doos new most
changes in intended use, method or operation, material or design that could affect safety or effectiveness.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2005

Mr. Paul Krumm Director of Regulatory Affairs Limerick, Inc. 1313-23Td Road KANOPOLIS KS 67454

Re: K051926 Trade/Device Name: pj's comfort jr® Portable Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: November 20, 2005 Received: November 22, 2005

Dear Mr. Krumm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your section 910(x) prehemially equivalent (for the indications for use stated in above and nave decemined the act redicate devices marketed in interstate commerce prior to the enclosure) to tegary mankeled prodical Device Amendments, or to devices that have been May 26, 1970, the clacinent date of the Federal Food, Drug, and Cosmetic Act (Act) that If classified in accondatice with the proval application (PMA). You may, therefore, market the do not require approval of a prematics approval spfth Act. The general controls provisions of the Act device, subject to the general controls provided to the severes, 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 (Premarket IT your device is clasified (366 above) hitional controls. Existing major regulations affecting your Approval), it may be subject to satinaderal 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 Flease be advised mar 1271 s tobailed on the vice complies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all r curral statues and regulations adminissited to registration and listing (21 CFR Part 807); labeling ACT STEQuirements metading bactive practice requirements as set forth in the quality systems (QS) (21 CT K F art 801); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k)
10 leval This letter will allow you to ochinations your and convalence of your device to a legally
premarket notification. The FDA finding of substantial course and thus, permits you premarket notification. The FDA Inding of Sabsantial of 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 If you desire specific advice for your device on our leasing organisms.
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "forsonation on your responsibilities under the Act from the 807.97). You may obtain other general information of Jour Peopleter
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) Division of 201) 443-6597 or at its Internet address

058-2041 Of (2017)v/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brigdon

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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Name of Company: Limerick Inc. Name of Osmplication – 510(k) Premarket Notification = 5 ro(K)
Name of Device: pj's comfort jr ® Portable Electric Breast Pump

EXHIBIT B

# INDICATIONS FOR USE

KOG1926 510(K) Number:

pj's comfort jr ® Portable Electric Breast Pump Device Name:

Indication for Use:

The intended use of the electrically powered suction The intended use of the Srounday (1) (1) (1) device is to lactating women.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | or | Over-the-Counter Use | X |
|----------------------|----|----------------------|---|
| (Per 21 CFR 801.109) | | | |

Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and

Radiological Devices

| 510(k) Number | K051926 |
|---------------|---------|
|---------------|---------|

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