This portable electric breast pump model 1002 is powered by a variable speed DC motor that drives a diaphragm pump. The diaphragm pump creates the negative pressure reguired to extract breast milk. This pump has variable speed cycling rates, which is controlled by a knob located on the control panel. The breast pump is capable of providing multiple vacuum levels, which are user selectable by use of a knob located on the front panel. A maximum vacuum of 250-mm Hg. is applied to one or both breast through a disposable filter that is connected by way of flexible tubing to the breast cup(s).

It can be operated by use of either an AC/DC wall converter or a 12-Volt battery.

All materials used in the manufacturing of this device that has contact with food or human tissue meet requirement of the FDA and international regulations concerning food contact and/or biocompatability.

AI/ML Overview

The provided text is a 510(k) summary for the Limerick Portable Electric Breast Pump Model 1002. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where specific acceptance criteria are defined and then proven by the device's performance through a rigorous study. Therefore, the requested information elements related to such a study are not available in the provided text.

Specifically, the document states: "As our comparison chart indicates, as well as our testing data, Limerick Portable Electric Breast Pump Model 1002 raises no new questions of safety or effectiveness." This implies that internal testing was conducted to ensure the device's performance aligns with its intended use and safety profile, similar to its predicates. However, the details of this "testing data" are not provided.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or a table of device performance against such criteria are provided in the document. The document's closest equivalent is a comparison table that outlines the characteristics of the proposed device against predicate devices.

Characteristics	Proposed Device (Limerick Portable Electric Breast Pump Model 1002)	Predicate Devices (Medela Pump In Style, Ameda/Egnell Expresse, Ameda/Egnell Premier)
Intended Use	As described in 21 CFR 884.5160	As described in 21 CFR 884.5160
Suction Levels	20-240 mm Hg.	80-240 mm Hg. (Medela), <100-265 mbar (Ameda/Egnell)
Suction Cycle	20-50 cycles per minute	48 per minute (Medela), 30-60 cycles per minute (Ameda/Egnell)
Filter between kit and pump	Yes	No
Power Supply	Rechargeable NiMH battery, AC adapter, 12 V adapter	Rechargeable battery, AC adapter, 12 V adapter (varies by predicate model)
Cycle/Suction Control mechanism	Mechanical cycling suction regulator	Mechanical cycling suction regulator (Medela), Microprocessor (Ameda/Egnell)
Weight	5.5 pounds	7 pounds (Medela), 1.1 pounds (Ameda/Egnell)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "testing data" but does not detail the specifics of any test set, its sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the document does not describe a study involving expert-established ground truth for a test set. This type of detail is typical for diagnostic algorithms, not for physical medical devices of this nature.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. This is not relevant for the type of device and submission described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CAD devices, not for a breast pump.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

A standalone algorithm performance study was not done. This is not applicable to a physical device without an AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" in the context of diagnostic performance is not applicable or provided for this device. The demonstration of safety and effectiveness relies on comparison to predicate devices, material biocompatibility, and functional testing (referred to only as "testing data" without details).

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not provided. This is not applicable to the device described.

Summary

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Name of Company: Limerick Inc. Premarket Notification - 510(k) Name of Devise: Portable Electric Breast Pump Model 1002

EXHIBIT #1 Page 1 Of 3

510(K) SUMMARY

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

The assigned 510(k) number is: KD21739

1. Submitter's Identification:

Limerick Inc. 903 North San Fernando Blvd., Suite 5 Burbank, California 91504

Date Summary Prepared: April 25, 20002

2. Name of the Device:

Portable Electric Breast Pump Model 1002

3. Predicate Devices Information:

Medela Pump In Style Breast Pump (510 (k) not known) Ameda Egnell Expresse and Premier Powered Breast pump K973501

4. Device Description:

It can be operated by use of either an AC/DC wall converter or a 12-Volt battery.

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Name of Company: Limerick Inc. Premarket Notification - 510(k) Name of Devise: Portable Electric Breast Pump Model 1002 EXHIBIT #1 Page 2 of 3

ર. Intended Use:

The intended use of the electrically powered (diaphragm-type) suction device is to express milk from the breast.

Comparison to Predicate Devices: 6.

Table of Comparison to Legally Marketed Device:

The following is a comparison chart outlining differences and similarities between Limerick Portable Electric Breast Pump Model 1002, Medela Pump In Style, the Expresse and Premier .:

	Proposed Device		Predicate Devices
Characteristics	Limerick PortableElectric BreastPump Model 1002	Medela Pump InStyle-K unknown	Ameda/EgnellExpresseK973501	Ameda/EgnellPremierK973501
Intended Use	As described in 21CFR 884.5160	As described in 21CFR 884.5160	As described in 21CFR 884.5160	As described in 21CFR 884.5160
Suction Levels	20-240 mm Hg.	80-240 mm Hg.	<100-265mbar	<100-265mbar
Suction Cycle	20-50 cycles perminute	48 per minute	30-60 cycles perminute	30-60 cycles perminute
Filter betweenkit and pump	a) yes	a) No	a) No	a) No
Power Supply	b) rechargeableNiMH batteryc) AC adapterd) 12 V adapter foruse in motorvehicle	b) rechargeablebatteryc) AC adapterd) 12 V adapterfor use inmotor vehicle	b) rechargeableNiCdbatteriesc) 5 AA alkalineBatteriesd) AC Adaptere) 12V adapterfor use inmotor vehicle	b) rechargeableNiCdbatteriesc) 5 AA alkalinebatteriesd) AC adaptere) 12V adapterfor use in amotor vehicle
Cycle/SuctionControlmechanism	Mechanical cyclingsuction regulator	Mechanicalcycling suctionregulator	Microprocessor	Microprocessor
Weight	5.5 pounds	7 pounds	1.1 pounds	1.1 pounds

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Name of Company: Limerick Inc. Premarket Notification - 510(k) Name of Devise: Portable Electric Breast Pump Model 1002

EXHIBIT #1 Page 3 of 3

7. Conclusions:

Limerick Portable Electric Breast Pump Model 1002 has the same intended use, similar design and technology as the Medela Pump In Style, Expresse and Premier. As our comparison chart indicates, as well as our testing data, Limerick Portable Electric Breast Pump Model 1002 raises no new questions of safety or effectiveness. Thus, when compared to the predicated device, Limerick Portable Electric Breast Pump Model 1002 does not incorporate any significant changes in intended use, method or operation, material or design that could affect safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

JAN 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia A. Kelly President Limerick 903 N. San Fernando Blvd. Suite 5 BURBANK CA 91504-4327 Re: K021739

Trade/Device Name: Limerick's Portable Electric Breast Pump, Model 1002 Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: September 16, 2002 Received: November 15, 2002

Dear Ms. Kelly:

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 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 C. 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) Name of Devise: Portable Electric Breast Pump model 1002

EXHIBIT B

INDICATIONS FOR USE

510(K) Number: Ko21739

Portable Electric Breast Pump model 1002 Device Name:
Indication for Use: The intended use of the electrically powered (diaphragmtype) suction device is to express milk from the breast of lactating women.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109),

X Over-the-Counter Use_

Thinh La Nguyen

(Divi Division of Reproductive and Radiological Devic 510(k) Num

Regulation Number and Section

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).