pj.s comfort® Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm unity oontaine a clapmelling a filter, soft silicone tube and plastic tubing. An accessory kit includes silicone breast cups and a collection cup. The device is battery and line-powered for 12V DC by an external transformer or utilizes a 12V-battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The bacterial filter contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the bacterial. The pump can be used with the Single Breast Pump Kit #6166-3 or the Double Breast Pump Kit #6166-0. Dimensions are 7 x 12 x 3 .5 inches and the weight is 4.5 lbs. Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the bacterial filter, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. The bacterial filter should be changed regularly.

AI/ML Overview

Here's an analysis of the provided information, focusing on the acceptance criteria and study details for the pj.s comfort® Portable Electric Breast Pump:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in the traditional sense of specific performance metrics or thresholds. Instead, the approach taken is a demonstration of substantial equivalence to predicate devices. This means the device is considered acceptable if it performs similarly to, and raises no new safety or effectiveness concerns compared to, established devices already legally marketed.

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the device's characteristics and performance are comparable to the identified predicate devices: White River Portable Electric Breast Pump (K#850705) and Luxmatic 12-15 ISC Portable Electric Breast Pump (K#971543).

Here's a table based on the comparison provided in the 510(k) summary, which outlines the similarities and differences, implicitly forming the basis for acceptance:

Parameter	Predicate Device (White River/Luxmatic) Performance (implicitly "Acceptance Criteria")	pj.s comfort® Performance (Reported Device Performance)	Notes on Equivalence/Difference
Pump Type	Diaphragm	Diaphragm	Same
Vacuum Control Cycle	Yes	Yes	Same
Adjustable Suction Range	Not available (White River) / 150-220 mm Hg (Luxmatic)	150-220 mm Hg	Equivalent to Luxmatic, improved on White River
Vacuum Gauge	Yes	Yes	Same
Bacteria Filter	Not available (White River) / Yes (Luxmatic)	Yes	Equivalent to Luxmatic, improved on White River
Collection Bottles	Yes	Yes	Same
Single Patient Use	Yes	Yes	Same
Indications For Use	To express milk from the breast	To express milk from the breast	Same
Timer	Not available	Yes	New Feature, considered not raising new safety/effectiveness questions
Weight	10 lbs. (White River) / 4.5 lbs. (Luxmatic)	4.5 lbs.	Equivalent to Luxmatic, lighter than White River

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This submission is for a medical device (breast pump) and does not involve clinical data with a "test set" in the context of biological data or performance against a specific disease. The "testing" referred to is non-clinical engineering and materials testing.
Data Provenance: The "testing information" referenced for safety and effectiveness was "conducted in accordance with the FDA November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions', DCRND, which outlined Electrical, Mechanical and Environmental Performance Requirements." This indicates the data is likely prospective as it was generated specifically for this submission, following FDA guidance for non-clinical testing. The country of origin for the data is implicitly the United States, as it's a US company submitting to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this device does not involve a diagnostic or prognostic claim that requires expert interpretation of images or patient data, "ground truth" established by experts in a clinical sense is not relevant. The "truth" here is established by engineering and materials science standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication.

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

Not applicable. This device is a breast pump, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device does not involve an algorithm with standalone performance.

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

The "ground truth" for this device's performance is based on engineering standards and material science specifications. This includes:
- Demonstrating the pump's electrical, mechanical, and environmental performance meets established safety and functionality requirements.
- Confirming that patient-contacting materials (breast cups, milk-contacting internal parts) comply with 21 CFR Parts 176, 177, and 178 for materials approved for food contact.

8. The sample size for the training set

Not applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set."

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

Not applicable. There is no training set for this device.

Summary

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JAN 0 7 2002

Name of Company: Limerick Inc. Premarket Notification - 510(k) r remantel Notification - Scomfort® Portable Electric Breast Pump

EXHIBIT #1 Page 1 Of 3

510(K) SUMMARY

This summary of 510 (k) safety and effectiveness information is being submitted This summary of of of to (k) oursty and 21 CFR §807.92.

The assigned 510(k) number is: _150120 צו 201201

Submitter's Identification: 1.
Limerick Inc. 903 North San Fernando Blvd., Suite 5 Burbank, California 91504

Date Summary Prepared: March 27, 2001

Name of the Device: 2.

pi·s comfort® Portable Electric Breast Pump

Predicate Devices Information: 3.

K#850705, White River Portable Electric Breast Pump, White Rive, Division of Natural Technologies, Inc.

K971543, Luxmatic 12-15 ISC Portable electric Breast Pump, KaWeCo GmbH

Device Description: র্ব .

pirs comfort® Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm unity oontaine a clapmelling a filter, soft silicone tube and plastic tubing. An accessory kit includes silicone breast cups and a collection cup. The device is battery and line-powered for 12V DC by an external transformer or utilizes a 12V-battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The bacterial filter contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the bacterial. The pump can be used with the Single Breast Pump Kit #6166-3 or the Double Breast Pump Kit #6166-0. Dimensions are 7 x 12 x 3 .5 inches and the weight is 4.5 lbs.

{1}------------------------------------------------

K012275

Name of Company: Limerick Inc. Premarket Notification - 510(k) Name of Devise: The pj•scomfort® Portable Electric Breast Pump

EXHIBIT #1 Page 2 of 3

Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the bacterial filter, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. The bacterial filter should be changed regularly.

5. 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 pj.s comfort® Portable Electric Breast Pump, White River Portable Electric Breast Pump and Luxmatic 12-15 ISC Portable Electric Breast Pump:

PARAMETER	pj's comfort	WHITE RIVER (K#850705)	LUXMATIC (K#971543)
Pump Type	Diaphragm	Same	Same
Vacuum Control Cycle	Yes	Same	Same
Adjustable Suction Range	150-220 mm Hg	Not available	Same
Vacuum Gauge	Yes	Same	Same
Bacteria Filter	Yes	Not available	Same
Collection Bottles	Yes	Same	Same
Single Patient Use	Yes	Same	Same
Indications For Use	Same	Same	Same
Timer	Yes	Not available	Not available
Weight	4.5 lbs.	10 lbs.	4.5 lbs.

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KO12275

Name of Company: Limerick Inc. Premarket Notification - 510(k) Name of Devise: The pj•scomfort® Portable Electric Breast Pump

EXHIBIT #1 Page 3 of 3

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence is as follows:

Testing information demonstrating safety and effectiveness of the pj•s comfort® a) Portable Electric Breast Pump in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlined Electrical, Mechanical and Environmental Performance Requirements.
Patient-contacting material includes both skin contacted material (breast cups) b) and milk contacting materials. 21 CFR Parts 176, 177 and 178 were reviewed in order to ascertain materials approved for food contact. Materials are approved for food contact.

Discussion of Clinical Tests Performed: 8.

Non-Applicable

9. Conclusions:

The pirs comfort® Portable Electric Breast Pump has the same intended use, similar design and technology as the White River Portable Electric Breast Pump and the Luxmatic 12-15 ISC Portable Electric Breast Pump. As our comparison chart indicates, as well as our testing data, the pjrs comfort® Portable Electric Breast Pump raises no new questions of safety or effectiveness. Thus, when compared to the predicated device, the pj.s comfort® Portable Electric Breast Pump 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 logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three wavy lines that resemble a caduceus, a symbol often associated with healthcare.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 7 2002

Ms. Patricia A. Kelly President Limerick, Inc. 903 N. San Fernando Boulevard Suite 5 BURBANK CA 91504-4327

Re: K012275 Trade/Device Name: pj.s comfort® Portable Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: November 9, 2001 Received: November 13, 2001

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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Name of Company: Limerick Inc. Namo of Golmpacation - 510(k) 0 122 25 Name of Devise: The pj.scomfort® Portable Electric Breast Pump

EXHIBIT B

INDICATIONS FOR USE

510(K) Number:

1012275

The pj•scomfort® Portable Electric Breast Pump Device Name:

The intended use of the electrically powered (diaphragm-Indication for Use: type) suction device is to express milk from the breast of 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	K012275
---------------	---------

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).