The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 4 major assemblies: a pump assembly, a breast cup assembly, a carry bag, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 5 pre-set suction levels and 5 pre-set speed settings, which are selectable by the user via a button pad. The device is powered by a 12V DC power supply, which is included with the package.

AI/ML Overview

Here's an analysis of the provided text regarding the Playtex Breast Pump (K022594), addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for the Playtex Breast Pump (K022594) does not outline explicit acceptance criteria or report specific device performance metrics in the way one would expect for a diagnostic or AI device (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence for this medical device (a breast pump) is primarily demonstrated through comparison to predicate devices and adherence to material safety standards.

However, based on the comparative table, we can infer some "performance" characteristics relative to the predicate devices:

Characteristic	Acceptance Criteria (Inferred from Predicate Devices)	Reported Playtex Breast Pump Performance
Intended Use	To express milk from the breast of lactating women.	To express milk from the breast of lactating women.
Highest Vacuum Setting	Within range of predicate devices (e.g., 6.7 - 9.8 in Hg)	9.0 in Hg
Lowest Vacuum Setting	Within range of predicate devices (e.g., 0.0 - 3.7 in Hg)	2.5 in Hg
Range of Cycle Speeds	Within range of predicate devices (e.g., 29 - 60 cycles/min for adjustable, 49 for fixed)	45 - 75 cycles/min
Power Source	DC Power Supply (some predicates also offer batteries)	DC Power Supply
Pump Type	Reciprocating Piston or Diaphragm	Reciprocating Piston
Single or Double Pumping	Both	Both
Adjustable Suction Levels	Yes	Yes
Adjustable Cycle Speed	Yes (most, but not all predicates)	Yes
Overflow Protection	Yes (most, but not all predicates)	Yes
Breast Cup-to-Breast Interface	Rigid Plastic (some with partial silicone)	Soft Silicone (difference highlighted as a feature)
Active Breast Massage	No (for predicate devices)	Yes (difference highlighted as a feature)
Hospital Grade System	Yes (some predicates)	Yes
Usable on Tabletop or Inside Bag	Tabletop (some predicates), Inside (one predicate)	Both
Material Safety	All milk and human contact components manufactured from FDA food additive compliant materials.	All milk and human contact components meet FDA food additive criteria (21 CFR Parts 176, 177, 178). Silicone breast cup insert tested for biocompatibility.
Functionality	Provides sufficient vacuum pressure to effectively express and collect milk.	"provides sufficient vacuum pressure to effectively express and collect milk from lactating women." (Conclusion)

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

The 510(k) summary explicitly states:

"No clinical tests have been conducted on this device."
"Testing of the device has demonstrated that the Playtex breast pump meets established requirements when used in the manner and environment specified in product labeling."

Therefore, there was no "test set" in the context of clinical studies with human subjects or a dataset for algorithm evaluation. The testing mentioned refers to non-clinical, likely engineering or bench testing, to confirm specifications and material compliance.

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

Not applicable. As no clinical tests or data-driven evaluations were performed for a "test set," no experts were used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or clinical evaluation requiring adjudication was 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

Not applicable. This device is a breast pump, not an AI-powered diagnostic or interpretive system that would involve human "readers" or an MRMC study.

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

Not applicable. This device is a mechanical breast pump and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's approval is primarily established through:

Predicate Device Comparison: The functional and performance characteristics (vacuum, cycle speeds, etc.) are deemed acceptable by virtue of being comparable to, or within the established range of, legally marketed predicate breast pumps.
Material Science and Biocompatibility Standards: Compliance with FDA food additive criteria and biocompatibility testing for human contact components serves as a "ground truth" for safety.
Engineering Specifications: The "testing of the device" mentioned in the non-clinical tests section implies verification against internal engineering specifications.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI or machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML model, no ground truth was established in this manner.

Summary of Approach for this Device:

The 510(k) clearance for the Playtex Breast Pump relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This approach primarily involves:

Comparing the new device's intended use, technological characteristics, and performance specifications to predicate devices.
Ensuring material safety and biocompatibility through standard testing and compliance with regulations.
Verifying that non-clinical tests (likely engineering/bench testing) confirm the device meets established requirements.

The submission explicitly states that "No clinical tests have been conducted on this device," which is common for devices seeking 510(k) clearance where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.

Summary

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Premarket Notification 510(k) Playtex® Breast Pump Playtex Products, Inc.

K022594

Playtex

Technical Center 75 Commerce Drive Allendale, New Jersey 07401-1600 201 785-8000

Playtex Products, Inc.

510(k) Summary of Safety and Effectiveness

July 9, 2002

Submitter:	Playtex Products, Inc.75 Commerce DriveAllendale, NJ 07401Phone: 201-785-8000
Contact Name:	Dr. Paul A. SiracusaSenior Vice President, Research & Development
Trade name:	Playtex Breast Pump
Common name:	Powered Breast Pump for Mother's Milk
Classification name:	Powered Breast Pump, 21 CFR 884.5160 (85 HGX) Class II
	Substantial Equivalence: Playtex Breast Pump is substantially equivalent to the followingcurrently marketed breast pumps:
Company	Product Name	510(k) Clearance Number
Ameda EqnellAmeda EgnellMedela	Express and PremierElitePump-in-Style.	K973501 K950531 K950750

General Description:

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Design and Materials:

All milk and human contact components are manufactured from materials that meets FDA food additive criteria as set forth in Part 21 Code of Federal Regulations Parts 176, 177 and 178. In addition, the silicone breast cup insert has been tested for biocompatibility per established guidelines.

Intended Use:

The intended use of the Playtex Breast Pump is to express milk from the breast of lactating women.

Comparison to Predicate Devices

The following is a chart showing the similarities and differences between the Playtex Breast Pump and the Predicate Devices:

	PlaytexBreast Pump	Medela Pump-in-Style	Ameda PurelyYours	Ameda Elite
510(k) Number	N/A	K950750	K973501	K950531
Intended Use	To ExpressMilk	To Express Milk	To Express Milk	To ExpressMilk
Power Source	DC PowerSupply	DC PowerSupply	DC Power Supplyor 6 AA Batteries	DC PowerSupply
Pump Type	ReciprocatingPiston	ReciprocatingDiaphragm	ReciprocatingPiston	ReciprocatingPiston
Single or Double Pumping	Both	Both	Both	Both
Adjustable Suction Levels	Yes	Yes	Yes	Yes
Adjustable Cycle Speed	Yes	No	Yes	Yes
Overflow Protection	Yes	No	Yes	Yes
Highest Vacuum Setting (inHg)	9.0	7.3	6.7	9.8
Lowest Vacuum Setting (inHg)	2.5	3.7	1.2	0.0
Range of Cycle Speeds(Cycles/min)	75 - 45	49	60 - 29	60 - 30
Breast Cup-to-BreastInterface	Soft Silicone	Rigid Plastic	Rigid Plastic(partial siliconecovering avail.)	Rigid Plastic
Active Breast Massage	Yes	No	No	No
Hospital Grade System	Yes	No	Yes	Yes
Usable on Tabletopor Inside Bag	Both	Inside	Tabletop	Tabletop

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KO22594 p.3

Discussion of Non-Clinical Tests:

Testing of the device has demonstrated that the Playtex breast pump meets established requirements when used in the manner and environment specified in product labeling.

Discussion of Clinical Tests Performed:

No clinical tests have been conducted on this device.

Conclusion:

In conclusion, the Playtex Breast Pump is substantially equivalent to its predicate devices. Based upon the test data submitted, the device provides sufficient vacuum pressure to effectively express and collect milk from lactating women.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2002

Paul A. Siracusa, D. En. Sc. Senior Vice President Research and Development Playtex Products, Inc. 75 Commerce Drive ALLENDALE NJ 07401

Re: · K022594

Trade/Device Name: Playtex Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: 85 HGX Dated: July 26, 2002 Received: August 5, 2002

Dear Dr. Siracusa:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour 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 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) Playtex® Breast Pump Playtex Products, Inc. March 22, 2002

Indications for Use Statement

Applicant:	Playtex Products, Inc.
510(k) Number (if known):	KC22544
Device Name:	Playtex® Breast Pump
Indications for Use:	An electrically powered breast pump used to expressmilk from the breast of a lactating woman.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use or

(Optional format 1-26-99)

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David M. Simpson

(Division Sign-C Division of Repro and Radio 510(k) Nun

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).