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 3 major assemblies: a pump assembly, a breast cup assembly, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 1 pre-set speed level and 3 pre-set suction setings, which are selectable by the user via a rotating dial. The device is powered by a 12V DC power supply, which is included with the package.

AI/ML Overview

The provided document is a 510(k) summary for the Playtex Embrace Petite Double Electric Breast Pump. It focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a study proving device performance against those criteria, or details regarding algorithm-based device performance.

Therefore, I cannot provide the requested information from the given text. The document explicitly states:

"No clinical tests have been conducted on this device." This directly addresses and negates the possibility of finding information related to clinical studies, acceptance criteria for such studies, sample sizes, ground truth establishment, or expert evaluations.
The "Discussion of Non-Clinical Tests" section only states that "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." It does not provide details about what those "established requirements" (acceptance criteria) are, nor the specific results of those tests. The only performance data given are vacuum settings and cycle speeds, which are presented as a comparison to predicate devices, not as criteria against which the device was tested.

In summary, the provided text does not contain the information needed to answer your request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by your questions 2-9.

Summary

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AUG 1 2006

Playtex

K061013

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

Playtex Products, Inc.

510(k) Summary of Safety and Effectiveness

March 27, 2006

Submitter:

Playtex Products, Inc. 75 Commerce Drive Allendale, NJ 07401 Phone: 201-785-8000

Contact Name:	Karin JordanSenior Regulatory Affairs and Compliance Manager
Trade name:	Playtex Embrace Petite Double Electric 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
Playtex Products, Inc.Ameda EgnellMedela	EmbraceElitePump-in-Style	K022594 K950531 K950750

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Kobe013

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. These items have been previously approved under 510(k) #K022594.

Intended Use:

The intended use of the Playtex Embrace Petite 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:

	PlaytexEmbracePetite BreastPump	PlaytexEmbraceBreast Pump	Medela Pump-in-Style	Ameda PurelyYours
510(k) Number	N/A	K022594	K950750	K973501
Intended Use	To ExpressMilk	To ExpressMilk	To Express Milk	To Express Milk
Power Source	DC PowerSupply	DC PowerSupply	DC PowerSupply	DC Power Supplyor 6 AA Batteries
Pump Type	ReciprocatingPiston	ReciprocatingPiston	ReciprocatingDiaphragm	ReciprocatingPiston
Single or Double Pumping	Both	Both	Both	Both
Adjustable Suction Levels	Yes	Yes	Yes	Yes
Adjustable Cycle Speed	No	Yes	Yes	Yes
Overflow Protection	Yes	Yes	No	Yes
Highest Vacuum Setting (inHg)	8.4	9.0	7.2	6.4
Lowest Vacuum Setting (inHg)	2.8	3.1	3.8	0.8
Range of Cycle Speeds(Cycles/min)	45	57-40	66-41	67-29
Breast Cup-to-Breast Interface	Soft Silicone	Soft Silicone	Rigid Plastic	Rigid Plastic(partial siliconecovering avail.)
Active Breast Massage	Yes	Yes	No	No

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.

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Discussion of Clinical Tests Performed:

No clinical tests have been conducted on this device.

Conclusion:

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

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Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird with three curved lines forming its body and wings. The overall design is simple and conveys a sense of official authority.

Food and Drug Administration 9200 Corporate Blyd. Rockville MD 20850

AUG 1 5 2006

Ms. Karin E. Jordan Senior Regulatory Affairs and Compliance Manager Playtex Products, Inc. 75 Commerce Drive ALLENDALE NJ 07401

Re: K061013

Trade/Device Name: Playtex® Petite Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: July 6, 2006 Received: July 7, 2006

Dear Ms. Jordan:

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 (Premarket Approval), 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.

Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is a large "FDA" in bold letters. Underneath "FDA" is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of our device complies with other requirements of the Act that IDA has made a delerimiation administered by other Federal agencies. You must or ally if edelal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, more 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 801), good manager and 820); and f applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) I his letter will anow you to ocgin manceing your antial equivalence of your device to a legally premarket nothleadon: "The PDF Intellig of easing 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 If you desire specific article for your do 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" Also, prease note the regulation chared, information on your responsibilities under (21CFK Fall 807.97). 10d may other generalisms and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.litml.

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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Indications for Use Statement

Page 1 of 1

Applicant:	Playtex Products, Inc.
510(k) Number (if known):	K061013
Device Name:	Playtex® Petite Breast Pump
Indications for Use:	An electrically powered breast pump used to express milk 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

(Optional format 1-26-99)

Nancy C. Brogdon

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

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).