The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user.

Device Description

The Powered Breast Pump provides the option of pumping on one breast or on both breasts at the same time. The Powered Breast Pump can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle-mode and suction level. The Powered Breast Pump is capable of providing vacuum levels from 75 to 220 mmHg with 3 different cycle modes. Mothers are able to choose the most comfortable / preferred vacuum level and cyclemode.

AI/ML Overview

This is a device for a powered breast pump. The provided content indicates that this is a Special 510(k) submission for modifications to a previously cleared breast pump, primarily to cycle speeds and suction settings to enhance user comfort.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly state "acceptance criteria" for the performance tests in a quantitative manner. Instead, it states that the tests were conducted to ensure "satisfactory performance" or to "illustrate substantial equivalence." The performance data is primarily presented as a comparison to the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Suction curves demonstrate substantial equivalence to predicate	Suction curves provided (details not explicitly given)
Satisfactory backflow performance	Backflow test conducted (details not explicitly given)
Validated cleaning instructions	Cleaning validation study conducted (details not explicitly given)

Device Comparison Details (from the table provided):

Feature	New Device (Powered Breast Pump)	Predicate Device (Affinity Double Electric Breast Pump)
Suction Levels (stimulation)	55 - 140 mmHg	50 - 150 mmHg
Cycles per Second (stimulation)	1.55 - 2.4	1.85 (fixed)
Suction Levels (expression)	80 - 220 mmHg	50 - 250 mmHg
Cycles per Second (expression)	0.61 - 1.52	0.51 - 1.0
Suction Settings	8	8
Power Supply	6 AA batteries, AC Adapter	6 AA batteries, AC Adapter
Pumping Option	Single or Double	Single or Double
Back Flow Protection	Yes	Yes
Let Down Function	Yes	Yes
Cycling/Suction Control Mechanism	Microprocessor	Microprocessor

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

The document mentions "Performance Testing" including "Suction Curves," "Back Flow Test," and "Cleaning Validation Study." However, it does not specify the sample sizes used for these tests. There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The performance tests described (suction curves, backflow, cleaning validation) are technical tests of the device's functionality rather than assessments requiring expert medical interpretation or "ground truth" derived from patient data.

4. Adjudication Method for the Test Set:

This information is not applicable or provided. The tests mentioned are objective engineering and validation tests, not clinical studies requiring adjudication of results based on expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted as this is a breast pump, not a diagnostic imaging device typically evaluated with such studies. The document focuses on demonstrating substantial equivalence to a predicate device through technical performance characteristics and intended use.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study, as typically understood for an algorithm or AI without human interaction, was not done. The "device" is a physical breast pump, and its performance is evaluated through its functional capabilities (suction, cycles, backflow protection).

7. Type of Ground Truth Used:

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) is not relevant for this breast pump submission. The performance assessment is based on physical and functional measurements and validation against pre-defined engineering or safety standards (e.g., suction curves, backflow prevention, cleaning effectiveness). The "ground truth" for these types of devices is their ability to perform their intended mechanical function within acceptable parameters.

8. Sample Size for the Training Set:

This information is not provided and is likely not applicable in the context of this device. A breast pump does not typically involve machine learning algorithms that require a "training set" of data in the sense that an AI diagnostic tool would.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided and is not applicable for the reasons stated in point 8.

Summary

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K122474
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Section 5: 510(k) Summary

DEC 2 8 2012

Applicant: Lansinoh Laboratories Saglik Gerecleri San. Tic. Ltd. Sti. 10006 sokak, No:64 A.O.S.B. Cigli - Izmir 35620 TURKIYE Tel: 0090 232 328 05 56/57 Fax: 0090 232 328 05 58 www.lansinoh.com.tr Attn: Halit Cahit Üstündağ

Contact: Calley Herzog Biologics Consulting Group, Inc. 13417 Quivas St. Westminster, CO 80234 Ph. 720-883-3633 Fax. 720-293-0014

Date Summary Prepared:	10/10/12
Proprietary Name:	Lansinoh Powered Breast Pump
Common Name:	Powered Breast Pump
Regulatory Class:	Class II
Product Codes:	HGX
Predicate Device(s):	K092783 - Affinity Breast Pump, Lansinoh Laboratories SaglikGerecleri Tasarim San. Tic. Ltd. Sti.

Device Description: The Powered Breast Pump provides the option of pumping on one breast or on both breasts at the same time. The Powered Breast Pump can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle-mode and suction level. The Powered Breast Pump is capable of providing vacuum levels from 75 to 220 mmHg with 3 different cycle modes. Mothers are able to choose the most comfortable / preferred vacuum level and cyclemode.

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K122474
page 2 of 3

The purpose of this Special 510(k) is for modifications to the previously cleared breast pump. The modifications are made to the cycle speeds and suction settings of the pump to create more comfortable settings for the nursing mother.

Intended Use: The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user.

Performance Testing:

l) Suction Curves suction curves are provided to illustrate that the performance of the Powered Breast Pump is substantially equivalent to the predicate device.
1. Back Flow Test Additionally a backflow test was conducted to ensure satisfactory performance of the pump in the unlikely event that milk was to backflow into the pump unit.
1. Cleaning Validation Study A cleaning validation study was conducted to validate the recommended cleaning instructions for the device.

Substantial Equivalence: The Powered Breast Pump is substantially equivalent to the predicate device, in intended use, technological characteristics and device design. The table below provides a comparison of the Powered Breast Pump to the predicate device.

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K122474
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Device Comparison Table

	New Device	Predicate Device
Manufacturer	Lansinoh LaboratoriesSaglik Gerecleri Tasarim San.Tic. Ltd. Sti.	Lansinoh LaboratoriesSaglik Gerecleri Tasarim San.Tic. Ltd. Sti.
Device Name	Powered Breast Pump	Affinity Double ElectricBreast Pump (DEBP)
510(k) #	K122474	K092783
Intended Use	The Powered Breast Pump isintended to express and collectthe breast milk of a nursingwoman for the purpose offeeding the collected milk to ababy. The Powered BreastPump is intended for a singleuser.	The DEBP is intended toexpress and collect the breastmilk of a nursing woman forthe purpose of feeding thecollected milk to a baby.
Suction Levels(stimulation)	55 - 140 mmHg	50 - 150 mmHg
Cycles per Second(stimulation)	1.55 - 2.4	1.85 (fixed)
Suction Levels(expression)	80 - 220 mmHg	50 - 250 mmHg
Cycles per Second(expression)	0.61 - 1.52	0.51 - 1.0
Suction Settings	8	8
Power Supply	a) 6 AA alkaline batteriesb) AC Adapter	a) 6 AA alkaline batteriesb) AC Adapter
Pumping Option	Single or Double	Single or Double
Back Flow Protection	Yes	Yes
Let Down Function	Yes	Yes
Cycling/Suction ControlMechanism	Microprocessor	Microprocessor

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human figures in profile, stacked on top of each other, with their arms outstretched.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 28, 2012

Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti. % Ms. Calley Herzog Consultant Biologics Consulting Group, Inc. 13417 Quivas Street WESTMINSTER CO 80234

Re: K122474

Trade/Device Name: Powered Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: November 30, 2012 Received: December 3, 2012

Dear Ms. Herzog:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address .

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Herbert R. Lerner

Acting Director for: Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Powered Breast Pump

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner

tive, Gastro-Renal, and

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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).