HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) by PHILIPS ELECTRONICS UK LIMITED

The Philips Avent Manual Breast Pump expresses and collects milk from the breast of a lactating woman. The device is designed to be reusable by a single user. The pump diaphragm is activated by a manual pivoting handle. The duckbill valve closes to prevent backflow and seal the device under negative pressure as the handle is depressed. The valve then relaxes to allow milk flow into the bottle between pump actuations. Pumping can only be performed on one breast at a time. The vacuum level can be adjusted to comfort by varying the speed and travel of the manual handle. The device is comprised of the manual breast pump parts and feeding bottle. The Philips Avent Manual Breast Pump operates in one mode - manual. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

AI/ML Overview

This document is a 510(k) summary for the Philips Avent Manual Breast Pump, seeking to establish substantial equivalence to predicate devices. The study conducted is a performance test comparing the subject device to existing predicate devices, focusing on vacuum pressure levels.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Philips Avent Manual Breast Pump)
Maximum pressure under normal use should be comparable to predicate devices and generally fall within approximately -240 to -300 mmHg. (Inferred from predicate device performance.)	Average: -249 mmHg; Top Outlier: -258.9 mmHg
Maximum pressure under worse-case use should not exceed 350 mmHg. (Stated directly.)	Average: -328 mmHg; Top Outlier: -338.8 mmHg
Biocompatibility: Materials should not be cytotoxic, irritating, or a dermal sensitizer.	Not cytotoxic, irritating, or a dermal sensitizer

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

Sample Size:
- For vacuum pressure testing: Not explicitly stated as a number of devices tested, but it mentions "All devices were tested" for the subject device and the two predicate devices. This implies at least one of each device was tested, but more details like replicates are not provided.
- For biocompatibility: Not specified in terms of sample size of materials or tests.
Data Provenance: The document does not specify the country of origin for the data. The study appears to be a prospective performance test specifically conducted for this 510(k) submission, comparing the new device against existing ones under controlled conditions.

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

This information is not applicable. This study is a technical performance test (measuring vacuum pressure and biocompatibility), not a study requiring expert interpretation of diagnostic images or clinical outcomes to establish ground truth. The "ground truth" here is the physical measurement of pressure and the results of standardized biocompatibility tests.

4. Adjudication Method for the Test Set

This information is not applicable. As this is a technical performance test rather than a clinical trial requiring subjective assessments, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a manual breast pump, and the study focuses on its physical performance characteristics (vacuum pressure and biocompatibility) compared to predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable. This device is a physical, non-electronic medical device (a manual breast pump) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

Vacuum Pressure: The ground truth used was direct physical measurement of vacuum pressure (in mmHg) under specified operating conditions (recommended use and worse-case use).
Biocompatibility: The ground truth was established by standardized laboratory tests for cytotoxicity, irritation, and dermal sensitization, which provide objective results based on established protocols (e.g., ISO10993).

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML device, so there is no training set in the typical sense.

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

This information is not applicable. As there is no training set, there is no ground truth established for one.

Summary

{0}------------------------------------------------

K101538

NOV - 5 2010 .

510(k) SUMMARY

510(k) Owner:	Contact:	Diana Korda HewittApprobation and Regulatory ManagerPhilips Consumer LifestylePhilips AventARCC, Pampisford RoadGreat Abington, CambridgeU.K.
	Phone:	+44 (0) 1787 267069
	Fax:	+44 (0) 1223 894635
	E-mail:	diana.korda.hewitt@philips.com
Date SummaryPrepared:	June 2, 2010
Device:	Trade Name:	Common/Classification Name:	Philips Avent Manual Breast PumpNonpowered Breast Pump
	Device Classification:		Class I
	Product Code:		HGY
	Classification Regulation:		21 C.F.R. § 884.5150
Predicate Devices:	Ameda Hand Breast Pump (K823591)ISIS IQ Uno Handheld Electronic Breast Pump, Model 101 (K052047)Medela Manual Breast Pump (K828340)
Device Description:	The Philips Avent Manual Breast Pump expresses and collects milk from the breast ofa lactating woman. The device is designed to be reusable by a single user. The pumpdiaphragm is activated by a manual pivoting handle. The duckbill valve closes toprevent backflow and seal the device under negative pressure as the handle isdepressed. The valve then relaxes to allow milk flow into the bottle between pumpactuations. Pumping can only be performed on one breast at a time. The vacuumlevel can be adjusted to comfort by varying the speed and travel of the manual handle.The device is comprised of the manual breast pump parts and feeding bottle.
	The Philips Avent Manual Breast Pump operates in one mode - manual. In themanual mode, the user controls the frequency and level of vacuum by varying thestroke/cycle of the control handle lever.
	All milk-contacting and human tissue-contacting components are manufactured frommaterials that meet the appropriate regulations regarding food contact and/orbiocompatibility.
Intended Use:	The Philips Avent Manual Breast Pump is intended to express and collect milk fromthe breasts of a lactating woman.

ﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ

く

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

TechnologicalCharacteristics:	The Philips Avent Manual Breast Pump is substantially equivalent to the predicatedevices with regard to intended use and technological characteristics. There are nonew questions of safety or effectiveness presented. All breast contacting materialsmeet biocompatibility regulations (ISO10993), and all milk contacting materials meetfood contact regulations.
BiocompatibilityData	Cytotoxicity, irritation, and dermal sensitization studies conducted on user-contactingmaterials demonstrate that the Philips Avent Manual Breast Pump is not cytotoxic,irritating, or a dermal sensitizer.
PerformanceTesting	The Philips Avent Manual Breast Pump and the predicated devices were measured forpressure in use as per their directions for use and worse use as well. All devices weretested using the same testing protocol.
	Recommended Use Testing
	The recommended use was with the cushion/inserts in place – as is instructed in thedirections for use of the devices.
	The maximum pressure recorded with the cushion/inserts in place was an average of-249mmHg with the top outlier of -258.9mmHg for the Philips Avent Manual BreastPump. The ISIS iQ UNO Handheld Breast Pump (K052047) predicate device was-248mmHg with the top outlier of -254.5mmHg. The Ameda One Handed ManualPump Kit (K823591) was -288.3mmHg with a top outlier of -312.7mmHg.
	Worse Case Use Testing
	The worse case testing was without the cushion/inserts in place. This allows thebreast/nipple to travel further down the tube reducing the dead volume and thereforeincreasing vacuum.
	The pressure recorded for the Philips Avent Manual Breast Pump was an average of-328mmHg and a top outlier of -338.8mmHg. The ISIS iQ UNO Handheld BreastPump (K052047) predicate device in worse case use testing was -333mmHg with thetop outlier of -337.5mmHg. The Ameda One Handed Manual Pump Kit (K823591)was -272.4mmHg with a top outlier of -282.5mmHg.
	Vacuum testing of the Philips Avent Manual Breast Pump and its predicate devicesindicate that the average maximum vacuum pressures of all of these pumps range fromapproximately -240 to -300 mmHg under normal use and under worst case conditionsdo not exceed 350mmHg. This is due to the component architecture and design of thepump.
Conclusions	Based on the biocompatibility and nonclinical performance testing, it is concluded thatthe Philips Avent Manual Breast Pump is safe and effective for its intended use, and issubstantially equivalent to the named predicate devices.

・

ﻢ

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a tail. The emblem is black and the background is white.

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

Ms. Diana Korda Hewitt Approbation and Regulatory Manager Philips Electronics UK Limited Avent Research Centre Cambridge Pampisford Road Great Abington Cambridge CB21 6AH United Kingdom

NOV - 5 2010

Re: K101538

Trade Name: Phillips AVENT Manual Breast Pump Regulation Number: 21 CFR §884.5150 Regulation Name: Nonpowered breast pump Regulatory Class: I Product Code: HGW Dated: November 1. 2010 Received: November 1, 2010

Dear Ms. Hewitt:

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, Drue, 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.

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 of medical device-related

{3}------------------------------------------------

Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

{4}------------------------------------------------

Indications for Use

NOV - 5 2010

510(k) Number (if known):	K101538
Device Name:	Philips Avent Manual Breast Pump
Indications for Use:	The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

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

Over-The-Counter Use _X (21 CFR 801 Subpart C)

blease do not write below this line -- continue on another bage if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------

Division of Reproductive, Abdominal and
Radiological Devices

510(k) Number	K101538
---------------	---------

Regulation Number and Section

§ 884.5150 Nonpowered breast pump.

(a)
Identification. A nonpowered breast pump is a manual suction device used to express milk from the breast.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.