(155 days)
No
The device description explicitly states it is a "manual" breast pump and operates in a "manual mode" where the user controls the vacuum level. There is no mention of any computational or adaptive elements that would suggest AI/ML.
No
The device is intended to express and collect milk from the breasts of a lactating woman, which is not considered a therapeutic function.
No
This device is intended to express and collect milk from the breasts of a lactating woman, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like a pump diaphragm, manual pivoting handle, duckbill valve, and feeding bottle, indicating it is a hardware device.
Based on the provided information, the Philips Avent Manual Breast Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breasts of a lactating woman." This is a physical process involving the body directly, not the examination of specimens taken from the body.
- Device Description: The description details a mechanical pump that applies vacuum to the breast to extract milk. It does not mention any analysis or testing of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting or measuring substances in these specimens.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on laboratory tests.
The device is a medical device, specifically a breast pump, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
Product codes
HGY, HGW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: The Philips Avent Manual Breast Pump and the predicated devices were measured for pressure in use as per their directions for use and worse use as well. All devices were tested using the same testing protocol.
Recommended Use Testing: The recommended use was with the cushion/inserts in place – as is instructed in the directions 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 Breast Pump. The ISIS iQ UNO Handheld Breast Pump (K052047) predicate device was -248mmHg with the top outlier of -254.5mmHg. The Ameda One Handed Manual Pump 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 the breast/nipple to travel further down the tube reducing the dead volume and therefore increasing 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 Breast Pump (K052047) predicate device in worse case use testing was -333mmHg with the top 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 devices indicate that the average maximum vacuum pressures of all of these pumps range from approximately -240 to -300 mmHg under normal use and under worst case conditions do not exceed 350mmHg. This is due to the component architecture and design of the pump.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ameda Hand Breast Pump (K823591), ISIS IQ Uno Handheld Electronic Breast Pump, Model 101 (K052047), Medela Manual Breast Pump (K828340)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV - 5 2010 .
510(k) SUMMARY
| 510(k) Owner: | Contact: | Diana Korda Hewitt
Approbation and Regulatory Manager
Philips Consumer Lifestyle
Philips Avent
ARCC, Pampisford Road
Great Abington, Cambridge
U.K. | | | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--|--|
| | Phone: | +44 (0) 1787 267069 | | | |
| | Fax: | +44 (0) 1223 894635 | | | |
| | E-mail: | diana.korda.hewitt@philips.com | | | |
| Date Summary
Prepared: | June 2, 2010 | | | | |
| Device: | Trade Name: | Common/Classification Name: | Philips Avent Manual Breast Pump
Nonpowered 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 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. | | | | |
| Intended Use: | The Philips Avent Manual Breast Pump is intended to express and collect milk from
the breasts of a lactating woman. | | | | |
ﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ
く
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| Technological
Characteristics: | The Philips Avent Manual Breast Pump is substantially equivalent to the predicate
devices with regard to intended use and technological characteristics. There are no
new questions of safety or effectiveness presented. All breast contacting materials
meet biocompatibility regulations (ISO10993), and all milk contacting materials meet
food contact regulations. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility
Data | Cytotoxicity, irritation, and dermal sensitization studies conducted on user-contacting
materials demonstrate that the Philips Avent Manual Breast Pump is not cytotoxic,
irritating, or a dermal sensitizer. |
| Performance
Testing | The Philips Avent Manual Breast Pump and the predicated devices were measured for
pressure in use as per their directions for use and worse use as well. All devices were
tested using the same testing protocol. |
| | Recommended Use Testing |
| | The recommended use was with the cushion/inserts in place – as is instructed in the
directions 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 Breast
Pump. The ISIS iQ UNO Handheld Breast Pump (K052047) predicate device was
-248mmHg with the top outlier of -254.5mmHg. The Ameda One Handed Manual
Pump 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 the
breast/nipple to travel further down the tube reducing the dead volume and therefore
increasing 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 Breast
Pump (K052047) predicate device in worse case use testing was -333mmHg with the
top 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 devices
indicate that the average maximum vacuum pressures of all of these pumps range from
approximately -240 to -300 mmHg under normal use and under worst case conditions
do not exceed 350mmHg. This is due to the component architecture and design of the
pump. |
| Conclusions | Based on the biocompatibility and nonclinical performance testing, it is concluded that
the Philips Avent Manual Breast Pump is safe and effective for its intended use, and is
substantially equivalent to the named predicate devices. |
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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 |
|---|---|
| --------------- | --------- |