(88 days)
No
The description details a standard electric breast pump with different operating modes based on user selection, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the text.
No.
The device is intended to express and collect milk from the breast of a lactating woman, which is not considered a therapeutic purpose.
No
Explanation: The device is a breast pump, intended to express and collect milk from the breast. Its function is to facilitate milk extraction, not to diagnose a medical condition.
No
The device description explicitly states it consists of a motor, pump body, user interface, and collection kit, which are all hardware components. The performance studies also include electrical safety, EMC, and biocompatibility testing, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breast of a lactating woman." This is a physical process involving the body directly, not a test performed on a sample taken from the body.
- Device Description: The description details a mechanical process of creating vacuum to extract milk. It doesn't involve analyzing any biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The Philips Avent Comfort Single/Twin Electric Breast Pump is a medical device, but it falls under a different category than In Vitro Diagnostics. It's a device used for a physiological process.
N/A
Intended Use / Indications for Use
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
Product codes
HGX
Device Description
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
The subject devices are electrically powered single (Comfort Single) and double (Comfort Double) breast pumps consisting of a motor and pump body, press-button user interface, and collection kit. A vacuum pump creates a vacuum at the breast of the lactating woman. This vacuum is released after a short period of time. By repeating this behavior, a cyclic vacuum generation pattern is created which enables expressing of milk from the breast. The expressed milk will be collected in the container which can be used for storage.
The breast pump supports different operating modes: stimulation, expression 1, expression 2 and expression 3. The stimulation mode is entered upon start of the device when suction is felt on the breast. Once the milk starts flowing an expression mode may be chosen that has the most comfort, e.g. the combination of rhythm and suction level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home
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
Verification and validation activities were designed and performed to support the substantial equivalence of this devices and the predicate device. The following performance data was provided:
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing was conducted on the Philips Comfort Single/Twin Electric Breast Pump. The device complies to the following standards: AAMI / ANSI ES60601-1:2005 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) and AAMI / ANSI / IEC 60601-1-2:2007 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests).
Software Verification and Validation
Software verification and validation testing was conducted complying to: AAMI / ANSI / IEC 62304:2006 Medical device software - Software life cycle processes. Documentation was also provided according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Usability Testing
Usability testing was conducted according to the FDA Guidance 1497, Medical Device Use-Safety Incorporating Human Factors into Risk Management. This testing demonstrated that the usability of the subject device is substantially equivalent to the predicate device.
Biocompatibility Testing
Biocompatibility testing was conducted following the FDA Blue Book Memorandum "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and according to the following standards: ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process), ANSI / AMI / ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity), and ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization). The biocompatibility testing demonstrated that the patient contacting materials are biocompatible.
Vacuum Performance Test
Performance testing to determine the vacuum performance, including minimum and maximum vacuum levels for the pump as compared to the predicate device, vacuum stability, durability and pump temperatures during operation. The vacuum performance testing demonstrated the mechanical performance and performance specifications of the subject device. The testing validated that the performance of the subject device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus symbol is made up of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2016
Philips Consumer Lifestyle-Innovation Site Eindhoven Marta Walker Sr. Safety, Compliance & Regulatory Manager High Tech Campus 37 Eindhoven, 5656 AE Netherlands
Re: K161532
Trade/Device Name: Philips Avent Comfort Single/Twin Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: May 29, 2016 Received: June 2, 2016
Dear Marta Walker:
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.
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.
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161532
Device Name
Philips Avent Comfort Single/Twin Electric Breast Pump
Indications for Use (Describe)
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Department of Health and Human Services Centre of Devices and Radiological Health Office of Device Evaluation Traditional 510(k) section 10
510(K) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION as required by section 21 CFR 807.92
1. SUBMITTER OF 510(K):
| Company name: | Philips Consumer Lifestyle - Innovation Site Eindhove |
|---|---|
| Registration number: | 3009226815 |
| Address: | High Tech Campus 37, Eindhoven |
| 5656 AE, The Netherlands | |
| Phone: | +31 6 319 78 546 |
| e-mail: | marta.walker@philips.com |
| Correspondent | Marta Walker, |
| Sr. Manager Safety, Compliance & Regulatory |
August 8th, 2016
Date of Preparation:
2. DEVICE(S):
Trade / Proprietary Name: Philips Avent Comfort Single/Twin Electric Breast Pump
Common / Usual Name: Regulation Name: Classification Name: Classification: Product Code:
Powered Breast Pump Obstetrics/Gynecology Powered Breast Pump 21 CFR 884.5160, Class II HGX
3. PREDICATE DEVICE(S):
Philips devices are based on the legally marketed devices cited in Table below:
Table 1: Predicate Device
| Manufacturer | Device | 510(k) # | Product Code: |
|---|---|---|---|
| Medela Ag | Freestyle Deluxe, Freestyle Solution Set, | ||
| Freestyle Basic, Freestyle Motor Warranty | K150499 | HGX |
4
4. DEVICE DESCRIPTION:
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
The subject devices are electrically powered single (Comfort Single) and double (Comfort Double) breast pumps consisting of a motor and pump body, press-button user interface, and collection kit. A vacuum pump creates a vacuum at the breast of the lactating woman. This vacuum is released after a short period of time. By repeating this behavior, a cyclic vacuum generation pattern is created which enables expressing of milk from the breast. The expressed milk will be collected in the container which can be used for storage.
The breast pump supports different operating modes: stimulation, expression 1, expression 2 and expression 3. The stimulation mode is entered upon start of the device when suction is felt on the breast. Once the milk starts flowing an expression mode may be chosen that has the most comfort, e.g. the combination of rhythm and suction level.
5. INDICATION FOR USE:
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
The indications for use for the subject and predicate devices are comparable (see Table 3), and the intended use of the subject and predicate devices are the same as they are both for use in expressing and collecting milk from the breast of a lactating woman.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of these devices are similar to those of the predicate device (Medela Free Style K150499).
A comparison of the basic characteristics of the Philips Avent Comfort Single/Twin Electric Breast Pump and of the Medela Freestyle BreastPump (K150499) is presented in Table 3.
| Parameter | Philips Avent Comfort
Single/Twin Electric Breast Pump | Medela Freestyle BreastPump
(K150499) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Philips Avent Comfort
Single/Twin electric breast
pump is intended to express
and collect milk from the
breast of a lactating women.
The device is intended for a
single user. | The Freestyle® is a powered
breastpump to be used by
lactating women to express and
collect milk from their breasts.
The Freestyle is intended for a
single user. |
| Intended Use | Express and collect milk | Express and collect milk |
| Single User Device | Yes | Yes |
| Environment of Use | Home | Home |
Table 3: Substantial Equivalence Comparison Table
5
| User Interface | Hardware Interfaces | Hardware Interfaces |
|---|---|---|
| User Control | On-off switch | On-off switch |
| Vacuum/Cycle-adjustable | Vacuum/Cycle-adjustable | |
| control | control | |
| Visual Indicator | LED Lights | LCD Display |
| Pumping Options | Single or Double | Single or Double |
| Specifications | ||
| Power Supply | AC-Adapter provided or 4xAA | |
| batteries | Li-ion battery or AC-Adapter | |
| provided | ||
| Suction levels (stimulation) | 127mmHg +/- 15mmHg | 40 - 140mmHg |
| Cycles per second (stimulation) | 1.42 - 2.0 | 1.7 - 1.93 |
| Suction levels (expression) | 168 – 250mmHg | 45 - 245mmHg |
| Cycles per second (expression) | 0.70 - 0.87 | 0.83 – 1.36 |
| Maximum Vacuum | 250mmHg | 270mmHg |
| Adjustable suction levels | Yes | Yes |
| Let-down button | Yes | Yes |
| Cycling control mechanism | Microcontroller | Microcontroller |
| Backflow protection | Yes | Yes |
| 2-Phase Expression | Yes | Yes |
The subject and predicate device have similar technological characteristics. The most relevant differences between the two devices are as follows:
- . Power Supply – the subject devices use an AC adaptor (Comfort Single and Twin) or AA batteries (Comfort Single only). The predicate uses both an AC adaptor and lithium ion batteries. This does not raise different questions of safety and effectiveness as AA batteries have a lower capacity than Li-ion batteries.
- Suction Levels - The upper limit of the expression suction levels is slightly higher in the subject device and the range is smaller compared to the predicate. These slight differences in suction levels do not raise different questions of safety and effectiveness as compared to the predicate device.
- Cycles per Second The range of stimulation cycles per second is slightly larger than the ● predicate device, while the range of expression cycles per second is slightly smaller. This does not raise different questions of safety and effectiveness as the clinical significance of the minor differences in cycles per second is negligible.
- Visual Display The subject device uses LED lights to display user interface buttons while the . predicate device uses an LCD screen. This does not raise different questions of safety and effectiveness as the usability of the subject device should not be affected.
As discussed above, the technological differences do not raise different questions of safety or effectiveness, and accepted test methods exist to assess the effects of these differences on device performance.
7. PERFORMANCE TESTING
6
Verification and validation activities were designed and performed to support the substantial equivalence of this devices and the predicate device. The following performance data was provided:
Electrical Safety and Electromagnetic Compatibility (EMC) 7.1.
Electrical safety and EMC testing was conducted on the Philips Comfort Single/Twin Electric Breast Pump . The device complies to the following standards:
| AAMI / ANSI ES60601-1:2005 | Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI / ANSI / IEC 60601-1-2:2007 | Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral
standard: Electromagnetic compatibility – Requirements and
tests. |
7.2. Software Verification and Validation
Software verification and validation testing was conducted complying to:
AAMI / ANSI / IEC 62304:2006 Medical device software - Software life cycle processes
Documentation was also provided according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
7.3. Usability Testing
Usability testing was conducted according to the FDA Guidance 1497, Medical Device Use-Safety Incorporating Human Factors into Risk Management. This testing demonstrated that the usability of the subject device is substantially equivalent to the predicate device.
7.4. Biocompatibility Testing
Biocompatibility testing was conducted following the FDA Blue Book Memorandum "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and according to the following standards:
| ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: Evaluation
and testing within a risk management process |
|-------------------------------|---------------------------------------------------------------------------------------------------------------|
| ANSI / AMI / ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5: Tests for in
vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices – Part 10: Tests for
irritation and skin sensitization |
The biocompatibility testing demonstrated that the patient contacting materials are biocompatible.
7.7. Vacuum Performance Test
7
Performance testing to determine the vacuum performance, including minimum and maximum vacuum levels for the pump as compared to the predicate device, vacuum stability, durability and pump temperatures during operation.
The vacuum performance testing demonstrated the mechanical performance and performance specifications of the subject device. The testing validated that the performance of the subject device is substantially equivalent to the predicate device.
9. CONCLUSION
The differences between the Philips Avent Comfort Single/Twin Electric Breast Pump and its predicate device Medela Freestyle (K150499) do not introduce a new intended use and do not represent new technological characteristics raising different questions of safety and effectiveness as compared to the predicate device.
From the results of nonclinical testing described, Philips concludes that the Philips Avent Comfort Single/Twin Electric Breast Pump is substantially equivalent to the legally marketed predicate device.