(128 days)
Not Found
No
The document describes a standard electric breast pump with embedded software for basic operation. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies focus on electrical safety, biocompatibility, and basic pump function.
Yes
The device is intended to "alleviate engorgement of the breast," which is a therapeutic purpose.
No
Explanation: The device is a breast pump, intended to express and collect milk from the breast and alleviate engorgement. It does not provide any diagnostic information or analysis of a medical condition.
No
The device description clearly states it is an electrically powered breast pump consisting of a motor unit, expression kit, milk collection container, and silicone tube. While it mentions embedded software, the device is fundamentally a hardware device with software controlling its operation.
Based on the provided information, 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, and to alleviate engorgement of the breast." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical device that applies suction to extract milk. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic purposes or providing information about a patient's health status based on sample analysis.
In summary, the Philips Avent single/double electric breast pump Advanced is a medical device, but it falls under the category of a therapeutic or assistive device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Philips Avent single/double electric breast pump Advanced is intended to express and collect milk from the breast of a lactating woman, and to alleviate engorgement of the breast. The device is intended for a single user.
Product codes
HGX
Device Description
The Philips Avent Single/Double electric breast pump Advanced 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 for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile.
The subject devices are electrically powered single (Single Advanced) and double (Double Advanced) breast pumps consisting of the following key components: a motor unit with a press-button user interface, and expression kit with milk collection container (double pump: two kits and containers) connected with the motor unit via a silicone tube. The motor unit operates on embedded software. Software updates by end-users are not supported.
The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, the expression kit includes a silicone diaphragm that physically separates the milk-contacting pathway from the vacuum system.
The motor unit operates on an external mains adapter that is provided with the system via a micro-USB type connection. Models SCF392 and SCF394 include a rechargeable battery that can be used for device operation. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation.
The expression kit is provided in two types: cushion-type and flange-type.
The cushion-type expression kit has a silicone cushion which is mounted on the expression kit pump body. The cushion comes into contact with the breast for the expression session.
In the flange-type expression kit, the silicone cushion is integrated in a rigid frame. This integrated part (flange) can be attached to the pump body with a screw connection. The silicone part comes into contact with the breast for the duration of the expression. The rigid frame is not in contact with the breast.
All other components of the subject devices are not in contact with the breast.
The subject devices consist of the following materials:
- Motor unit: ABS, mABS, HTV Silicone
- Cushion, tube, milk valve, diaphragm: Silicone
- Pump body, milk collection container: Polypropylene
- Flange: Polypropylene, Polybutylene Terephthalate, Silicone
All milk contacting components are compliant with 21 CFR 174-179, 21 CFR 177.1520 and 21 CFR 177.2600.
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 healthcare environment and professional healthcare environments.
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)
The Philips Avent Single/Double Electric Breast Pump Advanced complies with recognized consensus standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, software, biocompatibility, Lithium-Ion Battery Testing. The following performance data were provided to support the substantial equivalence determination:
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3rd Edition) with US deviations per AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009(R)2012 and A2:2010/(R)2012 (Consolidated Text).
- Electrical Safety Testing for use in the home in accordance with IEC 60601-1-11 Edition 2.0 2015-01.
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- Software Verification and Validation Testing as recommended in the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
- Biocompatibility Tests in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
- Lithium-Ion Battery Testing according to the IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
- Backflow protection testing, Vacuum/cycle performance testing, and use-life testing.
The performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 1, 2020
Philips Consumer Lifestyle - Innovation Site Eindhoven Aurore Millet Senior Regulatory Affairs Manager High Tech Campus 37 Eindhoven. 5656 AE NETHERLANDS
Re: K201381
Trade/Device Name: Philips Avent Single/Double electric breast pump Advanced Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Received: August 31, 2020
Dear Aurore Millet:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201381
Device Name
Philips Avent Single/Double electric breast pump Advanced
Indications for Use (Describe)
The Philips Avent single/double electric breast pump Advanced is intended to express and collect milk from the breast of a lactating woman, and to alleviate engorgement of the breast. 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K201381
1 Submitter Information
| Company Name:
Address: | Philips Consumer Lifestyle - Innovation Site Eindhoven
High Tech Campus 37
Eindhoven 5656 AE
The Netherlands |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Aurore Millet
Senior Regulatory Manager
- 31 6 181 91 888
aurore.millet@philips.com |
| Date of preparation: | September 30, 2020 |
Device Information 2
| Trade/Device Name: | Philips Avent Single/Double electric breast pump Advanced |
|---|---|
| Common /Usual Name: | Powered Breast Pump |
| Regulation Name: | Powered Breast Pump |
| Regulation Number: | 21 CFR 884.5160 |
| Product Code: | HGX (Pump, Breast, Powered) |
| Regulatory Class: | II |
3 Predicate Device Information
K161532 Manufacturer: Philips Electronics UK Limited Device Name: Philips Avent Comfort Single/Twin Electric Breast Pump
The predicate device has not been subject to a design-related recall.
4
Device Description 4
The Philips Avent Single/Double electric breast pump Advanced 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 for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile.
The subject devices are electrically powered single (Single Advanced) and double (Double Advanced) breast pumps consisting of the following key components: a motor unit with a press-button user interface, and expression kit with milk collection container (double pump: two kits and containers) connected with the motor unit via a silicone tube. The motor unit operates on embedded software. Software updates by end-users are not supported.
The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, the expression kit includes a silicone diaphragm that physically separates the milk-contacting pathway from the vacuum system.
The motor unit operates on an external mains adapter that is provided with the system via a micro-USB type connection. Models SCF392 and SCF394 include a rechargeable battery that can be used for device operation. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation.
The expression kit is provided in two types: cushion-type and flange-type.
The cushion-type expression kit has a silicone cushion which is mounted on the expression kit pump body. The cushion comes into contact with the breast for the expression session.
In the flange-type expression kit, the silicone cushion is integrated in a rigid frame. This integrated part (flange) can be attached to the pump body with a screw connection. The silicone part comes into contact with the breast for the duration of the expression. The rigid frame is not in contact with the breast.
All other components of the subject devices are not in contact with the breast.
| Trade/Device Name | Number
of pumps | User Interface | Battery | Expression kit
type | Model
Identification |
|----------------------------------------------------------|---------------------------|----------------------------------|--------------|------------------------|-------------------------|
| Philips Avent Single
electric breast pump
Advanced | 1
(Single
electric) | 4 buttons and
8-dot display | No battery | Cushion | SCF391/61 |
| | | 4 buttons and
8-dot display | No battery | Flange | SCF391/62 |
| Philips Avent Single
electric breast pump
Advanced | 1
(Single
electric) | 4 buttons and
2-digit display | With battery | Cushion | SCF392/61 |
| | | 4 buttons and
2-digit display | With battery | Flange | SCF392/62 |
| Philips Avent Double
electric breast pump
Advanced | 2
(Double
electric) | 4 buttons and
8-dot display | No battery | Cushion | SCF393/61 |
| | | 4 buttons and
8-dot display | No battery | Flange | SCF393/62 |
| Philips Avent Double
electric breast pump
Advanced | 2
(Double
electric) | 4 buttons and
2-digit display | With battery | Cushion | SCF394/61 |
| | | 4 buttons and
2-digit display | With battery | Flange | SCF394/62 |
The subject device versions are shown in the table below:
The subject devices consist of the following materials:
- Motor unit: ABS, mABS, HTV Silicone
- Cushion, tube, milk valve, diaphragm: Silicone ●
5
- Pump body, milk collection container: Polypropylene ●
- Flange: Polypropylene, Polybutylene Terephthalate, Silicone
All milk contacting components are compliant with 21 CFR 174-179, 21 CFR 177.1520 and 21 CFR 177.2600.
Indications for Use 5
The Philips Avent single/double electric breast pump Advanced to express and collect milk from the breast of a lactating woman, and to alleviate engorgement of the breast. The device is intended for a single user.
Comparison Intended Technological б Characteristics with the Predicate Device
| Subject Device | Predicate Device | |
|---|---|---|
| Philips Avent Single/Double | ||
| electric breast pump Advanced | ||
| (K201381) | Philips Avent Comfort | |
| Single/Twin Electric Breast | ||
| Pump | ||
| (K161532) | ||
| Product Name | Versions without battery: Single | |
| electric breast pump Advanced | ||
| (SCF391/61 and SCF391/62) | ||
| Double electric breast pump | ||
| Advanced (SCF393/61 and | ||
| SCF393/62) | ||
| Versions with battery: Single | ||
| electric breast pump Advanced | ||
| (SCF392/61 and SCF392/62) | ||
| Double electric breast pump | ||
| Advanced (SCF394/61 and | ||
| SCF394/62) | Comfort Single SCF332/11 | |
| Comfort Twin SCF334/12 | ||
| Comfort Twin SCF334/13 | ||
| Comfort Twin SCF334/14 | ||
| Comfort Twin SCF334/15 | ||
| Manufacturer | Philips Consumer Lifestyle BV | |
| Tussendiepen 4 | ||
| 9206 AD, Drachten | ||
| The Netherlands | Philips Electronics UK Limited | |
| LOWER ROAD | ||
| GLEMSFORD Suffolk, GB CO10 | ||
| 7QS | ||
| Product Code | HGX | HGX |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Class | Class II | Class II |
| Patient | ||
| Population | Lactating women | Lactating women |
| Environment | ||
| of Use | Home healthcare environment | Home healthcare environment |
| Subject Device | Predicate Device | |
| Philips Avent Single/Double | ||
| electric breast pump Advanced | ||
| (K201381) | Philips Avent Comfort | |
| Single/Twin Electric Breast | ||
| Pump | ||
| (K161532) | ||
| Indications | ||
| for Use | The Philips Avent single/double | |
| electric breast pump Advanced is | ||
| intended to express and collect milk | ||
| from the breast of a lactating | ||
| woman, and to alleviate | ||
| engorgement of the breast. The | ||
| device is intended for a single user. | 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. | ||
| Pump options | Single or double pumping | Single or double pumping |
| Backflow | ||
| Protection | Yes | |
| (Silicone diaphragm on the | ||
| expression kit, which separates the | ||
| vacuum system of the motor unit | ||
| from milk-contacting parts) | Yes | |
| (Silicone diaphragm on the expression | ||
| kit, which separates the vacuum system | ||
| of the motor unit from milk-contacting | ||
| parts) | ||
| Suction modes | Stimulation Mode | |
| and | ||
| Expression Mode | Stimulation Mode | |
| and | ||
| Expression Mode | ||
| Transition | ||
| between | ||
| suction modes | Automatic or manual | Manual |
| Adjustable | ||
| suction levels | Yes | Yes |
| Vacuum | ||
| range | ||
| Stimulation | -45 to -150 mmHg | $127 \pm 15$ mmHg |
| Vacuum | ||
| range | ||
| Expression | -45 to -270 mmHg | -168 to -250 mmHg |
| Cycle speed | ||
| (stimulation | ||
| mode) | 105 to 120 cycles/min | 85 to 120 cycles/min |
| Cycle speed | ||
| (expression | ||
| mode) | 53 to 85 cycles/min | 42 to 53 cycles/min |
| Controls | 4 Buttons (On-Off-Pause-Resume, | |
| Stimulation or Expression mode, | ||
| Decrease vacuum level, Increase | ||
| vacuum level) | On-off switch Vacuum/Cycle- | |
| adjustable control | ||
| Indicators | LED indicators: | |
| 8-dot display (versions without | ||
| battery) | ||
| 2-digit 7-segment display (versions | ||
| with battery) | LED Lights | |
| Power | ||
| connection | Micro-USB (power only) | Pin |
| Subject Device | ||
| Philips Avent Single/Double | ||
| electric breast pump Advanced | ||
| (K201381) | Predicate Device | |
| Philips Avent Comfort | ||
| Single/Twin Electric Breast | ||
| Pump | ||
| (K161532) | ||
| Power supply | AC-Adapter provided (100-240 V | |
| primary and 5 V secondary) |
or Lithium- ion battery
3.6 V 2600 mAh
(for battery-operated devices) | AC-Adapter provided
(100-240 V primary and 5 V
secondary (Comfort Single);
9 V secondary (Comfort Twin))
or 4xAA batteries
(Comfort Single only) |
6
7
The indications for use of the subject and predicate device are similar. In comparison to the predicate device, the subject device has an extended indication: "and to alleviate engorgement of the breast". However, the intended use of the subject and predicate devices is the same (express and collect milk from the breast of a lactating woman).
The subject and predicate devices have different technological features, including design, user interface, vacuum pressure range, cycle speeds, and power source. These technological differences do not raise different questions of safety and effectiveness.
7 Summary of Non-Clinical Performance Testing
The Philips Avent Single/Double Electric Breast Pump Advanced complies with recognized consensus standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, software, biocompatibility, Lithium-Ion Battery Testing. The following performance data were provided to support the substantial equivalence determination:
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3rd Edition) with US deviations ● per AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009(R)2012 and A2:2010/(R)2012 (Consolidated Text).
- Electrical Safety Testing for use in the home in accordance with IEC 60601-1-11 Edition 2.0 2015-● 01.
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- Software Verification and Validation Testing as recommended in the FDA Guidance Document ● "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
- Biocompatibility Tests in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
- Lithium-Ion Battery Testing according to the IEC 62133-2 Edition1.0 2017-02 Secondary cells and . batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
- Backflow protection testing, Vacuum/cycle performance testing, and use-life testing.
8 Conclusion
The performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence.