(28 days)
No
The description mentions embedded software but provides no indication of AI/ML capabilities. The focus is on the mechanical and electrical components for milk expression.
No
The device is described as an electric breast pump intended to express and collect milk and alleviate engorgement, which are functions related to milk production and comfort, not the treatment or diagnosis of a disease or medical condition.
No
The device description indicates its purpose is to "express and collect milk from the breast," which is a functional rather than a diagnostic use. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly states it is an electrically powered double breast pump consisting of a motor unit, expression kits, milk collection containers, and silicone tubes. While it mentions embedded software, it is clearly a hardware device with software controlling its operation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Philips Avent double electric breast pump Advanced is designed to physically express and collect milk directly from the breast. It does not analyze or test any biological specimen in vitro (outside the body).
- Intended Use: The intended use clearly states "to express and collect milk from the breast of a lactating woman, and to alleviate engorgement of the breast." This is a mechanical function, not a diagnostic one.
The device is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
The Philips Avent 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 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 double (Double Advanced) breast pumps consisting of the following key components: a motor unit with a press-button user interface, two expression kits with two milk collection containers connected with the motor unit via silicone tubes. 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 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 a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation.
The breast pump is provided with the same accessories as the predicate device (K201381), with the addition of a breast pump belt. The breast pump belt intended to carry the electrical breast pump while the device is used to express and collect milk. The belt is intended to be worn over clothes.
The expression kit is provided in two types: cushion-type (SCF394/61) and flange-type (SCF394/62).
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 duration of 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
single user.
home 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
Biocompatibility studies, including Skin Irritation Testing, Cytotoxicity, and Skin Sensitization testing were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-10:2010) ●
- Skin Irritation (ISO 10993-10:2010) ●
The testing supports the biocompatibility of the 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/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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 15, 2020
Philips Consumer Lifestyle - Innovation Site Eindhoven Aurore Millet Senior Regulatory Affairs Manager High Tech Campus 37 Eindhoven, 5656 AE NETHERLANDS
Re: K203383
Trade/Device Name: Philips Avent Double electric breast pump Advanced SCF394/61 Philips Avent Double electric breast pump Advanced SCF394/62 Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: Class II Product Code: HGX Dated: November 13, 2020 Received: November 17, 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
1
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 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 (QS) 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 medical devices and radiation-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 Garcia 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) K203383
Device Name
Philips Avent Double electric breast pump Advanced SCF39461, Philips Avent Double electric breast pump Advanced SCF394/62
Indications for Use (Describe)
The Philips Avent 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary - K203383
1. Submitter Information
| Applicant: | Philips Consumer Lifestyle - Innovation Site
Eindhoven |
|------------|-------------------------------------------------------------|
| Address: | High Tech Campus 37
Eindhoven 5656 AE
The Netherlands |
2. Correspondent Information
| Contact: | Aurore Millet |
|---|---|
| Senior Regulatory Manager | |
| Phone: | +31 6 181 91 888 |
| Email: | aurore.millet@philips.com |
3. Date prepared: December 11, 2020
4. Device Information
| Device Name: | Philips Avent Double electric breast pump Advanced |
|---|---|
| Common Name: | Powered Breast Pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Powered Breast Pump |
| Product Code: | HGX (Pump, Breast, Powered) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | Philips Avent Double electric breast pump Advanced |
|---|---|
| 510(k) Number: | K201381 |
| Manufacturer: | Philips Consumer Lifestyle BV |
| Product Code: | HGX (Pump, Breast, Powered) |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Philips Avent 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 double (Double Advanced) breast pumps consisting of the following key components: a motor unit with a press-button user interface, two expression kits with two milk collection containers connected with the motor unit via silicone tubes. 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 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
4
physically separates the milk-contacting pathway from the vacuum system.
The motor unit operates on a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation.
The breast pump is provided with the same accessories as the predicate device (K201381), with the addition of a breast pump belt. The breast pump belt intended to carry the electrical breast pump while the device is used to express and collect milk. The belt is intended to be worn over clothes.
The expression kit is provided in two types: cushion-type (SCF394/61) and flange-type (SCF394/62).
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 duration of 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.
Table 1: Subject Device variants
| Trade/Device
Name | Number of
pumps | User
Interface | Battery | Expression
kit type | Model
Identification |
|----------------------------------------------------------------|--------------------|----------------------------------|--------------|------------------------|-------------------------|
| Philips Avent
Double
electric breast
pump
Advanced | 2 | 4 buttons and
2-digit display | With battery | Cushion | SCF394/61 |
| | | | | Flange | SCF394/62 |
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 177.1520 and 21 CFR 177.2600.
7. Indications for Use
The Philips Avent 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 device is intended for a single user.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
5
| | Philips Avent Double
electric breast pump
Advanced
K203383 | Philips Avent Double
electric breast pump
Advanced
K201381 | Comparison |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | |
| Product Name | Double electric breast pump
Advanced (SCF394/61 and
SCF394/62) | Double electric breast pump
Advanced (SCF394/61 and
SCF394/62) | Same |
| Manufacturer | Philips Consumer Lifestyle BV
Tussendiepen 4
9206 AD, Drachten
The Netherlands | Philips Consumer Lifestyle BV
Tussendiepen 4
9206 AD, Drachten
The Netherlands | Same |
| Product Code | HGX | HGX | Same |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Class | Class II | Class II | Same |
| Patient Population | Lactating Women | Lactating Women | Same |
| Environment of use | Home Healthcare Environment | Home Healthcare Environment | Same |
| Indications for Use | The Philips Avent 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 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. | Same |
| Pump Options | Double | Single or Double | Similar: The affected
models of the predicate
are exclusively 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) | Same |
| Suction Modes | Stimulation Mode and Expression
Mode | Stimulation Mode and
Expression Mode | Same |
| Transition between
suction modes | Automatic or Manual | Automatic or Manual | Same |
| Adjustable suction levels | Yes | Yes | Same |
| Vacuum range:
Stimulation | -45 to -150 mmHg | -45 to -150 mmHg | Same |
| Vacuum range:
Expression | -45 to -270 mmHg | -45 to -270 mmHg | Same |
| Cycle Speed:
Stimulation | 105 to 120 cycles/min | 105 to 120 cycles/min | Same |
| Cycle Speed:
Expression | 53 to 85 cycles/min | 53 to 85 cycles/min | Same |
| Controls | 4 Buttons (On-Off-Pause-
Resume, Stimulation or
Expression mode. Decrease | 4 Buttons (On-Off-Pause-
Resume, Stimulation or
Expression mode. Decrease | Same |
| | vacuum level, Increase vacuum level) | vacuum level, Increase vacuum level) | |
| Indicators | LED indicators:
8-dot display (versions without battery)
2-digit 7-segment display
(versions with battery) | LED indicators:
8-dot display (versions without battery)
2-digit 7-segment display
(versions with battery) | Same |
| Power connection | Micro-USB (power only) | Micro-USB (power only) | Same |
| 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) or Lithium- ion battery 3.6 V 2600 mAh (for battery-operated devices) | Same |
| Accessories | Pump body
Cushion
Flange
Slave cap
Membrane
Tube
Milk valve
4oz bottle
Breast shield cover
Screw ring
Sealing disc
Teat (nipple)
Dormal cap
Pouch
Travel bag
Disposable breast pads
Breast pump belt | Pump body
Cushion
Flange
Slave cap
Membrane
Tube
Milk valve
4oz bottle
Breast shield cover
Screw ring
Sealing disc
Teat (nipple)
Dormal cap
Pouch
Travel bag
Disposable breast pads | Different: The subject device is packaged with a breast pump belt accessory. Through performance testing validation it was determined that the accessory does not raise additional questions of substantial equivalence. |
Table 2: Comparator Table for Subject and Predicate Devices
6
The indications for use of the subject and predicate device are identical.
The subject and predicate devices have similar technological features, including design, user interface, vacuum pressure range, cycle speeds, and power source. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies, including Skin Irritation Testing, Cytotoxicity, and Skin Sensitization testing were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-10:2010) ●
- Skin Irritation (ISO 10993-10:2010) ●
The testing supports the biocompatibility of the device.
10. 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.