Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)
Device Facts
| Record ID | K261622 |
|---|---|
| Device Name | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) |
| Applicant | Philips Consumer Lifestyle B.V. |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Sep 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
Indications for Use
The Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) and the Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) are powered breast pumps intended to express and collect milk from the breast of a lactating woman. The devices are intended for a single user.
Device Story
Wearable, battery-powered electric breast pump; single-user; home use. Input: mechanical suction applied to nipple via flange. Operation: lithium-ion battery-powered motor unit; embedded control program manages vacuum levels and cycling rates; stimulation mode (8 levels, 105-120 cpm) and expression mode (16 levels, 53-85 cpm). Warming mode (SCF594 models only) provides heat <41°C. Output: expressed milk collected in container. Backflow protection membrane prevents milk ingress into vacuum system. User interface: buttons on pump body with LED indicators. Benefit: facilitates milk expression for lactating women.
Clinical Evidence
Bench testing only. Includes biocompatibility (ISO 10993-5, -10, -23), electrical safety (ANSI/AAMI ES60601-1, IEC 62133-2, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), vacuum level verification, backflow protection, heating element performance, use-life testing, and battery performance.
Technological Characteristics
Wearable powered breast pump; ABS/TPE motor housing; PP/silicone milk-contacting components. Powered by internal rechargeable Li-ion polymer battery; 5V DC charging. Microcontroller-based control of vacuum (37-262 mmHg) and cycling (53-120 cpm). Non-sterile. Software-controlled. Warming element (SCF594 models) <41°C.
Indications for Use
Indicated for lactating women to express and collect milk from their breasts. Intended for single-user, home-environment use.
Regulatory Classification
Identification
A powered breast pump in an electrically powered suction device used to express milk from the breast.
Predicate Devices
- Magic InBra™ (K251377)
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
September 3, 2026
Philips Consumer Lifestyle B.V.
% Shaylee Masilunas
Sr. Regulatory Affairs Project Manager
Philips Personal Health, a subsidiary of Philips North America, LLC
1600 Summer St.
5th Floor
Stamford, Connecticut 06905
Re: K261622
Trade/Device Name: Philips Avent Natural Care Hands-free Wearable Electric
Breast Pump (Model: SCF593/52, SCF593/62); Philips
Avent Natural Care Warming Hands-free Wearable Electric
Breast Pump (Model: SCF594/52, SCF594/62)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: August 4, 2026
Received: August 5, 2026
Dear Shaylee Masilunas:
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 (the 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 available 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: The Center for Devices and Radiological Health (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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Federal Regulations, Title 21, Parts 800 to 898. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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(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-devices/device-advice-comprehensive-regulatory-assistance/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,
Monica D. Garcia -S
Monica D. Garcia, Ph.D.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K261622
Device Name
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62);
Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)
Indications for Use (Describe)
The Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) and the Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) are powered breast pumps intended to express and collect milk from the breast of a lactating woman. The devices are 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)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
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# 510(k) Summary – K261622
## 1. Submitter Information
Applicant: Philips Consumer Lifestyle B.V.
Contact: Mr. Jeff Chau
Phone: +852 61020252
Address: Tussendiepen 4,9206, AD Drachten, The
Netherlands Drachten 9206 AD Netherlands
## 2. Correspondent Information
Contact: Mrs. Shaylee Masilunas
Philips Personal Health, a subsidiary of
Philips North America LLC
Email: shaylee.masilunas@philips.com
Phone: +14125423485
Address: 1600 Summer Street 5th Floor Stamford CT
06905 United States
## 3. Date prepared: September 2, 2026
## 4. Device Information
| Device Name: | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) |
| --- | --- |
| 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: | Magic InBra™ |
| --- | --- |
| 510(k) Number: | K251377 |
| Manufacturer: | Medela AG |
The predicate device has not been subject to a design-related recall.
## 6. Device Description
The Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) and the Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts; and are intended for a single user. Both device series are powered by a lithium-ion battery, utilizing an embedded control program to manage all device functions. The Warming mode is an additional function and feature of the SCF594/52 and SCF594/62 models only, which can be activated through the user interface and is powered by the same rechargeable battery in the motor unit. The user interface allows the user to switch from stimulation and expression modes and control the vacuum levels within those modes.
Stimulation mode consists of 8 vacuum levels and expression mode consists of 16 vacuum levels. The devices
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are capable of providing vacuum levels from 45-150 mmHg with cycling rates from 105-120 cycles per minute in stimulation mode and vacuum levels from 37-262 mmHg with cycling rates from 53-85 cycles per minute in expression mode. The devices are charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided non-sterile.
The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adaptor if the motor unit is not in operation.
The breast pump extracts milk from the breast(s) by creating a seal around the nipple and applying and releasing suction to the nipple, which expresses milk from the breast. Each suction and release combination is called a cycle. The milk is collected in a milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
The operating life of the Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) and the Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) is 500 hours.
All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
### 7. Indications for Use
The Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) and the Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) are powered breast pumps intended to express and collect milk from the breast of a lactating woman. The devices are 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.
Table 1: Comparator Table for Subject and Predicate Device
| | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump(Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) K261622 Subject Device | Magic InBraTM K251377 Predicate Device | Comparison |
| --- | --- | --- | --- |
| Product Code | HGX | HGX | Same |
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| Indications for use | The Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) and the Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) are powered breast pumps intended to express and collect milk from the breast of a lactating woman. The devices are intended for a single user. | The Magic InBraTM breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Magic InBraTM powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment. | Similar |
| --- | --- | --- | --- |
| Single User | Yes | Yes | Same |
| Single/double pump | Single | Single | Same |
| Pump Type | Wearable | Wearable | Same |
| Media separation (backflow protection) | Yes | Yes | Same |
| Cycling control mechanism | Microcontroller | Microcontroller | Same |
| Expression pattern | 2-Phase | 2-Phase | Same |
| Power supply | Li-Ion Battery | Li-Ion Battery | Same |
| Suction levels (Stimulation) | -45 to -150mmHg | -60 to -110 (±15)mmHg and -135 to -160 (±20)mmHg | **Different** |
| Suction levels (Expression) | -37 to -262mmHg | Expression (first two minutes): -75 to -175 (±15)mmHg and -200 to -300 (±20)mmHg Expression (remaining session): -75 (+25/-40)mmHg, -100 to -275 (±40)mmHg and -300 (+40/-25)mmHg | **Different** |
| Cycles per minute (Stimulation) | 105-120 cpm | 45-110 cpm | **Different** |
| Cycles per minute (Expression) | 53-85 cpm | 45-110 cpm | **Different** |
| Suction levels | 8 stimulation levels, 16 expression levels | 10 levels | **Different** |
| User Interface | 5 buttons on pump body, LED | 6 buttons on pump body | **Different** |
| Heating element | Yes, SCF594/52, SCF594/62 only; less than 41°C±2°C | No | **Different** |
| Adjustable Suction Levels | Yes | Yes | Same |
| Wireless technology | No | Yes | **Different** |
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| Design | Wearable pump with combined Milk Collector and Flange | Wearable pump with combined Milk Collector and Flange | Same |
| --- | --- | --- | --- |
| Materials | Motor unit: ABS, TPE assembled cup: PP, silicone | Not specified | **Different** |
| Design | Wearable pump with combined Milk Collector and Flange | Wearable pump with combined Milk Collector and Flange | Same |
The indications for use of the subject and predicate device are similar. However, both devices have the same intended use (i.e., for collection of breast milk from the breasts of lactating women).
The subject and predicate devices have similar technological features, including wearable design, available expression modes, and power supply. However, as shown in the table above, there are technological differences between the subject and predicate device, including different vacuum specifications, user interface, and available vacuum levels. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.
### 9. Summary of Non-Clinical Performance Testing
#### Biocompatibility
The biocompatibility evaluation for the patient contacting components of the Philips Avent Natural Care Hands-free Wearable Electric Breast Pump(Model: SCF593/52, SCF593/62) and the Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) were conducted in accordance with the 2023 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,”” as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2021)
- Irritation (ISO 10993-23:2021)
The patient-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
#### Electrical Safety
Testing was conducted in accordance with the following standards:
- ANSI/AAMI ES60601- 1:2005/A2:2010 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance),
- IEC 62133-2:2017, 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, and
- IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
#### Electromagnetic Compatibility
Testing was conducted in accordance with the FDA Guidance “Electromagnetic Compatibility (EMC) of Medical Devices,” issued June 6, 2022 and IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: “General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.”
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# **Software**
Software was evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document “*Content of Premarket Submissions for Device Software Functions.*”
# **Performance Testing**
Other performance testing was conducted to show that the devices met design requirements and performs as intended. The performance tests include:
- Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
- Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
- Heating element performance to ensure temperature was within specification.
- Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
- Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
# **10. Conclusion**
The results of the performance testing described above demonstrate that the Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) and the Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) are as safe and effective as the predicate device and supports a determination of substantial equivalence.
