(128 days)
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 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 provided document is a 510(k) summary for the Philips Avent Single/Double electric breast pump Advanced. This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
The questions you are asking typically relate to the performance of AI/ML-driven medical devices in diagnostic or screening applications, where metrics like sensitivity, specificity, and reader performance are critical.
This document, however, describes a powered breast pump, which is a physical device, not an AI/ML diagnostic tool. Therefore, many of your specific questions regarding acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to the information provided for this type of medical device.
I can, however, extract the information that is relevant to the document for a medical device such as a breast pump, which focuses on safety and performance in a different context.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a direct "acceptance criteria table" with numerical thresholds for clinical performance metrics (like accuracy for an AI device). Instead, it lists various engineering and safety standards that the device complies with, along with technical specifications that define its functional performance. The "reported device performance" is compliance with these standards and the specified operating ranges.
| Category | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| General Compliance | Substantial equivalence to predicate device (K161532) in terms of indications for use, safety, and effectiveness. | "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." |
| Electrical Safety | 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) IEC 60601-1-11 Edition 2.0 2015-01 (for use in the home) | Complies with IEC 60601-1:2005 and IEC 60601-1-11 Edition 2.0 2015-01. |
| Electromagnetic | IEC 60601-1-2:2014 | Complies with IEC 60601-1-2:2014. |
| Software | FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005) | Software Verification and Validation Testing performed as recommended in the FDA Guidance Document. |
| Biocompatibility | ISO-10993 (including cytotoxicity, sensitization, and irritation tests: ISO 10993-5:2009, ISO 10993-10:2010) | Complies with ISO-10993 (cytotoxicity, sensitization, irritation). "All milk contacting components are compliant with 21 CFR 174-179, 21 CFR 177.1520 and 21 CFR 177.2600." |
| Lithium-Ion Battery | 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. | Lithium-Ion Battery Testing according to IEC 62133-2 Edition1.0 2017-02. |
| Backflow Protection | N/A (implicit: effective separation of milk-contacting pathway from vacuum system) | Backflow protection testing performed. Device features a silicone diaphragm on the expression kit that separates the vacuum system of the motor unit from milk-contacting parts (similar to predicate). |
| Vacuum Performance | Stimulation Mode: Vacuum range for predicate: 127 ± 15 mmHg. Expression Mode: Vacuum range for predicate: -168 to -250 mmHg. (Subject device aims to fulfill comparable function within safe limits.) | Stimulation Mode: -45 to -150 mmHg Expression Mode: -45 to -270 mmHg (Note: These ranges are comparable to the predicate. The subject device's range for expression is wider, extending to a higher suction level, but this is presented as a difference not necessarily an exceedance of criteria.) |
| Cycle Speed | Stimulation Mode: Cycle speed for predicate: 85 to 120 cycles/min. Expression Mode: Cycle speed for predicate: 42 to 53 cycles/min. (Subject device aims to fulfill comparable function within safe limits.) | Stimulation Mode: 105 to 120 cycles/min Expression Mode: 53 to 85 cycles/min (Note: The subject device's cycle speeds are generally within or overlapping the predicate device's ranges, or considered functionally equivalent by the FDA.) |
| Use-life | N/A (implicit: device maintains performance over its expected lifetime) | Use-life testing performed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes compliance with engineering and electrical standards through testing, not a clinical study with human subjects for performance evaluation in the way an AI diagnostic device would be tested. The tests are focused on the device's hardware and software functionality, and material safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. Ground truth established by medical experts is paramount for diagnostic AI/ML devices. For a breast pump, "ground truth" relates to physical and electrical performance, and biocompatibility, which are assessed through engineering and materials science tests, not expert clinical consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are used in studies involving subjective interpretation, typically by multiple human readers, which is not the case for device safety and performance testing for a breast pump.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable/not provided. This type of study is relevant for AI-assisted diagnostic tools. The breast pump is a therapeutic/supportive device, not a diagnostic one.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for this device in the context of typical AI/ML evaluation. While the device contains software, its "performance" is mechanical and electrical, not an AI algorithm making independent diagnostic decisions. The software verification and validation are for the embedded control software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on objective measurements and adherence to established engineering, electrical, and biocompatibility standards. For example:
- Electrical safety tests verify voltage, current, and insulation against specified limits.
- EMC tests verify emission and immunity levels against regulatory standards.
- Vacuum/cycle performance tests measure actual vacuum levels and cycles per minute against the device's specified operating ranges.
- Biocompatibility tests use standardized laboratory assays to detect cytotoxicity, sensitization, and irritation.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of an AI/ML algorithm for this breast pump. The software is likely deterministic control logic, not a machine learning model that requires training data.
9. How the ground truth for the training set was established
This information is not applicable/not provided due to the absence of a machine learning training set.
{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)
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}------------------------------------------------
510(k) SUMMARY K201381
1 Submitter Information
| Company Name:Address: | Philips Consumer Lifestyle - Innovation Site EindhovenHigh Tech Campus 37Eindhoven 5656 AEThe Netherlands |
|---|---|
| Contact Person: | Aurore MilletSenior Regulatory Manager+ 31 6 181 91 888aurore.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 | Numberof pumps | User Interface | Battery | Expression kittype | ModelIdentification |
|---|---|---|---|---|---|
| Philips Avent Singleelectric breast pumpAdvanced | 1(Singleelectric) | 4 buttons and8-dot display | No battery | Cushion | SCF391/61 |
| 4 buttons and8-dot display | No battery | Flange | SCF391/62 | ||
| Philips Avent Singleelectric breast pumpAdvanced | 1(Singleelectric) | 4 buttons and2-digit display | With battery | Cushion | SCF392/61 |
| 4 buttons and2-digit display | With battery | Flange | SCF392/62 | ||
| Philips Avent Doubleelectric breast pumpAdvanced | 2(Doubleelectric) | 4 buttons and8-dot display | No battery | Cushion | SCF393/61 |
| 4 buttons and8-dot display | No battery | Flange | SCF393/62 | ||
| Philips Avent Doubleelectric breast pumpAdvanced | 2(Doubleelectric) | 4 buttons and2-digit display | With battery | Cushion | SCF394/61 |
| 4 buttons and2-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/Doubleelectric breast pump Advanced(K201381) | Philips Avent ComfortSingle/Twin Electric BreastPump(K161532) | |
| Product Name | Versions without battery: Singleelectric breast pump Advanced(SCF391/61 and SCF391/62)Double electric breast pumpAdvanced (SCF393/61 andSCF393/62)Versions with battery: Singleelectric breast pump Advanced(SCF392/61 and SCF392/62)Double electric breast pumpAdvanced (SCF394/61 andSCF394/62) | Comfort Single SCF332/11Comfort Twin SCF334/12Comfort Twin SCF334/13Comfort Twin SCF334/14Comfort Twin SCF334/15 |
| Manufacturer | Philips Consumer Lifestyle BVTussendiepen 49206 AD, DrachtenThe Netherlands | Philips Electronics UK LimitedLOWER ROADGLEMSFORD Suffolk, GB CO107QS |
| Product Code | HGX | HGX |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Class | Class II | Class II |
| PatientPopulation | Lactating women | Lactating women |
| Environmentof Use | Home healthcare environment | Home healthcare environment |
| Subject Device | Predicate Device | |
| Philips Avent Single/Doubleelectric breast pump Advanced(K201381) | Philips Avent ComfortSingle/Twin Electric BreastPump(K161532) | |
| Indicationsfor Use | The Philips Avent single/doubleelectric breast pump Advanced isintended to express and collect milkfrom the breast of a lactatingwoman, and to alleviateengorgement of the breast. Thedevice is intended for a single user. | The Philips Avent ComfortSingle/Twin electric breast pump isintended to express and collect milkfrom the breast of a lactating woman.The device is intended for a single user. |
| Pump options | Single or double pumping | Single or double pumping |
| BackflowProtection | Yes(Silicone diaphragm on theexpression kit, which separates thevacuum system of the motor unitfrom milk-contacting parts) | Yes(Silicone diaphragm on the expressionkit, which separates the vacuum systemof the motor unit from milk-contactingparts) |
| Suction modes | Stimulation ModeandExpression Mode | Stimulation ModeandExpression Mode |
| Transitionbetweensuction modes | Automatic or manual | Manual |
| Adjustablesuction levels | Yes | Yes |
| VacuumrangeStimulation | -45 to -150 mmHg | $127 \pm 15$ mmHg |
| VacuumrangeExpression | -45 to -270 mmHg | -168 to -250 mmHg |
| Cycle speed(stimulationmode) | 105 to 120 cycles/min | 85 to 120 cycles/min |
| Cycle speed(expressionmode) | 53 to 85 cycles/min | 42 to 53 cycles/min |
| Controls | 4 Buttons (On-Off-Pause-Resume,Stimulation or Expression mode,Decrease vacuum level, Increasevacuum level) | On-off switch Vacuum/Cycle-adjustable control |
| Indicators | LED indicators:8-dot display (versions withoutbattery)2-digit 7-segment display (versionswith battery) | LED Lights |
| Powerconnection | Micro-USB (power only) | Pin |
| Subject DevicePhilips Avent Single/Doubleelectric breast pump Advanced(K201381) | Predicate DevicePhilips Avent ComfortSingle/Twin Electric BreastPump(K161532) | |
| Power supply | AC-Adapter provided (100-240 Vprimary and 5 V secondary)or Lithium- ion battery3.6 V 2600 mAh(for battery-operated devices) | AC-Adapter provided(100-240 V primary and 5 Vsecondary (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.
§ 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).