(28 days)
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 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.
The provided document is a 510(k) summary for the Philips Avent Double electric breast pump Advanced. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with performance metrics in the way one might expect for a novel diagnostic or therapeutic device.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, multi-reader studies, standalone performance, and ground truth establishment is not directly available or applicable in the context of this 510(k) summary.
The summary focuses on:
- Comparison to a Predicate Device: The core of the 510(k) is to show that the new device (Philips Avent Double electric breast pump Advanced SCF394/61 and SCF394/62) is substantially equivalent to a previously cleared predicate device (Philips Avent Double electric breast pump Advanced K201381). This means demonstrating that it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- Non-Clinical Performance Testing: The provided "performance testing" is limited to biocompatibility testing, which is a common requirement for devices that come into contact with the body.
Here's how the requested information maps to the provided document:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria for Device Performance (Clinical/Effectiveness): Not explicitly defined in terms of specific clinical efficacy metrics (e.g., milk volume expressed, comfort levels, duration of engorgement relief). The "acceptance criteria" here is primarily substantial equivalence to the predicate device.
- Reported Device Performance (Clinical/Effectiveness): No clinical performance data (e.g., how much milk is expressed, how effectively it alleviates engorgement in users) is reported in this summary. The summary states that the devices have "similar technological features, including design, user interface, vacuum pressure range, cycle speeds, and power source" and that any differences "do not raise different types of safety and effectiveness questions."
The only specific performance data mentioned are related to the biocompatibility studies:
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Pass | Passed |
| Skin Sensitization | Pass | Passed |
| Skin Irritation | Pass | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Test Set: Not applicable. No clinical test set for efficacy or effectiveness is described.
- Biocompatibility Test Set: The sample sizes for the in vitro and in vivo biocompatibility tests are not specified in the document. Data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests.
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)
- Clinical/Effectiveness Ground Truth: Not applicable. No clinical ground truth was established by experts for efficacy or effectiveness. The device's performance is assumed to be substantially equivalent to the predicate.
- Biocompatibility Ground Truth: Not applicable in the sense of expert consensus for a "ground truth." Biocompatibility testing follows established protocols and standards (ISO 10993) where results are interpreted against predefined pass/fail criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring adjudication.
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
- Not applicable. This device is a breast pump, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a mechanical/electrical breast pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For demonstrating substantial equivalence: The "ground truth" is the performance and safety profile of the legally marketed predicate device (K201381). The comparison is based on technical specifications and adherence to recognized standards.
- For biocompatibility: The ground truth is established by standardized testing protocols (ISO 10993) which define acceptable biological responses.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.
In summary: The provided 510(k) premarket notification is for a powered breast pump, which is typically cleared based on substantial equivalence to an existing product and adherence to general controls and performance standards, rather than complex clinical trial data demonstrating specific performance metrics against a defined acceptance criterion. The "study" referenced is primarily a comparison of technological characteristics to a predicate device and non-clinical biocompatibility testing.
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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
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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
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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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510(k) Summary - K203383
1. Submitter Information
| Applicant: | Philips Consumer Lifestyle - Innovation SiteEindhoven |
|---|---|
| Address: | High Tech Campus 37Eindhoven 5656 AEThe 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
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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/DeviceName | Number ofpumps | UserInterface | Battery | Expressionkit type | ModelIdentification |
|---|---|---|---|---|---|
| Philips AventDoubleelectric breastpumpAdvanced | 2 | 4 buttons and2-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.
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| Philips Avent Doubleelectric breast pumpAdvancedK203383 | Philips Avent Doubleelectric breast pumpAdvancedK201381 | Comparison | |
|---|---|---|---|
| Subject Device | Predicate Device | ||
| Product Name | Double electric breast pumpAdvanced (SCF394/61 andSCF394/62) | Double electric breast pumpAdvanced (SCF394/61 andSCF394/62) | Same |
| Manufacturer | Philips Consumer Lifestyle BVTussendiepen 49206 AD, DrachtenThe Netherlands | Philips Consumer Lifestyle BVTussendiepen 49206 AD, DrachtenThe 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 electricbreast pump Advanced is intendedto express and collect milk fromthe breast of a lactating woman,and to alleviate engorgement of thebreast. The device is intended for asingle user. | The Philips Avent single/doubleelectric breast pump Advanced isintended to express and collectmilk from the breast of alactating woman, and to alleviateengorgement of the breast. Thedevice is intended for a singleuser. | Same |
| Pump Options | Double | Single or Double | Similar: The affectedmodels of the predicateare exclusively doublepumping |
| Backflow Protection | Yes(Silicone diaphragm on theexpression kit, which separatesthe vacuum system of the motorunit from milk-contacting parts) | Yes(Silicone diaphragm on theexpression kit, which separatesthe vacuum system of the motorunit from milk-contacting parts) | Same |
| Suction Modes | Stimulation Mode and ExpressionMode | Stimulation Mode andExpression Mode | Same |
| Transition betweensuction 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 orExpression mode. Decrease | 4 Buttons (On-Off-Pause-Resume, Stimulation orExpression 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 bodyCushionFlangeSlave capMembraneTubeMilk valve4oz bottleBreast shield coverScrew ringSealing discTeat (nipple)Dormal capPouchTravel bagDisposable breast padsBreast pump belt | Pump bodyCushionFlangeSlave capMembraneTubeMilk valve4oz bottleBreast shield coverScrew ringSealing discTeat (nipple)Dormal capPouchTravel bagDisposable 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
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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.
§ 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).