(267 days)
No
The description details various pre-programmed modes and levels for the breast pump's operation, but there is no mention of the device learning or adapting based on user input or data, which are characteristics of AI/ML. The software control appears to be for executing these fixed modes.
No
A breast pump is generally considered a medical device, but its primary function is to collect milk, not to treat or diagnose a disease or condition, which is the defining characteristic of a therapeutic device. While it can assist in conditions like engorgement (through the massage mode), its main intended use is for expression and collection of milk.
No
This device is an electric breast pump used by lactating women to express and collect milk, and its description and intended use do not mention any diagnostic capabilities.
No
The device description clearly outlines physical components like a pump unit, breast shield assembly, collection bottles, tubing set, and power adapter, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "powered breast pump to be used by lactating women to express and collect milk from their breast." Its function is mechanical extraction of a bodily fluid, not analysis or testing of a sample.
- Intended Use: The intended use is to "express and collect milk," which is a physical process, 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 Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, and AOV6852) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.
Product codes
HGX
Device Description
The subject devices, Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, AOV6852), are powered breast pumps to be used by lactating women to express and collect milk from their breast. The proposed devices are battery powered, software-controlled, and intended for a single user. The devices are intended for home use.
The subject devices have the following modes: Massage mode, Expression mode, Bionic mode, Frequency Conversion mode A, Frequency Conversion mode B, Continuous suck mode and Mixed mode; each mode has multiple levels. Massage mode is for stimulating breast milk secretion. Expression mode is for pumping breast milk. Bionic mode cycles between massaging for 2 cycles and expressing for 2 cycles. Frequency Conversion mode A cycles between massaging for 3 cycles and expressing for 1 cycle. Frequency Conversion mode B cycles between massaging for 3 cycles and expressing for 2 cycles. Continuous suck mode applies a lower suction followed by a hold and then a second increase in suction before release as a cycle. Finally, Mixed mode cycles between massaging for 3 cycles and expressing for 1 cycle at levels 1-6, then cycles between massaging for 3 cycles and expressing for 2 cycles at levels 7-9.
The subject devices can be used in a single or double pumping configuration and have anti-backflow protection. The subject devices have a USB connecting cable and matching power adapter to supply power to the device. The subject devices are provided non-sterile and are not to be sterilized by the user prior to use. Each device includes a breast shield assembly, collection bottles, tubing set, feeding accessories, power adapter (for charging), and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body, which contacts the user's 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 / Breastfeeding women
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Electrical Safety and Electromagnetic Compatibility based on IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC TR 60601-4-2.
- Biocompatibility meeting Attachment G recommendations of the 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" (issued September 2023).
- Software Verification in accordance with the FDA Guidance document "Content of Premarket Submissions for Device Software Functions" dated June 14, 2023.
- Performance Testing including:
- Suction strength testing: All test results complied with design specifications throughout the use life.
- Backflow and overflow testing: Ensured no liquid backflow into tubing or pump motor, even if the bottle is over-filled. Test results showed no backflow.
- Cycle speed testing: All test results complied with design specifications throughout the use life.
- Battery indicator testing: Demonstrated that the battery status indicator remains functional during its stated battery life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name 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.
May 9, 2024
Jiangxi AOV Maternity & Baby Products Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Shanghai 200120 CHINA
Re: K232477
Trade/Device Name: Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: July 2, 2023 Received: August 16, 2023
Dear Diana Hong:
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: 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.
1
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-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 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.
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-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
2
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,
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
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232477
Device Name
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
Indications for Use (Describe)
The Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, and AOV6852) is a powered breast pump to be used by lactating women to express and collect milk from their breast Pump 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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4
510(k) Summary K232477
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR 807.92.
- Date of 510(k) Summary Preparation: May 7, 2024 1.
- Sponsor Identification 2.
Jiangxi AOV Maternity & Baby Products Co., Ltd.
- Nanhuan Road, Industrial Park, Guixi, Jiangxi, China
Contact Person: Xueping Huang Tel: +86-701-3330799 Email: sales@aovbaby.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Tel: +86-21-22815850 Fax: 240-238-7587
4. Device Information
Trade Name: Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) Common Name: Powered Breast Pump Regulation Name: Powered Breast Pump Regulation Number: 21 CFR 880.5160 Product Code: HGX (Pump, Breast, Powered) Regulatory Class: II
- ડ. Predicate Device Information
510(k) Number: K211024 Product Name: Electric Breast Pump (Models 918, HF918)
The predicate device has not been subject to a design-related recall.
5
Device Description: 6.
The subject devices, Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, AOV6852), are powered breast pumps to be used by lactating women to express and collect milk from their breast. The proposed devices are battery powered, software-controlled, and intended for a single user. The devices are intended for home use.
The subject devices have the following modes: Massage mode, Expression mode, Bionic mode, Frequency Conversion mode A, Frequency Conversion mode B, Continuous suck mode and Mixed mode; each mode has multiple levels. Massage mode is for stimulating breast milk secretion. Expression mode is for pumping breast milk. Bionic mode cycles between massaging for 2 cycles and expressing for 2 cycles. Frequency Conversion mode A cycles between massaging for 3 cycles and expressing for 1 cycle. Frequency Conversion mode B cycles between massaging for 3 cycles and expressing for 2 cycles. Continuous suck mode applies a lower suction followed by a hold and then a second increase in suction before release as a cycle. Finally, Mixed mode cycles between massaging for 3 cycles and expressing for 1 cycle at levels 1-6, then cycles between massaging for 3 cycles and expressing for 2 cycles at levels 7-9.
| Model | Modes |
|---|---|
| AOV6818 | Massage mode, Expression mode, Bionic mode, Frequency Conversion mode B |
| AOV6821 | Massage mode, Expression mode, Continuous suck mode, Mixed mode |
| AOV6826 | Massage mode, Expression mode |
| AOV6830 | Massage mode, Expression mode, Frequency Conversion mode A |
| AOV6852 | Massage mode, Expression mode, Bionic mode, Frequency Conversion mode A |
Table 1 Working mode differences between 5 models of the proposed device
The subject devices can be used in a single or double pumping configuration and have anti-backflow protection. The subject devices have a USB connecting cable and matching power adapter to supply power to the device. The subject devices are provided non-sterile and are not to be sterilized by the user prior to use. Each device includes a breast shield assembly, collection bottles, tubing set, feeding accessories, power adapter (for charging), and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body, which contacts the user's breast.
7. Indications for Use:
The Electric Breast Pump (Models AOV6818, AOV6821, AOV6830, and AOV6852) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.
6
Comparison of Intended Use and Technological Characteristics 8.
The table below compares the intended use and technological characteristics of the subject and predicate device.
| ITEM | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Electric Breast Pump (Models | |||
| AOV6818, AOV6821, AOV6826, | |||
| AOV6830, and AOV6852) | |||
| K232477 | Electric Breast Pump (918, | ||
| HF918) | |||
| K211024 | |||
| Product Code | HGX | HGX | Same |
| Class | II | II | Same |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Indications for Use | The Electric Breast Pump (Models | ||
| AOV6818, AOV6821, AOV6826, | |||
| AOV6830, and AOV6852) is a | |||
| powered breast pump to be used by | |||
| lactating women to express and | |||
| collect milk from their breast. The | |||
| Electric Breast Pump is intended for | |||
| a single user. | The Electric Breast Pump (Models | ||
| 918, HF918) is a powered breast | |||
| pump to be used by lactating women | |||
| to express and collect milk from | |||
| their breast. The Electric Breast | |||
| Pump is intended for a single user. | Same | ||
| Patient Population | Breastfeeding women | Breastfeeding women | Same |
| Anatomical Sites | Breast | Breast | Same |
| Single User | Yes | Yes | Same |
| Provided | Yes | Yes | Same |
| Non-sterile | |||
| Direct user contact | Yes | Yes | Same |
| Re-usable | Yes | Yes | Same |
| Pumping Options | Single and Double Pumping | Single and Double Pumping | Same |
| Visual Indicator | LED | LED | Same |
| Backflow Protection | Yes | Yes | Same |
| Suction level | Massage mode: | ||
| AOV6818: 9 levels | |||
| AOV6821: 6 levels | |||
| AOV6826: 5 levels | |||
| AOV6830: 9 levels | |||
| AOV6852: 9 levels | 918&HF918: 5 levels | Different | |
| Expression mode: | 918&HF918: 7 levels | ||
| AOV6818: 9 levels | |||
| AOV6821: 9 levels | |||
| AOV6826: 9 levels | |||
| AOV6830: 9 levels | |||
| AOV6852: 9 levels | |||
| Bionic mode: | 918&HF918: 7 levels | ||
| AOV6818: 9 levels | |||
| AOV6852: 9 levels | |||
| Frequency Conversion mode B: | 918&HF918: 7 levels | ||
| AOV6818: 9 levels | |||
| Continuous suck mode: | 918&HF918: 1 level | ||
| AOV6821: 6 levels | |||
| Mixed mode: | / | ||
| AOV6821: 9 levels | |||
| Frequency Conversion mode A: | / | ||
| AOV6830: 9 levels | |||
| AOV6852: 9 levels | |||
| Mode and Suction | |||
| strength (±5 mmHg) | Massage mode: | Stimulation mode: | Different |
| AOV6818: 80-200 | 918&HF918:60-217.5 | ||
| AOV6821: 100-200 | |||
| AOV6826: 80-180 | |||
| AOV6830: 80-200 | |||
| AOV6852: 80-200 | |||
| Expression mode: | Expression mode: | ||
| AOV6818: 150-280 | 918&HF918:105-285 | ||
| AOV6821: 160-280 | |||
| AOV6826: 120-280 | |||
| AOV6830: 120-280 | |||
| AOV6852: 100-260 | |||
| Bionic mode: | Two-in One mode: | ||
| AOV6818: min:80/240 | |||
| max: 200/280 | 918&HF918: | ||
| Min: 75/90 | |||
| Max:150/285 | |||
| AOV6852: min:80/100 | |||
| max: 200/260 | |||
| Frequency Conversion mode B: | Dual-frequency mode: | ||
| AOV6818: min:80/240 | |||
| max:200/280 | 918&HF918: | ||
| Min: 67.5/105 | |||
| Max: 187.5/277.5 | |||
| Continuous suck mode: | Simulation mode: | ||
| AOV6821: min:60/200 | 918&HF918:187.5 | ||
| max: 110/280 | |||
| Mixed mode: | |||
| AOV6821: min: 100/220 | |||
| max:180/280 | / | ||
| Frequency Conversion mode A: | |||
| AOV6830: min:80/220 | |||
| max:200/280 | |||
| AOV 6852: min:80/100 | |||
| max:180/260 | / | ||
| Cycling Speed (±2 | |||
| times/Min) | Massage mode: | ||
| AOV6818: 39-95 | |||
| AOV6821: 36-55 | |||
| AOV6826: 42-91 | |||
| AOV6830: 30-98 | |||
| AOV6852: 59-128 | 918&HF918: 39-123 | Different | |
| Expression mode: | |||
| AOV6818: 25-61 | |||
| AOV6821: 23-44 | |||
| AOV6826: 24-60 | |||
| AOV6830: 23-60 | |||
| AOV6852: 40-89 | 918&HF918:24-84 | ||
| Bionic mode: | |||
| AOV6818: 30-50 | |||
| AOV6852: 47-105 | Two-in-One mode: | ||
| 918&HF918: 59-123 | |||
| Frequency Conversion mode B: | |||
| AOV6818: 32-55 | Dual-frequency mode: | ||
| 918&HF918: 39-85 | |||
| Continuous suck mode: | |||
| AOV6821: 32-42 | Simulation mode: | ||
| 918&HF918: 14 | |||
| Mixed mode: | |||
| AOV6821: 30-46 | / | ||
| Frequency Conversion mode A: | |||
| AOV6830: 28-52 | |||
| AOV6852: 60-116 | / | ||
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Biocompatibility | Meets Attachment G | ||
| recommendations (FDA Guidance | |||
| document "Use of International | |||
| Standard ISO 10993-1, "Biological | |||
| evaluation of medical devices - Part | |||
| 1: Evaluation and testing within a | No cytotoxicity, irritation or | ||
| sensitization | Same | ||
| risk management process" (issued September 2023)) |
Table 1 General and Technological Comparison
7
8
9
The subject and predicate device have same indications for use statements, and the same intended use. They are both used to express and collect milk from a lactating woman's breast.
The technological differences between the subject devices and the predicate devices are pumping options, suction levels, suction strength, and cycle speed. These differences do not raise different questions of safety and effectiveness.
9. Non-Clinical Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.
Electrical Safety and Electromagnetic Compatibility
- A IEC 60601-1:2005, AMD1:2012, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
-
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility
- ♪ 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.
-
IEC TR 60601-4-2:2016 Medical electrical equipment - Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical svstems
Biocompatibility
This device meets the recommendations of Attachment G of the 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" (issued September 2023). Therefore, this device is considered biocompatible.
Software Verification
- A Software verification in accordance with the FDA Guidance document "Content of Premarket Submissions for Device Software Functions" dated June 14, 2023.
Performance Testing
10
Suction strength of subject devices was tested. All the test results complied with the design specifications of the subject device throughout the use life.
Backflow and overflow testing were conducted to ensure that even if the bottle is over-filled, no liquid will backflow into the tubing, and therefore no liquid can backflow into the pump motor. The test results showed that there was no backflow during the test.
Cycle speed of subject devices was tested. All the test results complied with the design specifications of the subject devices throughout the use life.
Battery 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 Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) are as safe and effective as the predicate device and supports a determination of substantial equivalence.