(190 days)
Not Found
No
The description details a standard electrically powered breast pump with user-controlled modes and vacuum levels. There is no mention of adaptive algorithms, learning from user data, or any other characteristics indicative of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
A breast pump is considered a general wellness device as its primary function is to express breast milk, not to treat or diagnose a disease or condition. While it supports breastfeeding, which has health benefits, the device itself does not provide therapeutic treatment.
No
Explanation: The device is described as a powered breast pump used to express and collect milk, not to diagnose a medical condition.
No
The device description explicitly lists multiple hardware components (funnel, insert, milk collector, valve, protector, charging cable, adaptor, cap, iBox accessory, pump body, LCD display, motor unit, battery) and describes their physical functions and interactions. While it mentions embedded software, the device is clearly a physical breast pump with integrated hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breast." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical pump that applies suction to the breast to extract milk. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in a sample
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is clearly a medical device, specifically a breast pump, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The imani i2Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The imani i2Plus Breast Pump is a single user device.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The imani i2Plus Breast Pump is an electrically powered wearable single breast pump consisting of the following key components: a funnel, insert, milk collector, valve, protector, charging cable, adaptor, cap, and iBox accessory. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free. The main body includes a press-button user interface, pump body, and LCD display. Pumping can be performed on one breast (single pumping) or two breasts (double pumping) when configured with the iBox accessory. The user interface allows the user to switch from massage to pumping mode and control the vacuum levels within those modes. Massage and pumping modes consist of 5 vacuum levels and fixed cycle speeds when used standalone. Massage mode consists of 5 vacuum levels and 1 cycle speed and pumping mode consists of 9 vacuum levels and 3 cycle speeds for each level.
The i2Plus in standalone configuration is capable of providing vacuum levels from 50-150 mmHg at a fixed cycling rate of 65 cycles per minute in massage mode and vacuum levels from 80-270 mmHg with cycling rates from 24-55 cycles per minute in pumping mode. The i2Plus with the iBox accessory is capable of providing vacuum levels from 150-200 mmHg at a fixed cycling rate of 60 cycles per minute in massage mode and vacuum levels from 150-270 mmHg with cycling rates from 24-55 cycles per minute in pumping mode. The imani i2Plus is charged with a 5 V DC USB type C adaptor and powered by a 3.7 V, 1400mAh internal rechargeable lithium-ion battery. The motor unit operates on embedded software updates by endusers are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.
The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
All other components (i.e., motor unit) of the subject device are not in contact with the breast.
The i2Plus operates on a rechargeable battery when standalone and does not function when charging. When configured with iBox, the pump is only operable when connected with the AC adapter. The rechargeable battery can be charged using the external USB adapter if the motor unit is not in operation.
All milk contacting components are compliant with 21 CFR 174-179.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Home environment
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)
Biocompatibility
Biocompatibility studies, including irritation, cytotoxicity, and sensitization testing were performed in accordance with the 2020 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". The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety
Testing was conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). IEC 6213-2:2017. 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 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.
Software
Software was evaluated as recommended in the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Performance Testing
Other performance testing was conducted to show that the device meets its 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.
- 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.
Key Results
The results of the performance testing described above demonstrate that the imani i2Plus Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 3. 2023
imani Co. % Kyung Jin, Lee Senior Consultant Global Medical Standard Consulting Co., Ltd. 34. Sangamsan-ro. Mapo-gu Seoul, 03909 Korea
K222573 Re: Trade/Device Name: imani i2Plus Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 3, 2023 Received: February 3, 2023
Dear Kyung Jin, Lee:
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
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
2
Indications for Use
510(k) Number (if known) K222573
Device Name imani i2Plus Breast Pump
Indications for Use (Describe)
The iman i2Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The imani i2Plus Breast Pump is a single user device.
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) |
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3
510(k) Summary - K222573
1. Submitter Information
| Applicant: | imani Co. |
|---|---|
| Contact: | Hwang Hyo-Soon |
| Phone: | +82-31-323-4435 |
| Email: | jea@hello-imani.com |
| Address: | 147, Hwasan-ro, Idong-eup, Cheoin-gu, |
| Yongin-si, Gyeonggi-do, Republic of Korea | |
| [Zip.17135] |
2. Correspondent Information
| Contact: | Kyung Jin, Lee
Senior Consultant |
|----------|----------------------------------------|
| Firm: | Global Medical Standard Consulting Co. |
| Phone: | + 82 (02) 604-96049 |
| Email: | kjlee@gmsc.kr |
- Date prepared: February 27, 2023
4. Device Information
| Device Name: | imani i2Plus Breast Pump |
|---|---|
| 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: | imani i2 |
|---|---|
| 510(k) Number: | K202045 |
| Manufacturer: | Imani Co. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The imani i2Plus Breast Pump is an electrically powered wearable single breast pump consisting of the following key components: a funnel, insert, milk collector, valve, protector, charging cable, adaptor, cap, and iBox accessory. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free. The main body includes a press-button user interface, pump body, and LCD display. Pumping can be performed on one breast (single pumping) or two breasts (double pumping) when configured with the iBox accessory. The user interface allows the user to switch from massage to pumping mode and control the vacuum levels within those modes. Massage and pumping modes consist of 5 vacuum levels and fixed cycle speeds when used standalone. Massage mode consists of 5 vacuum levels and 1 cycle speed and pumping mode consists of 9 vacuum levels and 3 cycle speeds for each level.
The i2Plus in standalone configuration is capable of providing vacuum levels from 50-150 mmHg at a fixed cycling rate of 65 cycles per minute in massage mode and vacuum levels from 80-270 mmHg with cycling rates from 24-55 cycles per minute in pumping mode. The i2Plus with the iBox accessory is capable of
4
providing vacuum levels from 150-200 mmHg at a fixed cycling rate of 60 cycles per minute in massage mode and vacuum levels from 150-270 mmHg with cycling rates from 24-55 cycles per minute in pumping mode. The imani i2Plus is charged with a 5 V DC USB type C adaptor and powered by a 3.7 V, 1400mAh internal rechargeable lithium-ion battery. The motor unit operates on embedded software updates by endusers are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.
The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
All other components (i.e., motor unit) of the subject device are not in contact with the breast.
The i2Plus operates on a rechargeable battery when standalone and does not function when charging. When configured with iBox, the pump is only operable when connected with the AC adapter. The rechargeable battery can be charged using the external USB adapter if the motor unit is not in operation.
All milk contacting components are compliant with 21 CFR 174-179.
7. Indications for Use
The imani i2Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The imani i2Plus Breast Pump is a single user device.
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.
| | imani i2Plus breast
pump
K222573 | imani i2
K202037
Predicate Device | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| | Subject Device | | |
| Product Name | imani i2Plus Breast Pump | imani i2 | N/A |
| Product Code | HGX | HGX | Same |
| Regulation Number | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Regulatory Class | Class II | Class II | Same |
| Patient Population | Lactating Women | Lactating Women | Same |
| Indications for Use | The imani i2Plus Breast Pump is
a powered breast pump to be
used by lactating women to
express and collect milk from
their breast. The imani i2Plus
Breast Pump is a single user
device. | The imani i2 breast pump is a
powered breast pump to be used
by lactating women to express
and collect milk from their
breasts. The imani i2 breast
pump is a single user device. | Same Intended Use |
| Pump Options | Single or Double | Single | Similar |
| Cycling control
mechanism | Microcontroller | Microcontroller | Same |
Table 1: Comparator Table for Subject and Predicate Devices
5
| Backflow Protection | Yes | Yes | Same |
|---|---|---|---|
| Mobile Application | No | No | Same |
| Indicators | Yes, LCD | Yes, LCD | Same |
| Single User | Yes | Yes | Same |
| Media separation | |||
| (backflow | |||
| protection) | Yes | Yes | Same |
| Expression pattern | 2-Phase | 2-Phase | Same |
| Power supply | Li-Ion Battery or mains when | ||
| connected to iBox | Li-Ion Battery | Same | |
| Suction levels | |||
| (massage) | I2Plus: | ||
| 50 - 150 mmHg, 5 levels | |||
| With iBox: | |||
| 150 - 200 mmHg, 5 levels | 50 - 150 mmHg, 5 levels | Different. Differences in massage | |
| suction levels do not raise | |||
| different questions of safety and | |||
| effectiveness | |||
| Suction levels | |||
| (pumping) | I2Plus: | ||
| 80 - 270 mmHg, 5 levels | |||
| With iBox: | |||
| 150 - 270 mmHg, 9 levels | 80 - 270 mmHg, 5 levels | Different. Differences in | |
| pumping suction levels do not | |||
| raise different questions of safety | |||
| and effectiveness | |||
| Cycles per minute | |||
| (stimulation) | I2Plus: | ||
| 65 CPM | |||
| With iBox: | |||
| 60 CPM | 65 CPM | Different. Differences in | |
| available cycle speed do not raise | |||
| different questions of safety and | |||
| effectiveness. | |||
| Cycles per minute | |||
| (pumping) | I2Plus: | ||
| 24-55 CPM, 5 levels | |||
| With iBox: | |||
| 30-40 CPM, 3 levels available | |||
| at each suction pressure | 24-55 CPM, 5 levels | Different. Differences in | |
| available cycle speed do not raise | |||
| different questions of safety and | |||
| effectiveness. | |||
| Suction levels | I2Plus: | ||
| 5 massage, 5 pumping | |||
| With iBox: | |||
| 5 massage, 9 pumping | 5 massage, 5 pumping | Different. Differences in | |
| available suction levels do not | |||
| raise different questions of safety | |||
| and effectiveness. | |||
| User Interface | On-Off switch, vacuum | ||
| adjustment, LCD charging | |||
| status indicator and working hr | |||
| indicator | On-Off switch, vacuum | ||
| adjustment, LCD indicator | Different. Differences in | ||
| available suction levels do not | |||
| raise different questions of safety | |||
| and effectiveness. | |||
| Adjustable Suction | |||
| Levels | Yes | Yes | Same |
| Design | Milk Collector and Flange | Milk Collector and Flange | Same |
The indications for use of the subject and predicate device are similar, and they 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 pumping options, control mechanism, user interface, backflow protection, and device indicators. However, as shown in the table above, there are technological differences between the subject and predicate device, including different vacuum and cycle specifications, power supply, wear configurations, and 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
6
Biocompatibility studies, including irritation, cytotoxicity, and sensitization testing were performed in accordance with the 2020 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 10993-10:2010) ●
- Irritation (ISO 10993-10:2010) ●
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety
Testing was conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). IEC 6213-2:2017. 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 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
Software
Software was evaluated as recommended in the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Performance Testing
Other performance testing was conducted to show that the device meets its 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. .
- 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 imani i2Plus Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.