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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a breast pump, not a clinical study or effectiveness study for a medical device that uses AI. Therefore, it does not contain information about acceptance criteria or studies that prove an AI device meets acceptance criteria.

The document discusses the substantial equivalence of the imani i2Plus Breast Pump to a predicate device (imani i2) based on non-clinical performance testing.

Here's a breakdown of the information that is available, and why the requested AI-specific information is not present:

Information available in the document (and why it's not AI-specific):

A table of acceptance criteria and the reported device performance:
- The document provides a "Comparator Table for Subject and Predicate Devices" (Table 1) which compares technological characteristics like suction levels, cycles per minute, power supply, etc.
- This table highlights differences and states that these differences "do not raise different questions of safety and effectiveness." This implicitly serves as a form of acceptance criteria (i.e., the differences are acceptable because they don't compromise safety or effectiveness compared to the predicate).
- Performance data reported: Ranges for suction levels (e.g., 50-150 mmHg for massage, 80-270 mmHg for pumping) and cycles per minute (e.g., 65 CPM for stimulation, 24-55 CPM for pumping) are detailed for both the subject device (i2Plus, with and without iBox) and the predicate (i2).
- Why it's not AI-specific: This is a comparison of physical and functional specifications of a "powered breast pump," not an AI-powered diagnostic or therapeutic device.
Sample size used for the test set and the data provenance:
- The document describes "Performance Testing" which included "Vacuum level verification testing," "Backflow protection testing," "Use life testing," "Battery performance testing," and "Battery status indicator testing."
- It also mentions "Biocompatibility studies" and "Electrical Safety" and "Electromagnetic Compatibility" testing.
- No specific sample sizes for these tests are provided. The document generally states that "testing was conducted."
- Why it's not AI-specific: These are engineering and safety tests for a physical device, not a performance evaluation of an AI algorithm on a medical dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for a breast pump's performance involves mechanical measurements (vacuum, cycles per minute), material safety, electrical safety, and battery life, not expert interpretation of medical images or data.
- Why it's not AI-specific: There is no medical data interpretation involved in evaluating the breast pump's function in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to methods for resolving discrepancies in expert interpretations, which is not relevant for the type of non-clinical tests described for a breast pump.
- Why it's not AI-specific: Not relevant for this type of device submission.
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:
- No. This document describes a 510(k) submission for a breast pump. MRMC studies are typically for diagnostic imaging devices where human readers (e.g., radiologists) interpret images, sometimes with AI assistance.
- Why it's not AI-specific: Not relevant to a breast pump.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. There is no AI algorithm in this device that would have a "standalone performance."
- Why it's not AI-specific: Not relevant to a breast pump.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on engineering specifications and recognized safety standards. For example, vacuum levels are measured against specified mmHg ranges, biocompatibility is evaluated against ISO standards, and electrical safety against IEC standards.
- Why it's not AI-specific: This is a fundamental difference in the nature of "ground truth" for a mechanical/electrical device versus an AI algorithm.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, and therefore has no "training set."
- Why it's not AI-specific: No AI, no training set.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.
- Why it's not AI-specific: No AI, no training set, no ground truth for a training set.

In summary, this document pertains to the regulatory clearance of a standard powered breast pump and not an AI-powered medical device. Therefore, the information requested regarding AI-specific acceptance criteria and study details is not present.

Summary

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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.

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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

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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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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, LeeSenior 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 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

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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 breastpumpK222573	imani i2K202037Predicate 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 isa powered breast pump to beused by lactating women toexpress and collect milk fromtheir breast. The imani i2PlusBreast Pump is a single userdevice.	The imani i2 breast pump is apowered breast pump to be usedby lactating women to expressand collect milk from theirbreasts. The imani i2 breastpump is a single user device.	Same Intended Use
Pump Options	Single or Double	Single	Similar
Cycling controlmechanism	Microcontroller	Microcontroller	Same

Table 1: Comparator Table for Subject and Predicate Devices

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Backflow Protection	Yes	Yes	Same
Mobile Application	No	No	Same
Indicators	Yes, LCD	Yes, LCD	Same
Single User	Yes	Yes	Same
Media separation(backflowprotection)	Yes	Yes	Same
Expression pattern	2-Phase	2-Phase	Same
Power supply	Li-Ion Battery or mains whenconnected to iBox	Li-Ion Battery	Same
Suction levels(massage)	I2Plus:50 - 150 mmHg, 5 levelsWith iBox:150 - 200 mmHg, 5 levels	50 - 150 mmHg, 5 levels	Different. Differences in massagesuction levels do not raisedifferent questions of safety andeffectiveness
Suction levels(pumping)	I2Plus:80 - 270 mmHg, 5 levelsWith iBox:150 - 270 mmHg, 9 levels	80 - 270 mmHg, 5 levels	Different. Differences inpumping suction levels do notraise different questions of safetyand effectiveness
Cycles per minute(stimulation)	I2Plus:65 CPMWith iBox:60 CPM	65 CPM	Different. Differences inavailable cycle speed do not raisedifferent questions of safety andeffectiveness.
Cycles per minute(pumping)	I2Plus:24-55 CPM, 5 levelsWith iBox:30-40 CPM, 3 levels availableat each suction pressure	24-55 CPM, 5 levels	Different. Differences inavailable cycle speed do not raisedifferent questions of safety andeffectiveness.
Suction levels	I2Plus:5 massage, 5 pumpingWith iBox:5 massage, 9 pumping	5 massage, 5 pumping	Different. Differences inavailable suction levels do notraise different questions of safetyand effectiveness.
User Interface	On-Off switch, vacuumadjustment, LCD chargingstatus indicator and working hrindicator	On-Off switch, vacuumadjustment, LCD indicator	Different. Differences inavailable suction levels do notraise different questions of safetyand effectiveness.
Adjustable SuctionLevels	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

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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.

Regulation Number and Section

§ 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).