(218 days)
Not Found
No
The description details a standard powered breast pump with pre-programmed modes and adjustable settings, with no mention of AI or ML capabilities. The software validation is for a "Moderate level of concern" device, which is typical for devices without complex AI/ML algorithms.
No
The device is a breast pump used to express and collect milk, not to treat a disease or condition.
No
The device is a breast pump, used to express and collect milk. Its intended use and description do not mention any diagnostic capabilities.
No
The device description explicitly lists multiple hardware components including a main pump body, diaphragm, cap, valve, milk bottle connector, storage packset, air hose hub, and AC adapter. While it includes software, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The imani i1 breast pump is designed to physically express and collect breast milk from a lactating woman's body. It does not analyze or test any biological specimens to provide diagnostic information.
- Intended Use: The stated intended use is "to be used by lactating women to express and collect milk from their breasts." This is a mechanical function, not a diagnostic one.
The information provided clearly describes a medical device used for a physical process (milk expression), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The imani i1 is a powered breast pump to be used by lactating women to express and collect milk from their breasts. This device is intended for multiple users.
Product codes
HGX
Device Description
The imani i1 breast pump is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. The pump component of this device can be used by multiple users using separate collection accessories. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). The imani i1 breast pump is comprised of a main pump body, diaphragm and cap for backflow protection, valve, milk bottle connector, a breastmilk storage packset (30pcs), and air hose hub. The only user-contacting material is polypropylene (breast shield). The device is provided non-sterile.
The imani i1 breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and breast pumping mode, are pre-programmed with variable levels and cycle speed (pump speed). The subject device is AC-powered (AC adaptor: 100 - 240 V, 50/60 Hz, 550 mA [Output: 12VDC, 2A]).
The imani i1 breast pump provides the following user features:
- Three displays for level of cycle, time, and vacuum
- Eight buttons for power on/off, mode selection, decrease vacuum and cycle, increase vacuum and cycle, and light control
- Breast Pumping Mode: This mode is used to express and collect milk from breast. This mode includes 12 vacuum levels and 6 cycle speed levels.
- Massage Mode: This mode is used to massage the breast before pumping. This mode includes 6 vacuum levels and 2 cycle speed levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breasts
Indicated Patient Age Range
lactating 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 Test Summary
- Electrical Safety/Electromagnetic Compatibility
Testing in accordance with the following standards:
- AAMI / ANSI ES 60601-1 /A1:2012, 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 Disturbances -Requirements and Tests
- 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 [Including: Technical Corrigendum 1 (2011)]. (General II (ES/EMC))
-
Software Validation
Software verification and validation testing were conducted as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software in Medical Devices." The software for this device was considered a Moderate level of concern. -
Biocompatibility
Biocompatibility testing was conducted in accordance with the 2020 FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Testing included the following assessments:
- Cytotoxicity per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2010
- Irritation per ISO 10993-10:2010
The user-contacting materials were shown to be biocompatible.
- Bench Performance Testing
Bench performance testing was conducted to demonstrate device performance, includinq vacuum level settings, cycle speed settings, and backflow/cross-contamination protection. Device specifications were met for all tests conducted.
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 26, 2021
Imani Co. % Do Gyun Lim Senior Consultant Global Medical Standard Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu Seoul. 03909 Republic of KOREA
Re: K202045
Trade/Device Name: imani i1 Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: January 27, 2021 Received: January 29, 2021
Dear Do Gyun Lim:
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 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) K202045
Device Name imani il
Indications for Use (Describe)
The imani il is a powered breast pump to be used by lactating women to express and collect milk from their breasts. This device is intended for multiple users.
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 K202045
1. Submitter's Information
- . Name of Manufacturer: imani Co.
| • | Address: | 147, Hwasan-ro, Idong-eup, Cheoin-gu, Yongin-si,
Gyeonggi-do, Republic of Korea [Zip.17135] |
|---|----------------|------------------------------------------------------------------------------------------------|
| • | Contact Name: | Hyo-Soon, Hwang |
| • | Telephone No.: | +82-31-323-4435 |
| • | Email Address: | jea@hello-imani.com |
| • | Date Prepared | February 26, 2021 |
2. Device Information
| Trade/Device Name | imani i1 |
|---|---|
| Common Name | Powered breast pump |
| Regulation Number | 21 CFR 884.5160 |
| Regulation Name | Powered breast pump |
| Regulation Class | Class II |
| Product Code | HGX (Pump, Breast, Powered) |
3. Predicate Device Information
- 510(k) Number: K190810
- OPERA, OPERA Eco . Trade/Device Name:
The predicate device has not been subject to a design-related recall.
4. Description of the Device
The imani i1 breast pump is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. The pump component of this device can be used by multiple users using separate collection accessories. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). The imani i1 breast pump is comprised of a main pump body, diaphragm and cap for backflow protection, valve, milk bottle connector, a breastmilk storage packset (30pcs), and air hose hub. The only user-contacting material is polypropylene (breast shield). The device is provided non-sterile.
4
The imani i1 breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and breast pumping mode, are pre-programmed with variable levels and cycle speed (pump speed). The subject device is AC-powered (AC adaptor: 100 - 240 V, 50/60 Hz, 550 mA [Output: 12VDC, 2A]).
The imani i1 breast pump provides the following user features:
- Three displays for level of cycle, time, and vacuum -
- । Eight buttons for power on/off, mode selection, decrease vacuum and cycle, increase vacuum and cycle, and light control
- Breast Pumping Mode: This mode is used to express and collect milk from breast. This mode includes 12 vacuum levels and 6 cycle speed levels.
- -Massage Mode: This mode is used to massage the breast before pumping. This mode includes 6 vacuum levels and 2 cycle speed levels.
5. Indications for use
The imani i1 is a powered breast pump to be used by lactating women to express and collect mills from their breasts. This device is intended for multiple users.
6. Comparison of Intended Use and Technological Characteristics
The table below presents comparisons between the subject device (imani i1) and the legally marketed predicate device (OPERA, OPERA Eco):
| Subject Device (K202045) | Predicate Device (K190810) | |
|---|---|---|
| Product Name | imani i1 | OPERA, OPERA Eco |
| Manufacturer | imani Co. | Unimom Co. |
| Indications for Use | The imani i1 is a powered breast pump to be used by lactating women to express and collect milk from their breasts. This device is intended for multiple users. | The OPERA & OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. |
| Single user device | Multiple users | Multiple users |
| Submission Number | K202045 | K190810 |
| Product Code | HGX | HGX |
| Device Class | II | II |
| Sterility | Not sterile | Not sterile |
| User Interface and Controls | ||
| User Controls | Display, button for on/off, mode selection, increase/decrease vacuum and cycle, and light control | Switch control |
- Power, Vacuum / Cycle Up or Down
- Mode switch
LCD Display |
| Pump Options | Single or double | Single or double |
| Accessories | Breast shield (size 24 mm, 28 mm [sold separately]) Protector (diaphragm and cover cap) Valve Milk bottle connector Adaptor (Output: 12 V d.c., 2A) Breastmilk Storage PackSet Air Hose Hub | Air tube Breast shield kit with back-flow protector Bottle Bottle cover Nipple Bottle cap Bottle disk Bottle stand Adapter |
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| Subject Device (K202045) | Predicate Device (K190810) | |
|---|---|---|
| Air tube connector Silicone massager | ||
| Specifications | ||
| Power sources | AC/DC wall adapter (12 V d.c., 2A) | AC/DC Adapter (14 V DC, 2A) |
| Rechargeable lithium polymer | ||
| battery (Opera) | ||
| Pump type | Diaphragm | Diaphragm |
| Suction strength | 30 – 270 mmHg | 45-280 mmHg |
| Cycles per minute | ||
| (massage mode) | 70-80 cycles/min (adjustable), 2 | |
| levels | 60-100 cycles/min | |
| Suction levels (massage | ||
| mode) | 6 | 5 |
| Cycles per minute | ||
| (expression mode) | 30-55 cycles/min (adjustable), 6 | |
| levels | 26-42 cycles/min | |
| Suction levels (pumping | ||
| mode) | 12 | 8 |
| Backflow Protection | Yes | Yes |
The subject and predicate device do not have identical indications for use statements; however, they have the same intended use, i.e., for collection of breast milk from the breasts of lactating women, and for use by multiple users.
The subject and predicate device have different technological features, including the user interface, vacuum range, cycle speed/range, and power sources. These technological differences do not raise different questions of safety or effectiveness.
7. Non-Clinical Test Summary
The following performance data were provided in support of the substantial equivalence determination:
- Electrical Safety/Electromagnetic Compatibility
Testing in accordance with the following standards:
- . AAMI / ANSI ES 60601-1 /A1:2012, 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 Disturbances -Requirements and Tests
- 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 [Including: Technical Corrigendum 1 (2011)]. (General II (ES/EMC))
2) Software Validation
Software verification and validation testing were conducted as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software in Medical Devices." The software for this device was considered a Moderate level of concern.
6
3) Biocompatibility
Biocompatibility testing was conducted in accordance with the 2020 FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Testing included the following assessments:
- Cytotoxicity per ISO 10993-5:2009
- . Sensitization per ISO 10993-10:2010
- . Irritation per ISO 10993-10:2010
The user-contacting materials were shown to be biocompatible.
4) Bench Performance Testing
Bench performance testing was conducted to demonstrate device performance, includinq vacuum level settings, cycle speed settings, and backflow/cross-contamination protection. Device specifications were met for all tests conducted.
8. Conclusion
The subject and predicate device have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject device is as safe and effective as the predicate device and support the determination of substantial equivalence.