(218 days)
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.
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.
This document describes the regulatory submission for the imani i1 powered breast pump (K202045) and compares it to a predicate device (OPERA, OPERA Eco; K190810). The information provided pertains to the device's technical specifications and non-clinical testing to demonstrate substantial equivalence, rather than a study proving performance against specific acceptance criteria in a clinical setting with human readers or AI.
The document does not contain information about a clinical study comparing the imani i1 to established acceptance criteria in the manner requested. Specifically, it does not include:
- A table of acceptance criteria and reported device performance in a clinical context.
- Sample sizes used for a test set, data provenance, ground truth establishment by experts, or adjudication methods for a clinical study.
- Information regarding Multi-Reader Multi-Case (MRMC) comparative effectiveness studies, effect sizes of human readers with/without AI assistance, or standalone algorithm performance.
- The type of ground truth used in a clinical study (e.g., pathology, outcomes data).
- Sample size for a training set or how ground truth for a training set was established.
The provided text focuses on the following non-clinical testing and comparisons:
1. Acceptance Criteria and Device Performance (Non-Clinical Bench Testing):
The document broadly states that "Device specifications were met for all tests conducted" under the "Bench Performance Testing" section. It does not provide a detailed table of explicit acceptance criteria or specific numerical results for these non-clinical tests beyond confirming compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Met AAMI / ANSI ES 60601-1 /A1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015 standards. |
| Electromagnetic Compatibility | Met IEC 60601-1-2:2014 and IEC 60601-1-11:2015 standards. |
| Software Validation | Conducted per 2005 FDA guidance for "Moderate" level of concern. |
| Biocompatibility | Passed Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), and Irritation (ISO 10993-10:2010), showing user-contacting materials are biocompatible. |
| Bench Performance Testing | Demonstrated device performance for vacuum level settings, cycle speed settings, and backflow/cross-contamination protection. "Device specifications were met for all tests conducted." |
2. Sample Size and Data Provenance (for the non-clinical tests mentioned):
Not applicable in the context of clinical "test sets" as described in the prompt. The testing performed is laboratory-based and does not involve human subjects or clinical data in the sense of patient cohorts and outcomes.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The ground truth for electrical safety, EMC, software validation, biocompatibility, and bench performance testing is based on established industry standards, test protocols, and engineering specifications, not expert clinical consensus on patient data.
4. Adjudication Method:
Not applicable to the described non-clinical testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported in this document. The device is a physical breast pump, not an AI or imaging diagnostic tool that would typically undergo such a study.
6. Standalone (Algorithm Only) Performance:
Not applicable. The device is a physical powered breast pump, not an algorithm or AI system.
7. Type of Ground Truth Used (for non-clinical tests):
The ground truth for the non-clinical tests (electrical safety, EMC, software validation, biocompatibility, and bench performance) is based on:
- Established national and international standards: e.g., AAMI / ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993 series.
- FDA guidance documents: e.g., "Guidance for the Content of Premarket Submissions for Software in Medical Devices," "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
- Device specifications: as defined by the manufacturer for parameters like vacuum levels, cycle speed, and backflow protection.
8. Sample Size for Training Set:
Not applicable. This document describes non-clinical testing for a physical medical device, not the training of an AI algorithm or model.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set mentioned for an AI algorithm.
§ 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).