(90 days)
The ISIS iQ DUO Twin Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
The ISIS iQ DUO Twin Electronic Breast Pump is a safe and effective powered breast pump for expressing and collecting breast milk from the breasts of a lactating woman. The pumping can be performed on one breast or two breasts simultaneously, from independent diaphragms. The diaphragms within the pump are activated by a 12V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 12V DC power supply, twin tubing with data cable, hand controller, Avent ISIS standard manual breast pump parts, and feeding bottles. The hand controller is designed to replicate the handle of the Avent standard manual ISIS Breast Pump, and is used to control the frequency and level of vacuum. A sealed AC/DC transformer powers the ISIS iQ DUO Breast Pump.
The ISIS iQ DUO Twin Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the strokelcycle of the control handle lever. After a comfortable manual pumping cycle has been established, the user engages the automatic pumping mode by depressing the control button on the hand controller. In the automatic mode, the pumping cycle is stored and controlled by the microprocessor. The user can switch between the automatic mode and manual mode at any time by repeatedly depressing the control button.
All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.
The provided text describes the ISIS iQ DUO Twin Electronic Breast Pump and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This type of regulatory submission often relies on non-clinical performance data and limited clinical data to show safety and effectiveness, rather than extensive comparative effectiveness studies typical for novel medical devices or AI-powered diagnostics.
Given the nature of this submission, direct acceptance criteria in a quantitative, prescriptive manner (e.g., "sensitivity must be >90%") are not explicitly stated for individual device performance metrics in the way one might expect for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the demonstration of conformance to applicable safety and performance standards and the overall conclusion of substantial equivalence to a pre-existing legally marketed device (the Medela Pump in Style Advanced Breast Pump).
Here's an analysis based on the provided text, structured to address your specific points where information is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Submission) | Reported Device Performance |
|---|---|
| Safety and Effectiveness: Consistent with predicate device. | Device is a "safe and effective powered breast pump". "The technological differences described above do not raise new concerns regarding the safety and effectiveness." |
| Electrical, Mechanical, and Environmental Standards Conformance: | Meets IEC 60601-1: 1998 + A1: 1991, A2: 1995, Corrigendum: 1994; ANSI/UL 60601:2003; EN-60601-1-1: 1990 + AI: 1993, AI 1: 1993, A12: 1993, A2: 1995, AI3: 1996, Corrigendum: 1994; CAN/CSA C22.2 No. 601.1 issued: 1994/01/05 Rev: 1997/01/01; EN60601-1-2: 2001; and FCC Part 15 for a class B device. |
| Biocompatibility/Material Safety (Milk/Tissue Contacting Parts): | "All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility." |
| Usability/Human Factors: Safe and effective use by consumers, appropriate User Guide. | "Studies demonstrated that consumers can safely and effectively use the ISIS iQ under conditions of actual use; and that the User Guide, Quick Reference Guide, ISIS iQ DUO's physical design, and other human factors characteristics are appropriate for consumers." |
| Functional Equivalence: Performs the intended function of expressing and collecting milk. | "Intended to express and collect milk from the breasts of a lactating woman." The device operates in manual and automatic modes, controlling vacuum and frequency, similar to the predicate's purpose but with different control mechanisms. |
2. Sample size used for the test set and the data provenance
- Sample Size: 72 study subjects. This was split into:
- 48 study subjects (24 English-speaking and 24 Spanish-speaking) for the Human Factors/Labeling Study.
- 24 study subjects for the Home Use Study.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, as they involve actively recruiting and observing subjects using the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. Given that the studies assess usability and safe/effective use for a breast pump, "ground truth" in the traditional sense of a diagnostic outcome is less applicable. The "ground truth" here is more about user experience, comprehension, and the device's ability to perform its function without adverse events, which would have been assessed by study personnel rather than clinical experts establishing a medical "ground truth."
4. Adjudication method for the test set
This information is not provided in the text. For human factors and home use studies, adjudication methods (like 2+1 review) are not typically used in the same way they would be for diagnostic accuracy studies. Assessment would likely be based on reported user feedback, observation, and analysis of safety events.
5. 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The ISIS iQ DUO Twin Electronic Breast Pump is a mechanical medical device, not an AI diagnostic, therefore, this type of study is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. The device is a mechanical breast pump. There is no "algorithm only" performance to evaluate in the context of an AI device. Its performance relies on its mechanical and electrical function, as well as user interaction. The "microprocessor" controls the pumping cycle based on user input, not autonomously interpreting medical data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic devices (e.g., pathology for cancer detection) is not directly applicable here. For this breast pump, the "truth" or primary endpoints assessed in the studies relate to:
- User Safety and Effectiveness: Whether users could safely and effectively operate the device and express milk. This would be observed and reported.
- Usability/Human Factors: The clarity and appropriateness of the User Guide and the device's physical design. This would be assessed through user feedback and observation.
- Conformance to Standards: Verification that the device meets defined electrical, mechanical, and biocompatibility standards.
8. The sample size for the training set
Not Applicable. This is a hardware medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no AI model or training set, the concept of establishing ground truth for it is irrelevant in this context.
§ 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).