Search Results
Found 1 results
510(k) Data Aggregation
(205 days)
Apex is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support.
Apex is a hand-held, home-use device designed to treat female stress urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
The provided text describes the 510(k) premarket notification for the Apex device, a non-implanted muscle stimulator for treating female stress urinary incontinence. The acceptance criteria and the study proving the device meets these criteria are primarily focused on demonstrating substantial equivalence to a predicate device (InTone K110179) and ensuring safety for over-the-counter use.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in a quantitative performance table (e.g., Sensitivity X%, Specificity Y%). Instead, it focuses on demonstrating substantial equivalence to a predicate device and confirming safety and intended performance through various tests for its over-the-counter use.
The "Acceptance Criteria" implicitly stem from comparability to the predicate and compliance with relevant standards and usability requirements for an OTC device. "Reported Device Performance" is presented in terms of compliance with these standards and successful completion of the studies.
| Acceptance Criteria (Implicitly based on Predicate Equivalence and OTC Safety) | Reported Device Performance (Apex) |
|---|---|
| Intended Use Equivalence: Treat female stress urinary incontinence by applying stimulation to pelvic floor muscles. | Substantially equivalent to InTone (K110179). Both apply electrical stimulation to strengthen pelvic floor muscles. Apex specifically designed for female stress urinary incontinence. |
| Primary Function Equivalence: Delivery of electrical stimulation. | Identical to InTone (K110179). |
| Warnings/Precautions Equivalence & Clarity: Improve end-user understanding for OTC use. | Substantially equivalent to InTone (K110179). Reworded for Apex to improve end-user understanding for OTC use. Validated through Human Factors and Usability Testing. |
| Contraindications Equivalence & Clarity: Improve end-user understanding for OTC use and ensure proper self-limitation. | Substantially equivalent to InTone (K110179). Reworded and reordered for Apex to improve end-user understanding for OTC use. Validated through collaboration with the supervising physician from the Human Factors and Usability Testing. |
| Labeling Summary Clarity: Improve end-user understanding. | Substantially equivalent to InTone (K110179). User manual reworded for Apex to improve end-user understanding for OTC use. Manual validated through collaboration with the supervising physician from Human Factors and Usability Testing. Enhanced labeling includes educational consumer-focused box, detailed IFU, quick reference guide, and instructional video. |
| Electrical Safety Standards Compliance: Meet IEC 60601-1 and IEC 60601-2-10 standards. | The device complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety. |
| Electromagnetic Compatibility (EMC) Standards Compliance: Meet IEC 60601-1-2 standard. | The device complies with the IEC 60601-1-2 standard for EMC. |
| Biocompatibility: Meet ISO 10993-1 for tissue contact. | Biocompatibility evaluation conducted per ISO 10993-1. Insertion Unit is tissue contacting for <24 hours. Completed Cytotoxicity, Sensitization, and Irritation tests. |
| Software Verification & Validation: Adhere to FDA guidance for "moderate" level of concern. | Software verification and validation conducted per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software deemed "moderate" level of concern. Passed all testing. |
| Human Factors/Usability (OTC specific): Enable self-identification of SUI, self-limitation if contraindicated, and safe use based on provided instructions. | A human factors/usability study was conducted. Objectives: 1) determine if a subject can self-identify as having SUI using package labeling, 2) self-limit usage if a contraindication is present, 3) safely use Apex using only the IFU. Results were favorable, leading to further labeling enhancements (educational box, detailed IFU, quick reference guide, inspirational video). |
| Risk Management: Risks reduced to as low as reasonably practicable, with acceptable risk/benefit analysis. | Evaluated for risks per ISO 14971. Risks reduced to as low as possible, and risk/benefit analysis was acceptable. |
| Technological Equivalence (Key Parameters): | Apex Performance compared to InTone (Predicate):- Power Source: 4 AAA Alkaline battery vs. 4/5 AA NiMH. Substantially equivalent; both battery powered, operate at 3.3V/5V. AAA chosen for ease of use/acquisition; battery insertion validated via HF/Usability. - Automatic Overload Trip: No vs. Yes. Substantially equivalent; Apex circuit design does not introduce safety risks, max stimulation is self-limiting. - Automatic No-Load Trip: No vs. Yes. Substantially equivalent; Apex circuit design does not introduce safety risks, max stimulation is self-limiting. - Indicator Display (Low Battery): No vs. Yes. Substantially equivalent; not a safety risk as device powers off when battery is too low. - Time On Off: 1s at 50Hz, 2s no stimulation (Apex) vs. 1s at 50Hz, 2s no stim & 2s at 13Hz, 2.1s no stim (InTone). Substantially equivalent; identical for 50Hz treatment algorithm. - Total Session Time: 10-15 minutes (5-10min stim, 5min self-directed cont.) vs. 12 minutes. Substantially equivalent; small variances allowed for end user preferences. - Max Output Voltage (500Ω): 34.2 V vs. 34.7 V. Substantially equivalent; slightly lower, 1% deviation within circuit component tolerance. - Max Output Current (500Ω): 68.2 mA vs. 69.1 mA. Substantially equivalent; slightly lower, 1% deviation within circuit component tolerance. - Maximum Phase Charge (500Ω): 13.6 µC vs. 13.8 µC. Substantially equivalent; slightly lower, 1% deviation within circuit component tolerance. - Max Current Density: 11.6 mA/cm² vs. 11.8 mA/cm². Substantially equivalent; slightly lower, <2% deviation within circuit component tolerance. - Max Average Power Density (500Ω): 3.95 mW/cm² vs. 4.05 mW/cm². Substantially equivalent; slightly lower, <2% deviation within circuit component tolerance. - Biofeedback: None vs. Air pressure, 0-2 psi. Feature removed; not a safety concern as biofeedback is an enhanced feature and its omission does not adversely impact safety. - Control housing material: N/A vs. ABS plastics. Feature removed; Apex is a single unit, control unit not present. - Packaging or Expiration Dating: NA vs. 1 year for insertion unit. Substantially equivalent; not needed due to material stability. - Operational Method: Home use, Over-the-counter vs. Clinic or Home use, under direction of physician. Substantially equivalent; OTC indication does not impact safety as stimulation is end-user controlled; additional safety features (max frequency, auto shut-off) built-in. - Patient Interaction (Override): No vs. Yes. Substantially equivalent; Apex is a single unit, designed for ease of use (powering off resets stimulation to 0). |
2. Sample sized used for the test set and the data provenance
- Human Factors / Usability Study (Test Set): The document mentions that a human factors/usability study was "conducted to assess the safety of the Apex device for over-the-counter use." However, it does not specify the sample size used for this study.
- Data Provenance: The document does not explicitly state the country of origin for the human factors/usability study or whether it was retrospective or prospective. Given the FDA submission, it implicitly refers to a study conducted to support the US market. The nature of a usability study suggests it would be prospective (new data collected on actual users).
- Clinical Literature Evaluation: This involved evaluating existing literature, so it's a retrospective review of published studies. No specific sample size for a "test set" applies here as it's a review, not primary data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Human Factors / Usability Study: The document states that "InControl Medical collaborated with the supervising physician from the Human Factors and Usability Testing" for labeling enhancements and validation of contraindication understanding. This implies at least one supervising physician served as an expert. Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond "supervising physician."
- Clinical Literature Evaluation: This involved an "appraisal of each article," which would typically be done by qualified individuals, but the document does not specify the number of experts or their qualifications for this appraisal.
4. Adjudication method for the test set
- For the Human Factors / Usability Study, the document mentions "collaboration with the supervising physician" for validating understanding of contraindications and refining labeling. This suggests an expert review/adjudication process for the usability and labeling aspects, but a formal (e.g., 2+1, 3+1) adjudication method is not explicitly described.
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 MRMC comparative effectiveness study was done. The Apex device is an electrical muscle stimulator, not an AI-assisted diagnostic device that would typically involve human readers interpreting images. The study focuses on the device's direct performance, safety for OTC use, and equivalence to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Again, this question is more relevant to AI/diagnostic algorithms. For the Apex device, the "standalone" performance relates to its electrical stimulation characteristics, which were tested for compliance with electrical safety and EMC standards. The electrical stimulation parameters and safety features (e.g., self-limiting output, auto shut-off) represent the device's "standalone" functional performance, which were verified through the "Electrical Safety and Electromagnetic Compatibility Testing" and presented in the equivalence table.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Human Factors / Usability Study: The "ground truth" for this study was the correct understanding and safe application of the device by the end-user based on the provided instructions and labeling, as verified by the supervising physician. It's effectively a form of user performance/behavioral data assessed against safety and usability benchmarks.
- Clinical Literature Evaluation: The ground truth for efficacy and safety was established by the peer-reviewed scientific literature on electrical stimulation for stress urinary incontinence. This relies on the outcomes data and conclusions from those published studies.
- Engineering/Electrical Testing: The ground truth was defined by international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which the device demonstrated compliance with.
8. The sample size for the training set
- The document does not mention a traditional "training set" as would be used for machine learning. The studies described are for verification and validation of a hardware device and its usability, not for training a model.
9. How the ground truth for the training set was established
- As there's no mention of a traditional machine learning "training set," this question is not applicable in the context of this device's submission.
Ask a specific question about this device
Page 1 of 1