(44 days)
The Impower device is used to assist in creating and maintaining an erection suitable for sexual intercourse. This device is intended for the treatment or management of erectile dysfunction/impotence.
The Imagyn Medical Technologies, Inc.'s Impower System vacuum erection device ("Impower") consists of a vacuum pump, tension rings, seal rings, clear plastic cylinder, and a tube of personal lubricant.
The provided text is a 510(k) summary for the Imagyn Medical Technologies, Inc.'s Impower™ Vacuum Erection Device. This submission primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a performance study with defined acceptance criteria and detailed study results as would be found in a clinical trial or a more extensive performance evaluation for a novel device.
Therefore, many of the requested elements for describing acceptance criteria and study details are not present in this type of regulatory document. I will fill in the information based on what is available and explicitly state when information is not provided.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the provided document. The primary 'acceptance criteria' for a 510(k) in this context is demonstrating substantial equivalence to a legally marketed predicate device. | The device uses "the same vacuum method and technological characteristics to create and maintain an erection as the predicate device." It also uses "the same components and materials as the predicate device." Therefore, it is "substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not provided. This submission relies on a comparison to a predicate device and its known performance, rather than new testing on a specific "test set" of patients.
- Data Provenance: Not applicable/Not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/Not provided.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, not applicable for this 510(k) submission.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This is a mechanical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the sense of a test set with established ground truth for performance metrics. The "ground truth" for this 510(k) submission is the performance and safety profile of the predicate device (Impower (Catalyst) System, 510(k) No. K920409), to which the new device is being compared for substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/Not provided. This is a mechanical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable.
Summary of the Study per the provided text:
The provided document describes a 510(k) notification of intent to market the Impower™ Vacuum Erection Device. The "study" presented here is a substantial equivalence comparison to a legally marketed predicate device, the Impower (Catalyst) System (K920409).
The core of the submission is the claim that the new Impower device is substantially equivalent because:
- It uses the same vacuum method and technological characteristics to create and maintain an erection as the predicate device.
- It uses the same components and materials as the predicate device.
The FDA reviewed this claim and determined that the device is substantially equivalent for its stated indications for use (treatment or management of erectile dysfunction/impotence). This means that, based on the comparison provided, the FDA found no new questions of safety or effectiveness were raised by the new device compared to the predicate. No new clinical trials or performance studies with specific acceptance criteria and patient cohorts are described in the provided summary as being part of this 510(k) submission process.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.