(44 days)
The VTU-E is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
The VTU-E™ consists of four silicone rubber constriction rings and a plastic penile cylinder attached to a battery-powered vacuum pump. The penis is placed into the penile cylinder and the vacuum pump is used to reduce the air pressure within the cylinder and thus cause a penile erection. Once the penis is erect, the silicone rubber ring is placed around the base of the penis in order to maintain the erection.
This 510(k) summary for the VTU-E™ Vacuum Erection System does not contain detailed acceptance criteria or a specific study proving the device meets them in the way modern AI/ML device submissions typically do.
The submission focuses heavily on demonstrating substantial equivalence to a predicate device (VTU-1™) by highlighting their identical technological characteristics, except for the type of vacuum pump. Because of this, the "acceptance criteria" here are implicitly based on the predicate device's established safety and effectiveness.
However, I can extract and infer information relevant to your request based on the provided document.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| A. Intended Use Equivalence: Aid in the production and maintenance of a penile erection in individuals suffering from impotence. | The VTU-E™ has the identical intended use as the predicate VTU-1™. |
| B. Technological Equivalence (except vacuum pump): Consists of silicone rubber constriction rings and a plastic penile cylinder. | The VTU-E™ has these components, identical to the predicate device. |
| C. Vacuum Pump Functionality: Effectively reduces air pressure within the penile cylinder to cause erection. | The battery-powered pump in VTU-E™ serves the same purpose and has similar performance characteristics to the manually operated pump in VTU-1™. |
| D. Erection Maintenance: Silicone rubber ring maintains the erection. | This functionality is inherent in the design and identical to the predicate device. |
Explanation: The "acceptance criteria" are not formally stated with numerical targets as they would be for a novel device. Instead, acceptance is predicated on demonstrating that the VTU-E™ is functionally equivalent to a legally marketed predicate device (VTU-1™) and thus shares its safety and effectiveness profile. The core "proof" is the statement that the battery-powered pump has similar performance characteristics to the manually operated pump. No specific performance metrics (e.g., vacuum pressure achieved, time to erection, duration of erection) are mentioned.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not provided.
- Data Provenance: Not applicable/Not provided.
Explanation: There is no mention of a "test set" in the context of clinical trials or performance testing for this specific submission. The submission relies on the established safety and effectiveness of the predicate device (VTU-1™).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not provided.
- Qualifications: Not applicable/Not provided.
Explanation: No "ground truth" was established based on expert consensus for a test set as described. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided.
Explanation: No clinical study or test set requiring an adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No.
- Effect size: Not applicable.
Explanation: This type of study is entirely irrelevant to this device and submission type. The VTU-E™ is a mechanical medical device, not an imaging diagnostic AI.
6. Standalone (Algorithm Only) Performance Study
- Was it done?: No.
Explanation: This is not an AI/algorithm-based device. No standalone algorithm performance was assessed.
7. Type of Ground Truth Used
- Type of Ground Truth: Historical performance and regulatory acceptance of the predicate device (VTU-1™).
Explanation: The "ground truth" for this submission is implicitly the established safety and effectiveness of the previously cleared VTU-1™. The VTU-E™ is deemed safe and effective because it is substantially equivalent to a device already deemed safe and effective.
8. Sample Size for the Training Set
- Sample Size: Not applicable/Not provided.
Explanation: This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable/Not provided.
Explanation: No training set was used.
§ 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.