(137 days)
Not Found
Not Found
No
The device description and intended use do not mention any computational or data-driven components, and the "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is described as an "erection enhancement device" used to aid in the "normal erection process," which addresses a physiological function.
No
The device description and intended use indicate it is an "erection enhancement device" that functions to "slow venous outflow from the penis," which is a treatment or aid, not a diagnostic function.
No
The device description clearly states it is a "linear elastic tube with an O ring and ball locking unit," which are physical hardware components.
Based on the provided information, the ACTIS® (Venous Flow Controller) device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ACTIS® Function: The ACTIS® device is a physical device placed externally around the base of the penis to mechanically slow venous outflow. It does not involve testing any biological samples.
- Intended Use: The intended use is to aid in the normal erection process by physically controlling blood flow, not by analyzing biological markers.
Therefore, the ACTIS® device falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACTIS® (Venous Flow Controller) device is an erection enhancement device that is designed to slow venous outflow from the penis and thus aid in the normal erection process.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The ACTIS® (Venous Flow Controller) device is an erection enhancement device that is designed to slow venous outflow from the penis and thus aid in the normal erection process. It is a linear elastic tube with an O ring and ball locking unit that allows ease of adjustment to increase or decrease tension. Placement is around the base of the penis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
962915 1962915
510(k) SUMMARY, SAFETY AND EFFECTIVENESS 12.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92:
The ACTIS® (Venous Flow Controller) device is an erection enhancement device that is designed to slow venous outflow from the penis and thus aid in the normal erection process. It is a linear elastic tube with an O ring and ball locking unit that allows ease of adjustment to increase or decrease tension. Placement is around the base of the penis.
Directions and diagrams for proper use, care, and recommended duration of application of the ACTIS® device are part of the materials provided to the patient. The ease of adjustability provides a high degree of safety when used according to the directions.
VIVUS ACTIS® device is substantially equivalent to the marketed ENCORE Revive® series of tension rings.
Neii Hernandez
Neil Gesundheit, M.D. Vice President Clinical and Regulatory Affairs VIVUS, Inc.
Originally submitted July 25, 1996 Revised October 7, 1996