(44 days)
Not Found
No
The device description details a mechanical vacuum pump and constriction rings, with no mention of AI or ML components or functions.
Yes
The device is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence, which is a therapeutic purpose.
No
The device's intended use is to aid in the production and maintenance of a penile erection for individuals suffering from impotence. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of physical components like silicone rings, a plastic cylinder, and a battery-powered vacuum pump, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the production and maintenance of a penile erection in individuals suffering from impotence. This is a therapeutic purpose, directly affecting the body, not a diagnostic one.
- Device Description: The device description details a mechanical system (vacuum pump, cylinder, constriction rings) used to physically induce and maintain an erection. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the VTU-E is a therapeutic device used to treat a physical condition, not a diagnostic device used to analyze samples for medical information.
N/A
Intended Use / Indications for Use
The VTU-E is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
Product codes
LKY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile
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.
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
PI91
Appendix C
510(k) Summary JAN - 9 1998 Encore, Inc. VTU-E™ Vacuum Erection System
General Information on Submitter: I.
Encore, Inc. Name: 2300 Plantside Drive, Louisville, KY 40299-1928 Address: (502) 499-1556 Telephone: (502) 499-1840 Fax: Name of Contact Person: Mr. Boyd Bennett Date Summary Prepared: November ______________________________________________________________________________________________________________________________________________
General Information on Device II.
VTU-ETM Vacuum Erection System Name:
External Penile Rigidity Device Classification Name:
Predicate Device: VTU-1™ (510(k) No. K971257) III.
Description of the Device: IV.
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.
V. Intended Use:
The VTU-E™ is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
Technological Characteristics of Device Compared to Predicate Device: VI. The VTU-E™ and the VTU-1™ have identical technological
characteristics with the exception of the type of vacuum pump used to reduce the air pressure within the penile cylinder. The VTU-1™ used a manually operated pump, while the VTU-E™ uses a battery-powered pump. Both pumps serve the same purpose and have similar perfomance characteristics.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 1998
ENCORE, Inc. c/o Donald R. Stone McKenna & Cuneo, L.L.P. 1900 K. Street, N.W. Washington, DC 20006-1108 Re: K974470
VTU-E™ Vacuum Erection System Dated: November 26, 1997 Received: November 26, 1997 Unclassified/Procode: 78 LKY
Dear Mr. Stone:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitts diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
VTU-E Vacuum Erection System Device Name:
Indications For Use:
The VTU-E is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K974970 510(k) Number _
State Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ✓
(Optional Format 1-2-96)