VTU-1 VACUUM ERECTION SYSTEM

K971257 · Mckenna & Cuneo · LKY · Oct 3, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971257
• Device Name: VTU-1 VACUUM ERECTION SYSTEM
• Applicant: Mckenna & Cuneo
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Oct 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VTU-1 is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.

Device Story

VTU-1 Vacuum Erection System; mechanical device for treatment of impotence. Operates by creating negative pressure around penis to induce blood engorgement; maintains erection via constriction ring. Used by patient at home. Output is physical erection; assists in sexual function. Non-invasive; manual operation.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Mechanical vacuum-based system. Consists of vacuum cylinder, pump mechanism, and constriction rings. Non-powered or manual operation. No software or electronic components.

Indications for Use

Indicated for individuals suffering from impotence to aid in the production and maintenance of a penile erection.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT - 3 1997

Encore, Inc.
c/o Donald R. Stone, Esq.
McKenna & Cuneo, L.L.P.
1900 K Street, N.W.
Washington, D.C. 20006-1108

Re: K971257
VTU-1™ Vacuum Erection System
Dated: July 22, 1997
Received: July 23, 1997
Regulatory class: unclassified
Product code: 78 LKY

Dear Mr. Stone:

We have reviewed your Section 510(k) notification of intent to market the device referenced above 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 (Special Controls) or class III (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 the Electronic Product 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known): K971257

Device Name: VTU-1 Vacuum Erection System

Indications For Use:
The VTU-1 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)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971257

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)