(104 days)
The VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring.
Vacuum Pump - used to create an erection in men with erectlie dysfunction by means of an applied vacuum to the penis, which draws blood into the penlle corpora cavernosa causing the penis to become erect and rigid.
Constriction Ring - used to maintain penile rigidity in me with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the ald of a vacuum pump.
VED VALU and VED VALU ULTRA are designed to help you create an erection sufficient to penetrate the vagina and have sexual intercourse. They are intented for use by men who have full or parlal impotence. NOTE: Neither the VED VALU nor the VED VALU ULTRA is a contraceptive.
The VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring.
The provided text is a 510(k) premarket notification letter from the FDA regarding two vacuum erection devices, VED® VALU™ (Manual Pump) and VED® VALU™ (Electric Pump). This document primarily establishes that the devices are substantially equivalent to previously marketed devices and permits them to be marketed.
It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter and the accompanying "Indications For Use" form do not detail performance metrics, sample sizes for testing, expert qualifications, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance studies based on the provided text. The document is a regulatory approval letter, not a performance study report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1998
Mission Pharmacal Company c/o Mr. Andrew I. Sealfon President Repro-Med Systems, Inc. 24 Carpenter Road Chester, New York 10918
Re: K980948
VED® VALU™ (Manual Pump) Vacuum Erection Device - OTC VED® VALU™ (Electric Pump) Vacuum Erection Device - OTC Dated: June 1, 1998 Received: June 2, 1998 Regulatory Class: Unclassified Product Code: 78 LKY
Dear Mr. Sealfon:
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 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 requirements, 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 (301) 594-4613. Additionally, for questions on the promotion 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/dsmaldsmamain.html".
Sincerely vours
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) Device Name:
K980948 VED VALU (manual pump) VED VALU ULTRA (electric pump)
Indications For Use:
Intended Use and Indications
The VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring.
Vacuum Pump - used to create an erection in men with erectlie dysfunction by means of an applied vacuum to the penis, which draws blood into the penlle corpora cavernosa causing the penis to become erect and rigid.
Constriction Ring - used to maintain penile rigidity in me with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the ald of a vacuum pump.
VED VALU and VED VALU ULTRA are designed to help you create an erection sufficient to penetrate the vagina and have sexual intercourse. They are intented for use by men who have full or parlal impotence. NOTE: Neither the VED VALU nor the VED VALU ULTRA is a contraceptive.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Sather /
Division
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 98094 510(k) Number _
Prescription Use (per 21 CFR 801.109) OR
Over-The-Counter Use
§ 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.