ERCO-RIBBON

{0}------------------------------------------------ ERCONS, Inc. ••• 66 Overlook Terrace, suite 2E New York, NY, 10040 Tel. 1-212-927 3275 Fax. 1-212-927 7387 Ka72353 # ersum16s #### 510(k) SUMMARY for OCT 2 8 1997 # ERCO-RIBBON™ Constriction Device for External Penile Rigidity System Submitter: Dr. Yakov Altshuler, Vice President Date: July 3, 1997 Trade name - Erco-Ribbon™ Common name - constriction device for external penille rigidity system Equivalence is claimed to: | 1. ErecAid | Osbon Medical Systems, Ltd. | K841257 | | |------------------------------------------|-----------------------------|---------|--------------| | 2. Revive | Revive System Corp. | K844445 | | | 3. Confidence | Performance, Inc. | K891125 | | | 4. VED | Mission Pharmacal Co. | K901223 | | | 5. VET | VET-CO, Inc. | K902240 | | | 3. Pos-T-Vac | POS-T-VAC | K960828 | | | Code of Federal Regulation (CFR) Number: | | | Unclassified | | Product Code: | | | 78 LKY | Ercons, Inc. PATENT PENDING Erco-Ribbon™ CONFIDENTIAL {1}------------------------------------------------ ## Intended Use Erco-Ribbon™ is used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump or naturally). Erco-Ribbon can be used for patients with following conditions: a) separately: premature ejaculation firm but short lasting erection b) as a part of a vacuum constriction system Diabetes Venous leakage Prostatectorny Hypertension Psychogenic condition Radiation therapy Spinal cord injury Ercons, Inc. PATENT PENDING Erco-Ribbon™ CONFIDENTIAL {2}------------------------------------------------ #### DESCRIPTION A constriction ribbon is made of elastic and soft silicone with generally rectangular cross section. A belt with release loop is used for keeping the constrictor in a prearranged tightened position and for unlocking the ribbon . The material conforms FDA regulation for devices contacting human skin. For unlocking of the constrictor. the belt's release loop is pulled forward. The belt slips off, allowing easy unwrapping of the constricting ribbon. A mounting tube comprises a segment of acrylic tube. For arrangement of Erco-Ribbon™ penile constriction device, the ribbon is wrapped with the tension by multyple turns over the segment of the proximal end of the mounting tube. (or a vacuum chamber, when Erco-Ribbon ™ is used as a part of a vacuum constriction system), #### SUBSTANTIAL EQUIVALENCY COMPARISON Comparison of design and performance of marketable constriction rings and Erco-Ribbon is made with consideration of the impact of device's design on its safety and effectiveness . marketable Predicate devices and Erco-Ribbon™ are constriction Considered with the same intended use, but have different technological devices characteristics. Ercons, Inc. Inc. Come PATENT PENDING Erco-Ribbon™ CONFIDENTIAL {3}------------------------------------------------ Predicate devices: To provide sufficient inward pressure on erected penis, one or more of constriction rings have to be placed at the edge of an open end of the vacuum chamber. Rings are molded of natural or synthetic rubber with different durometer numbers, usually in the range of 30 to 60 and are manufactured in large, medium and small sizes. To provide acceptable inward pressure, selection for individual users is based on size, durometer and a number of constriction rings used together. Despite high cost due to a number of expensive molds, there is no way to provide smooth control of the pressure which happens to be excessive and causes discomfort, numbness, bruises. Placement of rings presents certain technical difficulties. Recognizing this problem, special cone-shaped applicators are added to the system. Applicators facilitate the problem, but complicate the system and increase its cost. Discomfort and pain may be caused by twisting of doubled rings during their transfer onto the penis and because of intertwining with pubic hair. Removal of constriction ring from erected penis could be painful too, especially when two or more rings are used together. In this case after removal of the first ring the penis is still engorged, as the remaining ring prevents blood outflow. Erco-Ribbon ™: There are countless possibilities of providing proper pressure of the constricting device during fabrication: by selection of constricting ribbon's material, cross section, length. Erco-Ribbon™ PATENT PENDING Ercons, Inc. CONFIDENTIAL 4 {4}------------------------------------------------ With the constrictor of given properties and dimensions, the user may prearrange desirable pressure by changing the tension and number of turns during wrapping. The present design radically reduces major technical difficulties of constriction ring associated with its placement on the vacuum chamber. A multyturn constriction ribbon is much easier to apply than a solid constriction ring as the force necessary to extend multyturn constrictor is much lower than for solid ring. ### SUMMARY: Erco-Ribbon ™ has the same intended use as Predicate devices. Technological differences of Erco-Ribbon™ provide superior safety and performance. Erco-Ribbon™ is substantially equivalent to constriction devices that have been marketed for many years. Ercons, Inc. PATENT PENDING Erco-Ribbon™ CONFIDENTIAL 5 {5}------------------------------------------------ Public Health Service . . . . . . . DEPARTMENT OF HEALTH & HUMAN USA Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 8 1997 Yakov Altshuler, Ph.D. Vice President Ercons, Inc. 66 Overlook Terrace, Suite 2E New York, New York 10040 Dear Dr. Altshuler: Re: K972353 Erco-Ribbon™ Dated: September 18, 1997 Received: September 22, 1997 Regulatory class: unclassified Product code: 78 LKY 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, 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 OS 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 yitro 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/dsmamain.html". Sincerely yours. 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 {6}------------------------------------------------ 510(k) Number K972353 Erco-Ribbon "" Device Name: ### Indications for use: Erco-Ribbon™ is used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump or naturally). Erco-Ribbon can be used for patients with following conditions: a) separately: premature ejaculation firm but short lasting erection b) as a part of a vacuum constriction system #### Diabetes Venous leakage Prostatectomy Hypertension Psychogenic condition Radiation therapy Spinal cord injury Concurrence of CDRH2 Office of Device Evaluation (ODE) Amed H.P. (Division Sign, Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K972353 510(k) Number. **Prescription Use** (Per 21 CFR 801-109) OR Over-The-Counter Use