(126 days)
Not Found
No
The device description focuses on the mechanical components and materials of a penile constriction device, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as being used to treat erectile dysfunction and related conditions, which are medical conditions, and it maintains penile rigidity by restricting venous outflow, thus performing a therapeutic function.
No
This device is a penile constriction device used to treat erectile dysfunction by restricting venous outflow, not to diagnose a condition.
No
The device description clearly outlines physical components made of elastic and soft silicone, a belt with a release loop, and a mounting tube made of acrylic. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Erco-Ribbon™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Erco-Ribbon™ Function: The Erco-Ribbon™ is a physical device applied to the body (in vivo) to maintain penile rigidity. It does not analyze any biological specimens.
- Intended Use: The intended use clearly describes a mechanical function to restrict venous outflow, not a diagnostic test.
- Device Description: The description details the physical components and how the device is used externally.
Therefore, the Erco-Ribbon™ falls under the category of a medical device, but specifically a non-IVD device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
78 LKY
Device 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 multiple 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).
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)
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 constricted Considered with the same intended use, but have different technological devices characteristics.
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.
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.
K841257, K844445, K891125, K901223, K902240, K960828
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
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