(51 days)
Not Found
No
The document describes a mechanical vacuum constriction device and does not mention any AI or ML components or functionalities.
Yes
The device is described as creating and sustaining an erection in men with erectile dysfunction, which is a therapeutic purpose.
No
Explanation: The device, Erco-Vac ™ -C, is described as a vacuum constriction device used to create and sustain an erection. Its function is to facilitate an erection for men with erectile dysfunction, not to diagnose a condition.
No
The device description clearly describes a physical vacuum constriction device with a vacuum chamber and a constriction device, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Erco-Vac™-C Function: The description clearly states that Erco-Vac™-C is a vacuum constriction device used externally on the penis to create and sustain an erection. It does not involve the analysis of any bodily specimens.
Therefore, based on the provided information, the Erco-Vac™-C falls under the category of a medical device used for treatment/management of a condition, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Erco-VacTM -C is used to create an erection in men with erectile dysfunction and for augmenting of male potency. Erco-Vac TM -C can be used for patients with following conditions: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic condition Impotence due to radiation therapy Spinal cord injury
Product codes (comma separated list FDA assigned to the subject device)
78 LKY
Device Description
Erco-Vac ™ -C is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible after removal of vacuum chamber. Erco-Vac ™ -C is an improved version of Erco-Vac ™ which was developed with the goal to overcome known deficiencies and limitations of vacuum constriction devices. Novelty elements, introduced into the system's structure are listed below: 1. Transferable air tight penile seal 2. Constriction device with controllable inward radial pressure 3. Cuff and quick release loop for convenient mounting of constriction device on the vacuum chamber and safe removal from the penis. 4. Automatic vacuum release 5. Transferring device 6. Vacuum chamber with a domed closed end, customised to the user's penile anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients
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.)
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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, K901223, K960828, K981357
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.
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ERCONS, Inc. 66 Overlook Terrace, suite 2E New York, NY, 10040 Tel. 1-212-927 3275 Fax. 1-212-927 7387
510(k) SUMMARY for ERCO-VAC TM -C
External Penile Rigidity System
Submitter: Dr. Yakov Altshuler, Vice President Date: Dec.23, 1998 Trade name - Erco-Vac ™ -C
Common name -external penile rigidity device
Equivalence is claimed to:
| 1. ErercAid | Osbon Medical Systems, Ltd. | K841257 | |
|---|---|---|---|
| 2. VED | Mission Pharmacal Co. | K901223 | |
| 3. Pos-T-Vac | POS-T-VAC | K960828 | |
| 4. Erco-Vac TM | ERCONS, Inc. | K981357 | |
| Code of Federal Regulation (CFR) Number: | Unclassified | ||
| Product Code: | 78 LKY |
Ercons, Inc. PATENT PENDING Erco-Vac ™ -C Confidential Dec. 1998
1
SECTION 514 SPECIAL CONTROLS
Special Controls under Section 514 of the Act have not been developed for these devices. Reference is made in later sections of this document to voluntary industry standards.
DEVICE DESCRIPTION
Intended Use
Erco-Vac ™ -C is used to create an erection in men with erectile dysfunction and for augmenting of male potency
Erco-Vac ™ -C can be used by patients with following conditions: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic condition Impotence due to radiation therapy Spinal cord injury
Structure features
Erco-Vac ™ -C is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible after removal of vacuum chamber.
Ercons, Inc. PATENT PENDING Erco-Vac ™ -C Confidential Dec. 1998
2
Vacuum constriction treatment is now recognized as the first line remedy, preferable to other treatments of erection dysfunction - sex therapy, self injections. venous and arterial surgery, implantation of penile prosthesis. At the same time, known marketable devices have deficiencies and drawbacks which make them unacceptable to many potential users.
Erco-Vac ™ -C is an improved version of Erco-Vac ™ which was developed with the goal to overcome known deficiencies and limitations of vacuum constriction devices. Novelty elements, introduced into the system's structure are listed below:
-
- Transferable air tight penile seal
-
Constriction device with controllable inward radial pressure
-
Cuff and quick release loop for convenient mounting of constriction device on the vacuum chamber and safe removal from the penis.
-
Automatic vacuum release
-
Transferring device
- Vacuum chamber with a domed closed end, customised to the user's penile anatomy.
Comparison of technological characteristics
1. Air tight seal
Predicate devices:
The air tight seal is provided by pressing the open end of the vacuum chamber against the abdomen. To adjust to different penile sizes and to prevent scrotal tissue from sucking in, adapter inserts are needed. Ercons, Inc. PATENT PENDING Erco-Vac ™ -C Confidential Dec. 1998
3
3
Erco-Vac ™ -C:
Transferable air tight penile seal and baffle allow adjustment to different penile girth without additional inserts.
2. Constriction devices
Predicate devices:
Constriction device generally comprise rings of elastic rubber with C-shaped handles or tabs for removal from erect penis. To provide sufficient inward pressure, one or more of constriction rings with different durometer have to be placed at the edge of an open end of the vacuum chamber. Despite high cost due to a number of expensive molds, there is no way to provide smooth control of the inward pressure, which may happen to be excessive and cause discomfort, numbness, bruises.
Erco-Vac ™ -C:
Constriction device is an elastic ribbon wrapped with multiple turns (Erco-Ribbon ™ -C). The user may prearrange desirable inward pressure by changing the tension and number of turns during wrapping.
Other advanced features substantially improve performance of Erco-Vac ™ -C
3. Automatic vacuum release
During transfer of penile seal and constricting device the vacuum in the chamber releases automatically.
Ercons, Inc. PATENT PENDING Erco-Vac ™ -C Confidential Dec. 1998
4
4
- Transferring device provides easy slip off of the constriction device and transferable penile seal onto erect penis.
SUMMARY:
)
Erco-Vac ™ -C has the same intended use as Predicate devices. Technological differences of Erco-Vac ™ -C provide superior performance. and safety.
Ercons, Inc. PATENT PENDING Erco-Vac ™ -C Confidential Dec. 1998
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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Yakov Altshuler, Ph.D. Vice President ERCONS. Inc. 66 Overlook Terrace, Suite 2E New York, NY 10040
Re: K990006
Erco-VacTM -C, Vacuum Erection Device Dated: December 23, 1998 Received: January 4, 1999 Unclassified/Procode: 78 LKY
Dear Dr. Altshuler:
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 legally marketed predicate 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 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 requlations.
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/dsma/dsmamain.html".
Sincerely yours,
S.T.
Capt, Daniel G. Schultz, M.D. Acting 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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Erco-Vac™-C
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Indications for use:
510(k) Number
Device Name:
Erco-Vac™ -C is used to create an erection in men with erectile dysfunction and for augmenting of male potency.
Erco-Vac TM -C can be used for patients with following conditions:
Diabetes
Venous leakage
Prostatectomy
Hypertension
J
Psychogenic condition
Impotence due to radiation therapy
Spinal cord injury
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR
Over-The-Counter Use
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devic 990000 510(k) Number _