(167 days)
Not Found
No
The device description details a mechanical constriction device with no mention of AI/ML components or functions.
Yes
The device is indicated as an "over-the-counter treatment for men with erection problem due to penile venous leakage." This statement clearly indicates its therapeutic purpose.
No
The device is described as a treatment for erection problems by constricting penile veins, not for diagnosing them.
No
The device description explicitly states it is comprised of a split ring made of latex-free, bio-compatible rubberplastic, indicating it is a physical hardware device.
Based on the provided information, the ERECXEL Adjustable Penile Bands device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The ERECXEL device is an external mechanical device applied to the body. Its function is to physically constrict penile veins to treat erection problems. It does not analyze any biological samples.
The description clearly states it's an "external penile constriction device" and its mechanism of action is physical constriction. This aligns with the definition of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The ERECXEL Adjustable Penile Bands are indicated as over-the-counter treatment for men with erection problem due to penile venous leakage. During erection, the ERECXEL Adjustable Penile Bands device helps to produce penile rigidity by constricting the penile veins around the base of the penis to restrict the flow of blood from leaving the penis.
Product codes
78 LKY
Device Description
ERECXEL Adjustable Penile Band is an external penile constriction device that is comprised of a split ring made of latex-free, bio-compatible rubberplastic. It is designed with fastening parts, consisting of interlocking teeth and cavities carried on each end of the ring. This simple mechanism permits the user to easily adjust the diameter of the device, allowing him to set its size to provide him the optimum degree of penile constriction that the device will effect during use.
The device is designed with a urethral groove to allow the normal ejaculation process to occur during its use. It is also provided with tabs on each fastening end to facilitate its quick release from the penile shaft and is available in different sizes to accommodate the wide variation of penile sizes among men.
Full product description, directions for its proper use and contraindication warnings are contained in the device labeling.
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
over-the-counter
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 2 0 2000
K993343
Page 1 of 2
510(K) SUMMARY for ERECXEL ADJUSTABLE PENILE BANDS External Constriction Device for Penile Rigidity
| Submitter: | Pacifico R. Burgos
ERECXEL Enterprises
3249 San Fernando Rd.
Los Angeles, CA 90065
Phone (323) 340-8269
Fax (323) 340-8690 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Same as Above |
| Date Originally Submitted: | September 30, 1999 |
| Trade Name: | ERECXEL Adjustable Penile Bands |
| Common Name: | External Device for Penile Rigidity |
| Equivalence is claimed to: | REJOYN Constriction Rings
POST-T-VAC, Inc. K981180 |
| CFR Number: | Unclassified |
Product Code: 78 LKY
Description of the Device:
ERECXEL Adjustable Penile Band is an external penile constriction device that is comprised of a split ring made of latex-free, bio-compatible rubberplastic. It is designed with fastening parts, consisting of interlocking teeth and cavities carried on each end of the ring. This simple mechanism permits the user to easily adjust the diameter of the device, allowing him to set its size to provide him the optimum degree of penile constriction that the device will effect during use.
1
K993343
Page 2 of 2
The device is designed with a urethral groove to allow the normal ejaculation process to occur during its use. It is also provided with tabs on each fastening end to facilitate its quick release from the penile shaft and is available in different sizes to accommodate the wide variation of penile sizes among men.
Full product description, directions for its proper use and contraindication warnings are contained in the device labeling.
Indicated Uses of the Device:
The ERECXEL Adjustable Penile Bands are indicated as over-the-counter treatment for men with erection problem due to penile venous leakage. During erection, the ERECXEL Adjustable Penile Bands device helps to produce penile rigidity by constricting the penile veins around the base of the penis to restrict the flow of blood from leaving the penis.
Comparison to Predicate Devices
The ERECXEL Adjustable Penile Band is similarly indicated for use and application as the predicate device. It significantly differs in technological design as provided by its fastening/adjust-ment apparatus. This technological innovation of the device is designed to improve the efficacy, safety and comfort during its use.
The predicate device is a set of non-adjustable solid constriction rings. The ERECXEL Adjustable Penile Band has a simple fastening apparatus for easily changing its diameter to fit the user's penile size and to adjust the level of penile constriction that it effects during use.
The predicate device uses accessories to be set around the penile base and also require significant strength for the use for its release from the penile shaft. The simple fastening/adjustment apparatus of the ERECXEL Adjustable Penile Band, and the tabs on each of its fastening ends allow easy setting and quick release from the penile shaft with no need of any accessories.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three parallel lines that curve upwards and then split into wavy lines at the bottom.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2000
Mr. Pacifico R. Burgos General Manager ERECXEL ENTERPRISES 3249 San Fernando Road Los Angeles, CA 90065
Re: K993343 ERECXEL Adjustable Penile Bands Dated: January 25, 2000 Received: January 27, 2000 Unclassified/Procode: 78 LKY
Dear Mr. Burgos:
We have reviewed your Section 510(k) notification of intent to market the device 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 pror 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 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 Pracice requirements, as set forth in the Quality System Requlation (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 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 requiations.
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 predication 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) 594-4591. Additionally, for question 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" (21CFR 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/odrh/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
510(K) Number : ______________________________________________________________________________________________________________________________________________________________
Device Name: ERECXEL Adjustable Penile Bands
Indications for Use:
The ERECXEL Adjustable Penile Bands are indicated as over-the-counter treatment for men with erection problem due to penile venous leakage. During erection, the ERECXEL Adjustable Penile Bands device helps to produce penile rigidity by constricting the penile veins around the base of the penis to restrict the flow of blood from leaving the penis.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use
or
Over-the-Counter Use $\checkmark$
Elind le. Sezmm
ion Sign-Off Division of Reproductive. Abdominal and Radiological Devic 510(k) Number
(Optional Format 1-2-96)