(121 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest any AI/ML functionality.
Yes
The device is intended to help sustain an erection by limiting venous return from the major superficial veins of the penis, which addresses a physiological issue (penile venous system draining too rapidly or leaking blood). The E.I.D. system also induces penile rigidity for the same purpose.
No
The device, consisting of "Confidence Rings" and an "E.I.D. system," is described as an "external erection device" that helps "sustain an erection" by limiting venous return or inducing vascular engorgement. Its function is to assist with erection, not to diagnose a medical condition.
No
The device description clearly outlines physical components like rings, a vacuum pump, a vacuum chamber, inserts, lubricating gel, and a carrying case, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Performance Plus Confidence Rings and the E.I.D. system are external devices used to physically assist in achieving and sustaining a penile erection. They do not involve testing any biological samples.
The device's function is mechanical and external, not diagnostic.
N/A
Intended Use / Indications for Use
Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis.
The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.
Product codes
78LKY
Device Description
The Performance Plus Confidence rings are soft, pliable rings with a tab for removal. The E.I.D. system consists of a vacuum tumescence pump, a vacuum chamber with inserts, Confidence rings, lubricating gel, instructions for use, and a carrying case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
FEB 2 7 1998
2 pages Performance Plus Inc. 510(k) Notification: OTC Labeling Confidence Rings/Erection Inducer Device Attachment 1
Attachment #1
Performance Plus, Inc. Summary of Safety and Efficacy
Applicant Information:
1
Performance Plus, Inc. 801 South Church St., Suite 7 Mount Laurel, NJ 08054
510(k) Summary Prepared by:
Carolann Kotula Official Correspondent for Performance Plus, Inc. c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021
| Phone: | (516) 482-9001 |
|---|---|
| Fax: | (516) 482-0186 |
Date 510(k) Summary Prepared:
October 22, 19997
Name/Classification of the Device:
| Classification Name: | External penile rigidity device (product code 78LKY) |
|---|---|
| Common Name: | Penile constriction ring |
| Penile vacuum pump | |
| Proprietary Name: | The Performance Plus Confidence Rings |
| The Performance Plus Erection Inducer | |
| Device (E.I.D.) | |
| Classification/Panel: | External penile rigidity devices have not been classified. The Urology panel would classify this device. |
1
PG. Zor 2
Comparative Information: These devices are identical to the predicates, K891125(Confidence Rings) and K896060 (E.I.D) in materials,dimensions, performance, and intended use. The labeling is changed to provide the information needed for safe over the counter use of these devices.
Description of the Subject Devices: The Performance Plus Confidence rings are soft, pliable rings with a tab for removal. The E.I.D. system consists of a vacuum tumescence pump, a vacuum chamber with inserts, Confidence rings, lubricating gel, instructions for use, and a carrying case.
Intended Use: Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis.
The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird, with three curved lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 1998
Performance Plus, Inc. c/o Ms. Carolann Kotula Vice President RA/QA MDI Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021
Re: K974082
Performance Plus Confidence Rings - OTC Performance Plus Erection Inducer Device (E.I.D.) - OTC Dated: January 31, 1998 Received: February 3, 1998 Unclassified/Procode: 78 LKY
Dear Ms. Kotula:
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 ensement date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Felecal Food, Drug, and Comment Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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 Feleval Resulations, 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 (OS) for Medical Devices: General regulation (2) 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 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 deccribed 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) 594-4613. 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/cdr/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 3
Performance Plus Inc. 510(k) Notification: OTC Labeling Confidence Rings/Erection Inducer Device
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Performance Plus, Inc. Confidence Rings and Erection Inducer Device.
Indications for Use:
Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis.
The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.
(Please Do Not Write Below this Line/Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rabert R Matthing /
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974082
Prescription Use (per 21 CFR 801.109)
OR
Over the Counter Use \