(121 days)
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.
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.
This document is a 510(k) premarket notification for "Performance Plus Confidence Rings" and the "Performance Plus Erection Inducer Device (E.I.D.)" for over-the-counter (OTC) use. As such, it primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested elements for a performance study are not applicable or not provided in this type of regulatory submission. The document explicitly states: "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." This indicates that extensive new performance studies were not conducted for the device itself, but rather the focus was on the labeling for OTC use.
Here's a breakdown based on the provided text, addressing each point as much as possible:
1. A table of acceptance criteria and the reported device performance
Not provided in this document.
The document asserts that the devices are "identical to the predicates... in materials, dimensions, performance, and intended use." This implies that the performance of the predicate devices implicitly meets whatever criteria were established for their original clearance, and the subject devices are expected to perform the same. No specific numerical performance metrics or acceptance criteria are listed for this 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided.
No new performance study data (test set) is presented in this document. The submission relies on the substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided.
No new performance study requiring expert ground truth establishment is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided.
No new performance study requiring adjudication is presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not provided.
This device is a physical medical device (penile constriction rings and vacuum pump), not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study and AI-related effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided.
This is a physical medical device, not an algorithm. Standalone performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided.
No new performance study data, and thus no new ground truth, is discussed. The "performance" is implicitly deemed equivalent to the predicate devices, which would have had their own evidentiary basis for clearance.
8. The sample size for the training set
Not applicable/Not provided.
No "training set" in the context of machine learning or an algorithm is relevant for this device.
9. How the ground truth for the training set was established
Not applicable/Not provided.
As above, no training set or ground truth in this context is relevant for this device.
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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 ringPenile vacuum pump |
| Proprietary Name: | The Performance Plus Confidence RingsThe Performance Plus Erection InducerDevice (E.I.D.) |
| Classification/Panel: | External penile rigidity devices have not been classified. The Urology panel would classify this device. |
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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.
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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
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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 \
§ 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.