(75 days)
The Xtend ring is used to maintain engorgement of the penis for men that are having difficulty with organic or psychological erectile dysfunction.
The Xtend rings are used by men with erectile dysfunction to improve their ability to have sexual intercourse. When they have a sufficient erection for intercourse a Xtend constriction ring (K980752) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The Xtend ring kit consists of a set of 4 rings. The rings are elastic pharmaceutical quality material which come with an applicator and ring removal hooks. The ring safety removal loops were performance tested for strength. All warnings and precautions from the FDA internet address, www.fda.gov/cdch/ode/oxponrig.html, are included in the premarket notification.
The provided text describes a medical device called the "Xtend Ring Kit" and its 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. The core of this submission is about regulatory approval based on equivalence, rather than a clinical study demonstrating performance against specific medical criteria.
Therefore, the specific quantitative details regarding acceptance criteria, study design parameters (like sample size for test/training sets, expert qualifications, adjudication methods), and statistical outcomes (like effect size for MRMC studies or standalone algorithm performance) are not present in the provided document. The document focuses on regulatory compliance and mechanical performance testing, not diagnostic or therapeutic efficacy studies with clinical endpoints.
However, based on the information available, we can infer some "acceptance criteria" from a regulatory/engineering perspective and the "study" that proves these criteria were met, though it's not a clinical effectiveness study in the typical sense for AI/diagnostic devices.
Here's an analysis based on the provided text:
Acceptance Criteria and device performance
| Acceptance Criteria | Reported Device Performance/Evidence |
|---|---|
| Safety: Device must be removable within 30 minutes and not cause harm. | The rings "MAY be worn for a maximum of thirty minutes before it MUST be removed." This is a critical instruction for safe use. The safety removal loops were "performance tested for strength." |
| Material Quality: Rings are made of suitable material. | The rings "are elastic pharmaceutical quality material." |
| Kit Completeness: Kit includes necessary components for use and removal. | The kit "consists of a set of 4 rings... come with an applicator and ring removal hooks." |
| Substantial Equivalence: Device is equivalent to a legally marketed predicate device. | The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." The predicate device is named: "Reliant ring." |
| Labeling Compliance: Warnings and precautions are included as per FDA guidelines. | "All warnings and precautions from the FDA internet address, www.fda.gov/cdch/ode/oxponrig.html, are included in the premarket notification." |
Study that proves the device meets the acceptance criteria:
The "study" in this context is primarily the 510(k) premarket notification process itself, which relies on demonstrating substantial equivalence to a predicate device and fulfilling general control provisions, rather than a prospective clinical trial.
-
Sample size used for the test set and the data provenance:
- Test Set: Not applicable in the traditional sense of a clinical test set. The performance testing mentioned ("ring safety removal loops were performance tested for strength") would have involved a sample of the manufactured rings. The specific sample size for this mechanical strength test is not mentioned.
- Data Provenance: Not applicable. This is not a study using patient data but rather documentation and mechanical testing of the device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device's "performance" is based on mechanical properties (strength of loops), material specifications (pharmaceutical quality), and compliance with FDA regulations and labeling requirements, not expert interpretation of clinical data.
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Adjudication method for the test set:
- Not applicable. There was no human interpretation of data requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is typically done for diagnostic imaging or AI-assisted diagnostic devices to assess the impact on human reader performance. The Xtend Ring Kit is a physical medical device (an external penile rigidity device ring), not an imaging or AI diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithmic device. Mechanical performance tests were conducted on the device components (e.g., ring safety removal loops).
-
The type of ground truth used:
- The "ground truth" here is primarily engineering specifications for material quality and strength, and regulatory compliance (e.g., inclusion of required warnings, substantial equivalence to a predicate device). For the strength of the removal loops, the ground truth would be a defined force or stress threshold that the loop must withstand.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable.
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WALLING MEDICAL EQUIPMENT, INC. 3000 Candide Ln., McKinney, Tx 75070 Telephone(972)562-3230 Fax (972)542-0446
P1971
510K SUMMARY Prepared 3-19-98 Submitted By: Allan Walling Contact Person: Allan Walling
Device Trade Name: Xtend Ring Kit Common name: ring kit Classification name: external penile rigidity device ring
Legally marketed device to which this device is equivalent: Reliant ring
Summary: : The Xtend rings are used by men with erectile dysfunction to improve their ability to have sexual intercourse. When they have a sufficient erection for intercourse a Xtend constriction ring (K980752) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The Xtend ring kit consists of a set of 4 rings. The rings are elastic pharmaceutical quality material which come with an applicator and ring removal hooks. The ring safety removal loops were performance tested for strength. All warnings and precautions from the FDA internet address, www.fda.gov/cdch/ode/oxponrig.html, are included in the premarket notification.
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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH" are written in a curved fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 6 1998
Mr. Allan Walling President Walling Medical Equipment, Inc. 3000 Candide Lane McKinney, TX 75070
Re: K980752
Xtend (Over-the-Counter Use) Dated: March 20, 1998 Received: March 23, 1998 Unclassified/Procode: 78 LKY
Dear Mr. Walling:
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, 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 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 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/dsmadsmam.html".
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
Enclosure
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Indications for Use
510(k) Number: K980752 Device Name: Xtend
Indications for Use:
The Xtend ring is used to maintain engorgement of the penis for men that are having difficulty with organic or psychological erectile dysfunction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Stalling
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1980752 510(k) Number.
Prescription Use (Per 21 CFR 801.109) Or
Over-The-Counter
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$\text{moles of solute}$
§ 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.