XTEND

K980752 · Walling Medical Equipment Co. · LKY · May 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980752
• Device Name: XTEND
• Applicant: Walling Medical Equipment Co.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Xtend ring kit consists of 4 elastic, pharmaceutical-quality rings, an applicator, and removal hooks. Device used by men with erectile dysfunction to maintain erection for sexual intercourse. User places constriction ring over base of penis after achieving sufficient erection; acts as partial tourniquet to retain blood flow. Maximum wear time is 30 minutes; must be removed thereafter. Intended for over-the-counter use. Benefits patient by facilitating sexual intercourse. Safety features include removal hooks and loops; performance tested for strength.

Clinical Evidence

Bench testing only. Performance testing conducted on ring safety removal loops for strength.

Technological Characteristics

Elastic, pharmaceutical-quality material. Constriction ring form factor. Includes applicator and removal hooks. Mechanical operation; no energy source. Non-software device.

Indications for Use

Indicated for men with organic or psychological erectile dysfunction to maintain penile engorgement for sexual intercourse.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Reliant ring

Submission Summary (Full Text)

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WALLING MEDICAL EQUIPMENT, INC. 3000 Candide Ln., McKinney, Tx 75070 Telephone[phone] Fax [phone]

K980752

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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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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