RIGIDOMETER, MODEL DIR-4U

K061676 · Uroan 21 · LIL · Dec 27, 2006 · GU

Device Facts

• Record ID: K061676
• Device Name: RIGIDOMETER, MODEL DIR-4U
• Applicant: Uroan 21
• Product Code: LIL · GU
• Decision Date: Dec 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Indications for Use

The Uroan DIR-4U Rigidometer measures penile axial rigidity.

Device Story

The Uroan DIR-4U Rigidometer is a device designed for home use by men to measure penile axial rigidity. It consists of an instrument and an attached sensor. The device utilizes the same sensor and principle of operation as the predicate device to obtain rigidity measurements. Unlike the predicate, the DIR-4U uses indicator lights to display measured axial rigidity and does not measure glans temperature, estimate relative intracavernosal pressure, or store/tabulate measurements. The device provides immediate visual feedback to the user via indicator lights, allowing for self-monitoring of rigidity.

Clinical Evidence

Bench, biocompatibility, and clinical testing were performed to support substantial equivalence. No specific performance metrics or sample sizes were provided in the summary document.

Technological Characteristics

The device consists of an instrument and an attached sensor. It uses indicator lights for output. It is designed for home use. No specific materials, connectivity, or software algorithm class details were provided.

Indications for Use

Indicated for men to measure penile axial rigidity in a home setting.

Predicate Devices

• Uroan Model DIR-101C Rigidometer (K000194)

Submission Summary (Full Text)

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#### પં 510(k) Summary

K061676

| Submitter: | Frank B. Freedman, Ph.D.*<br>Alliancz Medical Consultants, Inc.<br>St. Louis Park, MN 55426<br>Phone: [phone]<br>Fax: [phone] | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| | * on behalf of Uroan 21 Electromedicine | | DEC 27 2006 |
| Contact Person: | Frank B. Freedman<br>Alliancz Medical Consultants, Inc. | | |
| Device Common Name: | Penile rigidity and/or tumescence monitor | | |
| Device Trade Name: | Uroan Model DIR-4U Rigidometer | | |
| Device Classification Name: | Not classified | | |
| Predicate Devices: | Uroan Model DIR-101C Rigidometer (K000194) | | |

## Device Description

The DIR-4U Rigidometer consists of an instrument and attached sensor that measures penile axial rigidity. It has been designed, so that men can use this instrument in the privacy of their homes to measure their penile axial rigidity.

### Indications for Use

The Uroan DIR-4U Rigidometer measures penile axial rigidity.

## Comparison to Predicate Devices

The Uroan Model DIR-4U Rigidometer is substantially equivalent to Uroan Model DIR-101C Rigdometer. It uses the same sensor and principle of operation to obtain these measurements. The DIR-4U uses indicator lights to indicate the measured axial rigitity. DIR-101Caxial rigidity measurements are displayed on a computer screen. Unlike the DIR-101C, the DIR-4U does not measure glans temperature, estimate relative intracavernosal pressure or tabulate or store measurements.

### Supporting Information

Bench, biocompatibility and clinical testing supported the substantial equivalency of the DIR-4U Rigidometer.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC 2 7 2006

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Uroan 21 Electromedicine c/o Frank B. Freedman, Ph.D. Alliancz Medical Consultants, Inc. 2530 Pennsylvania Avenue South ST LOUIS PARK MN 55426

Re: K061676

Trade/Device Name: Uroan DIR-4U Rigidometer Regulation Number: None Regulatory Class: Unclassified Product Code: LIL Dated: November 24, 2006 Received: November 27, 2006

### Dear Dr. Freedman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booken of the device is substantially equivalent (for the indications for releted in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encrosure) to regally manetical Device Amendments, or to devices that prior to May 20, 1970, and characters with the provisions of the Federal Food, Drug, and Cosmetic nave been roctablined in are approval of a premarket approval application (PMA). You may, Act (Free) market the device, subject to the general controls provisions of the Act. The general therefore, mailier the dorrol; salgoet to an igenerats for annual registration, listing of devices, good controls profitered or will be and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is classinod (500 a0010) historials. Existing major regulations affecting your Apploval), it may be subject to Jack at Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a stylized font at the center. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by a dotted circle.

noting Public -

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 (\$1 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K061676

510(k) Number (if known): (K061676)

Device Name: DIR-4U Rigidometer

Indications For Use: The Uroan DIR-4U Rigidometer measures penile axial rigidity.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.