(196 days)
The Uroan DIR-4U Rigidometer measures penile axial rigidity.
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.
Here's a breakdown of the acceptance criteria and study information for the Uroan DIR-4U Rigidometer, based on the provided text:
Acceptance Criteria and Device Performance
The provided text for K061676 does not explicitly state quantitative acceptance criteria for the Uroan DIR-4U Rigidometer. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Uroan Model DIR-101C Rigidometer). The supporting information mentions "Bench, biocompatibility and clinical testing supported the substantial equivalency of the DIR-4U Rigidometer," but does not provide specific performance metrics or thresholds.
Therefore, the table below reflects that the primary "acceptance criterion" was substantial equivalence to the predicate, and the "reported device performance" is that it met this criterion as determined by the FDA.
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Uroan Model DIR-101C Rigidometer) in measuring penile axial rigidity. | Achieved substantial equivalence, as determined by FDA. The device uses the same sensor and principle of operation as the predicate. |
Study Details
Based on the provided text, detailed information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not included. The document is a 510(k) summary and FDA clearance letter, which typically provides high-level information rather than granular study methodology.
Here's what can be inferred or explicitly stated from the text:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "clinical testing," but no details.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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:
- No indication of an MRMC study. This device is described as a direct measurement tool (penile axial rigidity monitor) rather than an AI-assisted diagnostic or interpretive system. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this type of device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a physical instrument that measures penile axial rigidity and uses indicator lights to show the result. It operates as a "standalone" device in the sense that it doesn't require human interpretation of complex outputs; it directly displays a measured value via indicator lights. However, the term "standalone algorithm performance" typically refers to AI/software performance. Since this is a hardware measurement device, this question is not directly applicable in the typical AI context. The document indicates it "measures penile axial rigidity" and "uses indicator lights to indicate the measured axial rigidity," which implies its performance is intrinsic to its measurement capability.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given it's a measurement device for "penile axial rigidity," the ground truth would likely be established through a gold-standard physical measurement technique, but this is not detailed.
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The sample size for the training set:
- Not applicable as this is a physical measurement device, not an AI/machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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પં 510(k) Summary
| Submitter: | Frank B. Freedman, Ph.D.*Alliancz Medical Consultants, Inc.St. Louis Park, MN 55426Phone: 763.717.1013Fax: 763.780.2227 | ||
|---|---|---|---|
| * on behalf of Uroan 21 Electromedicine | DEC 27 2006 | ||
| Contact Person: | Frank B. FreedmanAlliancz 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 (800) 638-2041 or (240) 276-3150
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
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.
N/A