(189 days)
Not Found
No
The description focuses on data acquisition, storage, and display, with no mention of AI/ML terms or functionalities like image processing, pattern recognition, or predictive analysis.
No
The device is used for measurement and assessment, not for treatment or therapy. It assists clinicians in their assessment but does not provide therapeutic intervention.
Yes
The device is used to measure penile tumescence and combine this data with other psychological testing procedures to assist clinicians with their assessment and treatment of sexual offenders. This aligns with the definition of a diagnostic device, which is used to identify or characterize a disease, condition, or physiological state.
No
The device description explicitly states it uses a strain gauge transducer for circumference measurement, which is a hardware component. The software is used to process data from this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PrefTest Professional Suite™ measures penile tumescence using a strain gauge transducer. This is a physical measurement taken directly from the body, not a test performed on a sample in vitro (in a lab setting).
- Intended Use: The intended use is to measure a physiological response (penile tumescence) to stimuli, which is then used to assist clinicians in assessing and treating sexual offenders. This is a clinical assessment tool, not a diagnostic test performed on a biological sample.
Therefore, the PrefTest Professional Suite™ falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PrefTest Professional Suite™ is used to measure penile tumescence in response to visual and auditory stimuli. Penile Tumescence data can later be combined with other standardized psychological testing procedures to assist clinicians with their assessment and treatment of sexual offenders.
Product codes
LIL
Device Description
Limestone Technologies Penile Plethysmograph is based on a circumference measurement using a strain gauge transducer which measure penile tumescence in millimeters. PrefTest Professional Suite™ computer software is used to store, tabulate, display and print out the acquired data from a personal computer or lap top.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing for the PrefTest Professional Suite™ software included software validation. A risk analysis performed according to ISO 14971: 2000 was conducted.
Testimonials and published literature supports the safety and effectiveness of this technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) SUMMARY
Applicant's Name, Address, Phone, Fax, Contact Person, Email, Date Prepared
Limestone Technologies Inc. Jamie Brown, President 556 O'Connor Drive Kingston, Ontario K7P 1N3 Canada Phone: (613) 634-2594 Fax: (613) 634-4098 Email: brownjs@limestonetech.com
APR 2 6 2006
PG. 1 VE 2
September 29, 2005 Date Prepared:
Device Name, Common/Generic Name and Classification Name
| Proprietary Name: | PrefTest Professional Suite TM |
|---|---|
| Common/Usual Name: | Penile Plethysmograph |
| Classification Name: | Monitor, Penile Tumescence |
| Predicate Device | |
| Device Name: | MONARCH 21 Penile Plethysmograph (K033126) |
Description of the Device
Limestone Technologies Penile Plethysmograph is based on a circumference measurement using a strain gauge transducer which measure penile tumescence in millimeters. PrefTest Professional Suite™ computer software is used to store, tabulate, display and print out the acquired data from a personal computer or lap top.
Intended Use of the Device
The PrefTest Professional Suite™ is used to measure penile tumescence in response to visual and auditory stimuli. Penile tumescence data can later be combined with other standardized psychological testing procedures to assist clinicians with their assessment and treatment of sexual offenders.
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Technological Summary between PrefTest Professional Suite and its predicate device
PrefTest Professional Suite™ has the same intended use and function as its' predicate device.
Performance Test Results
Testing for the PrefTest Professional Suite™ software included software validation. A risk analysis performed according to ISO 14971: 2000 was conducted.
Clinical Test Results
Testimonials and published literature supports the safety and effectiveness of this technology.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle is positioned within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 6 2006
Limestone Technologies, Inc. % Ms. Nancy Ruth Associate Director, Regulatory Services CanReg, Inc. 4 Innovation Drive Dundas, L9H 7P3 CANADA
Re: K052929
Trade/Device Name: PrefTest Professional Suite™ Regulation Number: None Regulatory Class: Unclassified Product Code: LIL Dated: March 31, 2006 Received: April 3, 2006
Dear Ms. Ruth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "FDA Centennial" in the center. The seal also includes the years "1906-2006" and the phrase "Protecting and Promoting Public Health". The text is in a serif font and is black and white.
3
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 (21 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
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): Ko52929
Device Name: PrefTest Professional Suite™
Indications For Use: The PrefTest Professional Suite™ is used to measure penile tumescence in response to visual and auditory stimuli. Penile Tumescence data can later be combined with other standardized psychological testing procedures to assist clinicians with their assessment and treatment of sexual offenders.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE.CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laura Garcia
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K052129
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