(29 days)
Not Found
No
The description focuses on sensor data acquisition and basic data processing (store, tabulate, display, print). There is no mention of AI/ML terms or complex analytical methods that would typically indicate AI/ML use.
No
The device is used to measure sexual response for evaluation and risk assessment, not to treat or cure a disease or condition.
Yes
The device is used to measure sexual response to stimuli to evaluate treatment needs and determine recidivism risk, which is a diagnostic purpose.
No
The device description explicitly states it "consists of attached sensors, which measure penile tumescence," indicating hardware components beyond just software.
Based on the provided information, the MONARCH 21 system 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.
- MONARCH 21 Function: The MONARCH 21 system measures a physiological response (penile tumescence) directly from the body using external sensors. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure a physiological response as part of a behavioral evaluation, not to diagnose a disease or condition based on analysis of a biological sample.
Therefore, the MONARCH 21 system falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MONARCH 21's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.
Product codes
78 LIL
Device Description
MONARCH 21 Penile Plethysmograph consists of attached sensors, which measure penile tumescence. A laptop computer is used to store, tabulate, display and print out the acquired data.
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K033126 PG. / OF 2
OCT 2 9 2003
Attachment #4
510(k) SUMMARY
Submitter's Name, Contact Person, Address, Phone, Fax, and Email
Behavioral Technology, Incorporated (BTI) Susan E. Olsen 24 M Street Salt Lake City, UT 84103 Phone: (801) 363-9017 Fax: (801) 363-9022 Email: susan@btimonarch.com
Device Name, Common/Generic Name and Classification Name
| Proprietary Name: | MONARCH 21 Penile Plethysmograph |
|---|---|
| Common/Generic Name: | Penile Plethysmograph |
| Classification Name: | Monitor, Penile Tumescence |
| Predicate Device | |
| Device Name: | CAT-600 Penile Plethysmograph, K936115 |
Description of the Device
MONARCH 21 Penile Plethysmograph consists of attached sensors, which measure penile tumescence. A laptop computer is used to store, tabulate, display and print out the acquired data.
Intended Use of the Device
The MONARCH 21's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.
1
K033126 PG. 2 DF 2
Technological Summary between MONARCH 21 and its predicate device
MONARCH 21 provides all the functionality of it's predicate devices into a truly portable and easy-to-use system. Differences between MONARCH 21 and predicate devices were subjected to mechanical, electrical safety, software testing and clinical validation to demonstrate that they do not diminish safety and effectiveness. Intercom and auxiliary traces support technicians in making standardized assessments. Non-standardized assessment capability is available for research.
Non-Clinical Test Results
A precision machined aluminum calibration cone with graduated circumference sizes was used to measure the penile sensors full range of values. Secondary agents were tested using simulated equivalent values. All testing mimicked prior predicate device examination resulting in substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Ms. Susan E. Olsen Executive Vice President Behavioral Technology, Inc. 24 M Street, Suite #1 SALT LAKE CITY UT 84103
Re: K033126
Trade/Device Name: MONARCH 21 Penile Plethysmograph System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LIL Dated: September 26, 2003 Received: October 2, 2003
Dear Ms. Olsen:
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, nuarket 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 (PMA), it may be subject to 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.
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.
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
4
Attachment #2
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
Behavioral Technology, Incorporated Applicant:
K03312-6 510(k) Number:
MONARCH 21 Penile Plethysmograph System Device Name:
Indications for Use: The MONARCH 21 system's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.
David b. leyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 133126 510(k) Number _
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |