MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM

K033126 · Behavioral Technology, Inc. · LIL · Oct 29, 2003 · GU

Device Facts

• Record ID: K033126
• Device Name: MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
• Applicant: Behavioral Technology, Inc.
• Product Code: LIL · GU
• Decision Date: Oct 29, 2003
• Decision: SESE
• Submission Type: Special
• Device Class: Class U

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.

Device Story

MONARCH 21 Penile Plethysmograph measures penile tumescence in response to visual and auditory stimuli. System consists of attached sensors and a laptop computer for data storage, tabulation, display, and printing. Used by technicians to facilitate standardized assessments of male sexual offenders; non-standardized mode available for research. Intercom and auxiliary traces support technician assessment. Output assists clinicians in evaluating treatment needs and recidivism risk.

Clinical Evidence

Clinical validation performed to demonstrate safety and effectiveness of the portable system compared to the predicate device. Bench testing included use of a precision machined aluminum calibration cone with graduated circumference sizes to measure sensor range and testing of secondary agents using simulated values.

Technological Characteristics

System includes penile sensors and laptop computer. Calibration performed using precision machined aluminum cone. Features include intercom and auxiliary trace capabilities. Portable form factor.

Indications for Use

Indicated for male sexual offenders to measure sexual response to visual and auditory stimuli for evaluation of treatment needs and recidivism risk.

Predicate Devices

• CAT-600 Penile Plethysmograph (K936115)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

### 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.

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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.

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (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 [phone] or [phone] 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

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# 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) | |