PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)

K062042 · Plethora Solutions · LIL · Sep 6, 2006 · GU

Device Facts

• Record ID: K062042
• Device Name: PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
• Applicant: Plethora Solutions
• Product Code: LIL · GU
• Decision Date: Sep 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Indications for Use

The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency.

Device Story

The Sexual Assessment Monitor (SAM) is a diagnostic system used to quantify penile tumescence and ejaculatory latency. The system comprises a control box, a vibrator with an integral 3m lead, a sensor lead adapter, a serial communications cable, and application software. The device is used in clinical settings by healthcare professionals to monitor sexual function. By measuring physiological responses, the device provides objective data to assist clinicians in diagnosing sexual dysfunction and evaluating treatment efficacy. The system is designed to be as effective as existing predicate monitoring systems while providing a standardized method for data collection.

Clinical Evidence

Evidence includes three prospective formal clinical studies and a peer-reviewed report (Dinsmore WW, et al., BJU Inter. 2006). Studies evaluated the device's ability to electronically quantify ejaculatory latency time. Results supported the device's clinical efficacy and safety as a diagnostic tool.

Technological Characteristics

System includes a control box, vibrator, sensor lead, and application software. Complies with EN 60601-1:1990 and EN 60601-1-2:2002 standards. Operates as a diagnostic monitoring system for physiological assessment.

Indications for Use

Indicated for use as a diagnostic tool for the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency in patients requiring such evaluation.

Predicate Devices

• Rigiscan System (K841202)
• Rigiscan Plus Rigidity Assessment System (K941781)

Submission Summary (Full Text)

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6 2006

Image /page/0/Picture/2 description: The image shows the logo for Plethora Solutions. The word "plethora" is written in a sans-serif font, with the word "SOLUTIONS" written in smaller letters underneath. To the right of the word "plethora" are three circles of varying sizes.

Lupus House 11-13 Macklin Street Covent Garden London WC2B 5NH

① [phone] ि [phone] ්‍රි) mail@piethomsolution:..co.ui:

## 2. 510(k) Premarket Notification Summary (Summary Prepared on July 18, 2006

| A. | 510(k) Owner: | Plethora Solutions Limited<br>Official FDA Correspondent: Miranda Tighe, Project<br>Manager for In-Licensed Programmes<br>Lupus House, 11-13 Macklin Street<br>Covent Garden, London, WC2B 5NH<br>United Kingdom<br>(T) [phone]<br>(F) [phone] |
|----|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | e-mail: [e-mail] |

| B. | Trade Name: | Sexual Assessment Monitor (SAM) |
|----|---------------------|-----------------------------------------------|
| | Common Name: | Penile Tumescence/Ejaculatory Latency Monitor |
| | Product Code: | LIL (Unclassified) |
| | Advisory Committee: | Gastroenterology/Urology |

#### C. Substantial Equivalence Predicate Device(s):

| Manufacturer | Device Name | 510-K Number | Decision Date |
|---------------------|---------------------------------------------|--------------|---------------|
| Dacomed Corporation | Rigiscan System | K841202 | 07/06/1984 |
| Dacomed Corporation | Rigiscan Plus Rigidity<br>Assessment System | K941781 | 08/25/1994 |

#### Device Description: D.

The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency.

The Sexual Assessment Monitor (SAM) includes the following components:

- SAM application software
- . device control box
- . vibrator with integral 3m lead
- serial port communications cable .
- . 0.5m sensor lead adapter
- . device charger.

16

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K062042 pg2of3

- device charger. .
### E. Intended Use of Device:

The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency.

#### F. Substantial Equivalence Discussion

SAM is substantially equivalent to the identified predicate devices based on the following:

- 1. The INTENDED CLINICAL USE for the Plethora Sexual Assessment Monitor (SAM) is SUBSTANTIALLY EQUIVALENT to the predicate devices.
- 2. The Plethora Sexual Assessment Monitor (SAM) and the 2 predicate devices are both substantially equivalent Medical Device Systems FOR USE IN THE SAME ANATOMICAL LOCATION and BY the SAME SYSTEM USERs in the SAME CLINICAL SETTINGS.
- 3. The OPERATIONAL FEATURES/TECHNOLOGICAL CHARACTERISTICS of the Plethora Sexual Assessment Monitor are the SAME or SIMILAR to those offered by the predicate device.
- 4. The SAFETY ASPECTS of the Plethora Sexual Assessment Monitor (SAM) are the SAME or very SIMILAR to those offered by the predicate devices. SAM is as safe or safer than the two predicate devices and the technological characteristics of SAM and its intended clinical uses provide NO ADDITIONAL SAFETY RISK TO patients or System operators.
- 5. The Plethora Sexual Assessment Monitor (SAM) has been observed to be an EFFECTIVE diagnostic tool (AS OR MORE EFFECTIVE THAN RIGISCAN DEVICE) in a clinical setting, as documented by Dinsmore WW, Ralph DJ, Kell P et al, Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically

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K062042 pg3 of 3

quantify ejaculatory latency time: findings from three studies. BJU Inter. 2006;1-6 with further evidence provided in this submission from the 3 full clinical study reports referenced.

### G. Bench and Clinical Testing Supporting Documentation

SAM received CE MARK approval in 2005 with demonstrated compliance to EN 60601-1:1990 and EN 60601-1-2:2002. Documentation from 3 prospective formal clinical studies including a peer-reviewed report of these clinical studies provides further clinical safety documentation of the Plethora Solutions Sexual Assessment Monitor in conjunction with the clinical efficacy of the device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP -6 200%

Plethora Solutions Limited c/o Ms. Kimberly Doney Consultant 54 Forest Street LEXINGTON MA 02421

Re: K062042

Trade/Device Name: Plethora Solutions Sexual Assessment Monitor (SAM) Regulation Number: None Regulatory Class: Unclassified Product Code: LIL Dated: July 18, 2006 Received: July 19, 2006

Dear Ms. Doney:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have ro ro row a ve determined the device is substantially equivalent (for the indications for reservlied in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the enerebare) for 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 therefore, maniel the deterroy cash one 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 n your do roo is chasilied (to such additional controls. Existing major regulations affecting your Apple vary, It the Joe 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/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo is surrounded by a dotted circle.

Protecting and Promoting Public Health

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Page 2 -

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 prematicate 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.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/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): Original Premarket Notification KO62047 Device Name: Plethora Solutions Sexual Assessment Monitor (SAM) Indications for Use:

The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency.

Prescription Use _ X_ (Part 21 CFR 801 Subpart D)

NaveyC Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number Ko 62042

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