(49 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device description focuses on hardware components and basic software for measurement.
No.
The device is clearly described as a "diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency," not for treatment.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "intended for use as a diagnostic tool."
No
The device description explicitly lists hardware components such as a device control box, vibrator, cables, and a charger, in addition to the software.
Based on the provided information, the Plethora Solutions Sexual Assessment Monitor (SAM) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- SAM's Function: The SAM directly measures physiological responses (penile tumescence and ejaculatory latency) on the human body. It does not analyze specimens taken from the body.
- Device Description: The components listed (control box, vibrator, leads, charger) are consistent with a device that interacts directly with the body, not one that processes biological samples.
- Anatomical Site: The specified anatomical site is "Penile," indicating direct application to the body.
Therefore, the SAM falls under the category of a medical device that performs physiological measurements, but it is not an IVD.
N/A
Intended Use / 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.
Product codes
LIL
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The text reads "K062042 p1 of 3". The handwriting is in black ink and is somewhat cursive in style. The text is likely a label or identifier for a document or page.
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 +44 (0) 207 2698 630 ि +44 (0) 207 2428 518 ්රි) mail@piethomsolution:..co.ui:
2. 510(k) Premarket Notification Summary (Summary Prepared on July 18, 2006
| A. | 510(k) Owner: | Plethora Solutions Limited
Official FDA Correspondent: Miranda Tighe, Project
Manager for In-Licensed Programmes
Lupus House, 11-13 Macklin Street
Covent Garden, London, WC2B 5NH
United Kingdom
(T) +44 (0) 207 2698 630
(F) +44 (0) 207 2428 518 |
|----|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | e-mail: miranda.tighe@plethorasolutions.co.uk |
| 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 | ||
| 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
1
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:
-
- The INTENDED CLINICAL USE for the Plethora Sexual Assessment Monitor (SAM) is SUBSTANTIALLY EQUIVALENT to the predicate devices.
-
- 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.
-
- The OPERATIONAL FEATURES/TECHNOLOGICAL CHARACTERISTICS of the Plethora Sexual Assessment Monitor are the SAME or SIMILAR to those offered by the predicate device.
-
- 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.
-
- 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
2
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.
3
Image /page/3/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 stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
4
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 (800) 638-2041 or (240) 276-3150
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
5
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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