(139 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithmic performance. The focus is on remote monitoring and data transmission.
No
The device is indicated for monitoring wetness events and collecting/transmitting data to help establish management care plans, not for directly treating a medical condition.
No.
The device monitors wetness events to help establish care plans, but it does not diagnose a medical condition or disease.
No
The device description explicitly states that SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, and hardware, in addition to software. This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of SIM™ is to monitor wetness events directly from the patient using sensors embedded in incontinence pads. It does not involve the analysis of biological samples like blood, urine, or tissue in a laboratory setting.
- The description focuses on monitoring and reporting wetness events. This is a physiological monitoring function, not a diagnostic test performed on a specimen.
- The device components (pads with sensors, transceiver, hardware, software) are consistent with a remote monitoring system. They are not typical components of an IVD used for analyzing biological samples.
Therefore, SIM™ falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.
Product codes
KPN
Device Description
SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals / clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities)
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
SIM™ was subjected to biocompatibility testing, electrical safety and electromagnetic safety testing, standard testing for electrical equipment intended for measurement purposes, safety testing for information technology equipment, and other relevant performance testing. In all instances, SIM™ functioned as intended and the results observed were as expected
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.2040 Enuresis alarm.
(a)
Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
510(k) SUMMARY
Simavita Pty Limited's SIM™ System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Simavita Pty Limited Level 6, 56 Berry Street North Sydney, NSW 2060 Australia
Phone: + 61 2 9331 7117 Facsimile: +61 2 8088 1301
Contact Person: Peter Curran
AUG 2 2 2013
Date Prepared: July 9, 2013
Name of Device and Name/Address of Sponsor
Smart Incontinence Management (SIM™) System
Simavita Pty Limited Level 6, 56 Berry Street North Sydney, NSW 2060 Australia
Common or Usual Name
Enuresis Alam
Classification Name
Conditioned Response Enuresis Alam; 21 C.F.R. 876.2040
Predicate Devices
Health Sense International, Inc.'s Remote A'Lert (K943559)
Intended Use / Indications for Use
SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.
\DC - 038364/000001 - 4717167 v1
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Technological Characteristics
SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.
Performance Data
SIM™ was subjected to biocompatibility testing, electrical safety and electromagnetic safety testing, standard testing for electrical equipment intended for measurement purposes, safety testing for information technology equipment, and other relevant performance testing. In all instances, SIM™ functioned as intended and the results observed were as expected
Substantial Equivalence
SIM™ is as safe and effective as the Remote A'Lert. SIM™ has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between SIM™ and its predicate devices raise no new questions of safety or effectiveness. Thus, SIM™ is substantially equivalent.
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Image /page/2/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all caps and is relatively small compared to the eagle symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Simavita Ptv Limited % John J. Smith, MD, JD Partner Hogan Lovells US LLP 555 13m St. NW Washington, DC 20004
Re: K130951
Trade Name: SIMTM System Classification Regulation Name and Number: 21 CFR§ 876.2040 - Enuresis alarm Regulatory Class: Class II Exempt Product Code: KPN Dated: July 9, 2013 Received: July 9, 2013
Dear John J. Smith, MD, JD.
We have reviewed your premarket notification submission and have found this device to be excmpt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.
The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 876.2040 - Enuresis Alarm. Your device's classification regulation name, regulatory class and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code.
In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 876.9 to determine whether or not your new device (s) meets the limitations of exemption from Section 510(k) of the Act.
If you have any questions regarding this letter, please contact Tuan Nguyen. Ph.D. at (301)796-5174. If you have procedural questions, please contact the Division of Small
3
Page 2 - John J. Smith, MD, JD
Manufacturers International and Consumer Assistance (DSMICA) at (301)796 7100 or at their toll free number (800)638 2041, or contact the 510k staff at (301)796 5640.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: SIM" System
Indications for Use: K130951
SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
No____________________________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130951 510(k) Number _
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