(139 days)
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.
SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.
The provided text does not contain information regarding specific acceptance criteria for device performance or a detailed study proving the device meets said criteria in the format requested. The document is a 510(k) summary for the Simavita SIM™ System, which outlines the device's substantial equivalence to a predicate device and its intended use, but does not provide quantitative performance metrics or a detailed study description with ground truth and expert involvement.
Here's a breakdown of what is and is not available in the provided text, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not available. The document states that "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." However, it does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or quantitative performance results for the device's primary function of monitoring wetness events.
2. Sample size used for the test set and the data provenance:
- Not available. The document states "SIM™ functioned as intended and the results observed were as expected" for various tests, but it does not specify any sample sizes for these tests, nor does it mention data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available. There is no mention of a test set requiring expert-established ground truth for performance evaluation of the wetness monitoring function. The reported testing focuses on safety and general functionality.
4. Adjudication method for the test set:
- Not available. This information is typically relevant when multiple experts are involved in establishing ground truth or reviewing cases, which is not described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- Not available. The document does not describe any MRMC study or an assessment of human reader improvement with or without AI assistance. This device is an "Enuresis Alarm" for remote monitoring of wetness, not a diagnostic imaging AI system that typically involves human readers in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not available in the sense of a detailed performance study. The device's function is standalone in terms of detecting wetness events, but the document doesn't provide a rigorous, quantitative standalone performance study with metrics like sensitivity, specificity, etc. It only states that the device "functioned as intended."
7. The type of ground truth used:
- Not explicitly stated for the core function of wetness detection. For the safety and electrical performance tests, the "ground truth" would be established by the adherence to regulatory standards and expected performance. However, for the primary function of wetness detection, no specific ground truth methodology (e.g., actual wetness measured by a different method, expert observation) is described in the provided text.
8. The sample size for the training set:
- Not applicable/Not available. The document describes a medical device for wetness monitoring, not an AI/machine learning system that typically requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable/Not available. As above, this is not relevant for the type of device and information provided in the 510(k) summary.
In summary, the provided 510(k) summary for the Simavita SIM™ System focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, and general safety/performance testing that "functioned as intended." It does not include the detailed quantitative performance metrics, study designs (e.g., sample sizes, expert involvement, ground truth methodologies), or comparative effectiveness studies that your request pertains to.
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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
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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
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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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YDC - 038384/000001 - 47 17 163 Y1
§ 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.