SIM

K130951 · Simavita Pty Limited · KPN · Aug 22, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130951
• Device Name: SIM
• Applicant: Simavita Pty Limited
• Product Code: KPN · Gastroenterology, Urology
• Decision Date: Aug 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.2040
• Device Class: Class 2

Intended 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.

Device Story

SIM™ system monitors patient wetness events in clinical settings. System components: disposable incontinence pads with embedded sensors, wireless transceiver, hardware, and software. Sensors detect moisture; transceiver transmits data to central system for collection and reporting. Healthcare professionals use output to track incontinence events and establish individualized care plans. System enables remote monitoring of multiple patients simultaneously, facilitating efficient management of continence care in facilities like hospitals and nursing homes.

Clinical Evidence

Bench testing only. Device underwent biocompatibility, electrical safety, electromagnetic safety, and standard performance testing for medical/IT equipment. Results confirmed device functioned as intended.

Technological Characteristics

System includes disposable incontinence pads with embedded sensors, wireless transceiver, hardware, and software. Operates via wireless data transmission. Subjected to standard electrical and electromagnetic safety testing.

Indications for Use

Indicated for use by healthcare professionals to remotely monitor wetness events in patients within clinical settings (hospitals, skilled nursing, residential care) to assist in developing continence management care plans.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Remote A'Lert (K943559)

Submission Summary (Full Text)

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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: [phone]

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 [phone]. 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 [phone] or at their toll free number [phone], or contact the 510k staff at [phone].

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

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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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