IBAG by FUTURE PATH MEDICAL, LLC

iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study conducted for the iBag™ Urine Management System:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance
Volume Accuracy	Not explicitly stated as a separate acceptance criteria, but for predicate device "Not stated"	±5% of the actual fill for 70 – 100% fill level readings.
Temperature Accuracy	± 0.2 °F (for predicate device)	± 0.2 °F
Temperature Range	50°F to 110°F (10°C to 43.3°C) (for predicate device)	50 to 110 °F in increments of 0.1 °F
Electrical Safety	Electrical Safety per IEC-60601 (for predicate device)	SAME (Implies compliance with IEC 60601-1)
Electromagnetic Comp.	N/A (not explicitly stated for predicate)	IEC 60601-1-2
FCC Compliance	N/A (not explicitly stated for predicate)	FCC Compliance Testing
RF Dosimetric Asses.	N/A (not explicitly stated for predicate)	RF Dosimetric Assessment Testing
Transmitter Range	N/A	Transmitter effective range testing was done
User Feedback	N/A	User Feedback Study was done
Battery Life	N/A	Battery life computations were done
Simulated Use	N/A	Simulated Use Testing was done
Leak Testing	N/A	Leak Testing was done
Sterility Testing	N/A	Sterility Testing was done

Note: The predicate device's specifications for volume accuracy and temperature range are used as a proxy for acceptance criteria where the iBag™ device states "SAME" or explicitly meets/exceeds them. For other tests, the text indicates that the testing was "successfully conducted" or that the device meets the respective standard.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: The document does not specify the sample sizes for the "Fill level accuracy" or "Temperature measurement accuracy" tests, nor for the "User Feedback Study" or "Simulated Use Testing."
Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Bench and test laboratory results indicate that the new device is as safe and effective as the predicate device" and lists the tests conducted.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the tests.

4. Adjudication Method for the Test Set

The document does not specify any adjudication methods for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, or any effect size related to human readers improving with or without AI assistance. This device is not an AI-based system.

6. Standalone Performance (Algorithm Only)

The document primarily focuses on the device's mechanical and electronic performance, not on an algorithm's standalone performance. It states that "iBag™ provides accurate, real-time assistive data" and "Software is designed to be used with little or no training," but does not detail an algorithm's standalone performance separate from the hardware.

7. Type of Ground Truth Used

Based on the provided information, the ground truth for volume and temperature accuracy would likely be established through:

Reference measurements: Using highly accurate, calibrated instruments to measure actual urine volume and temperature.
Bench testing: Controlled laboratory conditions for precise measurements.

For other tests like electrical safety, EMC, leak testing, and sterility, the ground truth would be defined by the relevant industry standards (e.g., IEC 60601-1, IEC 60601-1-2) and their specific test protocols.

8. Sample Size for the Training Set

No information is provided about a "training set" as this device is not an AI/ML-based system requiring a training phase in the typical sense. The testing described is for performance validation, not algorithm training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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510(k) Summary 510(k) Number K110518 Future Path Medical, LLC 3020 Hinsel Rd Columbus, Ohio 43232 Office: 614-863-5651 Fax: 614-573-6636 Date Prepared: April 18. 2011 Contact: Ty Bryant, Chairman

l . Identification of the Device: Proprietary-Trade Name: iBag™ Urine Management System Device: Urinometer, electrical Regulation Description: Urine flow or volume measuring system. Regulation Medical Specialty: Gastroenterology/Urology Review Panel: Gastroenterology/Urology Product Code: EXS Submission Type: 510(K) Exempt subject to 21CFR876.9 Regulation Number: 876.1800 Device Class: 2
1. Equivalent legally marketed devices: BARD CritiCore (K924436) Bard Urological 510(k); UROTRACK II Monitoring System
1. Indications for Use (intended use). This device is intended to measure/ display collected urine volume. It detects fill level and temperature.
1. Description of the Device: iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming. Features:
- Automatically measures and displays urine fill level and bladder temperature.
- · Re-usable wireless transmitter is inexpensive and has a one-year battery life
- · Performs functions such as email or text alerts on fill levels.
- · Software is designed to be used with little or no training.
- · Transmits data in real time.
1. Safety and Effectiveness, Summary of Testing and Comparison to Predicate Device. Bench and test laboratory results indicate that the new device is as safe and effective as the predicate device. The following testing has been successfully conducted:

JUN 2 4 2011

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Electrical Safety to IEC 60601-1 ●
Electromagnetic Compatibility to IEC 60601-1-2 .
FCC Compliance Testing .
. RF Dosimetric Assessment Testing
. Transmitter effective range.
User Feedback Study .
Fill level accuracy .
Temperature measurement accuracy .
. Battery life computations
Simulated Use Testing .
Leak Testing .
Sterility Testing .

6. Substantial Equivalence Chart

Characteristic	BARD CritiCore (K924436) BardUrological 510(k): UROTRACK IIMonitoring System	iBag™ Urine ManagementSystem
Intended Use:	This device is intended to measure/display collected urine volume. Itdetects fill level and temperature.	SAME
Configuration	Portable unit with integrated display	Wireless communication (418mHz) to Netbook type PC viaUSB
Power Source	6 "D" cell alkaline batteries	3 volt coin-cell size, lithiumbattery. (e.g., CR2032); 120VAC for the Netbook displayunit.
Urine Bag Capacity	0-2100 ml	1000 and 2000 ml
Volume Accuracy	Not stated	±5% of the actual fill for 70 –100% fill level readings.
Temperature	50°F to 110°F (10°C to 43.3°C)	Bladder core temperature ismeasured in degrees Fahrenheit,°F, units from 50 to 110 °F inincrements of 0.1 °F.
Temperature accuracy	± 0.2 °F.	Temperature measurementaccuracy is ± 0.2 °F.
Electrical safety	Electrical Safety per IEC-60601. ULlisted	SAME

7. Conclusion

After analyzing bench, simulated use, and compliance to standards testing using external laboratory testing to applicable standards, it is the conclusion of Future Path LLC that the iBag™ Urine Management System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60" Silver Spring, MD 20993-0002

Future Path Medical. LLC c/o Daniel Kamm, P.E. Principal Consultant .Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

JUN 2 4 2011

· Re: K110518

Trade/Device Name: iBag™ Urine Management System Regulation Number: 21 CFR $876.5250 Regulation Name: Urine Collector and Accessories Regulatory Class: Class II Product Code: KNX and EXS Dated: June 12, 2011 Received: June 16, 2011

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of 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 controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability i warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Par1 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

CAN

Sincerely yours,

Huchert Hemer MD

Herbert P. Lerner, M.D., Director (Acting) 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

510(k) Number (if known): K105 G

Device Name: iBag™ Urine Management System

Indications For Use: This device is intended to measure/ display collected urine volume. It detects fill level and temperature.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hogm 722

(Division Sign-Oft)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110518

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Regulation Number and Section

§ 876.5250 Urine collector and accessories.

(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.