SmartBag is intended for use inside and out of hospitals for any patient with a diversionary urinary or fecal stoma. It works in conjunction with 11 Health's care management platform known as Alfred. The SmartBag system uses integrated sensors to continuously monitor bag filling and drainage, providing cumulative output data to the patient and clinical team. The system also monitors skin condition, the occurrence of leaks and visual condition of the stoma.

SmartBag's intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11 Health's care management platform known as Alfred, designed for patients and medical professionals. The SmartBag system (including the wafer and Hub), offers a continuous ostomy monitoring system, tracks the estimated volumetric filling of the bag and visual condition of the stoma using integrated sensor technology.

The SmartBag Sytem is for adult use only. (22 years and above)

Device Description

The SmartBag with integrated thermistors and capacitive sensors can be used in place of a traditional ostomy bag. It notifies patients or medical professionals of any potential leaks around the peristomal skin as well as giving an estimate of the output volume within the bag.

Alfred software is a companion software suite for SmartBag. It consists of Alfred mobile app and Alfred hospital app. Alfred mobile app is a companion application for mobile phone. The application provides SmartBag user easy access to bag status, hydration tracking and restroom search functionalities. The SmartBag could operate without Alfred mobile app.

The sensors in the bag and the wafer will be able to transmit data to the hub via NFC protocol communication. The data from the hub will be transmitted to the cloud via LTE-M data transfer via secure MQTT protocol and then this data can be downloaded to web supported devices – such as an iPhone.

AI/ML Overview

The provided text is a 510(k) summary for the SmartBag (SmartPouch) device. While it describes the device's indications for use, comparison to predicate devices, and non-clinical performance data, it does not contain a table of acceptance criteria or a detailed study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity against a defined ground truth on a test set.

The document primarily focuses on demonstrating the functionality and usability of the device's volumetric and leakage detection features through a series of bench experiments and simulations. It concludes that the SmartBag prototype is "proven to be functional for volumetric measurement and leakage detection from our simulated bench tests."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone performance. The document does not describe a clinical study with these elements.

However, I can extract information about the types of non-clinical tests performed, which could be considered a form of "acceptance criteria demonstration" for basic functionality:

Non-Clinical Performance Data (Functionality Testing):

Acceptance Criteria (Implied Functionality)	Reported Device Performance (Conclusion)
Volumetric Sensor Sheet Functionality:	The volumetric sensor sheet is capable of:
Ability to detect dynamic simulated infusions.	- Detecting dynamic simulated infusions
Ability to detect static volume of infused materials.	- Detecting static volume of infused materials
Ability to recognize different viscosities of simulated infusions.	- Recognizing different viscosities of the simulated infusions
Ability to measure volume in different body positions (standing/supine).	- Measure volume of the simulated infusions when user is in standing or supine positions
Ability to measure volume in high heat environments (close to infusion temp).	- Measure volume of the simulated infusions when the environment temperature is close to infusion temperature, with the aid of capacitors
Wafer Sensor Sheet Functionality:	The wafer sensor sheet is capable to:
Ability to detect simulated leakage with correct log interval.	- Detect simulated leakage with the correct log interval
Durability and functionality after saturation in water at 37°C for 7 days.	- Remain durable and functional after 7 days of saturation in 37 °C water bath
Overall functionality:	Consequently, the SmartBag prototype is proven to be functional for volumetric measurement and leakage detection from our simulated bench tests. (Note: These are functional conclusions, not quantitative performance metrics like accuracy or sensitivity percentages).

Here's why the other requested information cannot be provided from this document:

Sample size for the test set and data provenance: The document details "in-house non-clinical bench experiments" and "simulated" tests, some on "human volunteers." It doesn't specify a rigorous, statistically powered "test set" in the context of typical AI/medical device clinical studies (where cases are adjudicated against a ground truth). It refers to test reports like "028_Testing Report 3_SmartBag Prototype Water and Apple Infusion Simulation Test," suggesting a focus on engineering verification rather than clinical validation. The provenance is "in-house."
Number of experts and qualifications, adjudication method: Not applicable as the testing described is primarily engineering bench testing and simulation, not expert-adjudicated clinical data.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The device's primary function is continuous monitoring and data collection, not an AI assisting human readers with interpreting medical images or data for diagnostic purposes in a comparative setting.
Standalone (algorithm only) performance: While the device collects data autonomously, the "performance" described is functional operation in simulated environments rather than a quantifiable diagnostic or predictive accuracy.
Type of ground truth used: The "ground truth" for these tests appears to be the known conditions of the simulations (e.g., specific volumes of fluid infused, presence/absence of simulated leaks, known temperatures, known viscosities). It's not a clinical ground truth like pathology or patient outcomes.
Sample size for the training set and how ground truth for training was established: The document does not describe a machine learning model that was "trained" in the typical sense with a separate dataset. The "sensors" and "algorithms" (implicitly) seem to be based on physical principles and engineering design, not data-driven machine learning from a large training dataset.

In summary, this 510(k) summary focuses on demonstrating the engineering functionality and safety of the SmartBag device through non-clinical bench tests and simulations, rather than providing clinical performance data from a statistically designed study involving ground truth established by experts.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

November 16, 2018

11 Health Technologies Limited Priya Woodun Regulatory Affairs The Kinetic Business Centre, Theobald Street Borehamwood WD6 4PJ UNITED KINGDOM

Re: K181643

Trade/Device Name: SmartBag (SmartPouch) Regulation Number: 21 CFR 876.5900 Regulation Name: Ostomy pouch and accessories Regulatory Class: Class I Product Code: EXB, EZQ, EZQ, EZS, LHQ Dated: September 13, 2018 Received: September 20, 2018

Dear Priya Woodun:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel G. Walter Jr -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

510(k) Number (if known) K181643

Device Name SmartBag(SmartPouch)

Indications for Use (Describe)

The SmartBag Sytem is for adult use only. (22 years and above)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	X Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary 807.92(c)

SPONSOR

Company Name:	11 Health Technologies
Company Address	Kinetic Business CentreTheobald StreetBorehamwood WD6 4United Kingdom
Telephone:	+44 (0) 20 8387 1308
Contact Person:	Priya Woodun
Summary Preparation Date:	June 15, 2018
DEVICE NAME		807.92(a)(2)
Trade Name:	SmartBag(SmartPouch)
Common/Usual Name:	Ostomy Bag/Pouch

Classification Name: Collector, Ostomy Regulation Number: 21 CFR 876.5900 Regulation Name: Ostomy Pouch and Accessories Product Code: EXB, EZQ, EZS, LHQ Device Class: Class I

PREDICATE DEVICE

807.92(a)(3)

807.92(a)(1)

Legally Marketed Equivalent Device

K Number	Product Name	Manufacturer
K140938	Alfred Alert	11 Health and Technologies Limited

REFERENCE DEVICE

Legally Marketed Reference Device

K Number	Product Name	Manufacturer
K150457	AlfaSight 9000 Thermographic System	Alfa Thermodiagnostics, Inc.

Our reference device (Alfasight 9000TM) suggests that skin thermal regulation and skin temperature can be utilized to identify various organ diseases including abnormalities in female breast, peripheral vascular disease, musculoskeletal disorders, extracranial cerebral and facial vascular disease, abnormalities of the thyroid gland, and various neoplastic conditions. Alfasight 9000TM utilizes thermal sensors and measures the subject's skin surface temperature to indicate deeper level organ diseases, while the SmartBag system has NTC thermistors integrated into the wafer to measure the peristomal skin temperature and indicate peristomal skin complication. In summary, there has been medical evidence of utilizing skin temperature for various diagnosis, supporting our hypothesis that peristomal skin temperature may indicate skin complications.

DEVICE DESCRIPTION

807.92(a)(4)

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SOFTWARE DESCRIPTION

The figure below illustrates how data transfer will take place within the SmartBag between the wafer, bag, hub, and 11 Health Cloud. The sensors in the bag and the wafer will be able to transmit data to the hub via NFC protocol communication. The data from the hub will be transmitted to the cloud via LTE-M data transfer via secure MQTT protocol and then this data can be downloaded to web supported devices – such as an iPhone.

Image /page/4/Figure/4 description: This image shows a schematic of a data transfer system. On the left side of the image, there is a thermistor integrated wafer and a thermistor and capacitive sensor integrated bag. Both of these devices are connected to a hub device via NFC. The hub device is connected to a cloud via LTE chip and secure MQTT protocol, and the cloud is connected to an Apple iPhone via HTTPS web-based data.

DEVICE INDICATIONS FOR USE

807.92(a)(5)

Prescription Use Only

The SmartBag Sytem is for adult use only. (22 years and above)

ОТС

The SmartBag Sytem is for adult use only. (22 years and above)

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COMPARISON OF TECHNICAL CHARACTERISTICS

807.92(a)(6)

Parameters	11 Health and Technologies, LLC	11 Health and Technologies, LLC
K Number	K140938	K181643
Regulatory	Class I	Class I
Classification	21 CFR 876.5600	21 CFR 876.5900
Product Code	EXB	EXB
Secondary Product	EZQ, EZS	EZQ, EZS
Indications for Use	The OSTOM-i Alert is intended tobe used as an accessory to anyostomy bag by monitoring thefilling of the bag whichinformation is sent via Bluetoothto a tablet computer to warnhealthcare personnel when apatient's bag is close to being full.	SmartBag is intended for use inside andout of hospitals for any patient with adiversionary urinary or fecal stoma. Itworks in conjunction with 11 Health'scare management platform known asAlfred. The SmartBag system usesintegrated sensors to continuouslymonitor bag filling and drainage,
	The Tablet computerautomatically captures the dataas to the volume and timing ofoutput for each patient.	providing cumulative output data tothe patient and clinical team. Thesystem also monitors skin condition,the occurrence of leaks and visualcondition of the stoma.
		SmartBag's intended use is to helpostomates acclimate to their lifestyle. Itworks in conjunction with 11 Health'scare management platform known asAlfred, designed for patients andmedical professionals. The SmartBagsystem (including the wafer and Hub),offers a continuous ostomy monitoringsystem, tracks the estimatedvolumetric filling of the bag and visualcondition of the stoma using integratedsensor technology.
		The SmartBag Sytem is for adult useonly. (22 years and above)
Use Environment	Hospital and home use	Hospital and home use
Patient Population	Patients using ostomy bags	Patients using ostomy bags
Disposable	Single use	Single use - wafer and SmartbagMultiple Use - Hub
Device Design:	Ostomy bag with portable sensor	Ostomy bag with portable sensor
Collection	attachment	attachment
Device Design: FillStatus	Visual and alert via temperaturesensor detection which sends fillalert to a dedicated tablet	Visual and alert via sensor detectionwhich sends fill alert to a dedicatedtablet computer
Parameters	11 Health and Technologies, LLC	11 Health and Technologies, LLC
Pictorialcomparison	Image: Ostomy bag and sensor	Image: Ostomy bag with temperature sensor
	Ostomy bag and sensor consistsof the bag and flexible resistorelement, whose resistancechanges depending on degree offlexure (bending). Once a desired"fill" level has been reached, analert/alarm is sent via Bluetoothto a table to alert healthcareprofessionals that the ostomybag requires immediateattention.	Ostomy bag with integratedtemperature sensors for notifyingpatients or medical professionals of anypotential leaks around the peristomalskin as well as giving an estimate of theoutput volume within the bag.

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NON-CLINICAL PERFORMANCE DATA

807.92(b)(1)

PERFORMANCE TESTING

A series of in-house non-clinical bench experiments were conducted to prove the usability and functionality of the thermistors and capacitors. The experiments include but were not limited to:

Simulated volumetric infusion test using materials with different viscosities to simulate i ostomy excretion: to verify the volumetric sensor sheet's functionality of volumetric measurement

Test Report:

028_Testing Report 3_SmartBag Prototype Water and Apple Infusion Simulation Test

i Simulated volumetric infusion test on human volunteers in different body positions and movement: to verify the volumetric sensor sheet's functionality of volumetric measurement when user is in different body positions and doing physical activities 7 4

Test Report:

029_Testing Report 4_Double_Thermistor Sheet Volumetric Test in a Mimic Pouch Using Four Different Fluids Human

032_Testing Report 7_Volumetric Test on Human Volunteer Using Water and Apple Sauce

Simulated volumetric test on human volunteers with different clothing options: to verify the ı volumetric sensor sheet's functionality of volumetric measurement when different pressure from clothing is applied to the ostomy bag as a wearable device 6

Test Report:

031 Testing Report 6 Clothing Test with Donut and Square Thermistor Sheets

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। Simulated volumetric infusion test under high heat environment: to verify volumetric sensor sheet's functionality of volumetric measurement when external temperature is close to infusion temperature 5

Test Report:

030_Testing Report 5_Infusion Test in Environment Chamber

। Simulated leakage test using water at 37 °C to verify the wafer sensor sheet's functionality of leakage detection 2

Test Report:

027_Testing Report 2_Leakage Simulation Test Trial 3 Standing and Supine

Simulated saturation durability test to verify the embedded water sensor sheet's durability 1 ı

Test Report:

025_Testing Report 1a_SCAPA Wafer Prototype Saturation Test 026 Testing Report 1b SCAPA Wafer Prototype 7 Days Saturation Test

CONCLUSION

807.92(b)(3)

The volumetric sensor sheet is capable of:

Detecting dynamic simulated infusions -
Detecting static volume of infused materials ı
-Recognizing different viscosities of the simulated infusions
। Measure volume of the simulated infusions when user is in standing or supine positions
-Measure volume of the simulated infusions when the environment temperature is close to infusion temperature, with the aid of capacitors

The wafer sensor sheet is capable to:

-Detect simulated leakage with the correct log interval
-Remain durable and functional after 7 days of saturation in 37 °C water bath

Consequently, the SmartBag prototype is proven to be functional for volumetric measurement and leakage detection from our simulated bench tests.

Substantial Equivalence Discussion

The primary intended use of an ostomy bag is a collection device. The SmartBag, does not alter an ostomy bag's function as a collection device but rather shares the same attributes with added features. The SmartBag offers a continuous ostomy monitoring system, tracking the estimated volumetric filling of the bag via integrated thermistor and capacitive sensors and potentially indicating the visual condition of the stoma with the optical sensor in the hub. Temperature distribution around the stoma, and anomalies in the temperature can suggest, inter alia, leakage occurrence, developing skin irritation and other phenomena in the peristomal region. Integrated sensors may indicate time of excretion, and data related to output, such as the phase (liquid, solid, semi-solid and gas). Data from the bag and wafer are transmitted securely by NFC to the hub which subsequently transmits data to the cloud via LTE. The data can be downloaded to a hand-held device like a cellphone or tablet for clinical purposes, if clinically indicated. The Smartbag raises no new issues of safety and effectiveness for its intended use but is a technological improvement of current approaches of simple visualization of ostomy fill and is substantially equivalent to both predicate device and reference device identified.

Regulation Number and Section

§ 876.5900 Ostomy pouch and accessories.

(a)
Identification. An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.(b)
Classification. Class I (general controls). 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.