OSTOM-I ALERT

K140938 · 11 Health and Technologies, LLC · EXB · Oct 10, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140938
• Device Name: OSTOM-I ALERT
• Applicant: 11 Health and Technologies, LLC
• Product Code: EXB · Gastroenterology, Urology
• Decision Date: Oct 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5900
• Device Class: Class 1

Intended Use

The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient. The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the hospital environment. The sensor-based OSTOM-i™ Alert is intended to be used by the patient outside of the hospital environment.

Device Story

Sensor-based accessory for ostomy bags; monitors bag fill status; utilizes flex sensor to measure curvature; converts resistance changes into volume (mL) data; transmits data via Bluetooth to tablet/mobile app; provides alerts when bag is near capacity; logs volume and timing of output. Used in hospital and home settings; operated by healthcare professionals or patients. Provides real-time fill status and historical output data; replaces intermittent visual checks; enables timely bag emptying; improves patient management.

Clinical Evidence

No clinical data. Bench testing performed: usability and label comprehension studies with ICU nurses and patients; performance testing across various patient positions (standing, lying, sitting, bending, driving, climbing stairs); device durability (water exposure); biocompatibility per ISO 10993; electromagnetic compatibility; and wireless coexistence.

Technological Characteristics

Flex sensor; Bluetooth connectivity; tablet/mobile app interface; battery-powered; single-patient use; biocompatible materials per ISO 10993; electromagnetic compatibility and wireless coexistence testing performed.

Indications for Use

Indicated for all patient populations using ostomy bags for fecal or urinary collection.

Predicate Devices

• Two Piece Ostomy System (K813269)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping heads or faces.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2014

11 Health and Technologies LLC % EJ Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K140938

Trade/Device Name: Ostom-i™ Alert Regulation Number: 21 CFR§ 876.5900 Regulation Name: Ostomy Bag Accessory Regulatory Class: I Product Code: EXB, EZO, EZS Dated: September 2, 2014 Received: September 2, 2014

Dear EJ Smith,

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 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 (reporting of medical device

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related 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140938

Device Name OSTOM-iTM Alert

#### Indications for Use (Describe)

The OSTOM-1™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare persomel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient.

The OSTOM-i™ Alert is indicated for all patient populations.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140938

Device Name OSTOM-iTM Alert

#### Indications for Use (Describe)

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the hospital environment.

The OSTOM-i™ Alert is indicated for all patient populations.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary 807.92(c)

| SPONSOR | | 807.92(a)(1) |
|-----------------|-------------------------------------------------------------------------------------|--------------|
| Company Name: | 11 Health Technologies | |
| Company Address | Kinetic Business Centre<br>Theobald Street<br>Borehamwood WD6 4PJ<br>United Kingdom | |
| Telephone: | [phone] | |
| Contact Person: | Michael Seres | |

Summary Preparation Date: October 9, 2014

#### DEVICE NAME

807.92(a)(2)

| Trade Name: | Ostom-i |
|----------------------|------------------------------|
| 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 |
| Device Class: | Class I |

# PREDICATE DEVICE

#### 807.92(a)(3)

Legally Marketed Equivalent Device

| K Number | Product Name | Manufacturer |
|----------|-------------------------|----------------|
| K813269 | Two Piece Ostomy System | Hollister, Inc |

#### DEVICE DESCRIPTION

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn the health care provider when their patients' bags are close to being full, or to the patient in the post-hospital setting.

The flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag. This information is relayed to the tablet generating an additional report on bag status versus the visual one now available.

# 807.92(a)(4)

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# DEVICE INDICATIONS FOR USE

# 807.92(a)(5)

# Prescription Use Only

The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient.

The OSTOM-i™ Alert is indicated for all patient populations.

# ОТС

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensorbased OSTOM-i™ Alert is intended to be used by the patient outside of the hospital environment.

The OSTOM-i™ Alert is indicated for all patient populations.

| Parameters | 11 Health and Technologies, LLC | Hollister, Inc. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | | K813269 |
| Regulatory<br>Classification | Class I Exempt<br>21 CFR 876.5900 | Class I Exempt<br>21 CFR 876.5900 |
| Product Code | EXB | EXB |
| Indications for<br>Use | The OSTOM-i™ Alert is intended to<br>be used as an accessory to any<br>ostomy bag by monitoring the filling<br>of the bag which information is sent<br>via Bluetooth to a tablet computer<br>to warn healthcare personnel when<br>a patient's bag is close to being full.<br>The Tablet computer automatically<br>captures the data as to the volume<br>and timing of output for each<br>patient.<br><br>The sensor-based OSTOM-i™ Alert<br>attaches to any ostomy bag and is<br>able to send messages via Bluetooth<br>to a mobile app to warn patient<br>when ostomy bag is close to being | An ostomy pouch and accessories is a<br>device that consists of a bag that is<br>attached to the patient's skin by an<br>adhesive material and that is intended<br>for use as a receptacle for collection of<br>fecal material or urine following an<br>ileostomy, colostomy, or<br>ureterostomy (a surgically created<br>opening of the small intestine, large<br>intestine, or the ureter on the surface<br>of the body). |

# COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

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| | full. The sensor-based OSTOM-i™™<br>Alert is intended to be used by the<br>patient outside of the hospital<br>environment. | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | The OSTOM-i™ Alert is indicated for<br>all patient populations. | |
| Use environment | Hospital and home use | Hospital and home use |
| Patient<br>Population | Patients using Ostomy Bags | Patients using Ostomy Bags |
| Disposable | Single patient use | Single patient use |
| Device Design:<br>Collection | Ostomy bag with portable level<br>sensor attached | Ostomy bag |
| Device Design:<br>Fill Status | Visual and alert via sensor detection<br>which sends fill alert via Bluetooth<br>to a dedicated device, a tablet<br>computer | visual |

# NON-CLINICAL PERFORMANCE DATA

# 807.92(b)(1)

Performance Testing-Usability and Label Comprehension Study by Intended User

The testing for ease of use and label comprehension of the 11 Health Ostom-i™ Hospital App with the Ostom-i™ Alert Sensor by nurses who would use this in a hospital setting was the object of this usability study. Nurses are the primary caregivers in the maintenance of ostomy bags in the hospital setting.

The usability factors included the ability of the healthcare professional to read and understand the Hospital App Instructions for Use, interface with Tablet by inputting patient information, attach the sensor to the ostomy bag and after enabling the battery, pair the sensor to the Tablet. An alert was simulated by curving the bag to the filling of the bag thereby creating the alarm condition.

# PERFORMANCE TESTING

The following performance tests were conducted:

- . Patient Usability Testing:
- o Patients standing
- o Patients lying down

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- Patients sitting down with ostomy bag folded in half o
- Device dropped in water o
- o Water splashed on device
- Patient climbing stairs o
- o Patient rolling over 360 degrees
- o Patient bending over
- o Patient driving
- Label comprehension study
- Usability study by ICU registered nurses
- Biocompatibility testing in accordance with ISO 10993
- Electromagnetic compatibility
- Wireless coexistence

# CONCLUSION

# 807.92(b)(3)

The primary intended use of an ostomy bag is a collection device. The OSTOM-i™ Alert is an accessory to the ostomy bag which does not alter an ostomy bag's function as a collection device but rather adds a graphic fill status and alert of critical fill level to the healthcare provider via BlueTooth to a tablet computer, which is a technological improvement over intermittent visualization. In addition, information concerning amount of out- put and time of output is available for clinical purposes, if clinically indicated. The OSTOM-i™ Alert raises no new issues of safety and effectiveness for its intended use, but is a technological advance of simple visualization of ostomy fill and is substantially equivalent to the predicate device.