SmartByte Device

K171165 · Scientific Intake · ONY · May 18, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K171165
• Device Name: SmartByte Device
• Applicant: Scientific Intake
• Product Code: ONY · Gastroenterology, Urology
• Decision Date: May 18, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5981
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SmartByte device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range of 27-35 kg/m² in conjunction with behavioral modification instruction.

Device Story

Oral removable palatal space-occupying device; includes temperature sensor to monitor usage; worn during eating episodes. Healthcare professional uses Palatal Mold Kit to create custom device. Optional SmartByte Reader collects usage data; transmits wirelessly via Bluetooth to mobile application. Patient uses app to view adherence and weight management progress. Device aids weight management by occupying palatal space during meals. No changes to oral component from predicate; modification limited to software platform transition from PC-based to mobile application.

Clinical Evidence

No clinical data presented. Substantial equivalence supported by software verification and validation testing and electrical safety testing (IEC 60950-1).

Technological Characteristics

Removable palatal space-occupying device; custom-fitted via Palatal Mold Kit. Includes temperature sensor for usage monitoring. Connectivity via Bluetooth for wireless data upload to mobile application. Biocompatible per ISO 10993. Not sold sterile.

Indications for Use

Indicated for overweight to obese individuals with a BMI of 27-35 kg/m² to aid in weight management, used in conjunction with behavioral modification instruction.

Regulatory Classification

Identification

An oral removable palatal space occupying device for weight management and/or weight loss is a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient use. This classification does not include devices that are intended to treat any dental diseases or conditions

Special Controls

In combination with the general controls of the FD&C Act, the Oral removable palatal space occupying device for weight management is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows: (i) Mechanical testing must demonstrate that the device performs as intended for the labeled use life and does not create forces that result in movement of teeth and damage to teeth. (ii) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended. (iii) Software verification and validation must demonstrate that the device performs as intended. (iv) Battery testing must demonstrate that the device battery performs as intended. (3) Clinical performance testing must demonstrate the device performs as intended and must include an evaluation for choking. (4) Device labeling must address the following: (i) Patient labeling must state: (A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss; (B) Treatment must be offered in combination with a behavioral modification program; (C) Instructions on how to use the device as intended; and (D) The use life of the device. (ii) Physician labeling must state: (A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss; (B) Treatment must be offered in combination with a behavioral modification program; (C) Instructions on how to use the device as intended; and (D) The use life of the device. (5) Training must be provided to health professionals that includes procedures for determining a patient's oral health status, instructions for making the palatal mold, and assessment of issues with the device that may require service by the manufacturer.

Predicate Devices

• Sensor Monitored Alimentary Restriction Therapy (SMART) Device (DEN150033)

Submission Summary (Full Text)

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

May 18, 2017

Scientific Intake % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103

Re: K171165 Trade/Device Name: SmartByte Device Regulation Number: 21 CFR§ 876.5981 Regulation Name: Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss Regulatory Class: II Product Code: ONY Dated: April 20, 2017 Received: April 20, 2017

Dear Janice M. Hogan:

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.

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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 (reporting of medical devicerelated 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,

Benjamin R. Fisher -S

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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510(k) Number (if known)

K171165

Device Name

#### SmartByte Device

Indications for Use (Describe)

The SmartByte device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range of 27-35 kg/m² in conjunction with behavioral modification instruction.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY Scientific Intake's SmartByte Device

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Scientific Intake 280 Merrimack Street Suite 503 Lawrence, MA 01843 E-mail: [e-mail] Phone: [phone] Contact Person: Marc Gibeley, CEO

| Date Prepared: | May 11, 2017 |
|-----------------------|---------------------------------------------------------------------------------------------------------------|
| Name of Device: | SmartByte Device |
| Common or Usual Name: | Oral Removable Palatal Space Occupying Device for Weight<br>Management and/or Weight Loss (Product Code: ONY) |
| Predicate Device: | Sensor Monitored Alimentary Restriction Therapy (SMART) Device<br>(DEN150033; Product Code ONY) |

## Intended Use / Indications for Use

The SmartByte device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range of 27-35 kg/m² in conjunction with behavioral modification instruction.

## Device Description

The Scientific Intake SmartByte device is an oral removable palatal space occupying device that includes a temperature recording sensor to monitor usage. The device includes a Palatal Mold Kit used by a healthcare professional to make the SmartByte device and an optional SmartByte Reader component that connects to a mobile application wirelessly via Bluetooth to allow usage data to be uploaded to assess frequency of device usage, i.e., adherence and patient reported weight management.

## Comparison of Technological Characteristics

The purpose of this 510(k) is to modify the predicate SMART device by converting the existing computer-based software to a wireless mobile application. No changes have been made to the SmartByte Device oral component that is inserted and removed by the patient to achieve the intended use. A detailed comparison between the predicate SMART device and the subject SmartByte device is provided below:

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| | Subject SmartByte Device | Predicate SMART Device<br>(DEN150033) | Substantially<br>Equivalent (Yes<br>or No) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Intended Use | Aid weight management in<br>overweight to obese individuals<br><br>The SmartByte device is intended<br>for prescription use only | Aid weight management in<br>overweight to obese individuals<br><br>The SMART device is intended for<br>prescription use only | Yes; Same |
| Indications for<br>Use | For individuals with a body mass<br>index (BMI) in the range of 27-35<br>kg/m² in conjunction with<br>behavioral modification instruction | For individuals with a body mass<br>index (BMI) in the range of 27-35<br>kg/m² in conjunction with<br>behavioral modification instruction | Yes; Same |
| User Population | Individuals with a body mass index<br>(BMI) in the range of 27-35 kg/m² | Individuals with a body mass index<br>(BMI) in the range of 27-35 kg/m² | Yes; Same |
| Technological<br>Characteristics | Removable palatal space<br>occupying device that includes a<br>temperature recording sensor to<br>monitor usage | Removable palatal space<br>occupying device that includes a<br>temperature recording sensor to<br>monitor usage | Yes; Same |
| Palatal Mold Kit | Used by a healthcare professional<br>to make the SmartByte device | Used by a healthcare professional<br>to make the SMART device | Yes; Same |
| Optional<br>Component | A SmartByte Reader that allows<br>usage data to be uploaded to<br>assess frequency of device usage,<br>i.e., adherence and patient<br>reported weight management<br>wirelessly | A SMART Reader that allows<br>usage data to be uploaded to<br>assess frequency of device usage,<br>i.e., adherence and patient<br>reported weight management | Yes,<br>Substantially<br>Equivalent |
| Use | To be worn during all eating<br>episodes | To be worn during all eating<br>episodes | Yes; Same |
| Biocompatibility | The SmartByte device has been<br>shown to be biocompatible per<br>ISO 10993 | The SMART device has been<br>shown to be biocompatible per<br>ISO 10993 | Yes; Same |
| Sterilization | Not sold sterile or sterilized by<br>user | Not sold sterile or sterilized by<br>user | Yes; Same |
| Shelf Life | Same labeled shelf life | Same labeled shelf life | Yes; Same |
| Optional User<br>Interface | SmartByte App interface with basic<br>progress information provided to<br>user | PC website portal interface with<br>basic progress information<br>provided to user | Yes,<br>Substantially<br>Equivalent |

# Verification and Validation Activities

Software verification and validation was performed and results demonstrated that the SmartByte and SmartByte added mobile software application (SmartByte App) are appropriate for release. In addition, the company completed testing per IEC 60950-1 for the added Bluetooth connection.

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# Conclusions

The subject SmartByte device is substantially equivalent to the predicate SMART device, with the same intended use and indications and minor technological differences. The conversion of the software platform to a mobile medical application with a wireless Reader does not raise new types of safety or effectiveness questions. The confirmatory software verification and validation testing, as well as testing to IEC 60950-1, further demonstrates that the device performs as intended and is substantially equivalent to the predicate device.