Noddle(TM)

K162817 · Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. · ILQ · Jan 18, 2017 · Physical Medicine

Device Facts

• Record ID: K162817
• Device Name: Noddle(TM)
• Applicant: Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.
• Product Code: ILQ · Physical Medicine
• Decision Date: Jan 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3710
• Device Class: Class 2

Indications for Use

The noddle™ is intended to be used by patients who cannot either access a standard nurse call and/or communicate traditionally. The noddle™ is used for alternate access to a nurse call and/or access to assistive and augmentative communication devices (speech generation devices) to communicate with caregivers.

Device Story

Noddle™ is a patient-assistive communication device; accepts input signals from a sensor to detect intentional gestures from disabled patients. Device interprets sensor signals to control up to three output switches. Outputs connect via hardwire or Bluetooth to external systems, including nurse call stations and speech generation devices. Used in clinical or home settings by patients with physical limitations; operated by the patient. Output allows patients to summon caregivers or access augmentative communication tools, facilitating interaction and improving patient autonomy.

Clinical Evidence

No clinical data provided; bench testing only. Device complies with AAMI ES60601-1, CSA C22.2#60601-1, IEC 60601-1, and IEC 60601-1-2 safety and electromagnetic compatibility standards.

Technological Characteristics

Powered communication system; accepts sensor inputs; provides three output switches via hardwire or Bluetooth. Complies with AAMI ES60601-1, CSA C22.2#60601-1, IEC 60601-1, and IEC 60601-1-2. Risk management per ISO 14971.

Indications for Use

Indicated for patients with physical limitations, weaknesses, and/or limited communication abilities requiring assistance to summon or communicate with caregivers via nurse call or speech generation devices. Patients must be sufficiently cognitively intact to produce intentional gestures.

Regulatory Classification

Identification

A powered communication system is an AC- or battery-powered device intended for medical purposes that is used to transmit or receive information. It is used by persons unable to use normal communication methods because of physical impairment. Examples of powered communication systems include the following: a specialized typewriter, a reading machine, and a video picture and word screen.

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 § 890.9.

Predicate Devices

• Comfort Keyboard (K930044)

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

January 18, 2017

Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. R. Rives Bird CEO 2500 Crosspark Road Ste W150 Coralville, Iowa 52241

Re: K162817

Trade/Device Name: Noddle™ Regulation Number: 21 CFR 890.3710 Regulation Name: Powered Communication System Regulatory Class: Class II Product Code: ILO Dated: October 3, 2016 Received: October 6, 2016

Dear R. Rives Bird:

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

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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.

# Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162817

Device Name Noddle™

#### Indications for Use (Describe)

The Noddle™ is indicated for use by patients who have physical limitations, weaknesses, and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the Noddle™ patients should be sufficiently intact so that they can produce intentional gestures and intend to communicate with caregivers.

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

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## Voxello

### 510(k) SUMMARY

| Company Name: | Voxello |
|-----------------------|---------------------------------------------|
| Address: | 2500 Crosspark Road<br>Coralville, IA 52241 |
| Telephone No: | 319-214-3023 |
| Registration No.: | N/A |
| Contact person: | R. Rives Bird |
| Date Prepared: | 29 November 2016 |
| Device (trade) name: | Noddle™ |
| Common/usual name: | Powered communication device |
| Classification Name: | System, communication, powered |
| Classification Panel: | Physical Medicine |
| CFR Section: | 890.3710 |
| Device Class: | Class II |
| Device Code: | ILQ |

#### Predicate device:

- Substantially equivalent to Comfort Keyboard (K930044)
#### Device description:

The Voxello noddle™ is a patient assistive communication device that accepts signals from a sensor to determine when a disabled patient is attempting to intentionally gesture for control of a device or system. The Voxello noddle™ interprets the signals from the sensor to allow the user to control up to three output switches. These outputs may be connected via hardwire or Bluetooth connection to control or access devices such as nurse call stations, and/or speech generation devices.

#### Intended use:

The noddle™ is intended to be used by patients who cannot either access a standard nurse call and/or communicate traditionally. The noddle™ is used for alternate access to a nurse call and/or access to assistive and augmentative communication devices (speech generation devices) to communicate with caregivers.

#### Indications for use:

The noddle™ is indicated for use by patients who have physical limitations, weaknesses and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the noddle™ patients should be sufficiently cognitively intact so that they can produce intentional gestures and intend to communicate with caregivers.

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## Voxello

#### Comparison with Predicate Device:

- It is the opinion of Voxello, that the noddle™ is similar to the Comfort Keyboard, Both . devices are used to increase access to control another, or multiple devices.
#### Substantial Equivalence:

The Voxello noddle™is substantially equivalent to the commercially available Comfort Keyboard. These devices assist the patient in communicating and have similar characteristics.

#### Safety information:

- The Voxello noddle™ complies with all relevant EN/IEC 60601-1 Safety Standards, . Particular and Collateral Standards, including the following:
AAMI ES60601-1 *BEI Issued: 2006/03/09 (R2012) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; Amd. C1: 2009, Amd. 2:2010

CSA C22.2#60601-1 *DEI Issued: 2014/03/01 Ed: 3 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-1:2005 Ed.3+A1;C1:2014 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-1-2 Issued 2007/03/02 Ed: 3.0 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance; - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

ISO 14971 Issued: 2007/10/01 Ed:2 Medical Devices - Application of Risk Management to Medical Devices

#### Conclusion:

The Voxello noddle™ does not introduce any new indications for use, nor does the use of the systems result in any new potential hazard. Voxello believes the noddle™ to be substantially equivalent with the predicate device with respect to safety and effectiveness.