Not Found
No
The description focuses on interpreting signals from a sensor to control output switches, which is a rule-based or deterministic process, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts like training/test sets.
No
The device is described as a patient assistive communication device to help patients summon and communicate with caregivers, not to treat a medical condition.
No
The device description and intended use state that it is an assistive communication device to help patients control other devices, not to diagnose a condition.
No
The device description explicitly states it "accepts signals from a sensor" and "interprets the signals from the sensor," indicating a hardware component (the sensor) is integral to the device's function.
Based on the provided information, the Noddle™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Noddle™ Function: The Noddle™ is a patient assistive communication device that uses signals from a sensor to interpret intentional gestures and control other devices. It does not analyze biological samples from the body.
- Intended Use: The intended use is to assist patients with physical limitations in communicating with caregivers by controlling external devices. This is a functional assistive technology, not a diagnostic test.
Therefore, the Noddle™ falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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 intact so that they can produce intentional gestures and intend to communicate with caregivers.
Product codes (comma separated list FDA assigned to the subject device)
ILO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients who cannot either access a standard nurse call and/or communicate traditionally.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3710 Powered communication system.
(a)
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.(b)
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.
0
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one above the other.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Voxello
510(k) SUMMARY
| Company Name: | Voxello |
|---|---|
| Address: | 2500 Crosspark Road |
| 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.
4
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.