(71 days)
Not Found
No
The description focuses on signal processing (converting sound to visual/auditory feedback) and data collection, without mentioning any adaptive learning, pattern recognition beyond simple thresholds, or complex decision-making processes characteristic of AI/ML. The feedback is based on pre-defined targets and simple comparisons.
Yes
The device is designed to improve vocal loudness in individuals with Parkinson's disease and other neurological disorders, which aligns with the definition of a therapeutic device as it provides a treatment or intervention for a medical condition.
No
The device is described as a "technical aid complementing person speech therapy to improve the vocal loudness" and a tool for "speech therapy tasks." It provides feedback and collects data on vocal parameters for clinicians to analyze. There is no mention of the device being used to diagnose a medical condition or disease.
No
The device description explicitly states that the device consists of software and relies on a calibrated microphone to receive sound, which is a hardware component.
Based on the provided information, the LSVT Companion Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The LSVT Companion Device works by receiving sound produced by an individual's voice via a microphone and providing visual and auditory feedback. It does not analyze any biological samples (like blood, urine, tissue, etc.).
- The intended use is for speech therapy and improving vocal loudness. This is a behavioral intervention and a technical aid for therapy, not a diagnostic test to identify a disease or condition based on analyzing bodily specimens.
- The device description focuses on processing sound and providing feedback. It describes the software, GUI, data collection on vocal parameters, and the feedback mechanisms, all related to speech production and therapy.
In summary, the LSVT Companion Device is a therapeutic aid used in conjunction with speech therapy, not a device used for in vitro diagnostic testing of human specimens.
N/A
Intended Use / Indications for Use
The LSVT Companion Device is designed:
To be used as a technical aid complementing person speech therapy to improve the vocal loudness of persons with Parkinson's disease.
To be used with adults, 18 years of age or older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes.
To be used for voice/speech impaired adults, 18 years of age and older, who are able to follow the directions of a Speech-Language Pathologist.
This device is sold only to licensed practitioners who have also completed a 2 day certification workshop on the LSVT (Lee Silverman Voice Treatment) behavioral therapy protocol. This certifies them to provide LSVT for patients with Parkinson's disease and other communicative impairments. The following specific labeling, therefore, is provided on the product: Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.
The LSVT Companion is designed as a technical aid for this behavioral intervention to increase communicative effectiveness. A "home study" function allows patients to complete voice exercises either under direct supervision by the practitioner in the clinic environment or at home, with feedback of performance provided to the clinician by results reporting via e-mail.
Product codes (comma separated list FDA assigned to the subject device)
LEZ
Device Description
The sound produced by an individual's voice is received by a calibrated microphone and converted to a visual display which consists of different visual and auditory feedback. The individual is given a target range of both vocal intensity (loudness) and fundamental frequency (pitch) and instructed to maintain a given loudness and or pitch for a given duration. Increases in the complexity of the spoken material are combined with these targeted vocal parameters. In this way, individuals are trained to increase both vocal loudness and variations in pitch through a series of exercises. This approach is designed for speech and hearing impaired adults, over the age of 18, who are unable to speak at a consistent and audible level of loudness such as those with Parkinson's disease and other causes.
The device consists of software that allows clinicians to manage speech therapy for clients as well as allow clients to perform speech "homework" on their home PC The Graphical User Interface (GUI) contains two modes of operation - client and clinician. In each mode, the speech therapy tasks are presented to the user and feedback is continually being given. The device collects data on the variables trained (vocal sound pressure level, fundamental frequency, and duration of phonation) and directs individuals through a series of speech exercises, while providing online feedback.
These data are recorded to a file that can be downloaded and analyzed by the clinician. Targets for vocal loudness, F0 and duration can be individualized and revised as often as needed. The interface was developed to be simple to use, while carefully considering the specific visual, motor, cognitive and voice/speech needs of individuals with Parkinson's disease and other communicative impairments. The backgrounds were designed in bright contrasting colors which have common meaning (e.g., green means "go") to make the targeted goals easier to identify. In addition, the visual displays utilize concrete, familiar objects (e.g., thermometer, piano, clock) which are designed to be intuitive and require little interpretation. Due to the fact that the device is intended to be used without a face to face clinician, feedback emulates what would be received from a clinician in a therapy session. Thus, in addition to the written comments shown on the screen, a wide variety of auditory feedback phrases, such as "Good job!", "Let's get louder," "Great!", "Can you go any higher?", and short instructions at the beginning of each exercise have been incorporated.
The Sound Server works with the GUI in that it sends it data from the microphone at regular intervals so that graphs can be created, feedback can be given to the user, and results for the speech tasks can be written.
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
Adults, 18 years of age and older
Intended User / Care Setting
Licensed practitioners who have also completed a 2 day certification workshop on the LSVT (Lee Silverman Voice Treatment) behavioral therapy protocol.
Clinic environment or at home.
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)
The new device in PDA form was the subject of a preliminary clinical investigation designed to explore device efficacy and user satisfaction. Sixteen individuals with PD were able to independently use the new device and showed therapeutic gains similar to those following classically/traditionally administered speech therapy. These gains were significant from pre to post and pre to follow-up and absolutely no adverse effects of using the assistive technology to improve vocal loudness. Individuals were highly enthusiastic about the use of the assistive technology. Anecdotal reports of the speech language pathologists participating in the study reveal that they were highly encouraged by the results and thus reported similar satisfaction as those referenced in the predicate device.
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
N/A
0
21 CFR 807.92 (a) 1
AUG 20 2009
Submitter:
Submitter's Address:
LSVT Global LLC
6890 E. Sunrise Suite 120, #241 Tucson, AZ 85750
Submitter's Telephone Number:
Submitter's Fax Number:
Contact Person:
Date of Preparation of Summary:
1.888.438.5788
1.520.615.8559
David H. McFarland
December 18, 2008
1
21 CFR 807.92 (a) 2
The Trade name of the device is LSVT Companion; the name LSVT is registered
trademark by the U.S. Office of Patents.
The Device Classification Name is AIDS, SPEECH TRAINING FOR THE
HEARING IMPAIRED as shown in 510 (k) number K982396 for the VISIVOX for which we claim equivalence.
2
21 CFR 807.92 (a) 3
IDENTIFICATION OF THE LEGALLY MARKETED DEVICE TO WHICH LSVT . GLOBAL LLC IS CLAIMING EQUIVALENCE
The legally marketed device to which LSVT Global, LLC is claiming equivalence
is the
RSQ, LLC Visivox, Model V-2
which was approved for marketing on September 14, 1998 under 510(k) K982396
RSQ, LLC is the assignee of the following patent:
Patent number: 5774558 Filing date: Oct 24, 1996 Issue date: Jun 30, 1998 Inventor: Doris Drucker Assignees: RSQ, LLC
U.S. Classification 381/56; 340/573; 381/58
International Classification H04R 2900
Device Classification Name: AIDS, SPEECH TRAINING FOR THE HEARING IMPAIRED (AC POWERED AND PATIENT CONTACT)
Applicant: LSVT Global, LLC
Product Code: LEZ
Classification Advisory Committee: EAR, NOSE & THROAT
3
21 CFR 807.92 (a) 4
DESCRIPTION OF THE DEVICE
The sound produced by an individual's voice is received by a calibrated microphone and converted to a visual display which consists of different visual and auditory feedback. The individual is given a target range of both vocal intensity (loudness) and fundamental frequency (pitch) and instructed to maintain a given loudness and or pitch for a given duration. Increases in the complexity of the spoken material are combined with these targeted vocal parameters. In this way, individuals are trained to increase both vocal loudness and variations in pitch through a series of exercises. This approach is designed for speech and hearing impaired adults, over the age of 18, who are unable to speak at a consistent and audible level of loudness such as those with Parkinson's disease and other causes.
The device consists of software that allows clinicians to manage speech therapy for clients as well as allow clients to perform speech "homework" on their home PC The Graphical User Interface (GUI) contains two modes of operation - client and clinician. In each mode, the speech therapy tasks are presented to the user and feedback is continually being given. The device collects data on the variables trained (vocal sound pressure level, fundamental frequency, and duration of phonation) and directs individuals through a series of speech exercises, while providing online feedback.
These data are recorded to a file that can be downloaded and analyzed by the clinician. Targets for vocal loudness, F0 and duration can be individualized and revised
4
as often as needed. The interface was developed to be simple to use, while carefully considering the specific visual, motor, cognitive and voice/speech needs of individuals with Parkinson's disease and other communicative impairments. The backgrounds were designed in bright contrasting colors which have common meaning (e.g., green means "go") to make the targeted goals easier to identify. In addition, the visual displays utilize concrete, familiar objects (e.g., thermometer, piano, clock) which are designed to be intuitive and require little interpretation. Due to the fact that the device is intended to be used without a face to face clinician, feedback emulates what would be received from a clinician in a therapy session. Thus, in addition to the written comments shown on the screen, a wide variety of auditory feedback phrases, such as "Good job!", "Let's get louder," "Great!", "Can you go any higher?", and short instructions at the beginning of each exercise have been incorporated.
The Sound Server works with the GUI in that it sends it data from the microphone at regular intervals so that graphs can be created, feedback can be given to the user, and results for the speech tasks can be written.
5
SUMMARY OF THE NEW DEVICE COMPARED TO THE PREDICATE
DEVICE
Intended Use [21 CFR 807.92 (a) 5]
The intended use of the predicate device is as follows: "To be used as an assistive device and training aid, complementing person-to-person speech therapy:
-
- For the deaf, and for people with hearing impairments who do not perceive the loudness of their speech.
-
- For people with speech impairments who are unable to speak at a consistent and audible level of loudness. The impairments may be due to stroke, Parkinson's, traumatic head or spine injuries, cleft palate, laryngectomies or other causes.
-
- For speech-and/or hearing impaired people of any age who are able to follow the directions of a speech therapist or audiologist"
The intended use of the new device the LSVT Companion is as follows:
To be used as a technical aid complementing person speech therapy to improve the vocal loudness of persons with Parkinson's disease.
To be used with adults, 18 years of age and older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes.
To be used for voice/speech impaired adults, 18 years of age or older, who are able to follow the directions of a Speech-Language Pathologist.
6
This device is sold only to licensed practitioners who have also completed a 2 day certification workshop on the LSVT (Lee Silverman Voice Treatment) behavioral therapy protocol. This certifies them to provide LSVT for patients with Parkinson's disease and other communicative impairments.
The following specific labeling, therefore, is provided on the product:
Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.
Technological Characteristics [21 CFR 807.92 (a) 6]
The New Device has similar technological characteristics as the predicate with the modernization that the device uses hardware and software as opposed to just hardware in the predicate device to transduce and provide feedback for vocal loudness.
In the new device, a calibrated microphone is used with a PC based software program to receive a speaker's acoustic signals. Targeted visual and auditory feedback is provided through a series of speech tasks. In the legally marketed device a microphone is attached to a hardware device imbedded in a box. Acoustic signals are converted to LED displays is logarithmic 3 db steps that vary with the individual's vocal loudness. The overall goal is to enable individual's to maintain vocal loudness at appropriate levels through this targeted visual feedback. This is extremely similar to the new device which adds auditory feedback to visual feedback and enables targeted vocal ranges to be established to improve both vocal loudness and fundamental frequency. The hardware device in the legally marketed device is substituted by a graphical user interface and other software components as described above. These differences are not critical to the intended therapeutic use of the device.
7
807.92 (b) (1, 2, 3)
ASSESSMENT OF NON-CLINICAL AND CLINICAL PERFORMANCE DATA
The only assessment known to the applicant that refers to the predicate legally marketed device is that provided in their previous 510(k) summary document and refers to the opinions of two practicing speech language pathologists of the utility of using the visual feedback instrument to improve vocal loudness in speech disordered and other individuals.
The new device in PDA form was the subject of a preliminary clinical investigation designed to explore device efficacy and user satisfaction. Sixteen individuals with PD were able to independently use the new device and showed therapeutic gains similar to those following classically/traditionally administered speech therapy. These gains were significant from pre to post and pre to follow-up and absolutely no adverse effects of using the assistive technology to improve vocal loudness. Individuals were highly enthusiastic about the use of the assistive technology. References to published abstracts referring to the new device are provided below. Anecdotal reports of the speech language pathologists participating in the study reveal that they were highly encouraged by the results and thus reported similar satisfaction as those referenced in the predicate device. We suggest, therefore, that performance data are highly similar between the New Device and the predicate.
8
References
Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., & Will, L. (2005). Technology supported speech treatment for Parkinson's disease. Movement Disorders. 20(10), p. S134.
Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Bennett, J. LSVTC- A PDA Supported Speech Treatment for Parkinson's Disease. Presented at the Coleman Institute for Cognitive Disabilities, "Research Frontiers & Partnerships in Cognitive Disability and Technology" Conference, October 9-10, 2003, Aurora, Colorado.
Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Bennett, J. LSVTC- A PDA Supported Speech Treatment for Parkinson's Disease. Presented at the Twelth Biennial Conference on Motor Speech, March 18-21, 2004, Albuquerque, New Mexico.
Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Bennett, J., Will, L. LSVTC- A PDA Supported Speech Treatment for Parkinson's Disease, Presented at the International Association of Logopedics and Phoniatrics, Brisbane, Australia, 2004.
Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Cole, R., Yan, J., Will, L. Technology Supported Speech Treatment for Parkinson's Disease. Poster presented at the 9th International Congress of Parkinson disease and Movement disorders, March 5-8, 2005, New Orleans, Louisiana.
Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Will, L. LSVTC- A PDA Supported Speech Treatment for Parkinson's Disease. Presented at the Annual Conference of the American Speech-Language Hearing Association, Philadelphia, Pennsylvania, 2004.
Halpern, A., Matos, C., Ramig, L., Spielman, J., Bennett, J. PDA-Enhanced Speech Treatment for Parkinson's Disease, Presented at the Fifth Annual Meeting of the American Society for Experimental NeuroTherapeutics, Washington DC, March 13-15, 2003.
Halpern, A., Matos, C., Ramig, L., Spielman, J., Bennett, J. PDA-Enhanced Speech Treatment for Parkinson's Disease. Presented at the Eleventh Biennial Conference on Motor Speech, March 14-17, 2002, Williamsburg, Virginia.
Matos, C., Halpern, A., Ramig, L., Spielman, J., Bennett, J. Updates to PDA-Enhanced Speech Treatment for Parkinson's Disease. Presented at the Coleman Institute for Cognitive Disabilities, "Research Frontiers & Partnerships in Cognitive Disability and Technology" Conference, September 26-27, 2002, Boulder, Colorado.
9
Substantial Equivalence Table (see also Substantial Equivalence Flow Chart as Attachment II)
| Characteristic | Predicate | LSVT C or LSVT Companion |
|---|---|---|
| Intended Use: | "To be used as an assistive device and training aid, complementing person-to-person speech therapy: |
-
For the deaf, and for people with hearing impairments who do not perceive the loudness of their speech.
-
For people with speech impairments who are unable to speak at a consistent and audible level of loudness. The impairments may be due to stroke, Parkinson's, traumatic head or spine injuries, cleft palate, laryngectomies or other causes.
-
for speech-and/or hearing impaired people of any age who are able to follow the directions of a speech therapist or audiologist" | The LSVT Companion Device is designed:
To be used as a technical aid complementing person-to-person speech therapy to improve the vocal loudness of persons with Parkinson's disease.
To be used with adults, 18 years of age and older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes.
To be used for voice/speech impaired adults, 18 years of age or older, who are able to follow the directions of a Speech-Language Pathologist. |
| Target Population | Persons of any age | Adults, 18 years of age and older |
| Physical Characteristics: | A microphone is attached to a hardware device imbedded in a box. Acoustic signals are converted to LED displays in logarithmic 3 db steps that vary with the | A calibrated microphone is used with a PC based software program to receive a speaker's acoustic signals. Targeted visual and auditory feedback is provided through a series of |
| | individual's vocal loudness.
The overall goal is to enable
individual's to maintain
vocal loudness at
appropriate levels through
this targeted visual
feedback. | speech tasks. The hardware
device in the legally
marketed device is
substituted by a computer, a
graphical user interface and
other software components. |
| Where Used | Inside and outside of a
clinical setting | Inside and outside of a
clinical setting |
| Performance Data: | Two practicing speech
language pathologists report
the utility of using the
visual feedback instrument
to improve vocal loudness
in speech disordered and
other individuals. | The LSVT Companion in
PDA form was the subject
of a preliminary
investigation to explore
device efficacy and user
satisfaction. Sixteen
individuals with PD were
able to independently use
the LSVT Companion and
showed therapeutic gains
similar to those following
classically/traditionally
administered LSVT
therapy. These gains were
significant from pre to post
and pre to follow-up and
there were absolutely no
adverse effects of using the
assistive technology to
improve vocal loudness.
Individuals were highly
enthusiastic about the use of
the assistive technology. |
10
:
and the state of the state of the states and the states of the states and
and the control control of the control of the control of
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
11
Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, creating a sense of protection and care. The logo is rendered in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
LSVT Global, LLC c/o David H. McFarland 6890 E. Sunrise Drive Suite 120, #241 Tucson, AZ 85750
AUG 2009
Re: K091682
Trade/Device Name: LSVT C or LSVT COMPANION, MODE Regulation Number: Unclassified Regulation Name: Regulatory Class: Unclassified Product Code: LEZ Dated: 5/26/2009 Received: 6/10/2009
Dear Mr. McFarland:
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.
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-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.
12
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
13
Indications for Use
510(k) Number (if known): _
Device Name: LSVT C or LSVT Companion
Indications for Use
The LSVT Companion Device is designed:
To be used as a technical aid complementing person speech therapy to improve the vocal loudness of persons with Parkinson's disease.
To be used with adults, 18 years of age or older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes.
To be used for voice/speech impaired adults, 18 years of age and older, who are able to follow the directions of a Speech-Language Pathologist.
This device is sold only to licensed practitioners who have also completed a 2 day certification workshop on the LSVT (Lee Silverman Voice Treatment) behavioral therapy protocol. This certifies them to provide LSVT for patients with Parkinson's disease and other communicative impairments. The following specific labeling, therefore, is provided on the product: Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.
The LSVT Companion is designed as a technical aid for this behavioral intervention to increase communicative effectiveness. A "home study" function allows patients to complete voice exercises either under direct supervision by the practitioner in the clinic environment or at home, with feedback of performance provided to the clinician by results reporting via e-mail.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
Sir Nanofon
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091682