(276 days)
Not Found
No
The description focuses on the mechanical nature of the device and a simple graphical user interface, with no mention of AI, ML, or related concepts.
Yes
The device is used for "external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization," which implies a therapeutic function.
No
The "Intended Use / Indications for Use" section states the device is for "external analysis and adjustment," implying it helps healthcare professionals interpret by providing data through analysis for the purpose of adjusting, rather than providing a diagnosis or diagnostic information related to a disease or condition. The device itself is described as a "mechanical device" used for analysis and adjustment/mobilization. While it assists with "analysis," it's within the context of a chiropractor's or medical doctor's assessment for adjustment, not for rendering a medical diagnosis.
No
The device description explicitly states it is a "mechanical device" and mentions "major components of the device" in the performance studies summary, indicating it includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- VSTAAR's Intended Use: The VSTAAR is described as a mechanical device for the external analysis and adjustment of the human spinal column and for soft tissue/musculoskeletal mobilization. It interacts with the body externally, not by analyzing samples taken from the body.
- Device Description: The description reinforces its mechanical nature and external application.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing laboratory tests, or providing diagnostic information based on internal bodily substances.
Therefore, the VSTAAR falls under the category of a physical therapy or chiropractic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VSTAAR is a mechanical device intended to be used by chiropractors, medical doctors and other licensed health care professions for the external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization.
Product codes (comma separated list FDA assigned to the subject device)
LXM
Device Description
The VSTAAR AdjusteR is a mechanical device used by chiropractors, medical and other licensed health care professionals for the external analysis and adjustment of the human spinal column, and for soft tissue and musculoskeletal mobilization.
The graphical user interface is mouse driven. All of the screens are easy to find and easy to understand. Navigating from screen to screen is quick and intuitive.
The main features of the device include:
Patient Data Screen - for patient demographic entry.
Single Evaluation test mode - to determine the articular and spinal tissue's relative compliance with a single impact on controlled preload instructions.
Lateral Evaluation - allows the user to evaluate the motion from side to side of the vertebrae, measuring the relative differences between two directions, identifying subluxation in the lateral axis.
Treatment - information from the Evaluation test mode allows the user to set a forced between 5 and 60 lbs and an impulse rate between 1 and 25 cycles per second.
Preload Bar Graph - allows the user to set a range that will be used to keep the device at a specific preload during all of the patients' treatments and assessments, typically based on body type for each patient - user feedback is provided graphically showing the pliability increase during the treating segment.
Real time Feedback - assists the user's treatment decisions. The LVDT position sensor measures depressions in the tissue made by the percussive force. The user can observe when there is a greater excursion of the LVDT denoting an increase in pliability or motion of the segment and tissue, documenting a change in the tissue consistency.
Treatment Focus – the user can focus on one region of concern at a time – cervical, thoracic or lumbar/sacral – allowing for a comparison between more like segments for bone structure.
Test "Pulse" - on seqments of the spine for comparison of relative compliance of those segments. Any vertebrae that will be considered a potential problem may or may not be selected by the practitioner for an adjustment.
Impulse Analysis - measuring depth of penetration and acceleration of penetration from an impact of a consistent force and the force has been shown to be essentially constant for specific substrates in both the evaluation of our instrument. The analysis assesses a region determining areas of low compliance (Minimal Pliability) and high compliance (Relatively High pliability compared to areas of Minimal Pliability). Once areas greater than 10% from one segment to the next are identified, the instrument is then used in a percussive mode (treatment) to break up muscle tension and loosen soft or articular tissue increasing mobility of the treated segments or regions. Bv repeated percussion affected areas are loosened, increasing the pliability of a muscle or segmental level thus increasing an area of low compliance or minimal pliability to a relatively higher level of compliance after mechanically palpating the tissue. This decreases muscle tension through mechanical compression and by simply mobilizing the affected areas allowing for more function and ROM in a segment or muscle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human spinal column, soft tissue, musculoskeletal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
chiropractors, medical doctors and other licensed health care professions
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)
Non-Clinical Testing: The submitted VSTAAR AdjusteR device has undergone significant verification and validation testing. Validation testing included verification testing of major components of the device to document conformance to device specifications and validation testing to confirm the device met its intended uses and requirements.
The performance data records documents that the VSTAAR AdjusteR device met its stated requirements and design specifications as intended.
Electrical Safety Testing - Electromagnetic Compatibility & Electrical Safety: The submitted device has been tested in conformance with IEC 60601-1 / EN 60601-1 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995), by Intertek, Twinsburg, OH, and IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, by a Keystone Compliance, New Castle, PA, both qualified testing laboratories.
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
Image /page/0/Picture/1 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 three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Spinal Acoustics, LLC Albert A. Torrence President and CEO Spinal Acoustics, LLC 640 Fourth Street Beaver, Pennsylvania 15009
Re: K160278 Trade/Device Name: VSTAAR AdjusteR Regulatory Class: Unclassified Product Code: LXM Dated: October 1, 2016 Received: October 4, 2016
Dear Albert Torrence:
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 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.
1
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 yours,
MichaelJ. Hoffmann -A
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) K160278
Device Name VSTAAR AdjusteR
Indications for Use (Describe)
The VSTAAR is a mechanical device intended to be used by chiropractors, medical doctors and other licensed health care professions for the external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization.
Type of Use (Select one or both, as applicable)
| ☑ Exportation (Part 21 CFR 600.81, Subpart E) | ☐ Own Use Consignment (21 CFR 600.80, Subpart D) |
|---|---|
| ------------------------------------------------------------------------------------------------ | -------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
| 510(k) Number: | K160278 |
|---|---|
| Company Name: | |
| Company Address: | Spinal Acoustics LLC |
| Fourth Street Professional Building | |
| 640 Fourth Street | |
| Beaver, PA 15009 | |
| Contact: | |
| Phone/FAX Numbers: | Albert Torrence, President and CEO |
| (724) 513-0354 (mobile) | |
| (724) 775-5200 | |
| Email Address: | torrencelaw@comcast.net |
| Trade Name: | VSTAAR AdjusteR |
| Common/Classification Name: | Chiropractic Adjusting Instrument |
| /Manipulator, Plunger-like Joint | |
| Classification Regulation: | Unclassified |
| Device Class: | Class II |
| Product Code (Procode): | LXM |
| Preparation Date: | June 29, 2012 |
LEGALLY MARKETED PREDICATE DEVICE - as required by A. 807.92(a)(3)
One of the identified legally marketed predicate devices identified by the submitter is Smart Adjuster, K962239, submitted by Sigma Company [now known as Sigma Instruments]. A second legally marketed predicate device is PulStarFRAS, K973914, submitted by Sense Technology. A third predicate device is the legally marketed Impulse IQ Adjusting Instrument, K080261, submitted by Neuromechanical Innovations, LLC.
SUMMARY DEVICE DESCRIPTION - as required by 807.92(a)(4) B.
The VSTAAR AdjusteR is a mechanical device used by chiropractors, medical and other licensed health care professionals for the external
4
analysis and adjustment of the human spinal column, and for soft tissue and musculoskeletal mobilization.
The graphical user interface is mouse driven. All of the screens are easy to find and easy to understand. Navigating from screen to screen is quick and intuitive.
The main features of the device include:
Patient Data Screen - for patient demographic entry.
Single Evaluation test mode - to determine the articular and spinal tissue's relative compliance with a single impact on controlled preload instructions.
Lateral Evaluation - allows the user to evaluate the motion from side to side of the vertebrae, measuring the relative differences between two directions, identifying subluxation in the lateral axis.
Treatment - information from the Evaluation test mode allows the user to set a forced between 5 and 60 lbs and an impulse rate between 1 and 25 cycles per second.
Preload Bar Graph - allows the user to set a range that will be used to keep the device at a specific preload during all of the patients' treatments and assessments, typically based on body type for each patient - user feedback is provided graphically showing the pliability increase during the treating segment.
Real time Feedback - assists the user's treatment decisions. The LVDT position sensor measures depressions in the tissue made by the percussive force. The user can observe when there is a greater excursion of the LVDT denoting an increase in pliability or motion of the segment and tissue, documenting a change in the tissue consistency.
Treatment Focus – the user can focus on one region of concern at a time – cervical, thoracic or lumbar/sacral – allowing for a comparison between more like segments for bone structure.
Test "Pulse" - on seqments of the spine for comparison of relative compliance of those segments. Any vertebrae that will be considered a potential problem may or may not be selected by the practitioner for an adjustment.
5
Impulse Analysis - measuring depth of penetration and acceleration of penetration from an impact of a consistent force and the force has been shown to be essentially constant for specific substrates in both the evaluation of our instrument. The analysis assesses a region determining areas of low compliance (Minimal Pliability) and high compliance (Relatively High pliability compared to areas of Minimal Pliability). Once areas greater than 10% from one segment to the next are identified, the instrument is then used in a percussive mode (treatment) to break up muscle tension and loosen soft or articular tissue increasing mobility of the treated segments or regions. Bv repeated percussion affected areas are loosened, increasing the pliability of a muscle or segmental level thus increasing an area of low compliance or minimal pliability to a relatively higher level of compliance after mechanically palpating the tissue. This decreases muscle tension through mechanical compression and by simply mobilizing the affected areas allowing for more function and ROM in a segment or muscle.
PRODUCT AND TECHNICAL SPECIFICATIONS
Control Unit:
| Power | 120VAC/60Hz |
|---|---|
| Single-phase | 2A |
| Dimensions | W 16.75"x D 16.75"x H 6.7" |
| Weight | 15 lbs |
| Cabinet | Brushed Aluminum & Steel |
Accessories:
| Display | PL 1900 LCD monitor or AOC e1649Fwu
USB LCD monitor |
|------------|--------------------------------------------------------|
| Applicator | Single Tip/Dual Tip Applicators |
Adiustment Device:
| Dimension | Diameter 2.5″ x Length 8.75′ |
|---|---|
| Weight | 1.88 lbs |
| Cover | Polished Aluminum |
| Cord | 8 ft |
Operating Conditions:
| Temperature | +18°C - +30°C |
|---|---|
| Humidity | 30% - 75% |
| Atmospheric Pressure | 500 - 1060 hPa |
Shipping and Storage Conditions:
6
Temperature................................................................................................................................................................... Humidity ..................................................................................................................................................................... Atmospheric Pressure .......... 500 - 1060 hPa
Operating System Software
Microsoft Windows XP and Windows 7
Application Software - Designed with National Instruments' LabView development software
| Provides preloaded settings user selects of 1 – 60 settings | |
|---|---|
| Feedback | preload feedback provided |
| Force setting | user definable default |
| Pulses | multiple pulses provided |
| Pulse rate | user selects from 1 to 25 Hz |
| User interface | touch screen or mouse driven |
C. INTENDED USE - as required by 807.92(a)(5)
The VSTAAR AdjusteR device is a tool designed by Chiropractors (DC), medical doctors (M.D. and D.O.), Physical Therapists (PT), Physicians Assistant (PA), Nurse Practitioner (NP), engineers and researchers to analyze and administer soft tissue, articular, spinal and extremity manipulations, including adjustment, and mobilization.
The graphical user interface is mouse driven. All of the screens are easy to find and easy to understand. Navigating from screen to screen is quick and intuitive.
INDICATIONS FOR USE - as required by 807.92(a)(5) D.
The VSTAAR is a mechanical device used by chiropractors, medical and other licensed health care professionals for the external analysis and adjustment of the human spinal column, and for soft tissue and musculoskeletal mobilization.
TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required E. by 807.92(a)(6)
Like the predicate devices, the VSTAAR AdjusteR device operates on 120v 50/60 Hz power and is designed for a typical professional medical clinic environment. Within that environment, the VSTAAR device, like its predicates, is easily transported.
7
Like the predicate devices, the VSTAAR AdjusteR operates within a computer hardware/computer operating system/submitter developed application software environment.
The VSTAAR AdjusteR device, like its predicates, delivers a light mechanical impulse through the hand held treatment device with user selected force, pulse rate The VSTAAR AdjusteR device, like its predicates, has more than one tip for the adjusting or hand held treatment device. Like the predicates, the VSTAAR AdjusteR device has a sensor within the adjusting or hand held treatment device. Like the predicates, the VSTAAR AdjusteR device provides the professional user with an electromagnetic coil, user definable default settings and pulse rate settings.
Like the predicate devices, the VSTAAR AdjusteR device provides the user with a software interface for patient information input, operational setting selections, and storage of system generated data. Like the predicates, there is a choice of preload settings for the VSTAAR AdjusteR device. The VSTAAR AdjusteR device, like the predicates, provides multiple pulses and pulse rates.
Unlike some of the predicate devices, the VSTAAR AdjusteR device provides "preload feedback" to show the professional user if/how much the preload changes during treatment.
The submitted VSTAAR AdjusteR device has the same technological characteristics as the predicate devices. The Substantial Equivalence Table provides a detailed COMPARISON MATRIX of the submitted device and the identified predicate devices.
8
PRODUCT COMPARISON TABLE
| 510(k) # | Subject Device (K122038 | Predicate Device (K962239) | Predicate Device (K973914) | Predicate Device (K080261) | Justification |
|---|---|---|---|---|---|
| Device Name | VSTAAR AdjusteR | Smart Adjuster | PulStarFras | Impulse IQ Adjusting Instrument | N/A |
| IFU | The VSTAAR AdjusteR is a mechanical device intended to be used by chiropractors, medical doctors and other licensed health care professions for the external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization. | The smart adjuster is intended to be used to do both analysis and adjustments to the human spinal column in accordance with standard chiropractic procedures. These procedures include the location and return to normal compliance of joint fixations and adhesions. | Indications for use of the pulstarfras include: musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, ligamentous strain. | The impluse IQ adjusting instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only | Similar |
| Power source | AC Powered | AC Powered | AC Powered | AC Powered | Identical |
| Method of delivering thrust force | Spring | Solenoid | Solenoid | Solenoid | Different but does not adversely affect the safety and effectiveness of the subject device |
| Force settings | 5 - 60lbs | 10 - 35lbs | 10 - 35lbs | 22.5 - 90lbs | Similar |
| Applicator | |||||
| tip velocity | 5.65 ft/s | Unknown | 3.0 ft/s | 6.29 ft/s | Similar |
| Pulse Rate | 1 - 12 Hz | Unknown | 2 -12 Hz | 4 - 12 Hz | Similar |
| Range of | |||||
| displaceme | |||||
| nt (inches) | Max 0.210 | Max 0.260 | Max 0.12 | Max 0.145 | Similar |
| Duration of | |||||
| Force | 2-4 ms | Unknown | Unknown | 2-4 ms | Similar |
| Patient- | |||||
| contacting | |||||
| material | 60 Durometer | ||||
| Silicone | Rubber | ||||
| Tipped | |||||
| Probe | Unknown | Rubber contact | |||
| end | Different | ||||
| but does | |||||
| not | |||||
| adversely | |||||
| affect the | |||||
| safety and | |||||
| effectiven | |||||
| ess of the | |||||
| subject | |||||
| device | |||||
| Sensor | |||||
| within | |||||
| handheld | |||||
| device | Linear | ||||
| Variable | |||||
| Differential | |||||
| Transformer | |||||
| (LVDT) | Force | ||||
| sensor | Force | ||||
| sensor | Accelerometer | Different | |||
| but does | |||||
| not | |||||
| adversely | |||||
| affect the | |||||
| safety and | |||||
| effectiven | |||||
| ess of the | |||||
| subject | |||||
| device | |||||
| Max count | |||||
| of | |||||
| impulses | 60 | Unknown | 1 - 200 | 12 | Similar |
9
NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW -F. as required by 807.92(b)(1)
Non-Clinical Testing
The submitted VSTAAR AdjusteR device has undergone significant verification and validation testing. Validation testing included verification testing of major components of the device to document conformance to device specifications and validation testing to confirm the device met its intended uses and requirements.
10
The performance data records documents that the VSTAAR AdjusteR device met its stated requirements and design specifications as intended.
Electrical Safety Testing - Electromagnetic Compatibility & Electrical Safety
The submitted device has been tested in conformance with IEC 60601-1 / EN 60601-1 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995), by Intertek, Twinsburg, OH, and IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, by a Keystone Compliance, New Castle, PA, both qualified testing laboratories.
SUMMARY STATEMENT
Spinal Acoustics, LLC believes the VSTAAR AdjusteR device's summary of non-clinical testing and electrical safety testing data further documents the submitter's claim of substantial equivalence.
CONCLUSION
The performance testing and testing data document that the submitted VSTAAR AdjusteR device is substantially equivalent to the Sigma Company's [now known as Sigma Instruments] predicate Smart Adjuster, K962239, Sense Technology Inc.'s predicate PulseStarFRAS, K973914, and Neuromechanical Innovations, LLC's predicate Impulse IQ Adjusting Instrument, K080281.