(791 days)
Not Found
No
The summary describes a mechanical traction device with optional heat and vibration. There is no mention of AI, ML, data analysis, or any features that would suggest the use of such technologies. The device operation appears to be based on controlled mechanical movements and optional physical modalities.
Yes
The device is intended to relieve pain and manage conditions such as facet syndrome, herniated disc, sciatica, and joint pain, which are therapeutic functions.
No
The device is described as therapeutic, designed to relieve pressure and pain of skeletal or muscular origin, not to diagnose conditions.
No
The device description explicitly states it is comprised of a reclinable therapeutic cushioned chair with movable sections and linear actuators, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve pressure on structures causing pain of skeletal or muscular origin through mechanical traction. This is a physical therapy/rehabilitation application, not a diagnostic test performed on biological samples.
- Device Description: The device is a mechanical chair with movable sections and actuators designed for applying traction. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical and physical.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Back on Trac (BOTGEN1) and Cervi-Trac Systems are in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder).
Back on Trac
The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)". The device may be used to manage and reduce pain associated with the following conditions:
- facet syndrome,
- herniated disc,
- . protruding disc,
- extruded disc,
- sciatica,
- spondylosis (degenerative disc disease & facet syndrome),
- joint pain.
Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.
Cervi-Trac
The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.
Product codes (comma separated list FDA assigned to the subject device)
ITH, ILZ, IRT, IRO
Device Description
The Ergo-Flex Technologies Systems that are the subject of this premarket notification are prescription use only and are intended for use by licensed, qualified healthcare professionals, such as physicians, chiropractors, physical therapists, etc.
Ergo-Flex Back on Trac System:
The Back on Trac (BOTGEN1) is intended for use in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder). The device may be used to manage and reduce pain associated with the following conditions: facet syndrome, herniated disc, protruding disc, extruded disc, sciatica, spondylosis (degenerative disc disease & facet syndrome), and joint pain.
Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.
The (BOTGEN1) is comprised of a reclinable therapeutic cushioned chair with back support portion and a second lower back, upper and lower leg support section that is movable in an axial direction with respect to the back support section and is also arcuately movable about a pivot axis that is perpendicular to the axial direction. The chair includes remotely controlled linear actuators to control the relative movement of the different sections of the device.
Ergo-Flex Cervi-Trac:
The Cervi-Trac (CT), as shown in Figure 2, is an accessory to the Back on Trac (BOTGEN1) that focuses specifically on the cervical region. The patient is not restrained by the Back on Trac arm bolsters, therefore lumbar traction is not activated by the Cervi-Trac during this therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic, lumbar, hip, shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed, qualified healthcare professionals, such as physicians, chiropractors, physical therapists, etc.
Professional healthcare facilities, clinics and/ or hospitals
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)
Clinical Performance: Not applicable. Clinical testing was not provided to demonstrate the substantial equivalence of the Back on Trac (BOTGEN1) and Cervi-Trac.
Non-Clinical Performance: The Back on Trac (BOTGEN1) and Cervi-Trac devices undergo 100% performance testing and Quality Assurance inspection by Ergo-Flex Technologies in accordance with the Company's written standard operating procedures (SOP) prior to release to inventory. All Quality Assurance and performance test documentation is maintained in the Device History Record at the Corporate site as required by 21 CFR 820.184.
Performance testing on the Back on Trac (BOTGEN1) and Cervi-Trac Systems demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device.
The Back on Trac (BOTGEN1) System has been evaluated and tested by independent certified testing facilities in conformance the following consensus standards:
- IEC 60601-1:2005 + A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic Compatibility
- IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment - Part1: General requirements for safety Collateral standard: Usability
- ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices
- IEC 62366-1:2015 Medical Devices - Part 1: Application of usability engineering to medical devices
- ANSI C63.27 ANSI for Evaluation of Wireless Coexistence
- IEC 10993:2017 Biocompatibility
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
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
February 22, 2024
Ergo-Flex Technologies, LLC % M. Heinrich President Texas Applied Biomedical Services 12101 Cullen Blve. Suite A Houston, Texas 77047
Re: K214037
Trade/Device Name: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II Product Code: ITH, ILZ, IRT, IRO Dated: February 7, 2024 Received: February 7, 2024
Dear M. Heinrich:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K214037
Device Name: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
Indications for Use (Describe)
The Back on Trac (BOTGEN1) and Cervi-Trac Systems are in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder).
Back on Trac
The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)". The device may be used to manage and reduce pain associated with the following conditions:
- facet syndrome, ●
- herniated disc, ●
- . protruding disc,
- extruded disc,
- sciatica,
- spondylosis (degenerative disc disease & facet syndrome),
- joint pain. ●
Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.
Cervi-Trac
The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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."
5
510K Summary
1. GENERAL INFORMATION
| Date Prepared:
Device Generic Name: | February 22, 2024
Power Traction Equipment |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Ergo-Flex Technologies Back on Trac
(BOTGEN1) and Cervi-Trac |
| Device Classification: | Class II, Performance
Standards
21CFR Part 890.5900 - Power Traction Equipment |
| Product Code:
Additional Product Codes: | ITH
ILZ, IRT, IRO |
| Applicant Name / Address: | Ergo-Flex Technologies, LLC
13622 Poplar Circle
Suite 403
Conroe, TX 77304
Telephone: 936-588-5510 |
| Key Contact: | M. Joyce Heinrich
Texas Applied Biomedical Services, Inc.
12101 Cullen Blvd, Suite A
Houston, Texas 77047
Telephone: 281-389-0531
Email: Tabsii2@comcast.net |
510(k) Number: K214037
2. Device Description
The Ergo-Flex Technologies Systems that are the subject of this premarket notification are prescription use only and are intended for use by licensed, qualified healthcare professionals, such as physicians, chiropractors, physical therapists, etc.
Ergo-Flex Back on Trac System:
510K SUMMARY
6
The Back on Trac (BOTGEN1) is intended for use in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder). The device may be used to \ manage and reduce pain associated with the following conditions: facet syndrome, herniated disc, protruding disc, extruded disc, sciatica, spondylosis (degenerative disc disease & facet syndrome), and joint pain.
Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.
The (BOTGEN1) is comprised of a reclinable therapeutic cushioned chair with back support portion and a second lower back, upper and lower leg support section that is movable in an axial direction with respect to the back support section and is also arcuately movable about a pivot axis that is perpendicular to the axial direction. The chair includes remotely controlled linear actuators to control the relative movement of the different sections of the device.
Image /page/6/Picture/4 description: The image shows a black chair with a unique design. The chair has a padded seat and backrest, as well as armrests. The chair is made of black leather and has a metal frame. The chair appears to be designed for comfort and support.
Figure 1. Ergo-Flex Back on Trac (BOTGEN1)
7
Ergo-Flex Cervi-Trac:
The Cervi-Trac (CT), as shown in Figure 2, is an accessory to the Back on Trac (BOTGEN1) that focuses specifically on the cervical region. The patient is not restrained by the Back on Trac arm bolsters, therefore lumbar traction is not activated by the Cervi-Trac during this therapy.
Image /page/7/Picture/3 description: The image shows a black chiropractic table with a headpiece and adjustable straps. The headpiece is positioned at the top of the table and has a vertical adjustment mechanism. The adjustable straps are located on either side of the table and have triangular supports at the ends. The table is made of black leather and has a smooth surface.
Figure 2. Cervi-Trac (attached to Back on Trac)
3. Indications for Use
The Back on Trac (BOTGEN1) and Cervi-Trac Systems are intended for use in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder).
Back on Trac (BOTGEN1)
The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)". The device may be used to manage and reduce pain associated with the following conditions:
- facet syndrome,
- herniated disc,
- protruding disc,
- extruded disc,
- sciatica,
- spondylosis (degenerative disc disease & facet syndrome), ●
8
. joint pain.
Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.
Cervi-Trac
The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.
9
4. Predicate Devices
The Back on Trac (BOTGEN1) and Cervi-Trac Systems are substantially equivalent to other power traction devices that have been previously cleared by the FDA via the 510K process.
| 510(k) Number | Predicate Device Name | Manufacturer |
|---|---|---|
| K053223 | Triton/Tru-Trac/TX/ | |
| Triton DTS Traction | Chattanooga Group |
5. Summary of the Technical Characteristics of the Subject Device to the Predicate Device.
The Indications for Use Statement listed for the Back on Trac (BOTGEN1) and Cervi-Trac accessory are similar to the indications for use of the predicate device. The technical characteristics and operational parameters of the Back on Trac (BOTGEN1) and Cervi- Trac and the predicate devices are substantially equivalent. Table 1 shows a comparison of the primary technological characteristics and operational parameters of the Back on Trac (BOTGEN1) and Cervi-Trac to the referenced predicate devices.
Table 1.
Comparison of the IFU and Technical Specifications and Performance Characteristics of the Back on Trac (BOTGEN1) and Cervi-Trac to the Triton/Tru-Trac/TX/Triton DTS Traction
| Parameter | Back on Trac (BOTGEN1)
/ Cervi-Trac | Triton/Tru-Trac/TX/
Triton DTS Traction | Similarities and
Differences |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K214037 | K053223 | N/A |
| Intended Use | Prescription use
only | Prescription use only | Same |
| Environment | Professional
healthcare
facilities, clinics
and/ or
hospitals | Professional healthcare
facilities, clinics and/ or
hospitals | Same |
| Use | The Back on Trac (BOTGEN1) and
Cervi- Trac Systems are intended
for use in professional healthcare
facilities, to relieve pressures on
structures that may be causing pain
of skeletal or muscular origin
(cervical, thoracic, lumbar, hip,
shoulder).
Back on Trac (BOTGEN1)
The Back on Trac is intended for
use to relieve pressures on
structures that may be causing | The Triton/ Tru-Trac/TX/Triton
DTS Traction devices provide
traction and mobilization
of skeletal structures and skeletal
muscles.
The Triton/ Tru-Trac/TX/Triton DTS
Traction devices provide a
treatment in static, intermittent,
progressive, regressive and cycling
distraction forces to relieve
pressures on structures that may be
causing pain of skeletal or muscular | Similarities:
The Back on Trac
(BOTGEN1),
Cervi-Trac and
the predicate
relieve pressures
on structures that
may be causing
pain of skeletal
or muscular
origin (cervical,
thoracic, lumbar,
hip, shoulder). |
| | pain of skeletal or muscular
origin (cervical, thoracic,
lumbar, hip, shoulder)". The
device may be used to manage
and reduce pain associated with
the following conditions:
• facet syndrome,
• herniated disc,
• protruding disc,
• extruded disc,
• sciatica,
• spondylosis
(degenerative disc
disease & facet
syndrome),
• joint pain.
Vibration and heat are available
options that can be utilized with
the Back on Trac at the
discretion of the healthcare
professional. When activated, the
vibration mode can provide
muscle relaxation and temporary
relief of minor aches and pains.
The heat mode, when activated,
can provide temporary relief of
minor aches and pains. The local
warmth temporarily stimulates
local blood circulation in your
lower back.
Cervi-Trac
The Cervi-Trac is intended for
use as an accessory to the Back
on Trac (BOTGEN1) to relieve
pressures on structures that
may be causing pain of skeletal
or muscular origin. The Cervi-
Trac accessory focuses
specifically on the cervical
region. | origin (cervical, thoracic, lumbar,
hip, wrist, shoulder). Therapeutic
distraction can be applied in a variety
of programmable patterns, cycles
and functions.
The Triton/ Tru-Trac/ TX/ Triton
DTS 'Traction devices with the
optional EMG (a.k.a. sEMG)
biofeedback feature may be used to
relieve peripheral radiation/sciatica
and pain associated with:
• Protruding discs
• Bulging discs
• Herniated discs
• Degenerative disc disease
• Posterior facet syndrome
• Acute facet problems
• Radicular pain
• Prolapsed disc
• Spinal root impingement
• Degenerative joint disease
• Facet syndrome
• Compression
fractures
• Joint pain
• Discogenic pain
EMG (a.k.a. sEMG)
Determination of the
activation magnitude and
timing of muscles for:
a) retraining of muscle
activation
b) coordination of muscle
activation
• Determination of the
force produced by
muscle for control and
maintenance of muscle
contractions.
• Relaxation muscle
training
• Muscle re-education | Differences:
The Back on Trac
has optional
Vibration and
Heat modes.
The Back on Trac
does not include
biofeedback
option. |
| Treatment Areas | Cervical /
Lumbar /
Thoracic / Hip /
Wrist / Shoulder | Cervical / Lumbar /
Thoracic / Hip / Wrist /
Shoulder | Same |
| Electrical
Classification
and Type | Class II
Type B | Not Publicly Available | UNK |
| Electrical Safety
Consensus
Standard | IEC 60601-1:2005 | UL 60601-1:2003 | Same |
| EMC Consensus
Standard | IEC 60601-1-2 | IEC 60601-1-2:2001 | Same |
| Usability
Consensus
Standard | IEC 60601-1-6 | Not Publicly Available | UNK |
| Biocompatibility | IEC 10993-5:2009 | Not Publicly Available | UNK |
| Traction
Mechanism | Electromechanical | Electromechanical | Same |
| Actuation
Mechanism | Electromechanical | Not Publicly Available | UNK |
| Traction Force | Min and Max traction force: BOT =
0 - 91lbs.
Cervi-Trac= 0 - 34.5 lbs. | Not Publicly Available | UNK |
| Operational
Components | Software controlled actuator for
traction and flexion | Software controlled traction | Same |
| Traction Speed | Continuous, Adjustable
(~0.25"/second) | Not Publicly Available | UNK |
| Treatment Time | 5 - 15 minutes | Not Publicly Available | Similar |
| Therapy Mode | Continuous | Not Publicly Available | UNK |
| Power Supply | 110-120V (60Hz)
220-240V (50Hz) | Not Publicly Available | UNK |
| Battery Backup | Yes | N/A | Back on Trac has a battery
backup should there be a power
failure. |
| Environmental
Conditions
(Temperature,
relative humidity,
air pressure) | Work: +10° to 40° C, 30 to
75% non-condensing, 700-1060
hPa storage: +5 to 45° C, not
exceeding 75% non-condensing,
700-1060 hPa
transport: +10 to 45° C,
20 to 95% non-condensing,
700-1060 hPa | Not Publicly Available | UNK |
10
510K Notification — K214037
Ergo-Flex Technologies. LLC Back on Trac (BOTGEN1), Cervi-Trac
11
510K Notification — K214037
Ergo-Flex Technologies. LLCC
Back on Trac (BOTGEN1), Cervi-Trac
12
6. Testing
Clinical Performance:
Not applicable. Clinical testing was not provided to demonstrate the substantial equivalence of the Back on Trac (BOTGEN1) and Cervi-Trac.
Non-Clinical Performance:
The Back on Trac (BOTGEN1) and Cervi-Trac devices undergo 100% performance testing and Quality Assurance inspection by Ergo-Flex Technologies in accordance with the Company's written standard operating procedures (SOP) prior to release to inventory. All Quality Assurance and performance test documentation is maintained in the Device History Record at the Corporate site as required by 21 CFR 820.184.
Performance testing on the Back on Trac (BOTGEN1) and Cervi-Trac Systems demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device.
The Back on Trac (BOTGEN1) System has been evaluated and tested by independent certified testing facilities in conformance the following consensus standards:
| FDA Recognition
| Number | Standard | Description |
|---|---|---|
| 19-46 | IEC 60601-1:2005 + | |
| A1:2012 | Medical electrical equipment - Part 1: | |
| General requirements for basic safety and | ||
| essential performance | ||
| 19-8 | IEC 60601-1-2:2015 | Medical electrical equipment - Part 1-2: |
| General requirements for safety - Collateral | ||
| standard: Electromagnetic Compatibility | ||
| 5-89 | IEC 60601-1-6:2010 |
- A1:2013 | Medical electrical equipment - Part1:
General requirements for safety Collateral
standard: Usability |
| 5-40 | ISO 14971:2007 | Medical Devices - Application of Risk
Management to Medical Devices |
| 5-114 | IEC 62366-1:2015 | Medical Devices - Part 1: Application of
usability engineering to medical devices |
| 19-29 | ANSI C63.27 | ANSI for Evaluation of Wireless Coexistence |
| | IEC 10993:2017 | Biocompatibility |
13
7. Conclusions
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device may have the same intended use and different technological characteristics if they can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
Pursuant to the testing and comparison to the predicate devices, the Ergo Flex Technologies, LLC Back on Trac (BOTGEN1) and Cervi-Trac devices have the same and/or equivalent intended uses, with similar technical, functional and performance characteristics as the predicate devices listed above.
The Back on Trac (BOTGEN1) and Cervi-Trac Systems perform as intended and do not raise any new safety or efficacy issues.