Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HAN

Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain

For DC Continuous Mode

Relaxation of muscle spasm

For FES

Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait

For EMG triggered Stim

Stroke rehab by muscle re-education
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion

For EMG

To determine the activation timing of muscles for:
Retraining of muscle activation
Coordinating of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education

For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

Relief of pain, muscle spasms and joint contractures
Relief of pain, muscle spasms and joint contractures that may be associated with :
-Adhesive capsulitis
Bursitis with slight calcification
-Myositis
Soft tissue injuries
Shortened tendons due to past injuries and scar tissues
Relief of sub-chronic and chronic pain and joint contractures resulting from:
Capsular tightness
Capsular scarring

For Infrared Lamp (laser)
To provide topical heating for the following:

Temporary increase in local blood circulation
Temporary relief of minor muscle and joint aches, pains and stiffness
Relaxation of muscles
Temporary relief of muscle spasms
Temporary relief of minor pain and stiffness associated with arthritis

Device Description

The Vectra Neo Clinical Therapy System is an electrotherapy product offering clinicians a modular design of muscle stimulation, ultrasound, laser and biofeedback modalities in one combination device. The Vectra Neo Clinical Therapy System is designed to give the most treatment options in one compact and integrated package.

The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides three storage drawers to conveniently house clinical essentials. The leadwire management system allows for easy, quick access in an uncluttered arrangement.

The electrotherapy module offers 12 waveforms: Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), Microcurrent, VMS, VMS Burst, VMS FR, Russian, High Voltage Pulsed Current, Symmetrical Biphasic (TENS), Direct Current, and HAN (TENS). The Vectra Neo Clinical Therapy System allows to sequence these waveforms for ease of use.

The Neo ultrasound module is dual frequency (1 MHz and 3.3 MHz) with selectable duty cycles of 10%, 20%, 50% and 100%, low BNR (5.0:1) {FDA method of measurement), pulse frequency 100Hz and selectable pulse durations of 1 mSec, ±20%; 2 mSec, ±20%; 5 mSec, ±20%.

The laser therapy module is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relaxation of muscles, temporary relief of muscle spasms, temporary relief of minor pain and stiffness associated with arthritis.

The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto a USB Thumb Drive. The sEMG features a clinician chosen trigger point that activates therapeutic stimulation. The sEMG feature is often used to treat stroke patients and for muscle re-education.

Online guided assistance is provided through Clinical Protocol Setup and On-Screen Indications to help guide therapy selections for electrotherapy waveform rationale, parameter selections, electrode placement images, laser and ultrasound applicator recommendations.

Combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3.3 MHz Ultrasound can be combined with Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), VMS, VMS Burst, VMS FR and High Voltage Pulsed Current.

AI/ML Overview

Acceptance Criteria and Study for Vectra Neo Clinical Therapy System

This document outlines the acceptance criteria and the study that demonstrates the Vectra Neo Clinical Therapy System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vectra Neo Clinical Therapy System are primarily based on its substantial equivalence to predicate devices, Vectra Genisys (K062354) and Vectra Genisys Laser System (Intelect XT Laser System) (K040662). This equivalence is demonstrated by meeting recognized consensus standards and showing comparable performance characteristics.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Technological Equivalence (Clinical Performance)	- Same Indications for Use as predicate devices (Vectra Genisys K062354 and Vectra Genisys Laser System K040662) for various electrotherapy, ultrasound, sEMG biofeedback, and laser functions. - Same fundamental technology. - Intended for the same target population and clinical environments.	- Indications for Use: The Vectra Neo Clinical Therapy System has the same Indications for Use as the Vectra Genisys (K062354) for electrotherapy (VMS, Russian, Monophasic Hi-Volt, Interferential, Premodulated, Microcurrent, TENS, HAN, DC Continuous Mode, FES, EMG triggered Stim, EMG) and Ultrasound. It also has the same Indications for Use as the Vectra Genisys Laser System (K040662) for Infrared Lamp (laser). - Fundamental Technology: The device uses the same fundamental technology as the predicate devices, simply combining their functionalities. - Target Population/Environment: Intended to be used by the same target population and in the same clinical environments.
Safety and Performance (Bench Testing & Compliance)	- Compliance with relevant FDA-recognized international consensus standards for medical electrical equipment, ultrasonic physiotherapy, nerve and muscle stimulators, and laser safety. - Software validation meeting FDA guidance. - Usability validation demonstrating safe and effective use. - Biocompatibility for patient-contacting accessories. - Outputs (waveforms) comparable to predicate devices.	- Standards Compliance: The device was tested and found to comply with: - IEC 60601-1 (basic safety & essential performance) - IEC 60601-1-2 (EMC) - IEC 60601-2-5 (safety of ultrasonic physiotherapy equipment) - IEC 60601-2-10 (performance of nerve and muscle stimulators) - IEC 60601-2-22 (safety & performance of surgical, cosmetic, therapeutic & diagnostic laser equipment) - IEC 60601-2-57 (safety & performance of non-laser light source equipment) - IEC 60825-1 (safety of laser products) - Software Validation: Software was validated per FDA guidance (May 11, 2005); tests demonstrated software meets design requirements. - Usability Study: A Summative Validation study supported instructions for use and substantiated acceptability of risks. - Biocompatibility: Evaluation per ISO 10993-1:2009 – Annex C for new accessories (Patient Remote) and equivalence to predicate materials for others, indicating safety. - Outputs: Bench performance testing demonstrated the same waveforms and other outputs as predicate devices, passing all verification and validation activities.
Minor Differences Impact	- Minor differences (e.g., user interface, updated components) do not raise new issues of safety or effectiveness and do not affect performance or efficacy.	- User interface simplified (16 buttons to 2 buttons + touchscreen), updated modern components, slightly modified outputs. - These differences are minimal, do not affect performance or efficacy, and could only improve device safety. - Bench testing confirmed comparable performance despite these changes.

The study supporting these criteria involves a combination of engineering analysis, software validation, usability testing, biocompatibility assessment, and extensive bench performance testing against recognized standards and predicate device characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not detail specific "test set" sample sizes in terms of patient data or clinical trials, as it's a device substantially equivalent to existing predicates.

Test Sets:
- Software Validation: The summary states "The software validation tests demonstrated that the software version meets its design requirements." This implies a set of test cases for software functionality, but the number of test cases or the data used for these tests is not quantified.
- Usability Study: A "Summative Validation" usability study was conducted. Details on the number of participants or specific scenarios are not provided.
- Bench Performance Testing: The summary mentions "Bench performance testing has demonstrated that the Vectra Neo Clinical Therapy System has the same waveforms and other outputs as the predicate devices and has passed all verification and validation activities." This would involve testing specific device parameters (e.g., BNR, ERA, frequencies, output power for ultrasound applicators, and various waveform outputs for electrotherapy) against their specifications and comparison with predicate data. No specific sample size for these tests (e.g., number of devices tested, number of measurements taken) is given, but it is implied to be sufficient for verification and validation.
- Biocompatibility: For new accessories like the Patient Remote, a literature review was conducted and compared to existing predicate device materials. This is a review-based approach rather than a direct physical 'test set' sample size.
Data Provenance: Not applicable in the context of a substantial equivalence submission relying primarily on bench testing, software validation, and a usability study for a therapy system. The data is generated internally by the manufacturer through testing and development processes. It is generally prospective relative to the device development but not retrospective clinical data. The document does not mention any country of origin for clinical data as no clinical trials were presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Software Validation: Ground truth is established by the documented software design requirements and specifications, which are typically developed by qualified software engineers and systems engineers. The number of such experts is not specified.
Usability Study: A "Usability Study" was conducted. The "ground truth" for usability is typically established via human factors engineering principles and user feedback (often healthcare professionals or simulated patients). The number and qualifications of experts involved in designing the study, observing users, and interpreting results are not provided.
Bench Performance Testing: The "ground truth" for technical performance parameters (e.g., BNR, ERA, waveform output) is established by recognized international standards (e.g., IEC 60601 series, IEC 60825-1) and the specifications of the predicate devices. The engineers and technicians conducting these tests are qualified in electrical engineering, biomedical engineering, and quality assurance. Their specific number and detailed qualifications are not disclosed in the summary.
Biocompatibility: The "ground truth" for biocompatibility is established by ISO 10993-1:2009. Experts in material science and toxicology would be consulted or involved in the literature review process to assess material safety.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for interpretation of imaging or clinical endpoints by multiple readers. This type of adjudication is not applicable to the testing performed for the Vectra Neo Clinical Therapy System as described in the 510(k) summary. The testing consists of:

Software Validation: Automated and manual testing against documented requirements.
Usability Study: Observation and data collection from users performing tasks, with analysis against predefined success criteria. Not an adjudication of a clinical outcome.
Bench Testing: Objective measurements against engineering specifications and international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or cited in this 510(k) submission. MRMC studies are typically done for diagnostic imaging devices where multiple human readers interpret cases, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy, sensitivity, and specificity. The Vectra Neo Clinical Therapy System is a therapeutic device, not a diagnostic one, and its equivalence was established through technical and performance comparisons with predicate devices and compliance with safety standards, rather than through comparative clinical effectiveness studies with human readers.

6. Standalone Performance Study

Yes, standalone performance (i.e., algorithm only without human-in-the-loop performance) studies were done for various aspects of the device:

Software Validation: The software was validated as a standalone component to meet its design requirements.
Bench Performance Testing: The device's various modules (electrotherapy, ultrasound, laser) were tested for their inherent performance characteristics (e.g., waveform accuracy, output power, BNR, ERA) against specifications and international standards. This demonstrates the device's capability to operate as intended independent of human interaction for its core therapeutic functions.
Biocompatibility: The materials used in patient-contacting accessories were evaluated in standalone fashion (via literature review and comparison to established materials).

7. Type of Ground Truth Used

The ground truth used for demonstrating the device's performance and safety is multifaceted:

Predicate Device Specifications: The technical specifications and established safety/efficacy profiles of the Vectra Genisys (K062354) and Vectra Genisys Laser System (K040662) serve as a primary ground truth for equivalence.
International Consensus Standards: Recognized standards such as the IEC 60601 series, IEC 60825-1, and ISO 10993-1 provide objective, independently established ground truth for safety, essential performance, and biocompatibility.
Internal Design Requirements: For software and specific hardware functions, the manufacturer's own detailed design requirements and specifications served as the ground truth for verification and validation.

No pathology, clinical outcomes data, or expert consensus (in the sense of clinical diagnostic agreement) was explicitly used or required for this 510(k) submission, as it relies on substantial equivalence to previously cleared devices through technical and performance testing.

8. Sample Size for the Training Set

Not applicable/Not mentioned.

The Vectra Neo Clinical Therapy System is a physical therapy device and not an AI/ML-driven diagnostic or predictive algorithm that typically requires a "training set" of data to learn patterns. The summary describes a system with pre-programmed waveforms, fixed ultrasound parameters, and biofeedback capabilities. There is no indication of machine learning or adaptive algorithms that would require a distinct "training set" of data in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned.

As there is no mention of a "training set" for an AI/ML algorithm, the method for establishing its ground truth is not relevant to this submission. The "ground truth" for the device's functionality is established by its engineering design specifications, compliance with international standards, and comparison with predicate device performance, as detailed in section 7.

Summary

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510(k) Summary

APR 1 0 2014

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K132284

Submitted by:

DIO, LLC 1430 Decision Street Vista, CA 92081

Contact Person:

Lorri Trotter Regulatory Affairs Manager Phone: 760-734-3049 Fax: 760-734-5544 Email: lorri.trotter@djoglobal.com

Vectra Neo Clinical Therapy System

Date Summary Prepared:

July 19, 2013

Trade Name:

Common/Usual Name:

Classification Name:

21 CFR 890.5500 Infrared lamp 21 CFR 890.5850 Powered muscle stimulator 21 CFR 890.5860 Ultrasound and Muscle stimulator 21 CFR 882.5890 TENS for pain relief 21 CFR 882.5050 Biofeedback device 21 CFR 882.5810 External functional neuromuscular stimulator Interferential current stimulator Unclassified

Product Code:

ILY Infrared lamp
IPF Powered muscle stimulator
IMG Ultrasound and muscle stimulator
Transcutaneous electrical nerve stimulator for pain relief GZJ
HCC Biofeedback device
GZI External functional neuromuscular stimulator
LIH Interferential current therapy

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Traditional 510(k): New Device Vectra Neo Clinical Therapy System

Image /page/1/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The globe is black and white and has a curved line running through it. The text "DJO" is in a bold, sans-serif font, and the text "GLOBAL" is in a smaller, sans-serif font below it.

Regulatory Class:	Class II *
Panels:	89 – Physical Medicine84 – Neurology
Predicate Device(s):	Vectra Genisys Laser System (Intelect XT Laser System)(K040662)

Device Description:

Vectra Genisys (K062354)

Clinicians have a variety of choices to best suit the needs of their individual practice. Below is an overview of the system choices/features.

ModelNumber	Description	BNR(FDAmethod)	StandardDeviation(BNR)	ERA(cm²)	ERA Limits(cm²)		BeamType(Pattern)	Frequency(MHz)	NumberofCrystals	Max.OutputPower(W)
27333	1 cm²ultrasoundapplicator	5:1	1	0.9	1	0.4	Collimating	3.3	1	1.5
27334	2 cm²ultrasoundapplicator	5:1	1	1.8	2	1.4	Collimating	1.0 and3.3	1	3.0

The following ultrasound applicators are provided with the Vectra Neo Clinical Therapy System:

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Image /page/2/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The globe is black and white and appears to be divided into sections. The text "DJO" is in a bold, sans-serif font, and the text "GLOBAL" is in a smaller, sans-serif font below it.

ModelNumber	Description	BNR(FDAmethod)	StandardDeviation(BNR)	ERA(cm²)	ERA Limits(cm²)		BeamType(Pattern)	Frequency(MHz)	NumberofCrystals	Max.OutputPower(W)
					High	Low
27335	5 cm²ultrasoundapplicator	5:1	1	4.0	5	3	Collimating	1.0 and3.3	1	6.0
27336	10 cm²ultrasoundapplicator	5:1	1	8.5	10	7	Collimating	1.0 and3.3	1	15.0

Intended Use:

Vectra Neo Clinical Therapy System is indicated for:

For VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)

. Relaxation of muscle spasms
. Prevention or retardation of disuse atrophy
Increasing local blood circulation .
. Muscle re-education
. Maintaining or increasing range of motion
. lmmediate postsurgical stimulation of calf muscles to prevent venous thrombosis

Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HAN

Symptomatic relief or management of chronic, intractable pain .

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Post-traumatic acute pain .
. Post-surgical acute pain

For DC Continuous Mode

Relaxation of muscle spasm �

For FES

. Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait

For EMG triggered Stim

. Stroke rehab by muscle re-education
. Relaxation of muscle spasms
. Prevention or retardation of disuse atrophy
. Increase local blood circulation
. Muscle re-education
. Maintaining or increasing range of motion

For EMG

To determine the activation timing of muscles for: .
- Retraining of muscle activation -
- Coordinating of muscle activation -
. An indication of the force produced by muscle for control and maintenance of muscle contractions ·
- Relaxation muscle training ।
- Muscle re-education -

For Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

. Relief of pain, muscle spasms and joint contractures
- Relief of pain, muscle spasms and joint contractures that may be associated with :
  - -Adhesive capsulitis
  - Bursitis with slight calcification l
  - -Myositis
  - Soft tissue injuries ।
  - Shortened tendons due to past injuries and scar tissues -
Relief of sub-chronic and chronic pain and joint contractures resulting from: .
- Capsular tightness -
- Capsular scarring -

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Image /page/4/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The word "DJO" is in a larger font size than the word "GLOBAL". The logo is black and white.

For Infrared Lamp (laser)

To provide topical heating for the following:

Temporary increase in local blood circulation .
Temporary relief of minor muscle and joint aches, pains and stiffness
. Relaxation of muscles
. Temporary relief of muscle spasms
. Temporary relief of minor pain and stiffness associated with arthritis

Indication for Use Comparison to Predicate Devices:

Vectra Genisys (K062354) primary predicate .
The Vectra Neo Clinical Therapy System has the same Indications for Use as the Vectra Genisys for the following types of treatment:
o VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, o Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), and Symmetrical Biphasic (TENS) and HAN
For FES 0
For DC Continuous Mode O
For EMG ಂ
For EMG triggered Stim ಂ
For Ultrasound ਼
Vectra Genisys Laser System (Intelect XT Laser System) (K040662) secondary predicate .

The Vectra Neo Clinical Therapy System has the same Indications for Use as the Vectra Genisys Laser System (Intelect XT Laser System)

For Infrared Lamp (laser) o

Technological Comparison to Predicate Devices:

The Vectra Neo Clinical Therapy System is technologically equivalent to Vectra Genisys (K062354) and Vectra Genisys Laser System (Intelect XT Laser System) (K040662) with respect to technical and performance characteristics.

The Vectra Neo Clinical Therapy System has the same indications for use and the same fundamental technology as the two predicate devices. It is intended to be used by the same target population and in the same clinical environments. The Vectra Neo Clinical Therapy System simply combines the functionality of the two predicates into one modular, adaptable device and has been upgraded with more modern components and has been engineered to meet FDA-recognized international consensus standards.

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Image /page/5/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The word "DJO" is in a larger font size than the word "GLOBAL", and there is a trademark symbol after the "O" in "DJO". The logo is black and white.

Some of the minor differences include: the user interface has been simplified from having 16 buttons to 2 buttons and a touchscreen, additional FDA recognized consensus standards have been conformed to, and some outputs have been modified slightly. These differences are minimal and do not affect the device's performance or efficacy. With respect to safety, these minor differences could only improve device safety. Additionally, bench performance testing has demonstrated that the Vectra Neo Clinical Therapy System has the same waveforms and other outputs as the predicate devices and has passed all verification and validation activities.

All differences noted above do not raise new issues of safety and effectiveness.

Performance Testing:

The device's software has been validated in accordance with the requirements set forth in . the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrated that the software version meets its design requirements.
. A Usability Study was conducted to validate the usability of the Vectra Neo Clinical Therapy System. The results of the Summative Validation support the instructions for successfully using the device as intended. The result of the Human Factors and Usability Study substantiates the acceptability of the risks identified during the risk assessment activities.
. The Vectra Neo Clinical Therapy System was tested and found to comply with the following standards:
- . IEC 60601-1 for basic safety and essential performance
- . IEC 60601-1-2 for electromagnetic compatibility
- . IEC 60601-2-5 for safety of ultrasonic physiotherapy equipment
- . IEC 60601-2-10 for performance of nerve and muscle stimulators
- 트 IEC 60601-2-22 for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . IEC 60601-2-57 for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (Radiology)
- . IEC 60825-1 for safety of laser products

Biocompatibility:

The Vectra Neo Clinical Therapy System has no direct contact with the patient. The table below identifies accessories that have direct contact with the patient at the treatment site, the material in contact with the patient, reference to the predicateand if applicable, reference devices. For new accessories, evaluation for biocompatibility is in accordance ISO 10993-1:2009 – Annex C, Suggested Procedure for Literature Review. The conclusion of these evaluations , as well as reference to the predicate and any associated reference devices, indicate that all materials selected are considered safe and effective for the intended use.

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Image /page/6/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The word "DJO" is in a larger, bolder font than the word "GLOBAL". The globe is made up of several curved lines and shapes.

Accessory	Patient ContactingMaterial	Predicate	ReferenceDevice	Biocompatibility Route
Electrodes	Hydrogel	Identical to predicate(K062354)	KaoostaK874469 K852267 K970426	n/a
Ultrasound Gel	Conductive gel	Identical to predicate(K062354)	K955246	n/a
Hivolt Probe	Cellulose PadPolyester	ldentical to predicate(K062354)	n/a	n/a
Ultrasound Applicators	No direct patientcontact(see Ultrasound Gel)	Identical to predicate(K062354)	n/a	n/a
Laser Applicators	AluminumChromeCopper-NickelPolycarbonate	Identical to predicate(K040662)	n/a	n/a
Laser Safety Glasses	Nylon	Identical to predicate(K040662)	n/a	n/a
Patient Remote	Polycarbonate/ABSSilicone	NEW	n/a	ISO 10993-1:2009 - Annex C,Suggested Procedure forLiterature Review, which includeda comparison to the same patientcontacting materials used for thepredicate device (K062354)remote

Conclusion:

Based on the performance testing and the supporting documentation, it can be concluded that the Vectra Neo Clinical Therapy System is safe, effective and substantially equivalent to the predicate devices.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. The text is in all capital letters and is smaller than the central graphic.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 10, 2014

DIO, LLC Lorri Trotter Regulatory Affairs Manager 1430 Decision Street Vista, CA 92081

Re: K132284

Trade/Device Name: Vectra Neo Clinical Therapy System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF; IMG; GZJ; HCC; GZJ; LIH; ILY Dated: March 6, 2014 Received: March 7, 2014

Dear Ms. Trotter:

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

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Page 2 - Ms. Lorri Trotter

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,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos Peña, PhD, MS for

Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K132284

Device Name Vectra Neo Clinical Therapy System

Indications for Use (Describe) Vectra Neo Clinical Therapy System is indicated for:

For VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)

· Relaxation of muscle spasms
· Prevention or retardation of disuse atrophy
Increasing local blood circulation
· Muscle re-education
· Maintaining or increasing range of motion
· Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HANS

· Symptomatic relief or management of chronic, intractable pain

· Post-traumatic acute pain
· Post-surgical acute pain

For DC Continuous Mode

· Relaxation of muscle spasm
For FES

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of thus improve the patient's gait

For EMG triggered Stim

· Stroke rehab by muscle re-education
· Relaxation of muscle spasms
· Prevention or retardation of disuse atrophy
· Increase local blood circulation
· Muscle re-education
· Maintaining or increasing range of motion

For EMG

· To determine the activation timing of muscles for:

Retraining of muscle activation -
Coordinating of muscle activation ﮯ
An indication of the force produced by muscle for control and maintenance of muscle contractions
- Relaxation muscle training •
- Muscle re-education -

For Ultrasound

1 of Unlabours
Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as: · Relief of pain, muscle spasms and joint contractures

See PRA Statement below.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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• Relief of pain, muscle spasms and joint contractures that may be associated with :
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
• Relief of sub-chronic and chronic pain and joint contractures resulting from:
- Capsular tightness
- Capsular scarring

For Infrared Lamp (laser)

To provide topical heating for the following:

• Temporary increase in local blood circulation
• Temporary relief of minor muscle and joint aches, pains and stiffness
• Relaxation of muscles
• Temporary relief of muscle spasms
• Temporary relief of minor pain and stiffness associated with arthritis

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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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Felipe Aguel -S Date: 2014.04.10 15:34:06

Felipe Aguel -S Dato0'

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Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).