(222 days)
The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand.
The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in osteoarthritis of the hand to reduce the level of pain and stiffness and to improve the function of the hand.
The BioniCare Hand System, Model BIO-2000 is portable, rechargeable, battery-operated, single Channel device that utilizes a voltage regulated output circuit to generate a spike-shaped Monophasic pulse with adjustable amplitude of 0 - 15 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. The device consists of electrodes, lead wires and a signal generator (BioniCare® Stimulator).
Please note that the provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining strict acceptance criteria for a novel device. The "clinical study results and summary" section describes a study done to support the device's efficacy, but it doesn't establish explicit acceptance criteria in the format typically seen with a novel AI/medical device.
Based on the information provided, here's a breakdown of the closest approximations to your requested points:
A. Table of "Acceptance Criteria" and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense (e.g., minimum sensitivity or specificity targets). Instead, it presents effect sizes from a clinical study to demonstrate the device's efficacy in conditions for which it seeks indications. The "acceptance" is implicitly tied to these observed effect sizes being considered favorable and robust enough to support the intended use, especially when compared to benchmarks like the effect sizes of NSAIDs.
| Performance Metric (Proxy for Acceptance Criteria) | Reported Device Performance (Effect Size) |
|---|---|
| OA pain in the study hand (past 48 hours) | 1.3 (Large effect) |
| OA pain in the study thumb (past 48 hours) | 0.8 (Moderate effect) |
| Patient global assessment | 1.2 (Large effect) |
| Physician global assessment | 1.1 (Large effect) |
| DASH Score (Functional outcome) | 0.5 (Moderate effect) |
| Pinch force (Functional outcome) | 0.4 (Small effect) |
| Grip strength (Functional outcome) | 0.3 (Small effect) |
B. Sample Size and Data Provenance for the Test Set
- Sample Size: 82 patients were enrolled in the study. (66 females, 16 males)
- Data Provenance: The study was a "prospective, multi center, open-label study." The patients were "entered from the investigating physicians practice, without advertising." The document does not specify the country of origin of the data, but given the FDA submission, it's highly likely to be U.S.-based.
C. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their specific qualifications for the "test set" (clinical study data). However, it mentions "physician global assessment" as an efficacy outcome, implying that the assessing physicians served as experts in evaluating the patient's condition. Their qualifications are implicitly that they are "investigating physicians" capable of diagnosing and managing osteoarthritis.
D. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study data. It was an "open-label study."
E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI or imaging device where human reader interpretation would be assisted by AI. The clinical study evaluated the device's direct effect on patients.
F. Standalone Performance
The "standalone performance" of the device is implicitly represented by the clinical study results described in section A and B. The device operates independently on the patient, and the study measures its direct therapeutic effect. There is no "human-in-the-loop" interaction in the typical sense of interpreting AI outputs.
G. Type of Ground Truth Used
The ground truth or primary outcome measures were based on:
- Patient-reported pain (VAS scale)
- Patient global assessment
- Physician global assessment
- Validated functional assessment questionnaire (DASH score)
- Objective physical measurements (pinch force, grip strength using JAMAR Hand Assessment Kit)
These are clinical outcomes and patient self-assessments, commonly used in clinical trials for pain and functional improvement.
H. Sample Size for the Training Set
The document does not mention a training set. This device is a physical therapeutic device (a stimulator), not a machine learning or AI algorithm that requires a training set. The clinical study described served as the primary evidence for its efficacy for regulatory submission.
I. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for this device, this question is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2015
Vision Quest Industries, Inc. Mr. Mohammed Ouerghi Director of OA/RA 1390 Decision Street, Suite A Vista. CA 92081
Re: K142236
Trade/Device Name: BioniCare Hand System, Model BIO-2000 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NYN Dated: February 17, 2015 Received: February 19, 2015
Dear Mr. Ouerghi:
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
{1}------------------------------------------------
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/Resourcesfor You/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 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.
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for 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) K142236
Device Name BioniCare Hand System, Model BIO-2000
Indications for Use (Describe)
The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand.
The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in osteoarthritis of the hand to reduce the level of pain and stiffness and to improve the function of the hand.
| 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) |
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) Owner: | Vision Quest Industries, Inc.18011 Mitchell South,Irvine, CA, 92614 |
|---|---|
| Contact: | Mohamed OuerghiDirector of QA/RAVision Quest Industries, Inc.Phone 760-477-8201Mobile 760-691-0168Fax 760-727-5950mouerghi@vqorthocare.com |
| Date Summary Prepared: | 3/23/2015 |
| Proprietary Name: | BioniCare Hand System, Model BIO-2000 |
| Device Name and Classification: | Transcutaneous Electrical Nerve StimulatorFor pain relief, Class II, 21 CFR 882.5890, ProductCode NYN |
| Predicate Devices: | BioniCare® Stimulator, Model BIO-1000, K052625and K030332 |
| Device Description: | The BioniCare Hand System, Model BIO-2000 isportable, rechargeable, battery-operated, singleChannel device that utilizes a voltage regulatedoutput circuit to generate a spike-shapedMonophasic pulse with adjustable amplitude of 0 -15 volts peak and repeating at a single fixedfrequency of 100 ± 5 Hertz. The device consists ofelectrodes, lead wires and a signal generator(BioniCare® Stimulator). |
| Statement of Intended Use: | The BioniCare Hand System, Model BIO-2000, isintended for use by patients with rheumatoid and/orosteoarthritis of the hand as: |
| ● An adjunctive therapy in reducing the level ofpain and stiffness associated with pain fromrheumatoid arthritis of the hand. | |
| ● As an adjunctive therapy in osteoarthritis of thehand to reduce the level of pain and stiffnessand to improve the function of the hand. |
{4}------------------------------------------------
Clinical Study Results and Summary:
The study was designed as a prospective, multi center, open-label study to evaluate the efficacy and safety of the BioniCare Hand System in the treatment of Osteoarthritis of the hand. Patients were entered from the investigating physicians practice, without advertising, if they were 18 years or older, had osteoarthritis of the hand that was symptomatic for at least 3 months with a pain score of at least 3 out of 10 on a VAS scale despite stable NSAIDs and/or analgesics for at least a month prior to study entry. Eighty two patients were enrolled, 66 females and 16 males, with a mean age of 64 and a range of 45 to 89 years. When both hands were effected the more symptomatic hand was designated the index hand to be treated. The primary outcome measure was osteoarthritis pain in the last 48 hours. Additional efficacy outcomes were pain in the study thumb in the last 48 hours, patient global assessment and the physicians global assessment. Efficacy assessment of function included the validated DASH functional assessment questionnaire and the traditional measures of strength, pinch force and grip strength as measured by a JAMAR Hand Assessment Kit which includes a squeeze (grip) dynamometer and a pinch dynamometer. Efficacy was expressed for each variable as the effect size. Effect sizes are generally recognized to be small if they are from 0.2-0.49, moderate from 0.5 to 0.99 and large if they are 1.0 or greater.
In the intent-to-treat statistical analysis, after 8 weeks of treatment, the effect size for OA pain in the study hand in the past 48 hours was 1.3, for OA pain in the study thumb for the past 48 hours was 0.8, for patient global assessment was 1.2, and for physician global assessment was 1.1. Functional outcome was moderately improved by the DASH Score with an effect size of 0.5. Smaller but still significant effect sizes were seen for the additional functional outcomes of pinch force, effect size 0.4 and grip strength with an effect size of 0.3. A limitation of this trial is that it was an open label study which includes the likelihood of bias caused by placebo effect. This was partially compensated by maintaining patients on stable NSAIDs and/or analgesics for the month prior to and for the entire study. This makes it more difficult to show efficacy as the benefit must be in addition to that of NSAIDs and/or analgesics. For example meta-analytic studies have shown an effect size for acetaminophen of 0.21 (95% confidence interval 0.02-0.41) and an effect size for NSAIDs of 0.32 (0.24-0.39). It should be noted that these effect sizes were in comparison to placebo. However, it should also be noted that all of the trials required discontinuation of previous pharmacotherapy for 3 to 14 days prior to study entry. The majority of trials additionally required a pre-defined flare of symptoms when NSAID treatment was discontinued in the pretreatment washout. This pretreatment washout and flair requirement makes it easier to demonstrate effectiveness by any treatment. This was evidenced by the mete-analysis as when they removed the studies which excluded nonresponders to NSAID treatment the effect size for pain decreased to 0.23 (0.15-0.31). Thus, even the effect size for pinch force and grip strength (0.4 and 0.3 respectively) are respectable, particularly since multiple studies have demonstrated that surgery of the hand can improve pain but does not increase strength as measured by pinch force and grip strength.
Open label clinical data was used to support the Substantial Equivalence of the BIO-2000 to the predicate. VQ OrthoCare conducted randomized clinical trials to support
{5}------------------------------------------------
clearance of the BioniCare BIO-1000 for rheumatoid arthritis (RA) of the hand and Osteoarthritis (OA) of the knee. Given that the pathophysiological process of osteoarthritis of the knee is similar to the degenerative process that would occur in the hand, data was leveraged from the randomized controlled clinical trial of the knee. The device was previously cleared for Rheumatoid Arthritis of the hand which is a more destructive process (worst case scenario) when compared to OA of the hand. Hence, the clinical data presented in support of the BioniCare BIO-2000 was found to be adequate to support Substantial Equivalence of this device to the predicate.
Substantial Equivalence
The device is substantially equivalent to the predicate devices because all changes made are categorized as changes to Performance Specifications, Ergonomics of User Interface and/or Firmware as the following tables demonstrate.
| 510(k) Number | K052625 | K142236 |
|---|---|---|
| Device Name | BIO-1000 | BIO-2000 |
| Manufacturer | BioniCare | VQ OrthoCare |
| Power Source | One 9V battery | One 3.7V battery |
| No. of Output Modes | 1 | 1 |
| Channels | 2 | 1 |
| Synchronous | Yes | N/A |
| Reciprocal | No | N/A |
| Computerized | No | Yes |
| Software Provided | N/A | Yes - Embedded Firmware |
| Constant Current | No | No |
| Constant Voltage | Yes | Yes |
| Channel Isolation as per AAMI NS43.2.3.2 | No | N/A |
| Line Current Isolation | N/A | N/A |
| Automatic Overload Trip | No | No |
| Automatic No-Load Trip | Yes | Yes |
| Patient Override Control | No | No |
| Max Leakage Current | N/A | N/A |
| Indicator Display | ||
| Unit Functioning | Yes | Yes |
| Low Battery | Yes | Yes |
| Other | LCD panel displays all parameter settings. | LCD panel displays all parameter settings. |
| Standards - AAMI NS4 | Yes - applicable parts | Yes - applicable parts |
BIO-2000/BIO-1000 Equivalency Table
{6}------------------------------------------------
| Timer Settings | No | No |
|---|---|---|
| Automatic Shut Off | N/A | N/A |
| Frequency | 100 Hz. | 100 Hz. |
| Waveform | Monophasic spike shaped pulse | Monophasic spike shaped pulse |
| Voltage Output | 0-12 Volts | 0-12 Volts (0 - 15V mfr override option) |
| Voltage Pulse Width (% of peak) | 1.8mS @ 10%; 0.64mS @ 50% | 1.8mS @ 10%; 0.64mS @ 50% |
| Current Output Range (500 Ohms) | 0 - 24mA peak | 0 - 24mA peak (30mA option) |
| Peak Charge (500 Ohm) | 20uC | 20uC (25uC optional) |
| Average Power (500 Ohm) | .092W | .092W (0.115W optional) |
| Minimum Electrode Size | >30cm2 | >30cm2 |
| Peak Current Density | < 0.667uC/cm2 | < 0.667uC/cm2 (< 0.833uC/cm2 optional) |
| Below AAMI NS4 Safe current limit (20uC + (0.8)(35t)uC | Yes (limit is 50.8uC) | Yes (limit is 50.8uC) |
| Less than AAMI safe average power (0.25W/ cm2) | Yes: 0.003W/ cm2 | Yes: 0.003W/ cm2 (0.0036W/ cm2 optional) |
| Area of stimulation | hand | hand |
| Weight (with batteries) in grams | 136 | 72 |
| Dimensions (mm) | 63.9 X 96.4 X 36.9 | 54.0 X 90.5 X 14.7 |
| Construction | Molded ABS/PC housing | Molded ABS/PC housing |
Summary of Non-Clinical Testing
The device and accessories were tested thoroughly using standard test equipment and methods and in accordance with company SOP's. All testing verified conformance to specifications as provided in 510(k). The device is substantially equivalent to the predicate devices. The following table contains a list of some of the non-clinical testing performed.
| Test or Standard | Name | Purpose |
|---|---|---|
| IEC 60601-1:1998+A1:1991 +A2:1995 | Medical electrical equipment — Part 1:General requirements for safety andEssential Performance | Safety and EssentialPerformance |
| IEC 60601-1-2:2001 | Medical electrical equipment. Generalrequirements for safety. Collateral | ElectromagneticCompatibility |
{7}------------------------------------------------
| +A1:2004 | standard. Electromagneticcompatibility. Requirements and tests. | |
|---|---|---|
| IEC 60601-2-10:19871.0b+A1:2001 | Medical electrical equipment. Part 2:Particular requirements for the safetyof nerve and muscle stimulators | Safety and EssentialPerformance |
| IEC 60601-1-11:2010 | Medical electrical equipment. Part 1-11: General requirements for basicsafety and essential performance –Collateral Standard: Requirements formedical electrical equipment andmedical electrical systems used in thehome healthcare environment | Safety and EssentialPerformance |
| P10-04-22R | Design Hardware Verification Report | Bench Verification andFunctional Testing forsubstantial equivalence andor verification ofperformance enhancement |
| P10-04-20R | Design Validation Report | Voice of the Customer |
Summary
The BioniCare Hand System stimulator generates a waveform with proven benefit that is substantially equivalent to the waveform provided by the predicate devices. This waveform used has been demonstrated in predicated devices to be effective as an adjunctive therapy in Osteoarthritis to reduce the level of pain and stiffness. The BioniCare Hand System delivers this same waveform in an effective manner to the hand.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).