(288 days)
The Xcite Clinical Station is intended for general rehabilitation for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- Maintaining or increasing range of motion
The Xcite system is for prescription use only.
Xcite is a multichannel Functional Electrical Stimulation (FES) system that delivers electrical stimulation to peripheral nerves in a coordinated fashion to facilitate various activities. The system is composed of:
- A tablet computer –
- Up to two 6 channel stimulators
- One or two stimulation cable(s) which connects the stimulator to cutaneous electrodes
- cutaneous electrodes
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- a mobile cart
Here's an analysis of the provided text regarding the acceptance criteria and study for the Xcite Clinical Station, formatted according to your request.
Please note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed clinical study report. Therefore, much of the requested information (especially regarding clinical efficacy and AI performance metrics) is not present in the document. The device in question is a Powered Muscle Stimulator, which typically relies on established physiological principles rather than complex algorithmic AI for its primary function.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" or present a table of quantitative performance metrics for the Xcite Clinical Station in the context of clinical efficacy (e.g., specific improvement in range of motion percentage, reduction in muscle spasm duration). Instead, the "acceptance criteria" appear to be met through demonstrating substantial equivalence to predicate devices with established safety and effectiveness.
The document focuses on technological characteristics and non-clinical testing to demonstrate that the new device is as safe and effective as the predicates.
Therefore, the table below reflects what can be inferred from the document regarding "acceptance" in the context of a 510(k) submission, primarily based on comparison to predicate devices and adherence to relevant standards.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Xcite Clinical Station) |
|---|---|
| Intended Use: Same as predicate devices. | The Xcite Clinical Station has the same intended use as the RT300 and Elpha 2000 predicate devices. |
| Technological Characteristics: No new questions of safety/effectiveness compared to predicates. | Utilizes the same FES stimulators and stimulation control system as the RT300 predicate device. Differences in technological characteristics (e.g., tablet PC controller, no ergometer on Xcite) do not raise new questions of safety and effectiveness. |
| Electrical Safety Standards: Compliance with mandated standards. | Complies with Electromagnetic Compatibility and Electrical Safety standards: IEC60601-1, ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-1-11, and IEC60601-2-10. |
| Performance to Specification (Non-Clinical): Verification of technical specifications. | "Confirm technical specifications for completion of new device details in comparison tables." "Conduct system testing to verify performance to specification." (Details of "specifications" not provided beyond comparison in the table). |
| Functionality: Equivalent functionality to predicate devices. | "Ensure that equivalent functionality is specified and implemented in the new device." |
| Clinical Safety & Effectiveness (Implied Equivalence): As safe and effective as predicate devices. | "RTI's testing and validation testing has demonstrated that Xcite is as safe and effective as the predicate devices." |
Study Details (as inferable from the document):
-
Sample size used for the test set and the data provenance:
- Sample Size: "five neurologically impaired individuals" were evaluated during "Validation Testing."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given the small sample size and context as "validation testing" within a 510(k) summary, it was likely conducted in a controlled environment, potentially at the manufacturer's site or a clinical partner. The document states it was "conducted on the Xcite Clinical Station".
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a powered muscle stimulator, "ground truth" for clinical efficacy would typically involve objective physiological measurements or expert clinical assessments, but the details of who conducted these or their qualifications are absent.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document. Adjudication methods are typically relevant for studies involving subjective interpretations (e.g., image reading by multiple radiologists). For a device like this, clinical evaluations might involve direct observation or measurement, not necessarily a formal adjudication process.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study (MRMC, measuring improvement with AI assistance) is typically performed for AI/CADe/CADx devices that assist human readers in diagnostic tasks (e.g., radiology). The Xcite Clinical Station is a Powered Muscle Stimulator, a therapeutic and rehabilitative device, not an AI-driven diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" does not apply to this device's function or the described studies.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the AI/algorithm sense. The device is a physical stimulator. Its "performance" is in delivering electrical stimulation and facilitating muscle activity. The "Validation Testing" involving five individuals would represent the device in its intended use, which inherently involves human interaction (patient receiving stimulation, clinician setting parameters). There isn't an "algorithm only" performance metric in the way it would be understood for an AI device.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the "Validation Testing" with five individuals, the document does not specify the "ground truth" used. For a physical therapy device, this would typically involve clinical assessments (e.g., measurement of muscle spasms, range of motion, blood circulation, muscle re-education markers) conducted by healthcare professionals. It's likely based on clinical observation and physiological measurements, but the specific details are not provided.
-
The sample size for the training set:
- This concept is not applicable in the context of the Xcite Clinical Station as described. There is no mention of a "training set" because this device is not an AI/machine learning system that learns from data. It's an electro-mechanical device whose function is based on fixed principles of electrical stimulation.
-
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above (no training set for an AI/ML algorithm).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2016
Restorative Therapies Inc. Scott Simcox CTO 1434 Fleet Street Baltimore, Maryland 21231
Re: K160614
Trade/Device Name: Xcite Clinical Station Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZI Dated: November 22, 2016 Received: November 23, 2016
Dear Mr. Simcox:
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 device
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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
Carlos L. 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) K160614
Device Name Xcite Clinical Station
Indications for Use (Describe) The Xcite Clinical Station is intended for general rehabilitation for:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle re-education
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
-
- Maintaining or increasing range of motion
The Xcite system is for prescription use only.
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)
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510(k) Summary
This 510(k) of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92
(1) Submitter:
Andrew Barriskill Restorative Therapies Inc 1434 Fleet St Baltimore, MD 21231
Phone: 800 609-9166
Prepared on February 1, 2016.
(2) Device Name and Regulatory Classification:
| Proprietary name: | Xcite Clinical Station ("Xcite") |
|---|---|
| Common name: | Powered Muscle Stimulator |
| Device Classification: | Class II |
| Classification name: | Powered Muscle Stimulator |
| Product code: | IPF (21 CFR 890.5850), GZI (21 CFR 882.5810) |
(3) Predicate Device:
DANMETER A/S product: "Elpha 2000", K032954, a class II device RESTORATIVE THERAPIES, INC. product: "RT300", K090750, a class II device
(4) Device Description:
Xcite is a multichannel Functional Electrical Stimulation (FES) system that delivers electrical stimulation to peripheral nerves in a coordinated fashion to facilitate various activities. The system is composed of:
- A tablet computer –
- 2 Up to two 6 channel stimulators
- One or two stimulation cable(s) which connects the stimulator to cutaneous ന electrodes
- ব cutaneous electrodes
- 5 an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- a mobile cart
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(5) Statement of the intended use of the device:
Xcite is intended for general rehabilitation for:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle re-education
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
-
- Maintaining or increasing range of motion
Xcite is for prescription use only.
THESE INDICATIONS FOR USE ARE THE STANDARD INDICATIONS FOR USE AS PER FDA GUIDANCE DOCUMENT "GUIDANCE DOCUMENT FOR POWERED MUSCLE STIMULATOR 510(K)S".
We have included the Elpha 2000 (K032954) as a second predicate device solely to demonstrate the additional two indications, number 4 and 5 above, which are not indications for use of RT300 (K090750).
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(6) Technological Characteristics
The function of Xcite is the same as the predicate devices however there are certain technological similarities and differences as described below:
| Technology | Xcite | RT300 predicate:K090750 | Elpha 2000predicate:K032954 |
|---|---|---|---|
| Ergometer | No ergometer | Cycle ergometer | No ergometer |
| Powersource(energyused) | Mains power andrechargeable batteryfor RT60 stimulators | Mains power andrechargeable batteryfor RT50 stimulators | Battery powered,alkaline or Ni-Cd |
| Controller | Based on tablet PCrunning customsoftware. | Based on Pocket PCrunning customsoftware. | Custom |
| Stimulator(energydelivered) | Up to 2 DC powered 0-140mA 6 channelcharge balancedstimulators (“RT60”s). | Built in AC mainspowered 0-140mA 6channel chargebalanced stimulator. | 0-100mA 2channels |
| Additionalstimulationchannels | N/A | Up to 5 additionalwireless batterypowered stimulationchannels delivering 0-140mA chargebalanced stimulation. | N/A |
| FESparameters | 0-140mA50-500usec10-100Hz | 0-140mA50-500usec10-100Hz | 0-100mA200-400usec2-100Hz |
| Stand alonestimulationmode | Always used in standalone stimulationmode. | Wireless batterypowered stimulationchannels may be usedin stand alone modewith out the cycleergometer. | Always used instand alonestimulationmode. |
| Stimweargarment | No stimwear garment. | Stimwear garmentincorporatingelectrodes availablefor lower extremitycycling, ages 12 andabove. | N/A |
| Musclesavailable forstimulation | Quadriceps,hamstrings, gluteals,gastroc, anteriortibialis, shoulder, | Quadriceps,hamstrings, gluteals,gastroc, anteriortibialis, shoulder, | Not specified. |
| Technology | Xcite | RT300 predicate:K090750 | Elpha 2000predicate:K032954 |
| anterior, posterior andmiddle deltoid, wristextensors and flexors,grasp, abdominals,erector spinae. | anterior, posterior andmiddle deltoid, wrist,grasp, abdominals,erector spinae. | ||
| Flywheel | N/A | Uses leg / arm crankmotor to createflywheel effect withreduced weight andspace. | N/A |
| Passivecycling | N/A | Utilizes motor toprovide assistanceduring passive cycling. | N/A |
| Databaseinterface | Utilizes databaseinterface for storageand retrieval of patienttherapy settings andstorage of sessionlogs. | Utilizes databaseinterface for storageand retrieval of patienttherapy settings andstorage of sessionlogs. | No database. |
| Motorizedarm crank | N/A | Allows active / passivearm cycling with FES | N/A |
| Pulseoximeterinterface | N/A | Utilize pulse and SpO2data for display,recording andalarming | N/A |
| Bilateral orUnilateralstimulation | Uses bilateral orunilateral stimulation. | Uses bilateral orunilateral stimulation. | Not specified. |
| Indications | 1.Relaxation of musclespasms2.Prevention orretardation of disuseatrophy3.Increasing localblood circulation4.Muscle re-education5.Immediate post-surgical stimulation ofcalf muscles to preventvenous thrombosis; and | 1.Relaxation of musclespasms2.Prevention orretardation of disuseatrophy3.Increasing localblood circulation; and4.Maintaining orincreasing range ofmotion | 1.Relaxation ofmuscle spasms2.Prevention orretardation ofdisuse atrophy3.Increasinglocal bloodcirculation4.Muscle re-education5.Immediatepost-surgicalstimulation ofcalf muscles to preventvenous thrombosis; and |
| Technology | Xcite | RT300 predicate:K090750 | Elpha 2000predicate:K032954 |
| 6.Maintaining orincreasing range ofmotion | prevent venousthrombosis; and6.Maintaining orincreasing rangeof motion |
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Table 1 Device technology comparison
(7) Performance data
Non-clinical testing to determine equivalence has been primarily composed of the following tests:
| Test or procedure | Description |
|---|---|
| Review of user documentation forpredicate devices | Ensure that equivalent functionality isspecified and implemented in the newdevice. |
| Output characteristic measurement ofnew device | Confirm technical specifications forcompletion of new device details incomparison tables |
| Conduct of system testing | Conduct system testing to verifyperformance to specification. |
| Validation Testing | Description |
|---|---|
| Testing the Xcite Clinical Station | The Xcite Clinical Station with 12stimulation channels was evaluatedwith five neurologically impairedindividuals. |
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Xcite Clinical Station. The system complies with Electromagnetic Compatibility and Electrical Safety The Xcite system conforms to the following standards; IEC60601-1, ANSI/AAMI ES60601-1,IEC60601-1-2, IEC60601-1-11, and IEC60601-2-10.
RTI concludes that:
Xcite Clinical Station has the same intended use as the RT300 and Elpha 2000 predicate devices.
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Xcite utilizes the same FES stimulators and stimulation control system as the RT300 predicate device. The different technological characteristics do not raise new questions of safety and effectiveness.
In conclusion, RTI's testing and validation testing has demonstrated that Xcite is as safe and effective as the predicate devices.
§ 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).