(288 days)
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No
The document describes a functional electrical stimulation (FES) system and its components, focusing on electrical stimulation delivery and data storage. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The 'Intended Use / Indications for Use' section clearly states several therapeutic purposes for the device, such as relaxation of muscle spasms, prevention of disuse atrophy, and maintaining or increasing range of motion.
No
The device is described as a Functional Electrical Stimulation (FES) system intended for rehabilitation purposes such as muscle relaxation, prevention of atrophy, increasing blood circulation, and muscle re-education. Its stated uses are therapeutic and do not involve diagnosing a condition.
No
The device description explicitly lists multiple hardware components including a tablet computer, stimulators, cables, electrodes, and a mobile cart. This indicates it is a hardware and software system, not software-only.
Based on the provided information, the Xcite Clinical Station is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for physical rehabilitation through electrical stimulation of muscles. This is a therapeutic application, not a diagnostic one.
- Device Description: The components listed (tablet, stimulators, cables, electrodes, database interface, cart) are consistent with a physical therapy device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Xcite Clinical Station's function is to deliver electrical stimulation to the body for therapeutic benefits.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZI
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 electrodes
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, shoulder, anterior, posterior and middle deltoid, wrist extensors and flexors, grasp, abdominals, erector spinae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing to determine equivalence has been primarily composed of the following tests:
| Test or procedure | Description |
|---|---|
| Review of user documentation for predicate devices | Ensure that equivalent functionality is specified and implemented in the new device. |
| Output characteristic measurement of new device | Confirm technical specifications for completion of new device details in comparison tables |
| Conduct of system testing | Conduct system testing to verify performance to specification. |
Validation Testing:
The Xcite Clinical Station with 12 stimulation channels was evaluated with five neurologically impaired individuals.
Electrical safety and electromagnetic compatibility (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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
0
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
1
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
2
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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3
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
4
(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).
5
(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 2000
predicate:
K032954 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ergometer | No ergometer | Cycle ergometer | No ergometer |
| Power
source
(energy
used) | Mains power and
rechargeable battery
for RT60 stimulators | Mains power and
rechargeable battery
for RT50 stimulators | Battery powered,
alkaline or Ni-Cd |
| Controller | Based on tablet PC
running custom
software. | Based on Pocket PC
running custom
software. | Custom |
| Stimulator
(energy
delivered) | Up to 2 DC powered 0-
140mA 6 channel
charge balanced
stimulators (“RT60”s). | Built in AC mains
powered 0-140mA 6
channel charge
balanced stimulator. | 0-100mA 2
channels |
| Additional
stimulation
channels | N/A | Up to 5 additional
wireless battery
powered stimulation
channels delivering 0-
140mA charge
balanced stimulation. | N/A |
| FES
parameters | 0-140mA
50-500usec
10-100Hz | 0-140mA
50-500usec
10-100Hz | 0-100mA
200-400usec
2-100Hz |
| Stand alone
stimulation
mode | Always used in stand
alone stimulation
mode. | Wireless battery
powered stimulation
channels may be used
in stand alone mode
with out the cycle
ergometer. | Always used in
stand alone
stimulation
mode. |
| Stimwear
garment | No stimwear garment. | Stimwear garment
incorporating
electrodes available
for lower extremity
cycling, ages 12 and
above. | N/A |
| Muscles
available for
stimulation | Quadriceps,
hamstrings, gluteals,
gastroc, anterior
tibialis, shoulder, | Quadriceps,
hamstrings, gluteals,
gastroc, anterior
tibialis, shoulder, | Not specified. |
| Technology | Xcite | RT300 predicate:
K090750 | Elpha 2000
predicate:
K032954 |
| | anterior, posterior and
middle deltoid, wrist
extensors and flexors,
grasp, abdominals,
erector spinae. | anterior, posterior and
middle deltoid, wrist,
grasp, abdominals,
erector spinae. | |
| Flywheel | N/A | Uses leg / arm crank
motor to create
flywheel effect with
reduced weight and
space. | N/A |
| Passive
cycling | N/A | Utilizes motor to
provide assistance
during passive cycling. | N/A |
| Database
interface | Utilizes database
interface for storage
and retrieval of patient
therapy settings and
storage of session
logs. | Utilizes database
interface for storage
and retrieval of patient
therapy settings and
storage of session
logs. | No database. |
| Motorized
arm crank | N/A | Allows active / passive
arm cycling with FES | N/A |
| Pulse
oximeter
interface | N/A | Utilize pulse and SpO2
data for display,
recording and
alarming | N/A |
| Bilateral or
Unilateral
stimulation | Uses bilateral or
unilateral stimulation. | Uses bilateral or
unilateral stimulation. | Not specified. |
| Indications | 1.Relaxation of muscle
spasms
2.Prevention or
retardation of disuse
atrophy
3.Increasing local
blood circulation
4.Muscle re-education
5.Immediate post-
surgical stimulation of
calf muscles to prevent
venous thrombosis; and | 1.Relaxation of muscle
spasms
2.Prevention or
retardation of disuse
atrophy
3.Increasing local
blood circulation; and
4.Maintaining or
increasing range of
motion | 1.Relaxation of
muscle spasms
2.Prevention or
retardation of
disuse atrophy
3.Increasing
local blood
circulation
4.Muscle re-
education
5.Immediate
post-surgical
stimulation of
calf muscles to prevent
venous thrombosis; and |
| Technology | Xcite | RT300 predicate:
K090750 | Elpha 2000
predicate:
K032954 |
| | 6.Maintaining or
increasing range of
motion | | prevent venous
thrombosis; and
6.Maintaining or
increasing range
of motion |
6
7
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 for | |
| predicate devices | Ensure that equivalent functionality is |
| specified and implemented in the new | |
| device. | |
| Output characteristic measurement of | |
| new device | Confirm technical specifications for |
| completion of new device details in | |
| comparison tables | |
| Conduct of system testing | Conduct system testing to verify |
| performance to specification. |
| Validation Testing | Description |
|---|---|
| Testing the Xcite Clinical Station | The Xcite Clinical Station with 12 |
| stimulation channels was evaluated | |
| with five neurologically impaired | |
| individuals. |
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.
8
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.