(33 days)
IPF, LIH
Not Found
No
The device description focuses on standard electrotherapy features and programmable/preset protocols, with no mention of adaptive learning, data analysis for personalized treatment, or any terms associated with AI/ML.
Yes
The device is intended for various therapeutic applications such as pain relief, relaxation of muscle spasms, prevention of disuse atrophy, and muscle re-education, clearly indicating its therapeutic nature.
No
The device is an electrotherapy device intended for treatment, not for diagnosing conditions.
No
The device description explicitly details hardware components such as a battery, stimulation channels, lead wires, and a physical device intended for clinic and outpatient use, indicating it is not software-only.
Based on the provided information, the RTM1000 Electrotherapy Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- RTM1000 Function: The RTM1000 is an electrotherapy device that applies electrical stimulation directly to the body for therapeutic purposes (muscle and nerve stimulation). It does not analyze biological specimens.
- Intended Use: The intended use clearly describes the application of electrical current for pain relief, muscle stimulation, and other physical therapy indications. This is a direct therapeutic intervention, not a diagnostic test performed on a sample.
Therefore, the RTM1000 falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RTM1000 Electrotherapy Device is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes, Interferential Current Stimulation and Neuromuscular Electrical Stimulation.
In the Interferential Current Mode the RTM1000 is indicated for the following conditions:
- . Symptomatic relief of acute pain
- . Symptomatic management and relief of chronic pain
- . Adjunctive treatment for the management of post traumatic and Post-surgical pain
In the Neuromuscular Stimulation Mode, the RTM1000 is indicated for the following conditions:
- . 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.
Product codes
IPF, LIH
Device Description
The Rvan Telemedicine RTM1000 Interferential Stimulator is a battery powered (rechargeable) device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The RTM1000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The RTM1000 incorporates the following features:
- . Two independent stimulation channels, which provide true interferential current, neuromuscular stimulation and transcutaneous electrical nerve stimulation.
- . Continuous or pulsed stimulation. Adjustable sweep and ramp times.
- . Adjustable amplitude and frequency
- . Four programmable therapy protocols
- . Five preset therapy protocols
- . Adjustable on and off times
- . Pause button to allow temporary cessation of treatment and a resume button to allow the continuance of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes it's countdown and the amplitude (intensity) is reset to zero.
- . Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
- . Timed therapy sessions.
- Robust rechargeable Nickel Metal Hydride battery system with . rapid recharge (85% recharge in 30 minutes - full charge in 2 hours)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The RTM1000 is designed for clinician and patient ease of use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed on the marketed device and the RTM1000 and the therapy output and performance characteristics for both units was very similar and consistent
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CS3101 Interferential Stimulator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
FEB 2 6 2003
Image /page/0/Picture/2 description: The image shows the logo for Ryan Telemedicine. The word "RYAN" is written in large, bold, black letters. Below the word "RYAN" is the word "TELEMEDICINE" in smaller, thinner, black letters. There are black dots arranged in a semi-circle around the word "RYAN".
510(k) Summary for RTM1000 Interferential Stimulator
1. Sponsor
Ryan Telemedicine 1011 Brioso Drive Suite 102 Costa Mesa, Ca 92627
| Contact Person: | Jim Klett |
|---|---|
| Telephone: | (949) 645-4140 |
| Fax: | (949) 645-1145 |
Date Prepared: January 7, 2003
2. Device Name
| Proprietary Name: | RTM1000 Interferential Stimulator |
|---|---|
| Common/Usual Name: | Electrical Muscle and Nerve Stimulator |
| Classification Names: | Interferential Current Stimulator, Powered |
| Muscle Stimulator | |
| Classification Panel: | Physical Medicine |
| Panel/Product Code: | 890.5850 / IPF |
3. Legally Marketed Device to Which Equivalence is Claimed
| Proprietary Name: | CS3101 Interferential Stimulator |
|---|---|
| Common/Usual Name: | Electrical Muscle and Nerve Stimulator |
| Classification Names: | Interferential Current Stimulator, Powered |
| Muscle Stimulator | |
| Classification Panel: | Physical Medicine |
| Panel/Product Code: | 890.5850 / IPF |
1
4. Intended Use
The RTM1000 Electrotherapy Device is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes, Interferential Current Stimulation and Neuromuscular Electrical Stimulation.
In the Interferential Current Mode the RTM1000 is indicated for the following conditions:
- . Symptomatic relief of acute pain
- . Symptomatic management and relief of chronic pain
- . Adjunctive treatment for the management of post traumatic and Post-surgical pain
In the Neuromuscular Stimulation Mode, the RTM1000 is indicated for the following conditions:
- . 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.
2
Device Description 5.
The Rvan Telemedicine RTM1000 Interferential Stimulator is a battery powered (rechargeable) device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The RTM1000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The RTM1000 incorporates the following features:
- . Two independent stimulation channels, which provide true interferential current, neuromuscular stimulation and transcutaneous electrical nerve stimulation.
- . Continuous or pulsed stimulation. Adjustable sweep and ramp times.
- . Adjustable amplitude and frequency
- . Four programmable therapy protocols
- . Five preset therapy protocols
- . Adjustable on and off times
- . Pause button to allow temporary cessation of treatment and a resume button to allow the continuance of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes it's countdown and the amplitude (intensity) is reset to zero.
- . Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
- . Timed therapy sessions.
- Robust rechargeable Nickel Metal Hydride battery system with . rapid recharge (85% recharge in 30 minutes - full charge in 2 hours)
3
Basis for Substantial Equivalence 6.
The RTM1000 is substantially equivalent to the legally marketed device and is similar in design, features and function and provides the intended therapy in a safe and effective manner. Both devices offer various preprogrammed treatment protocols and the clinician or patient can choose one or more of these pre-set options. Furthermore, both allow the clinician to customize a treatment protocol for each individual patient within the parametric ranges and save the treatment into memory.
Bench testing was performed on the marketed device and the RTM1000 and the therapy output and performance characteristics for both units was very similar and consistent
Differences Between the Marketed Device and the RTM1000 7.
The RTM1000 incorporates several improvements over the legally marketed device, including:
- Equal recharge time at a lower charging temperature. .
- . Improved safety due to the device software preventing therapy treatment while connected to wall current (recharging).
- . 29% smaller size while maintaining equal output characteristics and power.
- . Separate on and off buttons with easy to understand color-coding provides safer user interface.
- . Improved patient lead wire/cable assembly provides easier wire management and easier electrode connections due to colorcoding.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Ryan Telemedicine C/O: Mr. John So Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, WA 98607-8542
Re: K030254 Dated: February 11, 2003 Received: February 12, 2003
Trade/Device Name: Interferential Stimulator, Model RTM1000 Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: Class II Product Codes: IPF, LIH
Dear Mr. So:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
5
Page 2 - Mr. So
CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miall H. Williamson
- Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K030254 510(k) Number (if known):
Interferential Stimulator, Model RTM1000 Device Name:
Indications For Use:
The RTM1000 Electrotherapy device is a multifunction nerve stimulation device intended to be used for muscle and nerve stimulation using any one of its two therapy modes, Interferential Current Stimulation, Neuromuscular Electrical Stimulation.
In the Interferential Current Mode the RTM1000 is indicated for the following conditions:
- . Symptomatic relief of pain
- Symptomatic management and relief of chronic pain
- . Adjunctive treatment for the management of post traumatic and post-surgical pain.
In the Neuromuscular Stimulation Mode. the RTM1000 is indicated for the following conditions:
- Relaxation of muscle spasms; .
- . Prevention or retardation of disuse atrophy;
- . Increasing local blood circulation;
- Muscle re-education; ●
- Immediate post surgical stimulation of calf muscle to prevent venous thrombosis: ● and
- . Maintaining or increasing range of motion.
for Mark n Mulkerson
Division Sign-Off
and Neurological Devi
10(k) Number _________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)