(247 days)
No
The description focuses on traditional electrical stimulation modalities (muscle stimulation, interferential current, TENS) and sequencing, with no mention of AI or ML terms or functionalities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee," which defines it as a therapeutic device.
No
The device is described as a stimulator used for pain reduction, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the RS-4i Sequential Stimulator consists of a "hardware/software system" and is housed in a "plastic enclosure" with a "LCD patient display" and "operator keypad." It also includes physical accessories like "output cables," "electrode pads," and an "AC Charging Adapter." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee." This describes a therapeutic application, not a diagnostic one.
- Device Description: The device description details a stimulator that uses electrical currents (muscle stimulation, interferential current, TENS) applied to the body. This is consistent with a physical therapy or pain management device, not a device that analyzes samples from the body (which is the core of IVD).
- 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 RS-4i Sequential Stimulator does not fit this description.
N/A
Intended Use / Indications for Use
The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.
Product codes
NYN
Device Description
The RS-4i Sequential Stimulator consists of a hardware/software system that is the same as was described in its previous 510(k) notification (K032652). The RS-4i Sequential Stimulator also includes a TENS output.
The RS-4i Sequential Stimulator incorporates traditional muscle stimulation and interferential current stimulation modalities, as well as TENS output into one unit. Only one modality may be operated at a time, but modalities can be automatically sequenced. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4i muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec. (+/-10%) and a cycle frequency of 71 Hz (+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4i interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).
The RS-4i TENS (transcutaneous electrical nerve stimulation) modality operates from 0 volts to 54 volts maximum with 108 mA maximum current into a 500 ohm load resistor. The output pulse width is adjusted by a user control and determines the delivered charge. These variable-width pulses are delivered at a fixed 100 pulse-per-second rate. The output is biphasic meaning that every positive polarity pulse is followed by a negative polarity pulse. The alternating polarity also results in a zero net charge to the user.
The characteristics of the RS-4i TENS waveform were selected to maximize the stimulation of the sensory nerves (A-ß fibres) and minimize the effect on motor neurons. The pulse width operates from 0 us to 16 us with a maximum current of 108 mA. This creates a narrow spike like waveform that optimizes the stimulation area between the sensory and motor neurons on the strength-duration curve which provides comfortable stimulation with a minimum of motor recruitment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032652, K971437, K030332, K060669
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K062325
റ 510(k) Summary
APR 13 2007
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k) premarket notification was in accordance with 21 CFR 807.87.
Date prepared: March 30, 2007
1. Applicant, Official Correspondent and Owner of 510(k)
RS Medical 14401 SE First St. Vancouver, WA 98684 Attn: Bill Carroll, Vice President, Research & Development Telephone: 360-891-7290 Fax: 866-210-6928
Official Correspondent: Bill Carroll
2. Name of Device
Trade/Proprietary Name: RS-4i Sequential Stimulator Common/Usual Name: Transcutaneous electrical nerve stimulator (TENS) Classification Name:
882.5890 - Transcutaneous electrical stimulator for arthritis Product code - NYN
3. Legally Market Predicate Devices
The RS-4i Sequential Stimulator is substantially equivalent to legally marketed devices including the RS-4i model (K032652), the Bionicare Model BIO-1000 (K971437, K030332), and the Healthonics MedRelief ST Series (K060669).
4. Indications for Use
The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.
5. Device Description and Substantial Equivalence
The RS-4i Sequential Stimulator consists of a hardware/software svstem that is the same as was described in its previous 510(k) notification (K032652). The RS-4i Sequential Stimulator also includes a TENS output.
The RS-4i Sequential Stimulator incorporates traditional muscle stimulation and interferential current stimulation modalities, as well as TENS output into one unit.
1
Only one modality may be operated at a time, but modalities can be automatically sequenced. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4i muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec. (+/-10%) and a cvcle frequency of 71 Hz (+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4i interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).
The RS-4i TENS (transcutaneous electrical nerve stimulation) modality operates from 0 volts to 54 volts maximum with 108 mA maximum current into a 500 ohm load resistor. The output pulse width is adjusted by a user control and determines the delivered charge. These variable-width pulses are delivered at a fixed 100 pulse-persecond rate. The output is biphasic meaning that every positive polarity pulse is followed by a negative polarity pulse. The alternating polarity also results in a zero net charge to the user.
The characteristics of the RS-4i TENS waveform were selected to maximize the stimulation of the sensory nerves (A-ß fibres) and minimize the effect on motor neurons. The pulse width operates from 0 us to 16 us with a maximum current of 108 mA. This creates a narrow spike like waveform that optimizes the stimulation area between the sensory and motor neurons on the strength-duration curve which provides comfortable stimulation with a minimum of motor recruitment.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RS Medical % Mr. Steven Chernoff Vice President Drug & Device Development Co. P.O. Box 3515 Redmond, Washington 98073-3515
APR 1 3 2007
Re: K062325
Trade Name: RS-4i Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NYN Dated: March 30, 2007 Received: April 4, 2007
Dear Mr. Chernoff :
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.
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 -- Mr. Steven Chernoff
forth in the quality systems (OS) 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4.
510(k) Number (if known): __ K062325
RS-4i Sequential Stimulator Device Name: _________________________________________________________________________________________________________________________________________________________________
Indication for Use:
The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L062325
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)