(76 days)
Not Found
No
The description focuses on programmable sequencing of electrical signals based on user-defined profiles, not on adaptive or learning algorithms. The software is used for setting profiles, not for real-time analysis or decision-making based on data.
Yes
The device is intended for purposes such as "relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, or to maintain or increase range of motion," which are therapeutic applications.
No
The device description explicitly states: "The FT2000 is a sequencing device only - it does not generate stimulation signals, but directs the signals from the stimulator to the patient..." The device's intended use is for therapy (relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, etc.), not for diagnosing conditions.
No
The device description explicitly states that the system consists of a stimulator, a sequencer (FT2000), patient cable, and electrodes. While there is associated PC software (CI2000), the FT2000 itself is described as a physical sequencing device that mechanically and electrically mates with the stimulator and directs signals via relays. This indicates a hardware component beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as providing electrical neuromuscular stimulation for therapeutic purposes (muscle relaxation, atrophy prevention, re-education, circulation increase, range of motion). This is a direct interaction with the patient's body for treatment.
- Device Description: The description reinforces that the device directs electrical signals to the patient's skin via electrodes. It explicitly states it does not generate stimulation signals itself, but rather sequences signals from a separate stimulator.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the FT2000 Sequencer is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Midwest Development FT2000 Sequencer provides electrical neuromuscular stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, or to maintain or increase range of motion.
Sequencing provided by the FT2000 directs the stimulator signal from the stimulator device to selected patient electrode sites without modifying the original signal characteristics.
The FT2000 permits treatment in user selected time sequences of up to 24 pairs of electrodes by having 12 pairs on each side of the body. The C12000 Software allows the user to set treatment times for each electrode pair.
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for programmable timed channel selection, patient cable, and electrodes applied to the skin.
Various types of time-variable waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced systems may have more than one output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
The FT2000 is a sequencing device only - it does not generate stimulation signals, but directs the signals from the stimulator to the patient, applying a physician prescribed sequence to the treatment. Sequenced treatment has several advantages, including patient convenience and controlled treatment of specific sites.
The FT2000 Sequencer is designed to mechanically and electrically mate with the NT2000, manufactured by Bio-Medical Research, Ltd., a 510(k) listed device which provides muscle stimulation signals.
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
The FT2000 is a prescription device.
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)
Non-Clinical Tests Submitted:
The FT2000 has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and modioular requirements for safety of nerve and muscle stimulators. The FT2000 passed all of the tests.
Accessories also meet safety requirements: 510(k) listed electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements.
System level testing including waveform testing was performed in combination with the NT2000 stimulator.
FT2000 embedded software and CI2000 PC software was verified to requirements and validated to meet intended use. Risk analysis and failure analysis were performed - residual risks were determined to be acceptable.
Clinical Tests Submitted: (None)
Conclusions from Tests:
All of the testing demonstrates that the Midwest Development FT2000 with CI2000 PC software is as safe and effective as, and functions in a manner equivalent to the predicate devices: the NT2000 (Bio-Medical Research, Ltd.).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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
K65 c595
MAY 2 3 2005
Page 1 of 3
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
| (a) | (1) | Submitted by: | Midwest Development
1200 South York Road, #4180
Elmhurst, Illinois 60126 |
|-----|-----|----------------------|--------------------------------------------------------------------------------|
| | | | Tel.: 630.758.0470
Fax: 630.758.0471
E-mail: stan@drkovaklaser.com |
| | | Contact Person: | Dr. Stanley Kovak, M.D. |
| | | Position/Title: | President |
| | | Date of Preparation: | May 20, 2005 |
| | (2) | Trade Name: | FT2000 Sequencer for Muscle Stimulator
CI2000 PC Software |
| | | | Common/Classification Name: POWERED MUSCLE STIMULATOR |
| | | Product Code: | IPF, 21 CFR § 890.5850 |
| | | Class: | Class II |
| | (3) | Predicate Device(s): | |
| | | K972244 | NT2000, Bio-Medical Research, Ltd. |
Reason for Submission: New Device
- (4) Description of Device:
A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for programmable timed channel selection, patient cable, and electrodes applied to the skin.
Various types of time-variable waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced systems may have more than one output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
1
Page 2 of 3
The FT2000 is a sequencing device only - it does not generate stimulation signals, but directs the signals from the stimulator to the patient, applying a physician prescribed sequence to the treatment. Sequenced treatment has several advantages, including patient convenience and controlled treatment of specific sites.
The FT2000 Sequencer is designed to mechanically and electrically mate with the NT2000, manufactured by Bio-Medical Research, Ltd., a 510(k) listed device which provides muscle stimulation signals.
(5) Intended use:
Medical devices providing transcutaneous muscle stimulation have been available for many years. Indications have included muscle reeducation and toning, increasing local blood flow, and maintaining muscle range of motion.
Indications for Use:
When used in combination with a listed stimulator, such as the NT2000 manufactured by Bio-Medical Research Ltd., the Midwest Development FT2000 Sequencer provides electrical neuromuscular stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, or to maintain or increase range of motion.
Sequencing provided by the FT2000 directs the stimulator signal from the stimulator device to selected patient electrode sites without modifying the original signal characteristics.
The FT2000 permits treatment in user selected time sequences of up to 24 pairs of electrodes by having 12 pairs on each side of the body. The C12000 Software allows the user to set treatment times for each electrode pair.
The FT2000 is a prescription device.
Technological Characteristics: (6)
The FT2000 embodies similar technological characteristics as the predicate Both devices employ embedded microcontrollers to store and devices. provide treatment profiles to the user. Both have a means for the patient to easily control or suspend treatment. Both devices are battery operated to ensure that treatment is isolated.
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Page 3 of 3
As stated in (4), the FT2000 is a sequencing device only - it does not generate stimulation signals, but directs the signals from the stimulator to the patient via a bank of relays per a prescribed treatment profile.
The CI2000 PC software allows the physician to set up a treatment profile for the patient and store it in the FT2000. Treatment profiles cannot be modified by the patient.
Non-Clinical Tests Submitted: (1) (b)
The FT2000 has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and modioular requirements for safety of nerve and muscle stimulators. The FT2000 passed all of the tests.
Accessories also meet safety requirements: 510(k) listed electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements.
System level testing including waveform testing was performed in combination with the NT2000 stimulator.
FT2000 embedded software and CI2000 PC software was verified to requirements and validated to meet intended use. Risk analysis and failure analysis were performed - residual risks were determined to be acceptable.
(2) Clinical Tests Submitted: (None)
Conclusions from Tests: (3)
As described in (b)(1) above, all of the testing demonstrates that the Midwest Development FT2000 with CI2000 PC software is as safe and effective as, and functions in a manner equivalent to the predicate devices: the NT2000 (Bio-Medical Research, Ltd.).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2005
Midwest Development C/o Mr. Stephen Gorski Imagenix, Inc. S65 W35739 Piper Road Eagle, Wisconsin 53119
Re: K050595
Trade/Device Name: FT2000 Sequencer for Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: February 28, 2005 Received: March 8, 2005
Dear Mr. Gorski:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it toges and ment date of the Medical Device Amendments, or to Conninered processified in accordance with the provisions of the Federal Food, Drug, devices mat have been rocksonical require approval of a premarket approval application (PMA). and Cosmetic / rol (110) like the device, subject to the general controls provisions of the Act. The 1 ou may, utererore, maines of the Act include requirements for annual registration, listing of general controls provision 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 If your device is elabilitional controls. Existing major regulations affecting your device can may be subject to back and 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 r lease of advised that i Dri briounter serour device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must or any I call 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 CI K Fat 6077, laoomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisms by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter witi anow you to ough maing of substantial equivalence of your device to a legally premaince notineation "Thesults 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 If you desire specific advice in (240) 276-0120. Also, please note the regulation entitled, Comace the Ories of Comments to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation 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/industry/support/index.html
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K050595 510(k) Number (if known):
Midwest Development FT2000 Sequencer for Muscle Stimulator Device Name:
Indications for use:
When used in combination with a listed stimulator, such as the NT2000 manufactured by Bio-When Used In Combination With & Reton Development FT2000 Sequencer provides electrical Medical Research Ltd., the Mianoor of relaxation of muscle spasm, prevention of neuromuscular "Stimulation" for "the "parpore" increase local blood circulation, or to maintain or increase range of motion.
Sequencing provided by the FT2000 directs the stimulator signal from the stimulator device to Sequencing provided by the swithout modifying the original signal characteristics.
The FT2000 permits treatment in user selected time sequences of up to 24 pairs of electrodes The FT2000 permits troutinent in ass be body. The C12000 Software allows the user to set treatment times for each electrode pair.
Contraindications for use:
Electrical neuromuscular stimulation is contraindicated in patients with implanted biomedical electronic devices such as cardiac demand pacemakers.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
× Prescription Use _ (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K050575