(287 days)
K932897, K03048
Not Found
No
The description focuses on electrical signal generation and stimulation using established techniques (interferential and TENS). There is no mention of AI, ML, or any learning/adaptive capabilities.
Yes
The device is described with "Intended Use" that includes "Pain Management" and "Muscle Stimulation," both of which are therapeutic applications. It is also explicitly stated that the device stimulates nerves and muscles "for the purpose of providing pain relief or as an adjunctive treatment in physical therapy," which indicates a therapeutic function.
No
The device is described as an "electrical signal generator" that applies sinusoidal current to "stimulate muscles and peripheral nerves transcutaneously for the purpose of providing pain relief or as an adjunctive treatment in physical therapy." Its intended uses are pain management and muscle stimulation. These functions are therapeutic, not diagnostic.
No
The device description explicitly states it consists of a system console with control and display panels, control electronics, software, and accessories including electrodes and cables, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an "electrical signal generator which applies sinusoidal current through two pairs of contact electrodes... to stimulate muscles and peripheral nerves transcutaneously." This is a form of electrical stimulation applied externally to the body.
- Intended Use: The intended uses listed are for pain management and muscle stimulation, which are therapeutic applications, not diagnostic testing of bodily specimens.
- Lack of Specimen Handling: There is no mention of the device interacting with or analyzing any biological specimens.
Therefore, this device falls under the category of a therapeutic electrical stimulator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the NeuroMed Electroanagesic Delivery Systems is the same as for the predicate devices namely to:
Stimulate peripheral nerves for the purpose of providing pain relief Stimulate motor nerves for the purpose of muscle rehabilitation Management and symptomatic relief of chronic (long-term) intractable pain, Adjunctive treatment of post-traumatic pain syndromes Adjunctive treatment in the management of post-surgical pain problems Increasing local blood circulation
Maintaining or increasing range of motion Muscle Re-education Relaxation of muscle spasms Prevention or retardation of disuse atrophy Immediate post-surgical stimulation of the calf muscles to prevent phlebothrombosis
Product codes (comma separated list FDA assigned to the subject device)
LIH, IPF, GZJ
Device Description
NeuroMed Electroanalgesic Delivery Systems consist of a system console with a control and display panel, control electronics and software and device accessories including a suction cup electrode applicator, electrodes and cables. The device uses regular household current as a power source. The physical measurements of the device are 17.5" long x 11.5" wide x 5.5" high at a weight of approximately 9 Ibs.
NeuroMed Electroanagesic Delivery Systems is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate muscles and peripheral nerves transcutaneously for the purpose of providing pain relief or as an adjunctive treatment in physical therapy. Alternatively, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves, calf muscles
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): 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.
K932897, K03048
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
§ 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
510 (k) Summary
$\Upsilon08325\Omega$
AUG 1 8 2009
Submittor's Identification:
AA NeuroMed Company 1911 Rodger Avenue Port Coquitlam, BC V3C 1M9 Canada
Telephone: 604-941-0551 Facimile: 604-941-5659
Contact person: Hermann Dolker
Date prepared: 10/27/2008
Device identification:
Trade name: NeuroMed Electroanalgesic Delivery Systems Common name: Interferential Current Therapy Classification name: Interferential Current Therapy Device. Product Code: LIH (Unclassified), IPF, GZJ
Predicate Devices Information:
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (Nemectron EDiT) (K932897),
Metron Vectorsurge 5 (K03048)
Device Description:
NeuroMed Electroanalgesic Delivery Systems consist of a system console with a control and display panel, control electronics and software and device accessories including a suction cup electrode applicator, electrodes and cables. The device uses regular household current as a power source. The physical measurements of the device are 17.5" long x 11.5" wide x 5.5" high at a weight of approximately 9 Ibs.
NeuroMed Electroanagesic Delivery Systems is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate muscles and peripheral nerves transcutaneously for the purpose of providing pain relief or as an adjunctive treatment in physical therapy. Alternatively, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
Intended Use:
The intended use of the NeuroMed Electroanagesic Delivery Systems is the same as for the predicate devices namely to:
Stimulate peripheral nerves for the purpose of providing pain relief Stimulate motor nerves for the purpose of muscle rehabilitation Management and symptomatic relief of chronic (long-term) intractable pain, Adjunctive treatment of post-traumatic pain syndromes Adjunctive treatment in the management of post-surgical pain problems Increasing local blood circulation
1
Maintaining or increasing range of motion Muscle Re-education Relaxation of muscle spasms Prevention or retardation of disuse atrophy Immediate post-surgical stimulation of the calf muscles to prevent phlebothrombosis
Summary of technological characteristic in comparison to predicate devices:
The NeuroMed Electroanalgesic Delivery Systems and the predicate devices are console type electrical signal generators which apply sinusoidal current through two pairs of contact electrodes to the patient. Their output currents consist of similar intensity and frequency range. They have electronic control circuits with embedded software and use common household current as a power source. They are in compliance with equivalent IEC standards.
Conclusions:
The NeuroMed Electroanalgesic Delivery Systems have the same intended use and similar characteristics as the predicate devices. Documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new concerns of safety or effectiveness. Thus, the NeuroMed Electroanalgesic Delivery Systems can be determined to be substantially equivalent to the the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AA NeuroMed Corp. c/o Hermann Dolker 1911 Rodger Avenue Port Coquitlam, British Columbia Canada V3C 1B8
AUG 1 8 2009
Re: K083250
Trade/Device Name: NeuroMed Electroanalgesic Delivery System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ, LIH, IPF Dated: July 27, 2009 Received: August 13, 2009
Dear Mr. Dolker:
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 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
3
Page 2 - Mr. Hermann Dolker
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/Resourcecenter/You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
NeuroMed Electroanalgesic Delivery System
Indications For Use:
Pain Management for use with interferential and/or TENS mode programs/parameters
Stimulate peripheral nerves for the purpose of providing pain relief. Management and symptomatic relief of chronic (long-term) intractable pain. Adjunctive treatment of post-traumatic pain. Adjunctive treatment in the management of post-surgical pain.
Muscle Stimulation for use with muscle stimulation programs
Increasing local blood circulation. Maintaining or increasing range of motion. Muscle Re-education. Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.
Prescription Use
(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)
Lawrence P. Leyva
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083250
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