(287 days)
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.
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.
This 510(k) summary describes a traditional premarket notification where the predicate pathway is used to prove substantial equivalence rather than a clinical study with acceptance criteria. As such, the requested information (acceptance criteria, study details, sample sizes, ground truth, etc.) is not present in the provided document.
Here's why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. This document is a 510(k) summary for a device seeking substantial equivalence to predicate devices, not a report of a new clinical study with predefined acceptance criteria. The "performance" is demonstrated by showing that the new device has "similar characteristics" and "the same intended use" as the predicates.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or clinical study data of this nature is presented. The submission relies on a comparison of device characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication process is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is an "Electroanalgesic Delivery System" (a TENS/Interferential Current Therapy device), not an AI-powered diagnostic tool, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device, not an algorithm, so a standalone performance evaluation is not relevant in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As no clinical study with a test set is described, no ground truth type is relevant. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not Applicable. No training set for an algorithm is mentioned or relevant.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is relevant.
Summary of Device Comparison (as presented in the document):
The submission demonstrates substantial equivalence by comparing the NeuroMed Electroanalgesic Delivery Systems to two predicate devices: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (Nemectron EDiT) (K932897) and Metron Vectorsurge 5 (K03048).
The key findings for "proving" that the device meets the (unlisted) acceptance criteria for substantial equivalence are:
- Intended Use: The NeuroMed device has the "same intended use" as the predicate devices. This is a critical point for demonstrating substantial equivalence.
- NeuroMed Intended Use: Stimulate peripheral nerves for pain relief, stimulate motor nerves for muscle rehabilitation, management/symptomatic relief of chronic pain, adjunctive treatment of post-traumatic pain, adjunctive treatment of post-surgical pain, increasing local blood circulation, maintaining/increasing range of motion, muscle re-education, relaxation of muscle spasms, prevention/retardation of disuse atrophy, immediate post-surgical stimulation of calf muscles to prevent phlebothrombosis. These are explicitly stated as "the same as for the predicate devices."
- Technological Characteristics: The NeuroMed device and the predicates are described as:
- Console type electrical signal generators.
- Apply sinusoidal current through two pairs of contact electrodes.
- Output currents consist of "similar intensity and frequency range."
- Have electronic control circuits with embedded software.
- Use common household current as a power source.
- Are in compliance with equivalent IEC standards.
- Conclusion on Equivalence: The submission concludes that "any differences in their technological characteristics do not raise any new concerns of safety or effectiveness." Therefore, it is determined to be substantially equivalent.
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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
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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.
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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
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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
Page 1 of
§ 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).