(165 days)
(TENS) Transcutaneous Electrical Nerve Stimulator Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems. Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: relaxation of muscle spasm; muscle reeducation; prevention of disuse atrophy; maintaining and increasing the range of motion; and as immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. High Volt Pulsed Current Stimulator Mode: High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention of muscle of disuse atrophy, relaxation of muscle spasm, muscle reeducation, maintaining and increasing the range of motion, and as immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7
This document is a 510(k) premarket notification from the FDA, granting clearance for a medical device. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria in the format requested.
The document states that the device, a "Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7," has been determined to be "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the device is as safe and effective as a legally marketed device that does not require premarket approval.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria and Device Performance Table: The document does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or present performance data for the device against such criteria. Substantial equivalence is a regulatory standard, not a performance metric defined by specific statistical outcomes.
- Sample Size and Data Provenance for Test Set: This information is not part of a 510(k) clearance letter. The substantial equivalence determination is based on a comparison to predicate devices, which may or may not involve a new clinical study. If a study was performed, its details are not included here.
- Number and Qualifications of Experts: Not applicable or provided. The determination is made by FDA reviewers based on the submission from the manufacturer, not a consensus of external experts establishing a ground truth for a test set.
- Adjudication Method: Not applicable or provided.
- MRMC Comparative Effectiveness Study: Not mentioned or implied. A 510(k) clearance typically does not require a comparative effectiveness study showing human reader improvement with AI assistance, as this is not an AI device.
- Standalone Performance Study: The document does not detail any standalone performance study. The focus is on substantial equivalence to existing devices.
- Type of Ground Truth: Not applicable or provided in the context of a performance study.
- Training Set Sample Size: Not applicable. This device is not an AI/ML device that requires training.
- Ground Truth for Training Set Establishment: Not applicable.
In summary, this document is an FDA clearance letter for a device, confirming its substantial equivalence to other devices already on the market. It does not provide the detailed study information (acceptance criteria, performance data, clinical study specifics) typically associated with a clinical trial or performance evaluation designed to establish new performance claims.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2005
Mr. Gary Bussett Biomedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085
Re: K042711
Trade/Device Name: Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7 Regulation Numbers: 21 CFR 890.5850, 882.5890 Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief, and interferential current stimulator. Regulatory Class: II Product Code: IPF, GZJ, LIH Dated: February 23, 2005 Received: February 25, 2005
Dear Mr. Gary Bussett:
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 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.
{1}------------------------------------------------
Page 2 – Mr. Gary Bussett
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to ough finding of substantial equivalence of your device to a legally prematics notification: "The Pro on 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 advision at (240) 276-0120 . Also, please note the regulation entitled, Colliact the Office of Compullinemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
L. Marlin A. Millikenn
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
STATEMENT OF INDICATIONS FOR USE
KOYZZIL
510(k) Number (if known):
Device Name: Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Combination Transculatiedus Liectivel Norvo Gilhalator North Stimulator, Model BML S03-7
Indications for Use:
(TENS) Transcutaneous Electrical Nerve Stimulator Mode:
Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of nort surgical and Transcutaneous Electived Nerve Stimulation (TENO) is about the Symbon.
chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical post-traumatic acute pain problems.
Muscle Stimulator Mode:
External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: External electrical neuromuscular sumulation asing expractic e a pasm; muscle reculture, prevention of relariation of muscle disuse atrophy, roluxation of model of model on and as immediate mailitaining and increasing the range of event venous thrombosis.
Interferential Mode:
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an Interential Summation is used for Symptomation rates and post-fraumatic acute pain.
High Volt Pulsed Current Stimulator Mode:
High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention of muscle of High Voltage Pulsed Stimulation is Indicated as moralisation maintaining and increasing the range of disuse attophy, relaxation of muscle spash, music roodbated manaly and muscles to prevent venous thrombosis.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Wilkerson
510(k) Number K042711
§ 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).