NT2000 by BIO-MEDICAL RESEARCH, LTD.

Transcutaneous Electrical Nerve Stimulation (TENS) for the symptomatic relief and a) management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
b) 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, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Description

The NT2000 is a compact, battery powered transcutaneous electrical nerve and electronic muscle stimulator. Two channels are available on the NT2000. Each channel operates independently and if desired they may be used simultaneously. The clinician may set up to two prescribed programs from a list of defined programs for use by the patient. The parameters and options for two programs are variable. One option (dual program), the Rx and total treatment times may be set for all of the programs. The programmable parameters are frequency, pulse width, contraction time, relaxation time, ramp up time, ramp down time, amplitude limit and channel delay. The programmable options are synchronous or alternate mode, extended pulse or sub_pulse mode, monophasic or biphasic mode, single or dual frequency, load sensing on or off, audio off or on, trigger mode off or on and dual program off or on. The NT2000 is programmed using a detachable keypad connector called the NT2000C. The clinician may use the NT2000 with the NT2000C interlocked but it is generally designed for use without the NT2000C by the patient. The patient may use the selected program or another available program if provided. The patient may over ride the contraction/ relaxation cycle using an optional external trigger (if provided) or by using the override feature. The patient may also increase and decrease the amplitude of the stimulus. Use of the device is recorded internally, allowing the clinician to evaluate compliance with the prescribed treatment regimen.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the NT2000, a Transcutaneous Electrical Nerve Stimulator (TENS) and electronic muscle stimulator.

Here's an analysis of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of measurable performance metrics or thresholds for the NT2000. Instead, the "acceptance criteria" appear to be based on demonstrating substantial equivalence to a predicate device and adherence to recognized industry standards for safety and electrical performance.

Acceptance Criterion (Implied)	Reported Device Performance (Summary)
Substantial Equivalence to Predicate Device (Bio Tens Model: ST-601)	Comparisons of stimulation outputs for the NT2000 and the predicate Bio Tens Model: ST-601 show similar results. The NT2000 is effectively a more user controllable device which indicates patient compliance.
Adherence to Electrical Standards	The NT2000 is designed and tested to the electrical requirements of IEC 601-1, the electromagnetic compatibility requirements of IEC 601-1-2. The NT2000 also conforms to AAMI/ANSI NS4 #3.2.3.2. 1985.
Safety & Effectiveness	Testing of the stimulation output parameters of the NT2000 indicate that the device is safe, that it provides appropriate stimulation output for effective relief of chronic pain and that it performs as well as or better than the legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical testing was performed for the purpose of this 510(k) Premarket Notification." This means there was no "test set" in the context of clinical data. The evaluation was based on non-clinical tests (comparison of stimulation outputs and compliance with standards). Therefore, there is no sample size or data provenance information for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical testing was performed, no experts were used to establish ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As no clinical testing was performed, there was no ground truth to adjudicate.

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 a TENS/EMS unit, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers" are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The NT2000 is a physical medical device, not a standalone algorithm. Its performance is evaluated based on its electrical output parameters and adherence to safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" was established by comparison to the a legally marketed predicate device (Bio Tens Model: ST-601) and adherence to recognized electrical and electromagnetic compatibility standards (IEC 601-1, IEC 601-1-2, AAMI/ANSI NS4 #3.2.3.2. 1985). The "ground truth" is therefore based on established engineering and safety standards, and performance characteristics consistent with a previously cleared device.

8. The sample size for the training set

Not applicable. The NT2000 is a hardware device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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510(k) Summary of Safety and Effectiveness

This summary is submitted in compliance with the FDA interim rule 21 CFR 807.92.

(1)	Submitted by:	Bio-Medical Research Ltd.,BMR House,16 Merchants Road,Galway.Republic of Ireland
		Telephone: + 353 91 507300Fax: + 353 91 566907
	Contact Person:	Isaac Finnegan
	Position/ Title:	Regulatory Affairs Manager
	Date of preparation:	6 th June, 1997
(2)	Trade name of device:	NT2000
	Common name:	TENS
	Classification name:	Transcutaneous Electrical Nerve Stimulatorfor pain relief; §882.5890
(3)	Identification of predicateor legally marketed device:	Bio Tens Model: ST-601(Skylark Device Co. Ltd., 510(k) # K912178)

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(4) Description of device:

(5) Intended uses:
The NT2000 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 by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. This use is identical to the predicate marketed device identified in section (3) of this summary.

The NT2000 is also used for the purposes of relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion by providing electrical muscle stimulation to areas of the body that require therapy for the indicated medical conditions. These uses were previously cleared under FDA 510(k) # K933176.

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(6) Technological comparison
The NT2000 is similar to the Bio Tens Model: ST-601 in that both are portable, compact battery powered TENS devices. Both devices deliver similar pulses to surface electrodes. Both devices are similar in basic operational design and use the impedance of the output transformer to achieve a near net zero charge into the skin. The NT2000 is effectively a more user controllable device which indicates patient compliance.
(b) Non-clinical tests: (1)
Comparisons of stimulation outputs for the NT2000 and the predicate Bio Tens Model: ST-601 show similar results. To minimize potential electrical and mechanical hazards, Bio-Medical Research adheres to recognised and established industry practice and all devices are subject to final performance testing. The NT2000 is designed and tested to the electrical of IEC 601-1, the electromagnetic compatibility requirements requirements of IEC 601-1-2. The NT2000 also conforms to AAMI/ANSI NS4 #3.2.3.2. 1985.
(2) Clinical tests:
No clinical testing was performed for the purpose of this 510(k) Premarket Notification.
(3) Test conclusions:
Testing of the stimulation output parameters of the NT2000 indicate that the device is safe, that it provides appropriate stimulation output for effective relief of chronic pain and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this Summary.

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Image /page/3/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 three stripes forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Dr. Greg Shipp Bio-Reg Associates, Inc. Representing Bio-Medical Research Limited 14900 Sweitzer Lane, Suite 200 Laurel, Maryland 20707

K972244 Re: Trade Name: NT2000 Regulatory Class: II Product Code: GZJ December 12, 1997 Dated: December 15, 1997 Received:

Dear Dr. Shipp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent-determination-assumes-compliance with-----the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Greg Shipp

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. & Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): Not Available

Device Name: NT2000 Sponsor Name: Bio-Medical Research Ltd.

Indications for Use:

The NT2000 is indicated for:

Transcutaneous Electrical Nerve Stimulation (TENS) for the symptomatic relief and a) management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
b) 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, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

pcoell

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number
K972244

Prescription Use Over-The-Counter Use

Regulation Number and Section

§ 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).