The Fenzian Treatment System is an electrical device designed for use as a Transcutaneous Electrical Nerve Stimulator (TENS) which operates by delivering an electrical current through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. The complete system is comprised of the stimulator and battery.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Fenzian Treatment System based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

In this case, the Fenzian Treatment System claims substantial equivalence to the EMPI - Focus 795 (K951951). The evaluation focuses on comparing key technical specifications and indications for use.

Feature/Characteristic	Acceptance Criteria (based on Predicate: EMPI Focus 795)	Reported Device Performance (Fenzian Treatment System)
Indications for Use	- Symptomatic relief and management of chronic, intractable pain- Adjunctive treatment for post-surgical and post-trauma acute pain	- Symptomatic relief and management of chronic, intractable pain- Adjunctive treatment for post-surgical and post-trauma acute pain
Device Classification	Transcutaneous Nerve Stimulator (TENS) 882.5890	Transcutaneous Nerve Stimulator (TENS) 882.5890
Product Code	84 GZJ TENS	84 GZJ TENS
Regulated Voltage	Yes	Yes
Indicator Display - On/Off	Yes	Yes
Indicator Display - Low Battery	Yes	Yes
Waveform	Symmetrical biphasic (predicate)	Biphasic
Maximum Output Voltages	$\pm$ 100V @ 1 k ohm	88 V @ 500 ohms; 306 V @ 2 k ohms; 650 V @ 10 k ohms
Maximum Output Current	0-60 mA (normal), 0-100 mA (high)	46 milliamps @ 500 ohms, 16.8 milliamps @ 2 k ohms, 8.0 milliamps @ 10 k ohms
Pulse Width	300 $\mu$ S of peak amplitude	498 $\mu$ S
Frequency	25, 30, 35, 45, 50, 80 pps	15-350 Hz
Maximum Patient Leakage Current	<100 μΑ	<100 μΑ
Power Supply Voltage	9V	9V
Controller	Microprocessor	Microprocessor
Housing	ABS	ABS
Maximum Delivered Current	< 10 mA	< 7.0 mA
Range Load of Impedance	Unknown (predicate)	500-1000 ohms
Output Channels	2, simultaneous	1, alternating
Weight	145 gm with battery	0.4 kg excl. batteries
Dimensions	3.7 x 2.5 x 0.84 inches	7 x 2 x 2 inches
Electrodes	Snapease Brand	Stainless steel
Net Charge	30 $\mu$ C	1.16 $\mu$ C@ 500 ohms
Max. Phase Charge	40 $\mu$ C @ 500 ohm	10.6 $\mu$ C @ 500 ohms
Max. Current Density (mA/cm²)	3.11 mA/cm² @ 500 ohms	27.7 mA/cm² @ 500 ohms
Avg. Power Density (W/cm²)	0.187 W/cm² @ 500 ohms	0.177 W/cm² @ 500 ohms
Burst Mode	Unknown (predicate)	Pulses per burst: 1-8Bursts per second: 15-2800Burst duration: 1-5 seconds
Time On	2.5 – 50 seconds	1-5 seconds
Off Time	0-50 seconds	1 second
Maximum Charge per Pulse	Unknown (predicate)	37.5 µC @ 500 ohms
Maximum Average Current	Unknown (predicate)	2.19 mA

Points specific to the study and acceptance:

Sample size for the test set and data provenance:
- The document primarily presents a comparison of technical specifications between the new device and the predicate device, rather than a clinical study with a "test set" of patients.
- Therefore, there's no explicit sample size mentioned for a test set in the traditional sense of a clinical trial for device efficacy.
- The data provenance for the comparison features is from the manufacturer's reported specifications for both the Fenzian Treatment System (new device) and the EMPI - Focus 795 (predicate), which is a retrospective comparison based on published specifications for the predicate. Given "Eumedic Limited" is a UK company, and the predicate is from a US company, the data may originate from different countries in terms of where the devices were developed and tested, but the comparison itself is against documented specs.
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. This 510(k) summary does not describe a study involving expert assessment of a "test set" of patient data or outcomes. The "ground truth" for the comparison is the documented specifications of the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as there is no clinical test set requiring adjudication in this summary.
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 is not an AI-assisted diagnostic device, nor does the submission describe an MRMC study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a TENS device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the substantial equivalence claim is the technical specifications and cleared indications for use of the legally marketed predicate device (EMPI - Focus 795). The submission argues that the Fenzian device's specifications and intended uses are either identical or equivalent to the predicate.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established:
- Not applicable.

Overall Study Information / Conclusion:

The "study" demonstrating the device meets acceptance criteria in this 510(k) is a non-clinical comparative analysis against a predicate device.

Rationale for Substantial Equivalence: The manufacturer asserts substantial equivalence based on:
1. Same Indications for Use and equivalent output.
2. Equivalent technological characteristics.
3. Comparative information (presented in the table above) demonstrating this equivalence.
Non-Clinical Data: This submission relies on non-clinical data to support safety and performance, which include:
- Risk Analysis: Demonstrated acceptable and mitigated potential hazards.
- Standards Compliance: The device meets requirements for EN 60601-1-2 EMC (Electromagnetic Compatibility, covering radiated emissions, electrostatic discharge, radiated immunity) and general device safety.
- CE Mark: Meets European requirements for the CE Mark, indicating compliance with relevant EU directives for health, safety, and environmental protection.
Conclusion: The manufacturer concludes that the device is designed, labeled, and verified for performance and safety, and its performance is equivalent to a legally marketed predicate device, with no unmitigated design or performance potential hazards. The FDA's letter (K041575) confirms substantial equivalence based on the provided information.

Summary

{0}------------------------------------------------

K041575
510k Summary
pg 1 of 7

JUL 1 6 2004

510(k) Summary Fenzian Treatment System

Eumedic Limited 3 Charnham Lane Hungerford, Berkshire RG170EY United Kingdom 44(0)1488684008 Dominic Weiss, Director

Prepared 6-11-04 by: L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 303-530-4774 (fax)

{1}------------------------------------------------

510 k Summary
p 2 of 7

Device:	Fenzian Treatment System
Common Name:	Transcutaneous Electrical Nerve Stimulator
Classification	882.5890 TENS
SE Predicate:	Empi Focus 795K951951882.5890

Device Description: The Fenzian Treatment System is an electrical device designed for use as a Transcutaneous Electrical Nerve Stimulator (TENS) which operates by delivering an electrical current through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. The complete system is comprised of the stimulator and battery.

{2}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Fenzian Treatment System

Indications For Use:

TENS applications:

Symptomatic relief and management of chronic, intractable pain .
Adjunctive treatment for post-surgical and post-trauma acute pain .

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 NEDDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

{3}------------------------------------------------

COMPARISON CHART

Feature/Characteristic	Fenzian Treatment System	EMPI - Focus 795, Published Specs
510(k)	Unassigned. Application in process.	K951951
Manufacturer	Eumedic Ltd.3 Charnham LaneHungerford Berkshire RG170EYUnited Kingdom	Empi, Inc.49 Plain StreetNorth Attleboro, MA 02760U.S.A.
Device Classification	Transcutaneous Nerve Stimulator(TENS) 882.5890	Transcutaneous Nerve Stimulator(TENS) 882.5890
Product Code	84 GZJ TENS	84 GZJ TENS
Indications	As a TENS device:a) Symptomatic relief and management of chronic, intractable painb) Adjunctive treatment for post-surgical and post-trauma acute pain	As a TENS device:a) Symptomatic relief and management of chronic, intractable painb) Adjunctive treatment for post-surgical and post-trauma acute pain
Output channels	1, alternating	2, simultaneous
Regulated voltage	Yes	Yes
Indicator display- On/Off display	Yes	Yes
- Low Battery	Yes	Yes
Weight	0.4 kg excl. batteries	145 gm with battery
Dimensions	7 x 2 x 2 inches	3.7 x 2.5 x 0.84 inches
Electrodes	Stainless steel	Snapease Brand
Waveform	Biphasic	Symmetrical biphasic
Maximum Output Voltages	88 V @ 500 ohms306 V @ 2 k ohms650 V @ 10 k ohms	$\pm$ 100V @ 1 k ohm
Maximum Output Current	46 milliamps @ 500 ohms16.8 milliamps @ 2 k ohms8.0 milliamps @ 10 k ohms	0-60 mA (normal)0-100 mA (high)
Pulse width	498 $\mu$ S	300 $\mu$ S of peak amplitude
Frequency	15-350 Hz	25, 30, 35, 45, 50, 80 pps
Net Charge	1.16 $\mu$ C@ 500 ohms	30 $\mu$ C
Max. Phase Charge	10.6 $\mu$ C @ 500 ohms	40 $\mu$ C @ 500 ohm
Feature/Characteristic	Fenzian Treatment System	EMPI - Focus 795, PublishedSpecs
Max. Current Density(mA/cm²)	27.7 mA/cm² @ 500 ohms	3.11 mA/cm² @ 500 ohms
Avg. Power Density(W/cm²)	0.177 W/cm² @ 500 ohms	0.187 W/cm² @ 500 ohms
Burst Mode		Unknown
- Pulses per burst	1-8
- Bursts per second	15-2800
- Burst duration	1-5 seconds
Time On	1-5 seconds	2.5 – 50 seconds
Off Time	1 second	0-50 seconds
Power Supply Voltage	9V	9V
Max. Delivered Current	< 7.0 mA	< 10 mA
Range Load of Impedance	500-1000 ohms	Unknown
Controller	Microprocessor	Microprocessor
Housing	ABS	ABS
Maximum Patient LeakageCurrent	<100 μΑ	<100 μΑ
Maximum Charge per Pulse	37.5 µC @ 500 ohms	Unknown
Maximum Average Current	2.19 mA	Unknown

{4}------------------------------------------------

{5}------------------------------------------------

Substantial Equivalence Rationale

1. The Fenzian Treatment System has the same Indications for Use and equivalent output.
1. The technological characteristics are equivalent.
1. Comparative information demonstrates substantial equivalence.

{6}------------------------------------------------

Non-Clinical Data:

1. Risk Analysis results demonstrate acceptable and mitigated potential hazards.
1. The device meets the requirements for EN 60601-1-2 EMC, Radiated Emissions, Electrostatic Discharge, Radiated Immunity and device safety.
1. The device meets European requirements for application of the CE Mark.

Conclusion:

The device is designed and labeled and verified for performance and safety. The performance is equivalent to a legally marketed predicate device. Risk Analysis does not demonstrate any design or performance potential hazards that are not adequately mitigated.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2004

Eumedic Limited C/o Mr, Lewis W. Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301

Re: K041575

Trade/Device Name: Fenzian Treatment System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: GZJ Dated: June 11, 2004 Received: June 15, 2004

Dear Mr. Ward:

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.

{8}------------------------------------------------

Page 2 -- Mr. Lewis W. Ward

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milkerner

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{9}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Fenzian Treatment System

Indications For Use:

TENS applications:

Symptomatic relief and management of chronic, intractable pain .
Symptomative for post-surgical and post-trauma acute pain .

Prescription Use X (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 NEDDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices

510(k) Number_ K041575

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).