(131 days)
The Model 7500 Microcurrent TENS Device is intended to be used for the relief of chronic intractable pain.
A number of TENS and microcurrent devices have been cleared for marketing by FDA that have just a few discrete output settings, rather than having a continuously adjustable output. Such devices have been shrinking in size in recent years as advances in integrated circuits and other components allow for smaller circuits. Now NewCare Products is introducing a microcurrent TENS device that has the generator unit builtin to the back of the electrodes. By eliminating the bulky controls, the generator may be made very small and can be mounted on the electrode pad.
By providing three versions of the device, three different output levels The three versions of the Model 7500 are equivalent to are obtained. one traditional generator with three discrete output levels.
The provided text is a 510(k) summary for the Model 7500 Microcurrent TENS Device, which seeks to establish substantial equivalence to predicate devices. It does not describe a study involving specific acceptance criteria, device performance metrics, or the typical elements of a clinical trial used to prove a device meets acceptance criteria in the way a diagnostic or AI-driven device might.
Instead, the submission focuses on demonstrating that the Model 7500 Microcurrent TENS Device is substantially equivalent to already legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics. The "testing" section refers to conformance with recognized electrical safety and performance standards for TENS devices, rather than clinical efficacy studies with specific performance metrics.
Therefore, many of the requested categories for a clinical study on acceptance criteria cannot be extracted from this document, as such a study was not performed or described in this 510(k) summary. I will answer based on the information available and indicate where information is not present.
Acceptance Criteria and Study for Model 7500 Microcurrent TENS Device
This 510(k) submission, K013167, for the Model 7500 Microcurrent TENS Device, aims to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving a specific performance metric against a set of acceptance criteria through a clinical trial. The "acceptance criteria" in this context refer to conformance with established electrical safety and performance standards for TENS devices, not diagnostic accuracy or efficacy metrics.
The "study" conducted for this device was primarily focused on bench testing to ensure compliance with these recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance (Conformance) |
|---|---|---|
| Electrical Safety | ANSI/AAMI NS4 (1985) Transcutaneous Electrical Nerve Stimulators | Tested and found to conform. |
| UL2601-1, 2nd Edition (1997) Medical Electrical Equipment, Part 1: General Requirements for Safety | Tested and found to conform. | |
| CAN/CSA C22.2 No. 601-1-M90 Medical Electrical Equipment, Part 1: General Requirements for Safety | Tested and found to conform. | |
| EN60601-1 (1990) Medical Electrical Equipment Part 1: General Requirements for Safety | Tested and found to conform. | |
| Performance (TENS Specific) | IEC 60601-2-10 1st edition (1987) Particular Requirements for the Safety of Nerve and Muscle Stimulators | Tested and found to conform. |
| Regulatory Guidance | Guidance for TENS 510(k) content (Draft: August 1994) | The submission adheres to this guidance. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The "test set" in this context refers to the device itself being subjected to bench testing against engineering standards, not a clinical data set.
- Data Provenance: Not applicable. The testing described is bench testing of the device hardware, not data derived from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for compliance with electrical and safety standards is determined by the standards themselves and objective measurements during bench testing, not by expert human interpretation in a clinical sense.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Compliance with standards is typically determined by measurement against predefined limits, not by an adjudication panel.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a microcurrent TENS device for pain relief, not a diagnostic imaging device utilizing AI that would involve human readers.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device does not incorporate AI; it is an electronic medical device with discrete electronic components. Two of the predicate devices employed software, but the Model 7500 and the Healthonics unit do not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this 510(k) submission relates to the device meeting established electrical safety and performance standards. This is determined by objective measurements and verifications against the specifications outlined in documents like ANSI/AAMI NS4, UL2601-1, and IEC 60601-2-10. It is not based on expert consensus, pathology, or outcomes data related to patient treatment efficacy in a clinical trial.
8. The sample size for the training set
- Sample Size: Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
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KO13167
510(k) Summary
JAN 3 0 2002
Model 7500 Microcurrent TENS Device
Common/Classification Name: TENS Device, 21 CFR 882.5890
NewCare Products, LLC 182B Sandbank Road Cheshire, CT. 06410
Contact: Doug Johnson, Prepared: September 12, 2001
LEGALLY MARKETED PREDICATE DEVICES A.
The Model 7500 Microcurrent TENS Device is substantially equivalent to the Healthonics MedRelief Microcurrent TENS device, which was cleared for marketing by FDA on February 21, 2001 under K003507. It is also substantially equivalent with respect to some characteristics to the Advance Medequip Model 850 Microcurrent TENS device, 510(k) number unknown, but the device is currently marketed, and to the Ito Trio (K990787).
DEVICE DESCRIPTION B.
A number of TENS and microcurrent devices have been cleared for marketing by FDA that have just a few discrete output settings, rather than having a continuously adjustable output. Such devices have been shrinking in size in recent years as advances in integrated circuits and other components allow for smaller circuits. Now NewCare Products is introducing a microcurrent TENS device that has the generator unit builtin to the back of the electrodes. By eliminating the bulky controls, the generator may be made very small and can be mounted on the electrode pad.
By providing three versions of the device, three different output levels The three versions of the Model 7500 are equivalent to are obtained. one traditional generator with three discrete output levels.
C. INTENDED USE
The Model 7500 Microcurrent TENS Device is intended to be used for the relief of chronic intractable pain.
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SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Model 7500 Microcurrent TENS Device is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices. The Model 7500 Microcurrent TENS Device has the same technological characteristics as the predicate devices. This premarket notification has described the characteristics of the Model 7500 Microcurrent TENS Device in sufficient detail to assure substantial equivalence.1
TECHNOLOGICAL CHARACTERISTICS E.
The Model 7500 Microcurrent TENS Device has the same technological characteristics as the currently marketed devices. All use discrete electronic components to generate electrical pulses that are delivered to the patient through a pair of patient electrodes. Two of the predicate devices employ software, but the Model 7500 and the Healthonics unit The Model 7500 device is different from the predicate do not. Healthonics device in that the three amplitude settings are realized through three separate versions of the device, each with different component values, while in the Healthonics Medrelief the three amplitude levels are realized through use of a single device with a three-position However, this is not really a difference in technological switch. characteristics since the underlying technology is the same.
F. TESTING
The Model 7500 has been tested and found to conform to the following standards:
- ANSI/AAMI NS4 (1985) Transcutaneous Electrical Nerve . Stimulators
- Guidance for TENS 510(k) content (Draft: August 1994) ●
- UL2601-1. 2nd Edition (1997) Medical Electrical Equipment, Part . 1: General Requirements for Safety, 2nd edition including amendments 1 and 2.
- CAN/CSA C22.2 No. 601-1-M90 Medical Electrical Equipment, ● Part 1: General Requirements for Safety including C22.2 No. 601.1S1-94 (IEC 601-1 Amendment 1:1991) Supplement No. 1-94 to CAN/CSA 22.2 No. 601.1-M90.
1 The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in this 510(k) is limited to the way they are defined in, and used by FDA in accordance with, Sections 513(f)(1) and 513(l)(1) of the Federal Food, Drug, and Cosmetic Act.
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- EN60601-1 (1990) Medical Electrical Equipment Part 1: . General Requirements for Safety including amendments A1 + A2.
- IEC 60601-2-10 1* edition (1987) Particular Requirements for . the Safety of Nerve and Muscle Stimulators.
CONCLUSIONS G.
This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized symbol that resembles a bird in flight, composed of three curved lines. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
T. Whit Athey, Ph.D. Senior Consultant Representing NewCare Products, LLC C. L. McIntosh & Associates 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
Re: K013167
Trade/Device Name: Model 7500 Microcurrent TENS Device. Versions MCT-F5, MCT-F50, and MCT-F500 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: January 3, 2002 Received: January 4, 2002
Dear Dr. Athey:
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
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Page 2 - T. Whit Athey, Ph.D.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ilsung (21 es rearly of the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form aroduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and in your finding of substantial equivalence of your device to legally premained newices 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 11 you desire specific acres on for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 McMullerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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FDA 510(k) Premarket Notification
I DA 510(K) Predition Networker.
Newcare Products LLC Newcare MCT-F5, Model 7500 Micro Current Therapy Patch
5 10(k) Number (if known): K013167
Device Name: Newcare Products LLC MCT Micro Current Therapy
Indications For Use: The subject device is intended to be used for the symptomatic relief of chronic intractable pain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Genel, Restorative
and Neurological Devices
510(k) Number K013167/
000021
MUM
§ 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).