(246 days)
The device is intended to be used by clinicians in symptomatic relief of chronic intractable pain. Also, for post traumatic and post surgical pain relief.
The Z Tech Tens Device is designed to produce 0-60μc H-WAVE type pulse which is described as a bi-polar asymmetrical exponentially decaying impulse type waveform. It has a pulse width of approximately 1.5ms and and delivers a maximum frequency of 55Hz. Essentially the device originates an astable type pulse of controllable peak voltage, frequency and pulse width, which is amplified and passed to the output electrodes through an isolation transformer, which also eliminates any D.C. component in the output. The device also employs a recharging type circuit which effectively inhibits any patient use during the recharging of permanently installed ni-cad type batteries. The case which is of a lexan plastic type material. Front and rear controls are clearly marked as to their function for ease of patient use.
Here's an analysis of the provided text regarding the Z Tech Model F7 (TENS DEVICE) and its acceptance criteria and supporting study information:
This submission is a 510(k) premarket notification, which determines substantial equivalence to a predicate device, rather than a full premarket approval (PMA) that would typically involve extensive clinical trials with pre-defined acceptance criteria and detailed study reports. Therefore, much of the requested information regarding detailed study design, sample sizes, and expert ground truth is not explicitly available or applicable in the provided document format for a 510(k) submission.
The core of this submission is demonstrating technical identity and equivalent performance to the predicate device, the H-WAVE Model P-4 (TENS DEVICE).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from Predicate/Standards) | Reported Z Tech F7 Performance |
|---|---|
| Output type: Bi-polar asymmetrical exponentially decaying impulse type waveform | Bi-polar asymmetrical exponentially decaying impulse type waveform |
| Pulse width: Approximately 1.5ms | Approximately 1.5ms |
| Maximum frequency: up to 55Hz (within safe range) | Maximum frequency: 55Hz |
| Charge per phase: 7μc to 75μc (safe/effective range) | Output range: 0-60μc (within safe/effective range) |
| Output limited to safe levels (charge per phase, charge density, current, voltage, frequency, pulse width) | Technological values controlled and limited to safe levels, consistent with specifications and clinical testing for optimum pain reduction. |
| Elimination of DC component in output (safety feature) | Isolation transformer eliminates any D.C. component in the output. |
| Inhibition of patient use during recharging | Recharging circuit inhibits any patient use during recharging of batteries. |
| No 110 Volt A.C. component available to output | No 110 Volt A.C. component ever allowed to be present or available to the output. |
| Conformance to "American National Standard for Transcutaneous Electrical Nerve Stimulators." | Output characteristics and data conform to all safety and effectiveness standards as prescribed by this standard. |
| Effective in symptomatic relief of chronic intractable pain, post traumatic, and post surgical pain relief | Device is intended for these indications and conclusions from clinical/nonclinical tests demonstrate it will effectively relieve pain. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated in terms of a formal clinical test set with a specific number of patients/cases. The "clinical experimentation" mentioned refers to the general body of knowledge and previous studies conducted on TENS devices, rather than a specific new clinical trial for the Z Tech F7.
- Data Provenance: The document refers to "clinical experimentation" generally, and cites articles like "Transcutaneous Neural Stimulation for Relief of Pain" by Mark Linzer and Doulin M. Long, along with an "N-S4 article." This indicates reliance on existing scientific literature and established clinical data for TENS devices, particularly the H-Wave, rather than new, primary data from a dedicated clinical study for the Z Tech F7. It implies a retrospective analysis of existing knowledge and a comparison of the Z Tech F7's technical specifications to those known to be effective and safe from prior studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document references general "clinical experimentation" and standards, implying that the "ground truth" for the efficacy and safety of TENS devices, in general, has been established by the scientific and medical community over time. There wasn't a specific "test set" with individually adjudicated ground truth as would be found in a diagnostic AI study.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Given the nature of a 510(k) for a TENS device relying on substantial equivalence to an existing technology, a formal independent adjudication of a new test set's ground truth by multiple experts is not part of the standard process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. This type of study (MRMC) is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is being measured. This is a therapeutic device (TENS), and the submission focuses on technical equivalence and adherence to general performance standards, not on improving human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the conventional sense for an AI algorithm. The device itself (the TENS unit) is a standalone therapeutic device. Its "performance" is its ability to generate the specified electrical waveform and deliver it safely and effectively for pain relief, matching the predicate. This is assessed through engineering analysis and comparison to established clinical efficacy for similar waveform parameters, not through a "standalone algorithm" performance study.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" here is based on established clinical efficacy and safety of TENS devices with specific waveform characteristics, derived from historical clinical experimentation and literature. It's not individual patient outcome data from a new trial for this specific device, but rather the understanding that devices producing certain electrical outputs (like the H-Wave) are known to be effective for pain relief. The Z Tech F7 simply demonstrates it produces those same effective and safe outputs.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This device is not an AI/machine learning algorithm requiring a "training set" in the computational sense. The "training" for its design and performance specifications comes from the established knowledge base and technical specifications of the predicate device (H-Wave) and general TENS technology.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there's no "training set" for an AI algorithm. The "ground truth" for the design principles of this TENS device is based on scientific research and clinical understanding of how specific electrical parameters (waveform, pulse width, frequency, charge) interact with the human body to achieve pain relief. This knowledge has been established through decades of research in electrophysiology and TENS therapy.
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AUG 27 PPP 1
Summary of Safety and Effectiveness In reference to: 21CFR807.92
May 23, 1997
Z TECHNOLOGIES, INC. 2615 Woodacres Rd. Atlanta, Ga. 30345-1644 404-248-0159 Les Horn
Z TECH Model F7 (TENS DEVICE)- Z Technologies, Inc.
The Predicate device is the H-WAVE Model P-4 (TENS DEVICE)-
- Electronic Waveform Labs, Inc.
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#20 Safety and effectiveness in accordance with CFR 807.92.
The "Z Tech" TENS Device is technically identical to the "H-Wave" TENS Device, as indicated in the comparison table for the two devices. (SEE EXHIBIT I) The technical characteristics indicated represent the basic output for optimum performance as indicated by "Transcutaneous Neural Stimulation for Relief of Pain"; by Mark Linzer and Doulin M. Long. This article along with the N-S4 article articulates safety standards as well as minimum and maximum levels of output for TENS devices for control of pain. (7μc to 75μc)
The Z Tech Tens Device is designed to produce 0-60μc H-WAVE type pulse which is described as a bi-polar asymmetrical exponentially decaying impulse type waveform. It has a pulse width of approximately 1.5ms and and delivers a maximum frequency of 55Hz. These performance charactertistics have been shown through clinical experimentation to relieve pain in a significant number of patients in a wide variety of pain states.
Essentially the device originates an astable type pulse of controllable peak voltage, frequency and pulse width, which is amplified and passed to the output electrodes through an isolation transformer, which also eliminates any D.C. component in the output. (Eliminating any D.C. component is a necessary safety feature).
The technological values of charge per phase, charge density, current, voltage, frequency and pulse width, are all controlled and limited to safe levels. These levels are consistant and limited too specifications given and prescribed by clinical testing which is designed to give optimum values for the reduction of pain in human patients.
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The device also employs a recharging type circuit which effectively inhibits any patient use during the recharging of permanently installed ni-cad type batteries. Essentially no 110 Volt A.C. component is ever allowed to be present or available to the output of this TENS DEVICE. (Z TECH) The case which is of a lexan plastic type material. Front and rear controls are clearly marked as to their function for ease of patient use.
The device is intended to be used by clinicians in symptomatic relief of chronic intractable pain. Also for post traumatic and post surgical pain relief.
It is most important to note that a large number of patients receiving benefit from TENS type devices are those incapacitated by chronic pain for whom other treatment modalities have failed.
If care is taken by the placement of electrodes, when this device is in use, then an even greater beneficial result will be forthcoming. The device may be used by all type of patients that experience acute and or chronic pain. (especially in areas where other treatments have failed and where drug type thearapy is ill advised)
Waveform parameters were recorded using different loading conditions (500Ωto 10kΩ) for comparison to present and past technology and to the predicate device. These output characteristics and data conform to all safety and effectiveness standards as perscribed by "American National Standard for Transcutaneous Electrical Nerve Stimulators."
The conclusions drawn from clinical and nonclinical tests demonstrate that this TENS type device will effectively relieve patients of chronic and acute pain that otherwise might go untreated. Thus the device may succeed where other types of treatment have been unsuccessful.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1997
Mr.· Les W. Horn President Carlos and Career of Z Technologies, Inc. 2615 Woodacres Road Atlanta, Georgia 30345-1644
Re: K965244 Z Tech Transcutaneous Neural Stimulation Trade Name: Requlatory Class: II (two) Product Code: 84GZJ Dated: August 13, 1997 Received: August 14, 1997
Dear Mr. Horn:
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 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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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2 - Mr. Les W. Horn
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) 594-4648. 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 requlation entitled, "Misbrandinq 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page 2011 Coff 11 1
510(k) Number (if known): K965244
Z Tech Trancutaneous Neural Stimulation Device Name:
Indications For Use: The device is intended to be used by clinicians in symptomatic relief of chronic intractable pain. Also, for post traumatic and post surgical pain relief. ... ....... .. ... . ... ..........................................................................................................................
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ K965244
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) ()રિ
§ 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).