(53 days)
The Doctor Tecar device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The Doctor Tecar generates a high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a hand held electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitor resistive monopolar mode. The product consists of a power console on a moveable trolley, LCD monitor, and accessories including capacitive resistive electrodes and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 460 KHz to 600 KHz.
The provided FDA 510(k) summary for the "Doctor Tecar" device focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and a detailed study proving the device meets those criteria. The submission is for a Radiofrequency Induced Heat device, which is an electrosurgical cutting and coagulation device.
Here's an analysis of the available information in response to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for device performance. Instead, it relies on demonstrating that the Doctor Tecar device performs comparably to its predicate device, the Winback 3SE (K162828), and meets general safety and performance standards. The "Explanation of Differences" column in the Predicate Device Comparison Table (page 5) serves as an indirect way of stating performance equivalence rather than specific acceptance metrics.
| Criteria Category (Implied) | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Doctor Tecar) |
|---|---|---|
| Regulation & Product Classification | Same as Predicate (21 CFR 878.4400, PBX) | Met: 21 CFR 878.4400, PBX |
| Indications for Use | Comparable to Predicate (topical heating for pain relief, muscle spasms, increased local circulation) | Met: "The Doctor Tecar device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation." (Note: Predicate also included "temporary reduction in the appearance of cellulite" which Doctor Tecar does not, but this was deemed "No significant difference for radiofrequency device"). |
| Electrode Shapes | Comparable to Predicate (Square and circular) | Met: Square and circular |
| Infrared Light | Absence of Infrared Light (Identical to Predicate) | Met: No |
| Vacuum (suction) | Absence of Vacuum (Identical to Predicate) | Met: No |
| Treatment Activation | Comparable to Predicate (Finger selection on console) | Met: Finger selection on console |
| RF Type | Unipolar or Multipolar/Unipolar (Comparable to Predicate) | Met: Unipolar |
| RF Frequency | Within a comparable range to Predicate (460 KHz - 600 KHz vs. 300kHz - 1 MHz) | Met: 460 KHz - 600 KHz ("No significant difference") |
| Max RF Power | Within a comparable range to Predicate (120 W vs. 300 W) | Met: 120 W ("Max RF Power NO significant difference") |
| Intensity Adjustment | Identical to Predicate (0-100%) | Met: 0-100% |
| Configuration | Identical to Predicate (Cart mounted console with accessories) | Met: Cart mounted console with accessories |
| Patient Safety Switch | Identical to Predicate (Presence of switch) | Met: Yes |
| Standards Compliance | Compliance with relevant electrical safety, EMC, and biocompatibility standards (e.g., ISO10993, IEC60601-1, IEC60601-1-2) | Met: ISO10993, IEC60601-1, IEC60601-1-2 Compliant & IEC 60601-2-2: 2017 (6.0 Ed.) for use in conjunction with IEC 60601-1: 2005 AM1:2012 |
| Tissue Temperature Elevation | Satisfactory safe therapeutic increases in tissue temperature. | Met: Studies indicated satisfactory safe therapeutic increases in tissue temperature. (Page 6) |
| Usability & Risk Management | Satisfactory verification of user interface, safety features, and performance. | Met: Assessments done using worst-case assumptions to verify user interface, safety features and satisfactory performance. (Page 6) |
| Biocompatibility | No cytotoxicity, sensitization, or intracutaneous reactivity. | Met: Samples of the tissue contacting probes were tested for cytotoxicity, sensitization and intracutaneous reactivity. (Results implied as satisfactory) (Page 6) |
| Software Assessment | Compliance with FDA software validation guidelines for Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing. | Met: All addressed and assessed. (Page 6) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Studies were done in Italy using volunteers of varying skin colors to assess the capacity of the device to elevate tissue temperature in the treatment areas." (page 6).
- Sample Size: Not specified. The term "volunteers" is used, but no number is given.
- Data Provenance: Italy.
- Retrospective or Prospective: Implied to be prospective as studies were "done" using volunteers.
For other tests (electrical safety, EMC, biocompatibility, usability, software) which are typically conducted in a laboratory or simulated environment, specific "test sets" in the sense of patient data are not applicable. These tests use engineering samples or components of the device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is generally not applicable for the tests described for this device.
- Tissue Temperature Elevation Assessment: The ground truth for safe therapeutic temperature increase would be based on established medical and physiological understanding, not expert consensus in the typical sense of reading medical images. The "ground truth" here is the objective measurement of temperature and its comparison to known physiological thresholds for safety and efficacy.
- Other Tests (e.g., electrical safety, EMC, biocompatibility): Ground truth is established by compliance with international standards and validated testing methodologies, not by expert interpretation in the medical sense.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers assess medical images or clinical outcomes, and their disagreements need to be resolved to establish ground truth for algorithm performance evaluation.
This information is not applicable to the type of studies presented here, which are primarily engineering and bench testing, as well as a volunteer study for temperature elevation.
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
This information is not applicable. The Doctor Tecar device is a treatment device (Radiofrequency Induced Heat) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study assessing human reader improvement with or without AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Doctor Tecar device is a physical treatment device, not an algorithm. Its performance is evaluated through its physical characteristics, safety, and physiological effects, not as a standalone algorithm.
7. The Type of Ground Truth Used
- Tissue Temperature Elevation: The ground truth is the objective measurement of tissue temperature elevation in volunteers, compared against established physiological thresholds for safe and therapeutic heating.
- Electrical Safety & EMC: The ground truth is compliance with specific international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
- Biocompatibility: The ground truth is the absence of cytotoxic, sensitizing, or reactive responses to the device materials as defined by ISO 10993 standards.
- Usability & Risk Management: The ground truth is the successful verification of user interface and safety features against predetermined functional requirements and risk assessments.
- Software Assessment: The ground truth is compliance with FDA software validation guidelines, ensuring proper functionality, hazard analysis, and validation against specified requirements.
8. The Sample Size for the Training Set
This information is not applicable. The Doctor Tecar device is not an AI/ML algorithm that requires a training set. Its development involves engineering design and testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.