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The Diacare 7000 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 Diacare 7000 is a diathermy device that generates a high frequency sinusoidal current with a monopolar and bipolar 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 the electrode is in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive and resistive monopolar modes. The Diacare 7000 consists of a power console on LCD monitor, and accessories including capacitive and resistive bipolar and monopolar electrodes. The unit can be adjusted to provide various levels of treatment from 400 KHz to 1.2 MHz.

This document describes the 510(k) premarket notification for the "Diacare 7000" device, which is an electrosurgical cutting and coagulation device. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (Winback 3SE, K162828).

Acceptance Criteria and Device Performance for Diacare 7000

The acceptance criteria for the Diacare 7000 are not explicitly stated in numerical terms (e.g., a specific power output range that must be met) as would be the case for traditional performance metrics. Instead, the focus is on demonstrating substantial equivalence to the predicate device in terms of intended use, operating principle, functionality, and safety. The performance is assessed through non-clinical testing to ensure it functions as intended and safely.

The document highlights the similarity of the Diacare 7000 to its predicate (Winback 3SE) across various technical characteristics and features. The "acceptance" can be inferred from the FDA's clearance, which indicates that the provided data satisfactorily demonstrates substantial equivalence.

Here's an attempt to structure the information based on the request, inferring criteria from the comparison and testing described:

1. Table of Acceptance Criteria and Reported Device Performance

| Feature/Metric | Acceptance Criteria (Inferred from Predicate Equivalence & Safety Standards) | Reported Device Performance (Diacare 7000) |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| Intended Use | Provide topical heating for elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. | Diacare 7000's stated intended use matches the predicate and is described to function for these purposes. |
| Functional Equivalence | Provide the same capabilities as the predicate, relevant to the indicated use and safety. |
| Operating Principle | Diathermy. Application of electromagnetic field to increase tissue temperature. | Diathermy. Application of electromagnetic field with proper power, frequency and wavelength increases tissue temperature. (Same) |
| Tissue Treated | Superficial, semi deep, and deep. | Superficial, semi deep, and deep. (Same) |
| Electrode Shapes | Square and circular. | Square and circular. (Same) |
| Infrared Light | No. | No. (Same) |
| Vacuum (suction) | No. | No. (Same) |
| Treatment Activation | Finger selection on console. | Finger selection on console. (Same) |
| Display | LCD Display. | LCD Display. (Same) |
| Patient Safety Switch | Yes. | Yes. (Similar - both have this critical safety feature) |
| Configuration | Console with accessories (predicate is cart mounted). | Console (Diacare 7000 is portable and does not require a cart, a difference but not affecting safety/effectiveness for the stated use nor raising new questions). (Similar) |
| Performance Parameters | Operate within safe and effective ranges comparable to the predicate. |
| RF Type | Multipolar/Unipolar. | Bipolar/Unipolar. (Similar - both offer multiple RF modes) |
| RF Frequency | 300 KHz - 1 MHz. | 400 KHz, 470 KHz, 700 KHz, 1000 KHz, 1200 KHz. (Diacare can operate at 1.2 MHz, higher than predicate's 1 MHz max, but within typical ranges for diathermy and deemed safe/effective). (Similar) |
| Max RF Power | 300 W. | 250 W. (Diacare 7000 has less power consumption, deemed safe and effective and not raising new questions). (Similar) |
| Intensity Adjustment | 0-100%. | 0-100%. (Same) |
| Tissue Temperature Elevation Performance | Capable of effective and safe tissue temperature elevation for therapeutic effect. | Capable. Studies using volunteers of varying skin colors indicated satisfactory safe therapeutic increases in tissue temperature. (Capable) |
| Safety Compliance | Meet applicable safety and EMC standards. |
| Standards Compliance | ISO10993, IEC60601-1, IEC60601-1-2, IEC60601-2-3 (for short-wave therapy equipment). | IEC60601-1:2005 + A1:2012, EN 60601-1:2006 + A2:2013 (Electrical Safety). IEC 60601-1-2:2015 (EMC). IEC 60601-2-3:2012 and EN 60601-2-3: 2015 (Short-wave therapy). ISO10993 (Biocompatibility). (Compliant) |
| Biocompatibility | Patient contact materials must be biocompatible. | Biocompatibility analysis conducted for biosafety; conductive cream previously market cleared. (Compliant) |
| Risk Management | Usability and risk analysis completed. | Software Usability and Risk Analysis done using worst-case assumptions; verified user interface, safety features, and performance. (Completed) |
| Software Validation | Software verified and validated according to FDA guidance for medical devices (for a "moderate" level of concern). | Software verification and validation testing conducted; documentation provided per FDA guidance. Software considered "moderate" level of concern, demonstrating compliance. (Completed) |

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: The document mentions "Studies were performed using volunteers of varying skin colors to assess the capacity of the device to elevate tissue temperature in the treatment areas." However, it does not specify the exact number of volunteers (sample size) used for these tissue temperature elevation assessments.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) summary, clinical studies often involve prospective data collection, but details are not provided. The testing appears to be internal non-clinical testing for device performance and safety.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable in the context of this 510(k). The submission focuses on demonstrating substantial equivalence of a physical therapy device (diathermy) through engineering and safety testing, not AI/imaging diagnostics that would require expert reads for ground truth.

4. Adjudication Method for the Test Set

As this is not a diagnostic study requiring human expert interpretation, an adjudication method is not applicable. The "ground truth" for the non-clinical tests (e.g., electrical safety, EMC, temperature elevation) is based on established engineering standards and physical measurements.

5. MRMC Comparative Effectiveness Study

An MRMC (Multi-Reader Multi-Case) comparative effectiveness study is not applicable. This type of study is used for evaluating human reader performance with and without AI assistance, typically in an imaging diagnostic context. The Diacare 7000 is a physical therapy device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

This concept is not applicable as the Diacare 7000 is a physical device, not a standalone algorithm. Its performance is evaluated as an integrated system.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance and safety testing was established through:

• Compliance with recognized international standards (e.g., IEC 60601 series for electrical safety and EMC, ISO 10993 for biocompatibility).
• Direct physical measurements and observations during testing (e.g., successful operation as designed, temperature elevation in volunteers).
• Risk analyses and software verification/validation against pre-defined safety and performance requirements.

8. Sample Size for the Training Set

There is no mention of a "training set" in this document. This term typically refers to data used to train machine learning models. The Diacare 7000 is a hardware device with associated software, not an AI/ML product that learns from a training set.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned, this point is not applicable.

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