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.

Device Description

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.

AI/ML Overview

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 |----------------------------- | Intended Use | Functional | Operating Principle | Tissue Treated | Electrode Shapes | Infrared Light | Vacuum (suction) | Treatment Activation | Display | Patient Safety Switch | Configuration | Performance Parameters | RF Type | RF Frequency | Max RF Power | Intensity Adjustment | Tissue Temperature | Safety Compliance | Standards Compliance | Biocompatibility | Risk Management | Software Validation | Acceptance Criteria (Inferred from Predicate Equivalence & Safety Standards) | Reported Device Performance (Diacare 7000) |
--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| 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. |
Equivalence | Provide the same capabilities as the predicate, relevant to the indicated use and safety. |
| Diathermy. Application of electromagnetic field to increase tissue temperature. | Diathermy. Application of electromagnetic field with proper power, frequency and wavelength increases tissue temperature. (Same) |
| Superficial, semi deep, and deep. | Superficial, semi deep, and deep. (Same) |
| Square and circular. | Square and circular. (Same) |
| No. | No. (Same) |
| No. | No. (Same) |
| Finger selection on console. | Finger selection on console. (Same) |
| LCD Display. | LCD Display. (Same) |
| Yes. | Yes. (Similar - both have this critical safety feature) |
| 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) |
| Operate within safe and effective ranges comparable to the predicate. |
| Multipolar/Unipolar. | Bipolar/Unipolar. (Similar - both offer multiple RF modes) |
| 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) |
| 300 W. | 250 W. (Diacare 7000 has less power consumption, deemed safe and effective and not raising new questions). (Similar) |
| 0-100%. | 0-100%. (Same) |
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) |
| Meet applicable safety and EMC standards. |
| 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) |
| Patient contact materials must be biocompatible. | Biocompatibility analysis conducted for biosafety; conductive cream previously market cleared. (Compliant) |
| Usability and risk analysis completed. | Software Usability and Risk Analysis done using worst-case assumptions; verified user interface, safety features, and performance. (Completed) |
| 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.

Summary

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June 6, 2022

Globus Sport and Health Technologies LLC % Jorge Millan, Ph.D. Regulatory Consultant Sigma Biomedical 7737 N University Drive. Suite 101 Tamarac, Florida 33321

Re: K211207

Trade/Device Name: Diacare 7000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: May 2, 2022 Received: May 9, 2022

Dear Dr. Millan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211207

Device Name Diacare 7000

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Submitter Information

Submitter	Ruben CurbelloGeneral ManagerGlobus Sport and Health Technologies7280 NW 7th St # 109, Miami, Florida 33126
Contact:	Jorge Millan, PhDRegulatory ConsultantSigma Biomedical7737 N University Drive, Suite 101, Tamarac, FL 33321
Telephone number	(786) 416-5587
Fax number	(954) 208-0292
E-mail	jmillan@sigmabiomedical.com
Date prepared:	June 3, 2022

Subject Device Name

Trade/Proprietary Name:	Diacare 7000
Regulation Number:	878.4400
Product Code:	PBX
Class	II
Panel	Physical Medicine

Predicate Device

Predicate Device:	Winback 3SE cleared under K162828
Regulation Number:	878.4400
Product Code:	PBX
Class	II
Panel	Physical Medicine

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Device Description

Indications for Use

Predicate Device

Primary predicate: Winback 3SE cleared under K162828

Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]: Diacare 7000 is comparable with and substantially equivalent to the Winback 3SE device.

Technical Characteristics Comparison:

The basic and main technical features of the subject device are the same as the predicated device

Feature Comparison:

Subject device has similar features and functionality as the predicate device:

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Product comparison

Element ofComparison	New Device:	Predicate Device:	Similarities orDifferences
	Diacare 7000	Winback Back 3SE
K#	K211207	K162828
Regulation and ProductClassification Code	21 CFR 878.4400PBX	21 CFR 878.4400PBX	Same
Regulatory Class	II	II	Same
Product Code	PBX	PBX	Same
Indications for Use	The Diacare 7000 device isintended to provide topicalheating for the purpose ofelevating tissue temperaturefor the treatment of selectedmedical conditions such asrelief of pain, muscle spasms,and increase in localcirculation.	The Winback Back 3SEdevice is intended toprovide topical heating forthe purpose of elevatingtissue temperature for thetreatment of selectedmedical conditions such asrelief of pain, musclespasms, and increase inlocal circulation.The Winback 3SE massagedevice is intended toprovide a temporaryreduction in the appearanceof cellulite.	Similar
Tissue treated	Superficial, semi deep, anddeep	Superficial, semi deep, anddeep	Same
Operating Principle	DiathermyApplication on a biologicaltissue of an electromagneticfield with proper power,frequency and wave lengthincreases tissue temperature	DiathermyApplication on a biologicaltissue of anelectromagnetic field withproper power, frequencyand wave length increasestissue temperature	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
RF Type	Bipolar/Unipolar	Multipolar/Unipolar	Similar
RF Frequency	400kHz, 470kHz, 700kHz,1000 kHz, 1200 kHz	300KHz – 1 MHz	Diacare canoperate at 1.2MHz
Max RF Power	250 W	300 W	Diacare 7000has less powerconsumption
Intensity Adjustment	0-100%	0-100%	Same
Configuration	Console	Cart mounted console withaccessories	Diacare 7000 isportable anddoes not requirea cart
Display	LCD Display	LCD Display	Same
Patient Safety Switch	Yes	Yes	Similar
Standards Compliance	ISO10993, IEC60601-1,IEC60601-1-2 & IEC60601-2-3 Compliant	ISO10993, IEC60601-1 &IEC60601-1-2 Compliant	Similar
Tissue temperatureelevation performance	Capable	Capable	Similar

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Evaluation of similarities and differences:

. The Diacare 7000 and the Winback 3SE have similar intended use, operating principle, functionality and similar technologies and ranges of operation. The DIACARE 7000 has demonstrated equivalent safety and effectiveness as shown in the safety and performance test reports.
Differences between both systems consist in user interface layout, navigation, icon coloring . and overall system presentation. The Diacare 7000 can operate with RF frequencies of 1.2 MHz. This frequency is in the range of other diathermy devices, which can operate up to 27 MHz, and does not raise issues of safety or effectiveness.

Non-Clinical Data and Performance Testing

Non-clinical product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes:

. Risk Management: Software Usability and Risk Analysis were done using worse-case assumptions to verify user interface, safety features and satisfactory performance.
. Electrical Safety Testing IEC 60601-1:2005 + A1:2012 and EN 60601-1:2006 + A2:2013 to demonstrate electrical safety of the device.
Electromagnetic Compatibility IEC 60601-1-2:2015 to demonstrate the device does not . interfere or interact with surrounding electromagnetic equipment.

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. Electrical Safety of short-wave therapy equipment IEC 60601-2-3:2012 and EN 60601-2-3: 2015.
Biocompatibility: Biocompatibility analysis of the patient contact materials was conducted for . biosafety. The conductive cream has previously received market clearance.
Tissue Temperature Elevation Assessment: Studies were performed using volunteers of varying ● skin colors to assess the capacity of the device to elevate tissue temperature in the treatment areas. Results indicated satisfactory safe therapeutic increases in tissue temperature.
Software verification and validation testing were conducted on the Diacare 7000 system and . documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.

Conclusion

GLOBUS

The subject device has similar technology characteristics and has the similar intended use and functionality as legally marketed devices. There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, Diacare 7000 is substantially equivalent to the predicate device with regards to safety and effectiveness.

Regulation Number and Section

§ 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.