(410 days)
Not Found
No
The device description and performance studies focus on standard diathermy technology and electrical/software safety testing, with no mention of AI or ML algorithms.
Yes
Explanation: 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. These are therapeutic uses.
No
The device description and intended use clearly state that the Diacare 7000 is for therapeutic purposes (heating tissue, pain relief, muscle spasm relief, circulation increase), not for identifying or diagnosing a medical condition.
No
The device description explicitly states it consists of a power console, LCD monitor, and accessories including electrodes, indicating it is a hardware device with integrated software, not a software-only device.
No, the Diacare 7000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "providing 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." This describes a therapeutic treatment applied directly to the patient's body.
- Device Description: The description details a diathermy device that generates a high-frequency electrical current and uses electrodes placed in contact with the patient. This is consistent with a physical therapy or medical treatment device, not a device used to examine specimens from the human body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Diacare 7000 does not perform this function.
The information provided describes a device used for physical therapy or medical treatment, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
PBX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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)
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.
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 Curbello
General Manager
Globus Sport and Health Technologies
7280 NW 7th St # 109, Miami, Florida 33126 |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jorge Millan, PhD
Regulatory Consultant
Sigma Biomedical
7737 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 |
4
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.
Indications for Use
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.
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 of
Comparison | New Device: | Predicate Device: | Similarities or
Differences |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| | Diacare 7000 | Winback Back 3SE | |
| K# | K211207 | K162828 | |
| Regulation and Product
Classification Code | 21 CFR 878.4400
PBX | 21 CFR 878.4400
PBX | Same |
| Regulatory Class | II | II | Same |
| Product Code | PBX | PBX | Same |
| Indications for Use | The Diacare 7000 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 Winback Back 3SE
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 Winback 3SE massage
device is intended to
provide a temporary
reduction in the appearance
of cellulite. | Similar |
| Tissue treated | Superficial, semi deep, and
deep | Superficial, semi deep, and
deep | Same |
| Operating Principle | Diathermy
Application on a biological
tissue of an electromagnetic
field with proper power,
frequency and wave length
increases tissue temperature | Diathermy
Application on a biological
tissue of an
electromagnetic field with
proper power, frequency
and wave length increases
tissue 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 can
operate at 1.2
MHz |
| Max RF Power | 250 W | 300 W | Diacare 7000
has less power
consumption |
| Intensity Adjustment | 0-100% | 0-100% | Same |
| Configuration | Console | Cart mounted console with
accessories | Diacare 7000 is
portable and
does not require
a 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 temperature
elevation performance | Capable | Capable | Similar |
6
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.
7
- . 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.