(51 days)
Not Found
No
The description focuses on radiofrequency diathermy and temperature measurement, with no mention of AI or ML algorithms for analysis, control, or interpretation.
Yes. The product description explicitly states, "The INDIBA COMPACT devices are therapeutic devices for deep, non-invasive diathermy."
No
The device is described as a therapeutic device intended to provide topical heating for conditions like pain relief and muscle spasms, and to reduce the appearance of cellulite. It does not mention diagnosing medical conditions.
No
The device description clearly outlines hardware components including a console, electrodes, handles, cables, and an IR thermometer or smart electrodes/handle for temperature measurement. While software verification is mentioned, it is part of a larger hardware system.
Based on the provided text, the INDIBA COMPACT device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain. muscle spasms and increase in local circulation." and for "a temporary reduction in the appearance of cellulite." These are therapeutic applications performed on the patient's body.
- Device Description: The description details a device that generates and delivers radiofrequency current to the patient's skin and subcutaneous tissue. This is a physical intervention on the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The provided text makes no mention of collecting or analyzing any biological specimens.
Therefore, the INDIBA COMPACT device is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
INDIBA COMPACT devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms and increase in local circulation.
The massage electrodes are intended to provide a temporary reduction in the appearance of cellulite.
Product codes
PBX
Device Description
The INDIBA COMPACT devices are therapeutic devices for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable.
In resistive mode the system delivers a high- frequency current of 448 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current at 448 kHz to pass. Current returns through the neutral return electrode.
INDIBA Compact devices are provided with an electroconductive media which is applied to the patients' skin prior to each treatment session. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue. In Compact Lite, the temperature on the skin is measured using a separate IR (Infra-red) thermometer and in Compact Plus and Compact Pro
temperature is measured through the smart electrodes and smart handle, which inform of the surface skin temperature trough a color scale. There are also other accessories available as massage electrodes with different shapes that can be used to massage the skin during cellulite treatment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.
The subject device was subjected to the following bench performance tests to support the assertation of substantial equivalence and evidence that no new safety or effectiveness concerns were raised:
- Electrical safety
- Electromagnetic compatibility
In addition to the electrical safety testing performed, software verification was conducted to IEC 62304: 2006 - Medical device software - Software Life-Cycle Processes, and FDA guidance on software validation. The results of this testing conclude the software has met these requirements. Patient contacting materials have been evaluated according to the requirements of ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and confirmed to be biocompatible for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 20, 2024
INDIBA S. A. U. Nieves Arias Badia HHRR, Legal and Regulatory Affairs Director Carrer del Moianès, 13 Sant Quirze del Vallès, BCN 08192 Spain
Re: K243164
Trade/Device Name: INDIBA COMPACT devices Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: September 27, 2024 Received: September 30, 2024
Dear Nieves Arias Badia:
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 (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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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/cdrh-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).
2
Sincerely,
Long H. Chen =5 -5
-5
Cher Chem = State =S =5
State Chem =S =5
State = Chem =S =5 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
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
3
Indications for Use
Submission Number (if known)
Device Name
INDIBA COMPACT devices
Indications for Use (Describe)
INDIBA COMPACT devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain. muscle spasms and increase in local circulation.
The massage electrodes are intended to provide a temporary reduction in the appearance of cellulite.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
SECTION 05 - 510(k) SUMMARY
DATE OF SUBMISSION: | 2024-09-27 |
---|---|
SUBMITTER NAME: | INDIBA S. A. U. |
SUBMITTER ADDRESS: | Carrer del Moianès, 13 |
08192 Sant Quirze del Vallès, Barcelona | |
Spain | |
CONTACT: | Nieves Arias Badia |
TELEPHONE: | +34 932 655 522 |
e-mail: | regulatory@indiba.com |
DEVICE TRADE NAME: | INDIBA COMPACT Devices |
COMMON NAME: | Radiofrequency device |
REGULATION DESCRIPTION: | Electrosurgical cutting and coagulation device and accessories |
CLASS: | Class II |
REGULATION NUMBER: | 21 CFR 878.4400 |
PRODUCT CODE: | PBX |
PREDICATE DEVICE Predicate device:
Indiba Diathermia Radiofrequency Device
DEVICE DESCRIPTION:
The INDIBA COMPACT devices are therapeutic devices for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable.
In resistive mode the system delivers a high- frequency current of 448 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current at 448 kHz to pass. Current returns through the neutral return electrode.
INDIBA Compact devices are provided with an electroconductive media which is applied to the patients' skin prior to each treatment session. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue. In Compact Lite, the temperature on the skin is measured using a separate IR (Infra-red) thermometer and in Compact Plus and Compact Pro
5
Image /page/5/Picture/0 description: The image shows the word "INDIBA" in all caps and in a bold, sans-serif font. The letters are black against a white background. There is a small circle with an R inside it in the upper right corner of the letter A, indicating that the word is a registered trademark.
SECTION 05 - 510(k) SUMMARY
temperature is measured through the smart electrodes and smart handle, which inform of the surface skin temperature trough a color scale. There are also other accessories available as massage electrodes with different shapes that can be used to massage the skin during cellulite treatment.
INTENDED USE / INDICATIONS FOR USE:
As established in the Indications for Use Statement:
INDIBA COMPACT devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms and increase in local circulation.
The massage electrodes are intended to provide a temporary reduction in the appearance of cellulite.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The INDIBA COMPACT Devices are substantially equivalent to the primary predicate device (INDIBA Diathermia Radiofrequency Devices, K161458) in intended use/indications and in important physical and performance specifications. The subject and predicate device are substantially equivalent in design, features, and material. The subject device was subjected to the following bench performance tests to support the assertation of substantial equivalence and evidence that no new safety or effectiveness concerns were raised:
- Electrical safety ●
- . Electromagnetic compatibility
In addition to the electrical safety testing performed, software verification was conducted to IEC 62304: 2006 - Medical device software - Software Life-Cycle Processes, and FDA guidance on software validation. The results of this testing conclude the software has met these requirements. Patient contacting materials have been evaluated according to the requirements of ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and confirmed to be biocompatible for their intended use.
SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.
6
Image /page/6/Picture/1 description: The image shows the word "INDIBA" in all capital letters. The font is a bold sans-serif font. There is a registered trademark symbol to the right of the letter A.
SECTION 05 - 510(k) SUMMARY
SUMMARY OF SUBSTANTIAL EQUIVALENCE DISCUSSION:
The subject and predicate device are substantially equivalent in design, features, and material. The technological characteristics of INDIBA COMPACT Devices raise no new issues related to safety and effectiveness. Based on the information provided in this submission, INDIBA COMPACT Devices are substantially equivalent to the predicate device (K161458).
CONCLUSIONS:
The design characteristics, material and intended use of the INDIBA COMPACT Devices are substantially equivalent to the predicate device INDIBA Diathermia Radiofrequency Devices (K161458). The safety and effectiveness of INDIBA COMPACT Devices are adequately supported by the substantial equivalence information, materials information and performance data provided within this Premarket Notification submission.