(211 days)
Not Found
No
The document describes a radiofrequency (RF) energy delivery system with adjustable power and temperature settings, but there is no mention of AI or ML being used for control, analysis, or any other function. The operation is based on manual adjustment and continuous movement.
Yes
The device is indicated for "temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation," which are therapeutic benefits.
No.
The device is indicated for temporary relief of muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation, which are therapeutic rather than diagnostic purposes.
No
The device description clearly outlines hardware components including hand pieces, cables, and a system unit that delivers RF energy. The performance studies also focus on hardware-related metrics like RF output power and temperature elevation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. These are therapeutic applications, not diagnostic ones.
- Device Description: The device delivers RF energy to heat tissue. This is a physical therapy modality, not a method for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function and intended use clearly fall outside of that definition.
N/A
Intended Use / Indications for Use
The InMode PLUS System with the PLUS/PLUS90 Hand pieces is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
Product codes (comma separated list FDA assigned to the subject device)
PBX, ISA
Device Description
The InMode PLUS System delivers RF energy to gradually heat the skin and subcutaneous tissue. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 42℃. The hand pieces are operated while continuously moving them over the treatment area. This ensures uniform and safe heating of the entire trea.
Each InMode PLUS hand piece is comprised of the hand piece handle, a cable 250 cm long, and a connector, which connects to the rear connector of the InMode PLUS System.
Two InMode PLUS hand pieces are available:
- InMode PLUS hand piece (held perpendicular to the treatment area) ●
- InMode PLUS90 hand piece (held parallel to the treatment area)
Following are the InMode PLUS System specifications: Maximal RF Output Power: 50 Watt RF Output Frequency: 1.0[MHz] ± 2% Maximum Temperature (skin surface): 42°C ± 2°C
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
Prescription Use
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 (Bench) Performance Data: The following performance tests were conducted utilizing the InMode PLUS System with the Plus/Plus90 hand piece:
-
- RF output power settings and temperature elevation profile
-
- Ex-vivo tissue study to evaluate the safety and temperature tissue penetration/depth profile
-
- Side by side bench tests to evaluate the device RF performance settings in comparison to the predicate device
The results of the performance tests demonstrated that the InMode Plus System operates in compliance with the system requirements, emitting RF energy of up to 50W, while elevating the tissue temperature up to 42ºC. Moreover, the side by side bench test results showed that the InMode Plus System is as safe and effective as the predicate device for the same intended use.
In all, the results of the performance tests demonstrated substantial equivalence of the InMode Plus System compared to the predicate device, the Viora V10 System with the ST hand piece.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized image of three human profiles facing right, with a design that resembles a bird or flowing fabric above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2016
InMode MD Ltd. Ms. Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 44425 Israel
Re: K153568
Trade/Device Name: InMode Plus System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Additional Product Code: ISA Dated: June 7, 2016 Received: June 10, 2016
Dear Ms. Stein:
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. 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.
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153568
Device Name InMode PLUS System
Indications for Use (Describe)
The InMode PLUS System with the PLUS/PLUS90 Hand pieces is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood 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 INMODE PLUS SYSTEM
510(k) Number K153568
Applicant Name:
| Company Name: | InMode MD Ltd. |
|---|---|
| Address: | Tabor Building, Shaar Yokneam |
| Yokneam 20692 | |
| Israel | |
| Tel: | +972-4-9097470 |
| Fax: | +972-4-9097471 |
| E-mail: | ahava@asteinrac.com |
Contact Person:
| Official Correspondent: Ahava Stein | ||
|---|---|---|
| Company Name: | A. Stein Regulatory Affairs Consulting Company Ltd. |
|---|---|
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 44425 | |
| Israel | |
| Tel: | +972-9-7670002 |
| Fax: | +972-9-7668534 |
| E-mail: | ahava@asteinrac.com |
| Date Prepared: | July 10, 2016 |
| Trade Name: | InMode PLUS System |
Classification Name: CFR Classification sections; 878.4400 and 890.5660 (Product codes; PBX and ISA)
Classification: Class II Medical Device
Predicate Device:
The InMode Plus System is substantially equivalent to the following predicate device:
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Viora Ltd. | Viora V-ST Handpiece (cleared | |
| together with the Viora V-10 | ||
| System) | K150035 |
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Device Description:
The InMode PLUS System delivers RF energy to gradually heat the skin and subcutaneous tissue. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 42℃. The hand pieces are operated while continuously moving them over the treatment area. This ensures uniform and safe heating of the entire trea.
Each InMode PLUS hand piece is comprised of the hand piece handle, a cable 250 cm long, and a connector, which connects to the rear connector of the InMode PLUS System.
Two InMode PLUS hand pieces are available:
- InMode PLUS hand piece (held perpendicular to the treatment area) ●
- InMode PLUS90 hand piece (held parallel to the treatment area)
Following are the InMode PLUS System specifications: Maximal RF Output Power: 50 Watt RF Output Frequency: 1.0[MHz] ± 2% Maximum Temperature (skin surface): 42°C ± 2°C
Intended Use/Indication for Use:
The InMode PLUS System with the PLUS/PLUS90 Hand pieces is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation
Performance Standards:
The InMode Plus device complies with the following voluntary recognized standards:
- . IEC 60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; + CORR. 1 (2006) + CORR. 2 (2007) + Amd.1(2012)
- IEC 60601-1-2 (2007): Medical Electrical Equipment-Part 1: General . requirements for safety and Part 1-2 Collateral standard: Electromagnetic Compatibility-Requirements and tests; and IEC 60601-2-2 (2009): Medical Electrical Equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (section 202.6.1 (Emission) and section 202.6.2 (Immunity).
- IEC 60601-2-2 (2009): Medical Electrical Equipment Part 2: Particular . requirements for the safety of high frequency surgical equipment; for use in conjunction with IEC 60601-1:2005
Non-Clinical (Bench) Performance Data:
The following performance tests were conducted utilizing the InMode PLUS System with the Plus/Plus90 hand piece:
5
-
- RF output power settings and temperature elevation profile
-
- Ex-vivo tissue study to evaluate the safety and temperature tissue penetration/depth profile
-
- Side by side bench tests to evaluate the device RF performance settings in comparison to the predicate device
The results of the performance tests demonstrated that the InMode Plus System operates in compliance with the system requirements, emitting RF energy of up to 50W, while elevating the tissue temperature up to 42ºC. Moreover, the side by side bench test results showed that the InMode Plus System is as safe and effective as the predicate device for the same intended use.
In all, the results of the performance tests demonstrated substantial equivalence of the InMode Plus System compared to the predicate device, the Viora V10 System with the ST hand piece.
Clinical Performance Data:
Not Applicable
Sterilization and Biocompatibility:
The InMode Plus is a non-sterile, reusable device, intended for multiple patients. The device had successfully passed the cleaning validation test. All of the handpiece materials are biocompatible based on the established biocompatibility of the materials and per ISO 10993-1.
Substantial Equivalence:
The indications for use and technological characteristics of the InMode Plus System are substantially equivalent to the indications for use and technological characteristics of the Viora V10 System with the ST hand piece.
The design and components of the InMode Plus System, including the console and its components (including the power supply, RF generator, controller and display panel) and the hand piece applicators (including the cable and connector to console) are similar to the design and components found in the predicate Viora V10 System. The performance specifications (including RF Frequency and output power) of the InMode Plus System are substantially equivalent to those in the predicate device. The safety features and compliance with safety standards in the InMode Plus System are similar to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are identical. The minor differences in the technological characteristics (electrode configuration and pulse vs. continuous mode) do not raise new safety or effectiveness concerns and are demonstrated to be substantially equivalent through relevant performance tests. Furthermore, the InMode Plus System underwent additional performance tests, including software verification and validation testing and electrical and mechanical safety testing according to IEC 60601-1, IEC60601-2-2 and
6
electromagnetic compatibility testing according to IEC 60601-1-2. The performance tests demonstrated that the minor differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Conclusions:
Based on the substantial equivalence demonstration and the device performance tests, it can be concluded that the InMode Plus System is substantially equivalent to the predicate Viora V10 System, cleared under 510(k) K150035.