(148 days)
No
The summary describes a device that uses RF energy and vacuum massage with adjustable parameters, but there is no mention of AI, ML, or any form of intelligent data processing or learning.
Yes
The device is intended for the treatment of medical conditions such as the relief of minor muscle aches and pains, relief of muscle spasm, and temporary improvement of blood circulation, which are therapeutic applications.
No
The device description and intended use indicate that the InMode WMbody device is for treatment (muscle aches, pains, cellulite reduction) and energy delivery (RF and massage), not for diagnosis. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly outlines hardware components such as an AC/DC power supply unit, RF generator, controller, user interface with LCD screen and buttons, a hand piece with a vacuum pump, vacuum chamber, electrodes, and a pressure sensor. It also provides physical specifications like dimensions and weight.
Based on the provided information, the InMode WMbody device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment of medical conditions on the body (relief of muscle aches/spasms, improved blood circulation, cellulite reduction) by applying non-thermal RF and massage. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a device that delivers energy and mechanical massage to the skin and subdermal fat. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The InMode WMbody device operates externally on the body for therapeutic and aesthetic purposes.
N/A
Intended Use / Indications for Use
The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:
- · Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of blood circulation; and
- Temporary reduction in the appearance of cellulite. ●
Product codes
NUV, ISA
Device Description
The InMode WMbody device is designed to deliver mechanical vacuum skin massaging and nonthermal RF energy to the skin and subdermal fat. RF energy does not cause thermal damage to the treated skin and adipose tissue.
The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The ergonomic hand piece allows efficient treatment of large tissue surfaces.
The InMode WMbody device consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a vacuum pump, vacuum chamber with two electrodes and a pressure sensor.
Following are the InMode WMbody device specifications: RF Output Power: 10-50 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 36cm W x 36cm D x 100cm H (14.2" W x 14.2" D x 40'' H) Weight: 30 Kg (66 lbs) Main Line Frequency (nominal): 50-60 Hz Inout Voltage (nominal): 100-240 VAC
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and subdermal fat
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 (Bench) Performance Data:
A bench test was performed to measure the accuracy of the RF output parameters in the InMode WMbody device and compare them to the RF output measurements in the predicate device (Viora Reaction System). The results of the bench test demonstrate that the InMode WMbody device has the same RF output specifications as the predicate Viora Reaction System and therefore, is substantially equivalent to the predicate device.
Clinical Performance Data:
Not Applicable
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
A. STEIN - REGULATORY AFFAIRS CONSULTING LTD
510(K) SUMMARY
INMODE SR DEVICE
510(k) Number K131362
Applicant Name:
J
. .
InMode MD Ltd. Company Name: Tabor Building, Shaar Yokneam Address: Yokneam 20692 Israel Tel: +972-4-9097470 Fax: +972-4-9097471 E-mail: ahava@asteinrac.com
OCT 08 2013
Contact Person:
Official Correspondent: Ahava Stein Company Name: A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Address: Kfar Saba 44425 Israel Tel: +972-9-7670002 Fax: +972-9-7668534 E-mail: ahava@asteinrac.com
May 6. 2013 Date Prepared:
Trade Name: InMode WMbody Device
Classification Name: CFR Classification section 878.4810; (Product code NUV, ISA)
Classification: Class II Medical Device
Predicate Device:
The InMode WMbody device is substantially equivalent to the following predicate devices.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Viora Ltd. | Reaction System | K090221 |
1
A. STEIN - REGULATORY AFFAIRS CONSULTING LTD
Device Description:
i
The InMode WMbody device is designed to deliver mechanical vacuum skin massaging and nonthermal RF energy to the skin and subdermal fat. RF energy does not cause thermal damage to the treated skin and adipose tissue.
The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The ergonomic hand piece allows efficient treatment of large tissue surfaces.
The InMode WMbody device consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a vacuum pump, vacuum chamber with two electrodes and a pressure sensor.
Following are the InMode WMbody device specifications: RF Output Power: 10-50 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 36cm W x 36cm D x 100cm H (14.2" W x 14.2" D x 40'' H) Weight: 30 Kg (66 lbs) Main Line Frequency (nominal): 50-60 Hz Inout Voltage (nominal): 100-240 VAC
Intended Use/Indication for Use:
The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:
- Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement . of blood circulation; and
- Temporary reduction in the appearance of cellulite. .
Performance Standards:
The InMode WMbody Device has been tested and complies with the following voluntary recognized standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988: Amendment 1, 1991-11, Amendment 2, 1995
- IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility --Requirements and Tests
- IEC 60601-2-2 (2006): Medical Electrical Equipment Part 2: Particular requirements for . the safety of high frequency surgical equipment.
2
A. STEIN - REGULATORY AFFAIRS CONSULTING LTD
Non-Clinical (Bench) Performance Data:
A bench test was performed to measure the accuracy of the RF output parameters in the InMode WMbody device and compare them to the RF output measurements in the predicate device (Viora Reaction System). The results of the bench test demonstrate that the InMode WMbody device has the same RF output specifications as the predicate Viora Reaction System and therefore, is substantially equivalent to the predicate device.
Clinical Performance Data:
Not Applicable
i
Substantial Equivalence:
The indications for use and technological characteristics of the InMode WMbody device are substantially equivalent to the indications for use and technological characteristics of the Viora Reaction device.
The design and components in the InMode WMbody device, including the console (with power supply, RF generator, controller and display panel) and the hand piece applicator (with cable, connector to console and vacuum pump) are similar to the design and components found in the predicate Viora Reaction device. The performance specifications (including frequency, nonthermal RF electrical power, pulse duration and vacuum power) of the InMode WMbody device are substantially equivalent to those in the Viora Reaction device. The safety features and compliance with safety standards in the InMode WMbody device are similar to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are also similar. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new InMode WMbody device underwent performance testing, including software validation testing (provided in Section 16) and electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 (provided in Section 17). These performance tests demonstrated that the minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the InMode WMbody device is substantially equivalent to the predicate Viora Reaction device, cleared under 510(k) K090221, and therefore, may be legally marketed in the USA.
Conclusions:
Based on the performance testing and comparison to predicate devices, the InMode WMbody device is substantially equivalent to the Viora Reaction predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2013
Inmode Md Ltd. % Ms. Ahava Stein Regulatory Manager 20 Hata'as Street. Suite 102 Kfar Saba, 44425 Israel
Rc: K131362
Trade/Device Name: Inmode WMbody device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: NUV, ISA Dated: August 8, 2013 Received: August 22, 2013
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 vou; 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical
4
Page 2 - Ms. Ahava Stein
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K | 3 | 362
Device Name: InMode WMbody Device
Intended Use Statement:
The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:
- · Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of blood circulation; and
- Temporary reduction in the appearance of cellulite. ●
Prescription Use V (Per 21 C.F.R. 801 Subpart D) C)
OR
Over-The-Counter Use (Optional Format Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IP NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Digitally signed by | Long H. Chen -A |
|---|---|
| OU: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Long H. Chen -A | |
| 0.9.2342.19200300.100.1.1=1100369056 | |
| Date: | 2013.10.04 10:17:00 -04'00' |
for MXM
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131362