(279 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on radiofrequency delivery via electrodes.
No
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which is not considered a therapeutic function based on the provided information.
No
The device is described for "ablation and resurfacing of the skin," which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is composed of a console, hand held applicator, and disposable tip, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring ablation and resurfacing of the skin." This describes a procedure performed directly on the patient's skin, not on a sample taken from the patient.
- Device Description: The device delivers "bipolar radiofrequency electrical current to the skin surface." This is a physical intervention on the body, not a test performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Product codes
GEI
Device Description
The Fractora is composed of a console, hand held applicator, and disposable tip, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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)
In this submission bench testing performance data as well as histology data presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Matrix RF applicator (K073572)
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
K10246/
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Invasix Ltd. Fractora
JUN - 2 2011
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter's information
| Name: | Invasix Ltd. |
|---|---|
| Address: | Apolo building, POB 533, Yokneam 20692, Israel |
| Contact: | Dr. Amir Waldman VP Regulatory Affairs |
Device information
| Trade/Proprietary name: | Fractora |
|---|---|
| Classification name: | Device, Electrosurgical Cutting and Coagulation and |
| Accessories (21CFR §878.4400) | |
| Product code: | GEI |
Predicate device
Matrix RF applicator (K073572).
Intended use:
The Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Device Description:
The Fractora is composed of a console, hand held applicator, and disposable tip, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins.
Performance data:
In this submission bench testing performance data as well as histology data presented.
1
Substantial Equivalence:
Intended use equivalence
Fractora's intended use is identical to the intended use of the predicate device: Matrix RF applicator.
Technological equivalence
The Fractora hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin. The predicate device uses similar technological characteristics.
The main output parameter that determines the ablative and coagulative effects is energy per pin, which is identical for Fractora and the predicate device. Minor differences in the number of pins, and array dimensions, may slightly affect the number of pulses required to cover the treatment area.
The Fractora is substantially equivalent to its predicate device. The data in this 510(k) submission demonstrate that the Fractora device has similar output and intended use as other predicate device. Therefore is substantially equivalent to its predicate devices.
Based upon an analysis of the overall performance characteristic for the device. Invasix Ltd. believes that no significant differences exist between the Fractora and the predicate device. Therefore the Fractora should raise no new issues of safety or effectiveness.
March 25, 2011
Date
Dr. Amir Waldman,
VP Regulatory Affairs Invasix Ltd.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Invasix Ltd. % Dr. Amir Waldman Vice President Regulatory Affairs Apolo Building, P.O. Box 533 Yokneam 20692 Israel
JUN - 2 2011
Re: K102461
Trade/Device Name: Fractora Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 26, 2011 Received: May 27, 2011
Dear Dr. Waldman:
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.
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 issuunce 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Dr. Amir Waldman
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vour
for Cett. N
No ca. N P.S.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known)_ K102461
Device Name___ Fractora
Indications For Use:
Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109) OR
Over The Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102461