(514 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on the physical components and energy delivery mechanisms.
Yes
The device is indicated for "temporary reduction in circumference of the abdomen," which is a therapeutic outcome.
No
The device is indicated for "temporary reduction in circumference of the abdomen," which is a treatment rather than a diagnostic purpose.
No
The device description explicitly states it consists of a console, applicators, power supply, vacuum pump, and other hardware components, delivering energy and vacuum to tissue. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary reduction in circumference of the abdomen." This is a therapeutic or aesthetic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a system that delivers energy (IR light and Radio Frequency) and vacuum to the treated tissue. This is consistent with a physical treatment device, not a device that analyzes biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is clearly intended for external application to the body for a physical effect, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Transcend is indicated for temporary reduction in circumference of the abdomen.
Product codes
NUV, GEI
Device Description
The Syneron Transcend is an optical energy in the Infra Red range and a radio frequency of 1 MHz powered system. The device consists of a console and two applicators that deliver electromagnetic energy (IR light and Radio Frequency) and vacuum to treated tissue for the temporary reduction in circumference of the abdomen.
The Transcend console includes a control panel, power supply modules, vacuum pump, main Digital Signal Processor, umbilical cable and an adaptor- for connecting the two available applicators, two applicators and two LCD touch-screens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen
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
The Transcend system performance was evaluated by lab tests and a supportive clinical study. Lab Testing included electromagnetic compatibility, electrical safety, Biocompatibility, and software verification and validation. All performance testing demonstrates that the Transcend System performs according to specifications and functions as intended. The Transcend fulfills the requirements for safety and efficacy.
The Transcend was evaluated in two prospective, multicenter studies for the intended use of abdomen circumference reduction, including over 100 subjects. Efficacy was evaluated based on the change in abdomen circumference from baseline to post treatment as evaluated at 1 week, 1 month, and 3 months following the last treatment session. Measurements were performed for both treated and control subjects. No serious adverse events related to the treatment were reported. The clinical study data for the Transcend subjects demonstrated significant reduction in waist circumference. The clinical data support the substantial equivalence of the Transcend system for the indication of temporary reduction in circumference of the abdomen. Additional data from clinical experience outside the United States further supports the performance of the Transcend for the intended use.
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
K 120510
JUL 1 9 2013
510(k) SUMMARY Syneron Medical Ltd's Transcend System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Syneron Medical Ltd. Industrial zone Yokneam Illit 20692 Israel Tel: +972 (0) 732-442-200 Fax: +972 (0) 732-442-202
Contact Person: Sam Wade, Global VP Regulatory Affairs
Contact details:
Tel: 508-358-7400 Ext. 330 Fax: 508-358-5602 E-mail: sam.wade(@candelalaser.com
Date Prepared: July 12, 2013
Name of Device Transcend System
Common or Usual Name
Laser surgical instrument for use in general and plastic surgery and in dermatology
Classification Name
NUV - Laser surgical instrument for use in general and plastic surgery and in dermatology GEI- Electrosurgical, Cutting & Coagulation & Accessories
Predicate Devices
Syneron VelaShape system (K071872) Alma Lasers Accent UniForm Massager Handpiece (K082622)
Intended Use / Indications for Use
The Transcend is indicated for temporary reduction in circumference of the abdomen.
Technological Characteristics
The Syneron Transcend is an optical energy in the Infra Red range and a radio frequency of 1 MHz powered system. The device consists of a console and two applicators that deliver electromagnetic energy (IR light and Radio Frequency) and vacuum to treated
1
tissue for the temporary reduction in circumference of the abdomen.
The Transcend console includes a control panel, power supply modules, vacuum pump, main Digital Signal Processor, umbilical cable and an adaptor- for connecting the two available applicators, two applicators and two LCD touch-screens.
Performance Data
The Transcend system performance was evaluated by lab tests and a supportive clinical Testing included electromagnetic compatibility, electrical safety, study. Lab Biocompatibility, and software verification and validation. All performance testing demonstrates that the Transcend System performs according to specifications and functions as intended. The Transcend fulfills the requirements for safety and efficacy.
The Transcend was evaluated in two prospective, multicenter studies for the intended use of abdomen circumference reduction, including over 100 subjects. Efficacy was evaluated based on the change in abdomen circumference from baseline to post treatment as evaluated at 1 week, 1 month, and 3 months following the last treatment session. Measurements were performed for both treated and control subjects. No serious adverse events related to the treatment were reported. The clinical study data for the Transcend subjects demonstrated significant reduction in waist circumference. The clinical data support the substantial equivalence of the Transcend system for the indication of temporary reduction in circumference of the abdomen. Additional data from clinical experience outside the United States further supports the performance of the Transcend for the intended use.
Substantial Equivalence
The Transcend is very similar to the VelaShape system and the Accent UniForm The Transcend has similar indications, technological Massager Handpiece. characteristics, and principles of operation as its predicate devices. Performance data demonstrate that the differences between the Transcend and the predicates do not adversely impact its performance. The efficacy of the Transcend was evaluated by a clinical trial to support the new indication for use.
Thus, the Transcend is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings. The emblem is rendered in a simple, bold design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-002
July 19, 2013
Syneron Medical, Ltd. % Mr. Sam Wade Industrial Zone, Tavor Building P.O. Box 550 Yokneam Illit, Israel 20692
Re: K120510
Trade/Device Name: Transcend System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 17, 2013 Received: May 17, 2013
Dear Mr. Wade:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Sam Wade
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 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/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
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Indications for Use
510(k) Number (if known): K120510
Device Name: TRANSCEND
Indications For Use: The Transcend is indicated for temporary reduction in circumference of the abdomen
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.07.12 14:07:54 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number_x120510
Page 1 of 1_ .