(147 days)
Not Found
No
The device description focuses on hardware components and basic programmable logic control, with no mention of AI/ML terms or functionalities like learning, adaptation, or data-driven decision making beyond simple user input and safety functions.
Yes
The device is intended for the non-invasive treatment of facial wrinkles and rhytides, which constitutes a therapeutic purpose.
No
The device is described as a treatment device for wrinkles and rhytides, not for diagnosing any condition.
No
The device description explicitly lists multiple hardware components including a hand-held device, user interface, PLC, RF power module, power supply, and RF electrodes.
Based on the provided information, the EndyMed Newa device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "non-invasive treatment of mild to moderate facial wrinkles and rhytides." This describes a therapeutic or cosmetic treatment applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a device that emits RF energy to heat the skin for collagen remodeling. This is a physical interaction with the body, not a process of analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device does not perform any tests or provide diagnostic information based on these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The EndyMed Newa does not fit this description.
N/A
Intended Use / Indications for Use
The EndyMed Newa is a prescription home use device intended for non-invasive treatment of mild to moderate facial wrinkles and rhytides
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Newa™ is a noninvasive, non-ablative, prescription home use hand held device consisting of:
- User interface .
- Programmable Logic controller (PLC) ●
- RF power module ●
- Power Supply .
- RF Electrodes ●
The interface allows the selection of heating level by using the Power Level Switch as follows:
- "0" mode = the device is "OFF". .
- . "1" mode = low heating level.
- . "2" mode = high heating level.
The PLC is a specially configured computer that provides the operational and safety function of the system.
The RF power module provides RF energy to the active tip, producing a sinusoidal signal at a 1MHz frequency.
Based on 3DEEP® technology, the Newa™ is comprised of 3 pairs of bipolar RF electrodes. The RF is emitted into the skin creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis, dermis or hypodermis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use, prescription device
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)
Subjects were asked to perform task scenarios, simulating the use of the Newa™ device, for independent treatment under the investigator's observation. Following task performance, subjects were provided with the Newa™. This study enrolled 69 subjects, 62 of these completed the required follow-up at 3 months after the last treatment. Of the subjects who completed the 3 month follow-up 85% were determined to be successful based on 2 of the 3 blinded evaluators agreeing that they observed a decrease of at least 1 in the Fitzpatrick Wrinkle Severity Score at 3 months post the last treatment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Successful treatment based on 85% of subjects showing a decrease of at least 1 in the Fitzpatrick Wrinkle Severity Score.
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.
0
Image /page/0/Picture/0 description: The image shows the logo for EndyMed, a company that specializes in 3DEEP technology. The logo features the company name in a bold, sans-serif font, with the "TM" symbol next to the "d". Below the company name is the tagline "THE 3DEEP COMPANY" in a smaller font. To the left of the company name is a pattern of dots arranged in a grid.
す
510(K) SUMMARY
EndyMed Newa™
510(k) Number K130793
| Applicant's Name: | EndyMed Medical Ltd. |
|---|---|
| 7 Bareket St. | |
| North Industrial Park | |
| Caesarea, 30889 Israel | |
| Tel: (972)4-630-9100 | |
| Fax: (972)4-630-9101 | |
AUG 1 6 2013
Yoram Levy, Qsite Contact Person: 31 Haavoda St. Binyamina, 30500 Israel Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
Newa™M Trade Name:
510(k) Summary Preparation Date: March 19, 2013
Name: Electrosurgical, cutting & coagulation device Classification: & accessories Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery
Intended Use Statement:
The EndyMed Newa is a prescription home use device intended for non-invasive treatment of mild to moderate facial wrinkles and rhytides
Predicate Devices:
Substantial equivalence to the following predicate devices is claimed:
| Device Name | Manufacturer | 510k No | Date of
Clearance |
|----------------------------------|----------------------------------------------------------|---------|----------------------|
| Imagine TC Skin Treatment System | EndyMed Medical
Ltd. (previously
EndyMion Medical) | K083461 | Jul 24, 2009 |
| Palomar LOI System | Palomar Medical
Technologies, Inc. | K090525 | June 1, 2009 |
1
Device Description:
The Newa™ is a noninvasive, non-ablative, prescription home use hand held device consisting of:
- User interface .
- Programmable Logic controller (PLC) ●
- RF power module ●
- Power Supply .
- RF Electrodes ●
The interface allows the selection of heating level by using the Power Level Switch as follows:
- "0" mode = the device is "OFF". .
- . "1" mode = low heating level.
- . "2" mode = high heating level.
The PLC is a specially configured computer that provides the operational and safety function of the system.
The RF power module provides RF energy to the active tip, producing a sinusoidal signal at a 1MHz frequency.
Based on 3DEEP® technology, the Newa™ is comprised of 3 pairs of bipolar RF electrodes. The RF is emitted into the skin creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis, dermis or hypodermis.
Performance Standards
Newa ™ complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following voluntary standards:
- IEC 60601-1:2005 Medical electrical Equipment -- Part 1: General . requirements for safety.
- IEC 60601-1-2:2004 Medical electrical equipment -- Part 1-2: . General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests.
- 1EC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: . General requirements for basic safety and essential performance --Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Summary of Clinical performance data
Subjects were asked to perform task scenarios, simulating the use of the Newa™ device, for independent treatment under the investigator's observation. Following task
2
Image /page/2/Picture/1 description: The image shows the logo for EndyMed, a company specializing in medical aesthetics. The logo features the company name in a bold, sans-serif font, with the "TM" symbol next to the "d". Below the name, in a smaller font, is the tagline "THE 3DEEP COMPANY". To the left of the company name is a grid of dots.
performance, subjects were provided with the Newa™
This study enrolled 69 subjects, 62 of these completed the required follow-up at 3 months after the last treatment. Of the subjects who completed the 3 month follow-up 85% were determined to be successful based on 2 of the 3 blinded evaluators agreeing that they observed a decrease of at least 1 in the Fitzpatrick Wrinkle Severity Score at 3 months post the last treatment
Comparison with Predicate Devices:
The Newa™ and its predicate devices are class II devices; Newa™ and Imagine TC Skin Treatment System have the same clinical indication, are based on the same technology of RF delivery and are classified under the same product code and regulation number. Newa™ and Palomar LOI System have similar intended uses.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
August 16, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
EndyMed Medical Ltd. % Mr. Yoram Levy Qsite 31 Haavoda Street Binyamina, Israel 30500
Re: K130793
Trade/Device Name: Newa™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, cutting & coagulation device & accessories Regulatory Class: Class II Product Code: GEI Dated: July 16, 2013 Received: July 19, 2013
Dear Mr. Levy:
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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Yoram Levy
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 STATEMENT
510(k) Number (if known): K130793
Newa™ Device Name: The EndyMed Newa™ is a prescription home use device intended Indications for Use: for non-invasive treatment of mild to moderate facial wrinkles and
rhytides
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Joshua @ Nipper -S
(Division Sign-off) Division of Surgical Devices 510(k) Number K130793