(379 days)
K08346,K083461
No
The summary describes a device that delivers RF energy for electrocoagulation and hemostasis, with no mention of AI or ML in its description, intended use, or performance studies.
Yes
The device is intended for "electrocoagulation and hemostasis" in dermatologic and general surgical procedures, which are therapeutic interventions.
No
The device is used for electrocoagulation and hemostasis, which are treatment procedures, not diagnostic ones. It delivers RF energy to heat tissue for coagulation, rather than to gather information for diagnosis.
No
The device description explicitly states it is a "treatment handpiece" with "micro electrodes" and a "disposable treatment element (tip)" that delivers "bipolar RF energy." This indicates a physical hardware component that interacts directly with the patient's tissue, 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 for "Dermatologic and General Surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The device delivers "bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation." This is a physical intervention on the tissue, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to directly treat tissue through electrocoagulation and hemostasis.
N/A
Intended Use / Indications for Use
The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
OUH, GEI
Device Description
EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation.
The Intensif Applicator consists of:
• Disposable treatment element (tip)
• RF electrodes on a disposable tip
• Operation trigger
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
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)
The safety and efficacy of the Intensif Applicator were established by a series of performance tests. Lab performance tests, design validation and software verification and validation. Verification and testing have shown that the Intensif Applicator device performs according to its specifications.
The following tests were conducted:
• Intensif Applicator 's power control and accuracy
• Intensif Applicator's safety features functionality
• Intensif Applicator needle depth validation.
In order to evaluate efficacy and safety Intensif Applicator, a few Ex Vivo laboratory studies and Ex Vivo animal studies tests were conducted, while the Intensif Applicator was connected to the EndyMed PRO (K083461) treatment console.
The results of these studies clearly indicate that the treatment with Intensif Applicator connected to the EndyMed PRO system produces thermal and biological effects similar to previously FDA cleared fractional skin hemostasis and coagulation devices.
The safety and efficacy of the Intensif Applicator was evaluated in a performance and preclinical testing.
The results of this testing clearly indicate that the Intensif Applicator offers a minimally invasive, effective, safe device for skin hemostasis and coagulation.
No clinical studies were conducted.
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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MAR 1 3 2014
Page 1 of 3
510(K) SUMMARY
Intensif Applicator
510(k) Number K130501
| Applicant's Name: | EndyMed Medical Ltd.
7 Bareket Street,
North Industrial Park,
Caesarea, 30889 Israel
Tel: (972)4-630-9100
Fax: (972)4-630-9101 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda Street
Binyamina, Israel 30500 |
Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
- Trade Name: Intensif Applicator (Ilooda Secret) Common Name: Electrosurgical RF applicator
- Preparation Date: February 7, 2013
Name: Electrosurgical, cutting & coagulation device Classification: & accessories Product Code: OUH, GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery
Device Description:
EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation
The Intensif Applicator consists of:
- . Disposable treatment element (tip)
- . RF electrodes on a disposable tip
2-1 EndyMed Intensif Applicator 510k Notification
1
- Operation trigger .
Intended Use Statement:
The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Substantial equivalence to the following predicate devices is Predicate Devices: claimed:
| Device Name | 510(k) No | Date of Clearance |
|---|---|---|
| Primaeva Medical System | K080145 | Feb 28, 2008 |
| EndyMed FSR | K101510 | Feb 17, 2011 |
| EndyMed Imagine TC Skin | ||
| Treatment System | K083461 | Jul 24, 2009 |
Performance Standards:
Intensif Applicator complies with the following standards:
- · IEC 60601-1:2005 / EN 60601-1:2006 Medical electrical equipment - part 1 General requirements for basic safety and essential performance, 3td edition
- · IEC/EN 60601-1-2 Electromagnetic compatibility (EMC)
Summary of Technologies
The Intensif Applicator uses microneedles and implies IMHz RF energy to achieve their intended use.
Performance Bench Testing Data
The safety and efficacy of the Intensif Applicator were established by a series of performance tests. Lab performance tests, design validation and software verification and validation. Verification and testing have shown that the Intensif Applicator device performs according to its specifications.
The following tests were conducted:
- . Intensif Applicator 's power control and accuracy
- . Intensif Applicator's safety features functionality
- . Intensif Applicator needle depth validation. 2-2
EndyMed Intensif Applicator 510k Notification
2
Summary of Preclinical Data
of the Intensif In order to evaluate efficacy and safety safety Applicator, a few Ex Vivo laboratory studies and Ex Vivo animal studies tests were conducted, while the Intensif Applicator was connected to the EndyMed PRO (K083461) treatment console.
The results of these studies clearly indicate that the treatment with Intensif Applicator connected to the EndyMed PRO system produces thermal and biological effects similar to previously FDA cleared fractional skin hemostasis and coagulation devices
Summary of Clinical performance data:
The safety and efficacy of the Intensif Applicator was evaluated in a performance and preclinical testing.
The results of this testing clearly indicate that the Intensif Applicator offers a minimally invasive, effective, safe device for skin hemostasis and coagulation.
No clinical studies were conducted.
Substantial Equivalence
Intensif Applicator device has the same intended use and similar indications as its predicate devices. The technology of the predicate devices is also the same.
The envelope of power and frequency of the submitted Intensif Applicator is covered by the envelopes of its predicate devices. Any minor differences in the human interface and accessories design do not raise any new types of safety and effectiveness issues, as verified by performance and ex vivo testing. Therefore the Intensif Applicator nonclinical and ex vivo testing submitted demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device and thus is substantially equivalent to its predicate devices.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2014
EndyMed Ltd. % Mr. Yoram Levy Qsite 31 Haavoda Street Binyamina, Israel 30500
Re: K130501
Trade/Device Name: Intensif Applicator Regulation Number: 21 CFR 878.4800 Regulation Name: Electrosurgical, Cutting, Coagulation, & Accessories Regulatory Class: Class II Product Code: OUH, GEI Dated: January 21, 2014 Received: January 27, 2014
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, 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 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.
Felipe Aguel
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/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 tagline "THE 3DEEP COMPANY" underneath. The logo is simple and modern, and the use of black and white gives it a clean and professional look.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
KI30201
Device Name:
Intensif Applicator
Indications for Use:
The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
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)
Lona e: 2014.03.11 12:24:08 -04 DO for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number: K130501