(167 days)
Not Found
No
The summary describes a radiofrequency ablation catheter and its function, focusing on electrical and mechanical performance. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is used to coagulate soft tissue, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is described as a catheter used for coagulation of soft tissue by generating heat, which is a therapeutic function, not a diagnostic one. It doesn't mention any capability for detecting or identifying diseases or conditions.
No
The device description clearly states it is a catheter and mentions hardware components like electrodes, cables, and a grounding pad, indicating it is a physical medical device, not software-only.
Based on the provided information, the Habib EUS RFA 6700 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of soft tissue". This describes a therapeutic procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a catheter used to deliver radio frequency energy to tissue within the body to cause coagulation. This is an interventional device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Habib EUS RFA 6700 is a therapeutic device used to treat tissue directly.
N/A
Intended Use / Indications for Use
The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.
Product codes
GEI, JOS
Device Description
The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 or 22 Gauge (G) endoscopic needles. The Habib EUS RFA 6700 is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via an accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by mans of coagulation necrosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Performance bench testing, biocompatibility testing, and electrical testing were performed on the proposed Habib EUS RFA 6700, which demonstrates that it met the required specifications for the completed design verification, biocompatibility tests, and electrical tests.
The following performance bench tests were performed:
- Compatibility with endoscope needle
- Trackability and pushability test
- Consistency of heating zone
- Abrasive test
- Fatigue bending resistance
- Pull test
- Shipping and transportation test
- Package evaluation using the burst test
- Visual inspection of medical packaging to determine integrity
- Package seal dye penetration test
- Functional validation for soft tissue indication
The following biocompatibility tests were performed:
- Elution Cytotoxicity and Hemolysis
- Implantation Test
- Intracutaneous toxicity
- Acute systemic injection
The following Electromagnetic and Electrical Testing was performed per the requirements of the following standards:
- IEC 60601-1:2006 + A1:2012, EN 60601-1:2006, ANSI/AAMI ES60601-1:2005 + C1:2009 + A2:2012 + A1:2010, and CAN/CSA-C22.2 No. 60601-1:2014: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-2:2009 + C1:2014 Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- EN IEC 60601-2-18:2009 Endoscopic equipment; In conjunction with BS EN 60601-1:2006 +A11 and IEC 60601-1:2005 Medical electrical equipment - Part 1 - General requirements for basic safety and essential performance
- EN 55011:2007 Limits and methods of measurements of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment
- EN 61000-3-2: 2006 Electromagnetic compatibility (EMC) -- Part 3-2: Limits for harmonic current emissions (equipment input current
§ 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, connected by flowing lines. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2015
EMcision LTD. % Mr. Louis-Paul Marin MMA Certification Incorporated 2025 Michelin Laval, Quebec H7L 5B7 Canada
Re: K150029
Trade/Device Name: Habib EUS RFA 6700 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, JOS Dated: May 21, 2015 Received: May 27, 2015
Dear Mr. Marin:
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
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150029
Device Name Habib EUS RFA 6700
Indications for Use (Describe)
The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
Image /page/3/Picture/0 description: The image shows the logo for EMcision Ltd. The logo consists of the word "EMcision" in a bold, sans-serif font. The "M" in "EMcision" is stylized with an orange swoosh above it. Below the main logo is the text "EMcision Ltd." in a smaller font.
Habib EUS RFA 6700
510(k) Summary
| 1. | Type of submission: | Traditional |
|---|---|---|
| 2. | Preparation Date | June 22, 2015 |
| 3. | Submitter | EMcision Ltd. |
| Address | Department of Surgery | |
| Hammersmith Hospital | ||
| DuCane Road | ||
| London W12 0HS | ||
| United Kingdom | ||
| Phone 1-514-994-9649 | ||
| Contact | François Poulin | |
| 4. | Contact Person: | Louis-Paul Marin, ing., LL.B., LL.M. |
| President, MMA Certification Inc. | ||
| Phone: | 1-450-781-1578 ext 225 | |
| Fax: | 1-450-681-9663 | |
| Email: | lpmarin@groupemma.ca | |
| 5. | Identification of the Device | |
| Proprietary Name/Trade Name | Habib EUS RFA 6700 | |
| Common Name: | Monopolar electrosurgical device | |
| Classification Name: | Electrosurgical cutting and coagulation device | |
| and | ||
| accessories | ||
| Device Classification: | II | |
| Regulation Number: | 878.4400 | |
| Panel: | 79 - General and Plastic Surgery | |
| Product Code: | GEL IOS |
6. Identification of the Predicate
Predicate Device Name: 510(k) Number:
Predicate Device Name: 510(k) Number:
LeVeen™Standard Needle Electrode System
ACE Monopolar Attachment
4
7. Intended use of the subject device
The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.
8. Device Description
The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 or 22 Gauge (G) endoscopic needles. The Habib EUS RFA 6700 is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via an accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by mans of coagulation necrosis.
9. Performance Data
Performance bench testing, biocompatibility testing, and electrical testing were performed on the proposed Habib EUS RFA 6700, which demonstrates that it met the required specifications for the completed design verification, biocompatibility tests, and electrical tests.
The following performance bench tests were performed:
- Compatibility with endoscope needle -
- -Trackability and pushability test
- Consistency of heating zone -
- Abrasive test -
- Fatigue bending resistance -
- -Pull test
- -Shipping and transportation test
- -Package evaluation using the burst test
- -Visual inspection of medical packaging to determine integrity
- -Package seal dye penetration test
- Functional validation for soft tissue indication -
The following biocompatibility tests were performed:
- Elution Cytotoxicity and Hemolysis -
- Implantation Test -
- -Intracutaneous toxicity
- -Acute systemic injection
10. Electromagnetic and Electrical Testing
Testing was performed per the requirements of the following electromagnetic compatibility and electrical standards:
- -IEC 60601-1:2006 + A1:2012, EN 60601-1:2006, ANSI/AAMI ES60601-1:2005 + C1:2009 + A2:2012 + A1:2010, and CAN/CSA-C22.2 No. 60601-1:2014: Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
5
- -IEC 60601-2-2:2009 + C1:2014 Medical electrical equipment = Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- -EN IEC 60601-2-18:2009 Endoscopic equipment; In conjunction with BS EN 60601-1:2006 +A11 and IEC 60601-1:2005 Medical electrical equipment - Part 1 - General requirements for basic safety and essential performance
- -EN 55011:2007 Limits and methods of measurements of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment
- EN 61000-3-2: 2006 Electromagnetic compatibility (EMC) -- Part 3-2: Limits for harmonic current emissions (equipment input current