(140 days)
Not Found
No
The summary describes a radiofrequency ablation catheter and its associated generator, focusing on mechanical and electrical performance testing. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is indicated for use in the "coagulation of bleeding and non-bleeding sites" in the gastrointestinal tract, addressing conditions such as ulcers and lesions, which indicates a direct therapeutic action on the body.
No
The device is described as a "bipolar device that delivers radiofrequency (RF) energy to the treatment tissue" for coagulation of bleeding and non-bleeding sites, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue through a copper electrode," indicating it is a physical hardware device. The performance studies also detail extensive bench testing and physical characteristics of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Barry™ Channel RFA Endoscopic Catheter is a device that delivers radiofrequency (RF) energy directly to tissue within the gastrointestinal tract for coagulation. This is a therapeutic procedure performed in vivo (within the living body), not a diagnostic test performed in vitro (outside the living body).
- Intended Use: The intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, which is a treatment, not a diagnostic process.
Therefore, the Barry™ Channel RFA Endoscopic Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Barry™ Channel RFA Endoscopic Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Product codes (comma separated list FDA assigned to the subject device)
GEI, KNS
Device Description
The subject device, the Barrx™ Channel RFA Endoscopic Catheter is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheter is used exclusively with the HALOFEN Energy Generator (cleared under 510(k) K092487).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract including but not limited to the esophagus
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
Bench testing for the Barry" Channel RFA Endoscopic Catheter consisted of the following tests: (1) catheter length testing (2) shaft revolution testing (3) endoscope articulation testing (4) push force testing (5) retraction force testing (6) electrode deflection force testing (7) torque force and stability testing (8) bend radius testing (9) electrical insulation testing (10) apposition testing (11) simulated use testing (12) esophageal damage test (13) tensile force test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation activity for the Barry " Channel RFA Endoscopic Catheter consisted of bench testing, biocompatibility testing, sterilization, packaging validation, shelf life testing, EMC and electrical safety testing, and user validation. The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.
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.
HALO® Catheter cleared under 510(k) K112454, HALO90 Catheter cleared under 510(k) K093008
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
510(k) Summary
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED
Covidien IIc 15 Hampshire Street Mansfield, MA 02048 Phone: (408) 328-7342 Facsimile: (408) 328-7342 (same as phone#) Contact: Richelle Hover Date Prepared: March 7, 2013
JUL 2 6 2013
NAME OF SUBJECT DEVICE AND NAME
Barrx™ Channel RFA Endoscopic Catheter
ESTABLISHMENT REGISTRATION NUMBER/OWNER OPERATOR NUMBER
Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497
Legal Manufacturer: Covidien, Ilc 15 Hampshire Street Mansfield, MA 02048
Manufacturing Facility: Covidien, Formerly BÂRRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
COMMON OR USUAL NAME
Electrosurgical Coagulation Catheter
REGULATION DESCRIPTION
Classification: Class II, 21 CFR 876.4300 Product Code: GEI, KNS
PREDICATE DEVICES
HALO® Catheter cleared under 510(k) K112454 HALO90 Catheter cleared under 510(k) K093008
DEVICE DESCRIPTION
The subject device, the Barrx™ Channel RFA Endoscopic Catheter is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheter is used exclusively with the HALOFEN Energy Generator (cleared under 510(k) K092487).
1
INDICATION FOR USE
The Barry " Channel RFA Endoscopic Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMAPRED TO PREDICATE DEVICE
The Barry " Channel RFA Endoscopic Catheter, the HALO" catheter, and the HALO" catheter have similar technological characteristics. All catheters are single-use, have similar construction, similar principles of operation, control mechanism, similar materials, same packaging, and the same energy type.
The main difference between the Barrx™ Channel RFA Endoscopic Catheter and the HALO® and HALO® catheters is the channel through which the catheter is delivered. The HALO® and HALO® catheters are delivered to the target tissue by mounting the device to the endoscope, whereas the Barrx™ Channel RFA Endoscopic Catheter is delivered through an endoscope. The Barrx™ Channel RFA Endoscopic Catheter is compatible with the Flex RFA Energy Generator only (K092487). The HALO'ER Energy Generator will be brand marketed as Flex RFA Energy Generator. No software change has been made to the Flex RFA Energy Generator in order to accommodate the Barrx™ Channel RFA Endoscopic Catheter.
PRINCIPLES OF OPERATION
The Barry" Channel RFA Endoscopic Catheter follows the same principles of operation as compared to the predicates HALO® (K112454) and HALO® catheters (K093008). The Barrx™ Channel RFA Endoscopic Catheter is connected to the Flex RFA Energy Generator using an output cable. Once connected, the Generator will recognize the catheter based on a unique identification in the plug and set the appropriate power density and energy density range.
The Barry " Channel RFA Endoscopic Catheter is introduced into the esophagus through the working channel of an endoscope. Once the targeted treatment area is identified, the catheter electrode is positioned against the tissue by deflecting the endoscope. The energy activation is performed by depressing either a front panel switch on the generator or the foot-pedal. After the energy is delivered, the coagulation effect can be verified.
SUMMARY OF TESTING PERFORMED
Verification and validation activity for the Barry " Channel RFA Endoscopic Catheter consisted of bench testing, biocompatibility testing, sterilization, packaging validation, shelf life testing, EMC and electrical safety testing, and user validation. Bench testing for the Barry" Channel RFA Endoscopic Catheter consisted of the following tests: (1) catheter length testing (2) shaft revolution testing (3) endoscope articulation testing (4) push force testing (5) retraction force testing (6) electrode deflection force testing (7) torque force and stability testing (8) bend radius testing (9) electrical insulation testing (10) apposition testing (11) simulated use testing (12) esophageal damage test (13) tensile force test.
2
CONCLUSION
Covidien, Ilc considers the Barry™ Channel RFA Endoscopic Catheter to be substantially equivalent to legally marketed predicates: HALO® Catheter cleared under 510(k) K112454 and HALO® catheters cleared under 510(k) K093008.
The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2013
Covidien, LLC % Richelle Hover Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K130623
Trade/Device Name: Barrx™ Channel RFA Endoscopic Catheter; Models TTS-1100 and TTS-1500 Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS, GEI Dated: June 20, 2013 Received: June 21, 2013
Dear Richelle Hover,
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.
4
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 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 yours,
Image /page/4/Picture/7 description: The image shows the name "Benjamin" in large, bold letters. The letters "R" and "A" are stylized with a decorative pattern. The last name "Fisher" is also present, followed by the letter "S".
Benjamin R. Fisher, Ph.D. · Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K130623
Device Name:
- Barry™ Channel RFA Endoscopic Catheter; Models TTS-1100 and TTS-1500 .
Indications for Use:
The Barry™ Channel RFA Endoscopic Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2013.07.26 14:52:22 -04'00'
Barry™ Channel RFA Endoscopic Catheter - Traditional 510(k) Covidien, Ilc
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130623 510(k) Number _