(37 days)
Not Found
No
The summary describes a radiofrequency ablation catheter and its function, with no mention of AI or ML capabilities. The performance studies focus on functional and safety testing, not algorithmic performance.
Yes
The device is indicated for the coagulation of bleeding sites in the gastrointestinal tract, including specific conditions like esophageal ulcers and Mallory-Weiss tears, which constitutes a therapeutic action.
No
The device description and intended use clearly state that this device is used for coagulation and delivering radiofrequency energy to ablate tissue, which are therapeutic actions rather than diagnostic ones. While it mentions sizing the esophageal diameter, this is to assist in selecting the appropriate device for ablation, not for diagnosing a condition.
No
The device description clearly states it is a sterile, single-use device that delivers radiofrequency energy and is used with an energy generator, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation of bleeding sites in the gastrointestinal tract". This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device "delivers radiofrequency (RF) energy to the treatment tissue". This is a mechanism for treating tissue within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to diagnose a condition. IVDs are used for diagnostic purposes, not therapeutic treatment.
The device is a therapeutic medical device used for ablation (coagulation) of tissue within the gastrointestinal tract.
N/A
Intended Use / Indications for Use
The Barry™ RFA Self Sizing Balloon Catheter is indicated for use in the coagulation of bleeding sites in the gastrontestinal tract including, but not limited to, the esophagus. Indications include Esophageal Ucers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Product codes
GEI
Device Description
The Barrx™ RFA Self Sizing Balloon Catheter is a sterile, single-use device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract. The catheter is used exclusively with the Barrx™ Flex RFA Energy Generator. The Barrx™ RFA Self Sizing Balloon Catheter design incorporates the functionality of the Barrx™ 360 RFA Balloon Catheter and the Barrx™ 360 Soft Sizing Balloon into a single device. The Barrx™ 360 Soft Sizing Balloon is used to size the esophageal diameter and assist the physician in determining the size of Barrx™ 360 RFA Balloon Catheter for ablation. The Barrx™ RFA Self Sizing Balloon Catheter design enables the device to fit the esophageal diameter and ablate tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrontestinal tract, esophagus
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)
Performance testing for the Barrx™ RFA Self Sizing Balloon Catheter consisted of in-vitro functional testing, biocompatibility testing, sterilization assessment, packaging validation, shelf life testing, electrical safety testing, and user validation. Results of performance testing demonstrate performance equivalence for the Barrx™ RFA Self Sizing Balloon Catheter when evaluated against the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2014
Covidien LLC Ms. Rachel Silva Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K142364
Trade/Device Name: Barrx™ RFA Self Sizing Balloon Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 22, 2014 Received: August 25, 2014
Dear Ms. Silva:
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,
Binita S. Ashar -S 2014.10.01 12:40:33 -04'00' 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142364
Device Name
Barrx™ RFA Self Sizing Balloon Catheter
Indications for Use (Describe)
The Barry™ RFA Self Sizing Balloon Catheter is indicated for use in the coagulation of bleeding sites in the gastrontestinal tract including, but not limited to, the esophagus. Indications include Esophageal Ucers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Type of Use (Select one or both, as applicable)
X 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)
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5.0 510(k) Summary
Submitter's Name and Address: Covidien Ilc 15 Hampshire Street Mansfield, MA 02048
Contact Person:
Rachel Silva Senior Regulatory Affairs Specialist Phone: (408) 328-7359 Fax: (408) 328-7359
Date Prepared: August 22, 2014
Name of Device:
Proprietary Name: Barrx™ RFA Self Sizing Balloon Catheter Common/Usual Name: Electrosurgical Coagulation Catheter Classification Panel: General & Plastic Surgery Device Regulation: 21 CFR 878.4400, Class II Product Code: GEI
Establishment Registration Number, Owner/Operator Number:
Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497
Predicate Device(s):
K083711 Barrx™ 360 RFA Balloon Catheter by Covidien, Formerly BÂRRX MEDICAL, Inc. K093855 Barrx™ 360 Soft Sizing Balloon by Covidien, Formerly BÄRRX MEDICAL, Inc.
Device Description:
The Barrx™ RFA Self Sizing Balloon Catheter is a sterile, single-use device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract. The catheter is used exclusively with the Barrx™ Flex RFA Energy Generator. The Barrx™ RFA Self Sizing Balloon Catheter design incorporates the functionality of the Barrx™ 360 RFA Balloon Catheter and the Barrx™ 360 Soft Sizing Balloon into a single device. The Barrx™ 360 Soft Sizing Balloon is used to size the esophageal diameter and assist the physician in determining the size of Barrx™ 360 RFA Balloon Catheter for ablation. The Barrx™ RFA Self Sizing Balloon Catheter design enables the device to fit the esophageal diameter and ablate tissue.
Indications for Use:
The Barrx™ RFA Self Sizing Balloon 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, and Angiodysplasia.
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Technological Characteristics of the Device Compared to Predicate Device
The Barrx™ RFA Self Sizing Balloon Catheter has the same technological characteristics as the predicate device; Barrx™ 360 RFA Balloon Catheter. Both devices are sterile, single use, circumferential catheters that have handles containing Electrically Erasable Programmable Read-Only Memories (EEPROMs) for connecting to the Barrx™ Flex RFA Energy Generator. Both devices have similar construction, materials, energy type, packaging, and principles of operation.
Principles of Operation
The Barrx™ RFA Self Sizing Balloon Catheter is used in connection with the Barrx™ Flex RFA Energy Generator. Once the catheter is connected, the EEPROM is read by the generator, recognizes the catheter type, and determines the operation parameters. The generator inflates air to a set pressure range. Once the pressure range has been reached, the user can initiate radiofrequency (RF) energy. Upon completion of energy delivery, the balloon automatically deflates.
The Barrx™ RFA Self Sizing Balloon Catheter has the same principle of operation as the Barrx™ 360 RFA Balloon Catheter predicate devices have an electrode attached to a balloon, use RF energy, and achieve same ablation depths. Both devices are used with the Barrx™ Flex RFA Energy Generator where the energy and power density settings are similar. Operation parameters for each device are stored in the device EEPROM connector.
Performance Data
Performance testing for the Barrx™ RFA Self Sizing Balloon Catheter consisted of in-vitro functional testing, biocompatibility testing, sterilization assessment, packaging validation, shelf life testing, electrical safety testing, and user validation. Results of performance testing demonstrate performance equivalence for the Barrx™ RFA Self Sizing Balloon Catheter when evaluated against the predicate devices.
Conclusion
Covidien 11c considers the Barrx™ RFA Self Sizing Balloon Catheter to be substantially equivalent to legally marketed predicate devices Barrx™ 360 RFA Balloon Catheter (K083711) and Barrx™ 360 Soft Sizing Balloon (K093855). Test results and compliance to applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.