(56 days)
No
The summary describes a radiofrequency energy generator for tissue coagulation and does not mention any AI or ML components or functionalities. The software change mentioned was minor and did not require a new submission, suggesting it was not a significant technological shift like incorporating AI/ML.
Yes.
The device is used to coagulate soft tissue and bleeding/non-bleeding sites in the gastrointestinal tract to treat various conditions, which directly relates to treating disease and restoring health.
No
Explanation: The device is described as an "Energy Generator" used for the "coagulation of soft tissue" and "bleeding and nonbleeding sites" in the gastrointestinal tract using radiofrequency (RF) energy. Its purpose is treatment through ablation, not diagnosis.
No
The device description explicitly states it is an "Energy Generator" that delivers radiofrequency energy and is used with physical catheters and a footswitch, indicating it is a hardware device with associated software.
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 soft tissue" and "coagulation of bleeding and nonbleeding sites in the gastrointestinal tract". This describes a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device delivers "radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract". This is a direct intervention on the patient.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. The device is used for treatment, not diagnosis based on sample analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.
The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of bleeding and nonbleeding 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.
Product codes
GEI
Device Description
The subject device, the Barrx™ FLEX RFA Energy Generator is intended to be used with the listed catheters to deliver radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheters include:
- . Barrx™ 360 RFA Balloon Catheter and Barrx™ Soft Sizing Balloon (K093855)
- Barrx™ 90 RFA Focal Catheter (K093008)
- Barrx™ 60 RFA Focal Catheter (K112454)
- Barrx™ ULTRA Long RFA Focal Catheter (K120431)
- Barrx™ Channel RFA Endoscopic Catheter (K130623) ●
- Barrx™ RFA Self Sizing Balloon Catheter (K142364) ●
- o Barrx™ Anorectal RFA Wand (150251)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K141357) is the addition of clinical information to the labeling resulting from one published peer-reviewed clinical study:
- Wolf WA, Pasricha S, Cotton C, et al. Incidence of Esophageal Adenocarcinoma and Causes of Mortality After Radiofrequency Ablation of Barrett's Esophagus. Gastroenterology 2015; Aug 28. [Epub ahead of print]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Barrx FLEX RFA Energy Generator, 510(k) K141357
Reference Device(s)
K093855, K093008, K112454, K120431, K130623, K142364, 150251
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.
0
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2016
Covidien LLC Gloria Dy Regulatory Affairs Specialist 540 Oakmead Parkway Sunnvvale, CA 94085
Re: K160360 Trade/Device Name: Barrx FLEX RFA Energy Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 5, 2016 Received: February 9, 2016
Dear Gloria Dy,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Herbert P. Lerner -S
for 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
2
Indications for Use Statement
510(k) Number (if known):
Device Name:
- X Barrx FLEX RFA Energy Generator
Indications for Use:
The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.
The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of bleeding and nonbleeding 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.
Prescription Use _ X __
AND/OR
Over-The-Counter Use
(Part 21 C.F.R. 801 Subpart D)
(21 C.F.R. 807 Subpart C)
3
510(k) Summary
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED
Covidien IIc 540 Oakmead Parkway Sunnyvale, CA 94085 Phone: Phone: (408) 328-7368 Facsimile: (408) 328-7368 Contact: Gloria Dy
Date Prepared: January 29, 2016
NAME OF SUBJECT DEVICE
Barrx FLEX RFA Energy Generator
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, Ilc
540 Oakmead Parkway
Sunnyvale, CA 94085
4
COMMON OR USUAL NAME
Electrosurgical cutting and coagulation device and accessories
REGULATION DESCRIPTION
Classification: Class II, 21 CFR 878.4400
Product Code: GEI
PREDICATE DEVICES
Barrx FLEX RFA Energy Generator, 510(k) K141357
DEVICE DESCRIPTION
The subject device, the Barrx™ FLEX RFA Energy Generator is intended to be used with the listed catheters to deliver radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheters include:
- . Barrx™ 360 RFA Balloon Catheter and Barrx™ Soft Sizing Balloon (K093855)
- Barrx™ 90 RFA Focal Catheter (K093008)
- Barrx™ 60 RFA Focal Catheter (K112454)
- Barrx™ ULTRA Long RFA Focal Catheter (K120431)
- Barrx™ Channel RFA Endoscopic Catheter (K130623) ●
- Barrx™ RFA Self Sizing Balloon Catheter (K142364) ●
- o Barrx™ Anorectal RFA Wand (150251)
INDICATION FOR USE
The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.
The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of bleeding and nonbleeding 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.
5
TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICE
As the subject of this submission is a labeling change only, the Barrx FLEX RFA Energy Generator has identical technological characteristics as compared to the predicate Barrx FLEX RFA Energy Generator (K141357). There have been no design or material changes to the generator since the predicate was cleared on. There has been a minor software change since the K141357 however, it did not require a submission and was documented via Letter to File to K141357. The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K141357) is the addition of clinical information to the labeling resulting from one published peer-reviewed clinical study:
- Wolf WA, Pasricha S, Cotton C, et al. Incidence of Esophageal Adenocarcinoma and Causes of Mortality After Radiofrequency Ablation of Barrett's Esophagus. Gastroenterology 2015; Aug 28. [Epub ahead of print]
PRINCIPLES OF OPERATION
As the subject of this submission is a labeling change only, the principleof operation of the Barrx FLEX RFA Energy Generator is unchanged and remains identical to the predicate device, K141357, cleared on August 21, 2014.
The Barrx FLEX RFA Energy Generator is an electrosurgical device that utilizes bipolar RF energy to coagulate biological tissue. The Generator is provided with a footswitch that can initiate inflation or deflation of the balloon and initiate or cease delivery of RF energy. The Barrx FLEX RFA Energy Generator is designed to function with a family of single use, disposable Ablation Catheters and Sizing Balloons to deliver the intended therapy. The family of catheters includes:
- Barrx™ 360 RFA Balloon Catheter and Barrx™ Soft Sizing Balloon (K093855)
- Barrx™ 90 RFA Focal Catheter (K093008)
- Barrx™ 60 RFA Focal Catheter (K112454)
- Barrx™ ULTRA Long RFA Focal Catheter (K120431)
- . Barrx™ Channel RFA Endoscopic Catheter (K130623)
- Barrx™ RFA Self Sizing Balloon Catheter (K142364)
- Barrx™ Anorectal RFA Wand (150251)
CONCLUSION
As the subject of this submission is a labeling change only, Covidien, Ilc considers the Barrx FLEX RFA Energy Generator to be substantially equivalent to legally marketed predicate: Barrx FLEX RFA Energy Generator (K141357).