(111 days)
K150251 Barrx™ Anorectal RFA Wand by Covidien
No
The summary describes a radiofrequency ablation wand and its connection to an energy generator. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device's operation parameters are determined by reading an EEPROM, which is a standard electronic component, not an AI/ML system.
Yes
It is indicated for coagulation of bleeding sites and treatment of anal intraepithelial neoplasia, which are therapeutic interventions.
No
The device is described as a treatment device that delivers radiofrequency energy for coagulation, not for diagnosis. Its intended use explicitly states "coagulation of bleeding sites."
No
The device description clearly states it is a sterile, single-use, bipolar device with physical components like a cap with electrode, EEPROM, shafts, and a handle, indicating it is a hardware device.
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 Barrx™ Anorectal RFA Wand is a therapeutic device that uses radiofrequency energy to coagulate bleeding sites and treat tissue directly within the anal canal and rectum. It is used in vivo (within the body) for treatment, not in vitro (outside the body) for diagnostic testing of samples.
- Intended Use: The intended use clearly describes a therapeutic application (coagulation of bleeding sites, treatment of AIN), not a diagnostic one.
Therefore, the Barrx™ Anorectal RFA Wand falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Barrx™ Anorectal RFA Wand is a sterile, single-use, bipolar device used to deliver radiofrequency (RF) energy to treatment tissue in the anal canal and rectum. The Barrx™ Anorectal RFA Wand consists of a cap with electrode, EEPROM, a proximal shaft and a rigid distal shaft with handle. The device is used exclusively in connection with the Barrx™ Flex RFA Energy Generator (K092487). Once the device is connected, the EEPROM is read by the generator, recognizes the device, and determines the operation parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal canal and rectum
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 Barrx™ Anorectal RFA Wand subject device is technologically identical to the predicate device cleared under K150251 and reference predicate cleared under K112454. Accordingly, no performance testing was 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.
K150251 Barrx™ Anorectal RFA Wand by Covidien
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.
K112454 Barrx™ 60 RFA Focal Catheter by Covidien
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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2017
Covidien LLC Rachel Silva Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield. MA 02048
Re: K162802 Trade/Device Name: Barrx Anorectal RFA Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 9, 2016 Received: December 12, 2016
Dear Rachel 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 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,
Benjamin R. Fisher -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
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Indications for Use
510(k) Number (if known) K162802
Device Name Barrx™ Anorectal RFA Wand
Indications for Use (Describe)
The Barry™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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5 510(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: October 3, 2016
Name of Device:
Proprietary Name: Barrx™ Anorectal RFA Wand 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 Devices:
K150251 Barrx™ Anorectal RFA Wand by Covidien K112454 Barrx™ 60 RFA Focal Catheter by Covidien
Reason for 510(k) Submission
The purpose of this submission is to include a specific indication for use, which is Anal Intraepithelial Neoplasia (AIN), and include clinical information in the labeling resulting from three AIN related clinical studies. The intent of this 510(k) submission aligns with information stated in the FDA Guidance document titled "Guidance for Industry: General/Specific Intended Use" dated November 4, 1998 as AIN is a specific type of tissue which has been treated by the clinical community under the generic indications for use of coagulating bleeding and nonbleeding sites within the gastrointestinal tract. Also, AIN is found within a narrow target population that falls within the broader population for the products intended use.
Device Description:
The Barrx™ Anorectal RFA Wand is a sterile, single-use, bipolar device used to deliver radiofrequency (RF) energy to treatment tissue in the anal canal and rectum. The Barrx™ Anorectal RFA Wand consists of a cap with electrode, EEPROM, a proximal shaft and a rigid distal shaft with handle. The device is used exclusively in connection with the Barrx™ Flex RFA
4
Energy Generator (K092487). Once the device is connected, the EEPROM is read by the generator, recognizes the device, and determines the operation parameters.
Indications for Use:
The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding and nonbleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiomata, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).
The Indication for Use statement for the subject device, Barrx™ Anorectal RFA Wand is not identical to the predicate device, however the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both, the subject and the predicate devices have intended use for the ablation of soft tissue using RF energy.
Technological Characteristics of the Device Compared to Predicate Device
The Barrx™ Anorectal RFA Wand has identical technological characteristics to the predicate device cleared under K150251 as well as the secondary predicate device cleared under K112454. There have been minor changes to the Barrx™ Anorectal RFA Wand that did not require a submission and were documented in a letter to file.
Performance Data
The Barrx™ Anorectal RFA Wand subject device is technologically identical to the predicate device cleared under K150251 and reference predicate cleared under K112454. Accordingly, no performance testing was conducted.
Conclusion
Clinical studies referenced within this submission demonstrate the Barrx™ Anorectal RFA Wand may be used for anal intraepithelial neoplasia and is substantially equivalent to the primary predicate and reference predicate devices.