(133 days)
No
The summary describes a radiofrequency ablation catheter and energy generator. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical device and its energy delivery function.
Yes
The device is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract to treat various conditions like ulcers, tears, and lesions, which are therapeutic interventions.
No
The device description and intended use indicate that the device is used for coagulation and treatment of various gastrointestinal conditions, rather than for diagnosing them.
No
The device description explicitly states it is a "single-use bipolar device" and a "catheter," which are hardware components. It also mentions being used with an "Energy Generator," another hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device description confirms it's a single-use bipolar device that delivers radiofrequency energy to the treatment tissue. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Activities: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action directly on the patient.
N/A
Intended Use / Indications for Use
The HALO60 Ablation Catheter (used with the HALOFER Energy Generator, model 1190A-115A) 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
GEI, KNS
Device Description
The HALO® (subject device) is a single-use bipolar device that delivers radiofrequency energy to the treatment tissue within the gastrointestinal tract. It is used solely with the HALOFES Energy Generator (model 1190A-115A), which provides the radiofrequency energy.
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
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
Not Found
Key Metrics
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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510(K) SUMMARY OF SAFETY & EFFECTIVENESS -BÂRRX's HALO60 Ablation Catheter
JAN - 5 2012
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED
BÂRRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085 Phone: (408) 328-7357 Facsimile: (408) 328-7395 Contact: Dawn Chang, Regulatory Affairs Manager Date Prepared: August 24, 2011
NAME OF SUBJECT DEVICE AND NAME/ADDRESS OF SPONSOR
HALO60 Ablation Catheter (model 90-9300) BÄRRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
ESTABLISHMENT REGISTRATION NUMBER
3004904811
COMMON OR USUAL NAME
Electrosurgical Coagulation Catheter
REGULATION DESCRIPTION
Electrosurgical Cutting and Coagulation Devices and Accessories (21 CFR 878.4400, Product Code GEI)
PREDICATE DEVICE
HALO90 Ablation Catheter (model 90-9100, cleared by the FDA under K093008, K083737, and K062723).
OVERVIEW
The HALO® Ablation Catheter (subject device, hereafter referred to as "HALO®") is a single-use bipolar device that delivers radiofrequency energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The HALO" is a modification of the HALO® Ablation Catheter (predicate device, cleared by the FDA under K093008, K083737, and K062723, hereafter referred to as "HALO""). The
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K112454
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primary modification is a dimensional reduction of the copper electrode surface area, from 2.6cm- (1.3cm x 2.0cm, HALO90) to 1.5cm- (1.0cm x 1.5cm, HALO80). Secondary modifications include dimensional reduction of the copper electrode supporting components.
The electrode surface area of the subject device is reduced to approximately 60% of the predicate device, hence the product name HALO60. This new product provides an option for physicians to treat smaller diseased area. The modification neither changes the intended use nor alters the fundamental scientific technology of the original device; therefore this submission is a Special 510(k).
DEVICE DESCRIPTION
The HALO® (subject device) is a single-use bipolar device that delivers radiofrequency energy to the treatment tissue within the gastrointestinal tract. It is used solely with the HALOFES Energy Generator (model 1190A-115A), which provides the radiofrequency energy.
PRINCIPLES OF OPERATION
Same as the HALO90, the HALO® is connected to the HALOFER Energy Generator using an output cable. Once connected, the Generator will recognize the catheter based on a unique ID and set the appropriate power density and energy density range.
The HALO® is introduced into the esophagus under endoscopic visualization. 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 endoscopically.
INDICATION FOR USE STATEMENT
The HALO60 Ablation Catheter (used with the HALOFER Energy Generator, model 1190A-115A) 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).
510(k) HALO" Ablation Catheter BÂRRX Medical, Inc. -
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K112454
pg. 30f.3
SUBSTANTIAL EQUIVALENCE DISCUSSION
As mentioned earlier, the HALO® (subject device) is a modification of the HALO90 (predicate device), cleared by the FDA under K093008, K083737, and K062723. The primary modification is a dimensional reduction of the copper electrode surface area, from 2.6cm² (1.3cm x 2.0cm, HALO90) to 1.5cm² (1.0cm x 1.5cm, HALO90) and the secondary modifications include dimensional reduction of the copper electrode supporting components. There is no change in the materials, amount of energy being delivered and the depth of the tissue being treated.
Both the subject and the predicate devices have the same intended use and fundamental scientific technology. Both devices are compatible with the HALO「EEX Energy Generator. No changes have been made to the HALOFER Energy Generator software in order to accommodate the HALO60.
SUMMARY OF DESIGN CONTROL ACTIVITIES
Failure Modes, Effects, and Criticality Analysis (FMECA) was used to analyze the risks associated with the design modification. Design verification activities demonstrate that the design outputs of the modified device meet the design input requirements.
CONCLUSION
In summary, the company's HALO® Ablation Catheter has the same intended use as all of the previously cleared HALO90 Ablation Catheter (K093008, K083737, K062723). In addition, the HALO® Ablation Catheter has identical indications, technological characteristics, and principles of operation as its predicate devices.
The minor differences between the HALO® Ablation Catheter model 90-9300 and its predicate device HALO90 Ablation Catheter model 90-9100 do not raise new questions of safety or effectiveness. Thus, the HALO® Ablation Catheter model 90-9300 is substantially equivalent.
510(k) HALO60 Ablation Catheter BÂRRX Medical, Inc.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Dawn Chang Regulatory Affairs Manager BÂRRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085
JAN - 5 2012
Re: K112454
Trade/Device Name: HALO60 Ablation Catheter, Model 90-9300 Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Codes: GEI, KNS Dated: December 8, 2011 Received: December 9, 2011
Dear Ms. Chang:
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
4
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,
C. Herbert Lemon w
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 Statement
510(k) Number (if known): K112454
Device Name:
- HALO® Ablation Catheter model 90-9300 .
Indications for Use:
The HALO® Ablation Catheter (used with the HALO' เช่น Energy Generator, model 11904-115A) is The HALU" Ablation Catherer (used with the mass on the gastrointesting sites in the gastrointesting the indicated for use in the coagulation of bleating and not and new and one of the mallory-Weiss tears,
including but not limited to the esophagus. Indications include Escophag including but not illinited to the Esophagus, Thanks in Submatoy Lesions, Angiodysplasia,
Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angi Arcchovenous Manoas Manova (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) – please go to page 2
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Simon
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112454
510(k) HALO60 Ablation Catheter BÂRRX Medical, Inc.