(80 days)
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical device and its energy delivery mechanism.
Yes.
The device is indicated for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, which describes a medical treatment for various conditions.
No.
The device is an ablation catheter used for coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, which is a treatment function, not 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, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The HALO® ULTRA Ablation Catheter is a device used within the body (in vivo) to deliver radiofrequency energy directly to tissue in the gastrointestinal tract for coagulation. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a therapeutic application (coagulation of bleeding and non-bleeding sites) and lists specific conditions treated by this method. It does not mention any diagnostic testing or analysis of samples.
Therefore, the HALO® ULTRA Ablation Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The HALO® ULTRA Ablation Catheter (used with the HALOEEK 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 (comma separated list FDA assigned to the subject device)
GEI, KNS
Device Description
The subject device, HALO® ULTRA Ablation Catheter (hereafter referred to as "modified ULTRA") is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. It is used exclusively with HALOFES Energy Generator model 1190A-115A (cleared under 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
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 modified ULTRA and the predicate devices, the original ULTRA and HALO®, are identical in the intended use, principle of operations, energy type, materials, packaging and sterilization method. The minor differences in component dimension are evaluated via the following bench testing: (1) Migration; (2) Deflection; (3) Catheter Distal Integrity; (4) Detachment. No new questions of safety and effectiveness were raised. The subject and the predicate devices are substantially equivalent.
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.
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.
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
K1204/31
510(K) SUMMARY OF SAFETY & EFFECTIVENESS BÂRRX's HALO90 ULTRA Ablation Catheter
MAY - 3 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} 328-7357 (same as phone#) Contact: Dawn Chang, Regulatory Affairs Manager Date Prepared: February 10, 2012
NAME OF SUBJECT DEVICE AND NAME/ADDRESS OF SPONSOR
HALO30 ULTRA Ablation Catheter (model 90-9200) BÂRRX 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
Primary predicate device:
-
HALO® ULTRA Ablation Catheter (model 90-9200, cleared under K101111), . hereafter referred to as "original ULTRA".
Secondary predicate device: -
HALO® Ablation Catheter (model 90-9300, cleared under K112545), hereafter . referred to as "HALO60".
DEVICE DESCRIPTION
The subject device, HALO® ULTRA Ablation Catheter (hereafter referred to as "modified ULTRA") is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. It is used exclusively with HALOFES Energy Generator model 1190A-115A (cleared under K092487).
1
TECHNOLOGICAL CHARACTERISTICS
The modified ULTRA is a modification of the original ULTRA. Both catheters have the same construction, principles of operation, materials and energy density. The differences between the modified ULTRA and the original ULTRA include a slight change in the manufacturing process of the endoscope mounting strap, as well as dimensional modification on the pivot mechanism components.
PRINCIPLES OF OPERATION
Same as the original ULTRA and HALO®, the modified ULTRA is connected to the HALOFEX Energy Generator using an output cable. Once connected, the Generator will recognize the catheter based on a unique ID in the plug and set the appropriate power density and energy density range.
The modified ULTRA 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 HALO® ULTRA Ablation Catheter (used with the HALOffer 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).
SUBSTANTIAL EQUIVALENCE DISCUSSION AND CONCLUSION
The modified ULTRA and the predicate devices, the original ULTRA and HALO®, are identical in the intended use, principle of operations, energy type, materials, packaging and sterilization method. The minor differences in component dimension are evaluated via the following bench testing: (1) Migration; (2) Deflection; (3) Catheter Distal Integrity; (4) Detachment. No new questions of safety and effectiveness were raised. The subject and the predicate devices are substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird, with three curved lines forming its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 3 2012
Ms. Dawn Chang Regulatory Affairs Manager BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085
Re: K120431
Trade/Device Name: HALO90 ULTRA Ablation Catheter model 90-9200 Regulation Number: 21 CFR§ 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, KNS Dated: February 10, 2012 Received: February 13, 2012
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 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
3
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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,
Benjamin R. Civiletti
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
4
K 120 431
Indications for Use Statement
510(k) Number (if known): To be determined
Device Name:
- HALO® ULTRA Ablation Catheter model 90-9200 .
Indications for Use:
The HALO® ULTRA Ablation Catheter (used with the HALOEEK 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).
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).
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120431
HALO90 ULTRA Ablation Catheter 510(k) BÂRRX Medical, Inc.