(58 days)
Not Found
No
The document explicitly states "There are no changes associated to the HALOFLEX Energy Generator software, hardware and accessories" and does not mention AI, ML, or related terms in the device description or performance studies.
Yes
The device is indicated for the "coagulation of bleeding and nonbleeding sites in the gastrointestinal tract," specifically mentioning indications like "Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP)," which are all conditions requiring medical treatment.
No
The device is described as an "Ablation Catheter" used for "coagulation of bleeding and nonbleeding sites" in the gastrointestinal tract, which implies a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly states it is an "Ablation Catheter" and describes physical components like electrodes, electrode cap, and base. It also mentions being used in conjunction with an "Energy Generator." These are all hardware components, not software.
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 nonbleeding sites in the gastrointestinal tract. This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is described as an ablation catheter used in conjunction with an energy generator. This further confirms its role in a therapeutic intervention.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, tissue, or other bodily fluids) to provide diagnostic information about a patient's condition. IVDs are specifically designed for this type of analysis.
Therefore, the HALO90 ULTRA Ablation Catheter is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HALO90 ULTRA Ablation Catheter model 90-9200 (when used with HALOFEN System) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The HALO® ULTRA Ablation Catheter model 90-9200 is a modification . of the predicate device HALO" Ablation Catheter model 90-9100 currently commercialized in USA. Both catheters have the same constructions, design, principle of operation, materials and energy density. The differences between HALO" ULTRA and its predicate consist in the electrode surface increase and the associated components electrode cap and base.
HALO90 ULTRA Ablation Catheter model 90-9200 is used in conjunction with HALOFER Energy Generator There are no changes associated to the HALOFLEX Energy Generator software, hardware and accessories.
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 HALO® ULTRA Ablation Catheter model 90-9200 and the predicate devices HALO® Ablation Catheter model 90-9100 are identical in construction except electrode and associated components (electrode cap and base) length change.
These differences were evaluated by performing the following Bench Tests and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
A- HALO90 ULTRA Ablation Catheter model 90-9200 Design Verification - Apposition
B- Tensile strengths of Base-cap & Litz wires
C- Attachment strength endoscope-elastomeric strap
D- Endoscope compatibility with the HALO® ULTRA Ablation Catheter model 90-9200
E- Insertion-Retraction performance in a tissue model
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.
HALO® Ablation Catheter model 90-9100 (K060169, K062723, K083737, and K093008)
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.
Not Found
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
JUN 1 8 2010
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K 101111
page 1 of 2
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510(k) SUMMARY
BARRX Medical's HALO" ULTRA Ablation Catheter Model 90-9200
Submitter's Name, Address, Telephone Number, Contact 1. Person, and Date Prepared:
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Phone: (408) 328-7302 (408) 328-7395 Facsimile:
Viorica Filimon Contact Person:
Date Prepared: April 20, 2010
- Name of device and Name/Address of Sponsor:
HALO® ULTRA Ablation Catheter Model 90-9200
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Common or Usual Name(s): 3.
Electrosurgical Coagulation System
- Classification Name:
Product code: GEI CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II Classification panel: General & Plastic Surgery
Predicate Devices 5.
HALO® Ablation Catheter model 90-9100 (K060169, K062723, K083737, and K093008) manufactured by BÂRRX Medical Inc.
HALO® ULTRA Ablation Catheter
2
Intended Use / Indications for Use
The HALO90 ULTRA Ablation Catheter model 90-9200 (when used with HALOFEN System) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Technological Characteristics 7.
The HALO® ULTRA Ablation Catheter model 90-9200 is a modification . of the predicate device HALO" Ablation Catheter model 90-9100 currently commercialized in USA. Both catheters have the same constructions, design, principle of operation, materials and energy density. The differences between HALO" ULTRA and its predicate consist in the electrode surface increase and the associated components electrode cap and base.
HALO90 ULTRA Ablation Catheter model 90-9200 is used in conjunction with HALOFER Energy Generator There are no changes associated to the HALOFLEX Energy Generator software, hardware and accessories.
Substantial Equivalence 8.
The HALO® ULTRA Ablation Catheter model 90-9200 and the predicate devices HALO® Ablation Catheter model 90-9100 are identical in construction except electrode and associated components (electrode cap and base) length change.
These differences were evaluated by performing the following Bench Tests and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
A- HALO90 ULTRA Ablation Catheter model 90-9200 Design Verification - Apposition
B- Tensile strengths of Base-cap & Litz wires
C- Attachment strength endoscope-elastomeric strap
D- Endoscope compatibility with the HALO® ULTRA Ablation Catheter model 90-9200
E- Insertion-Retraction performance in a tissue model
HALO" ULTRA Ablation Catheter
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an eagle emblem with three lines extending from its wing.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
JUN 1 8 2010
Mr. Randall Sullivan C.O.O. BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085
· Re: K101111
Trade/Device Name: HALO90 ULTRA Ablation Catheter Model 90-9200 Regulation Number: 21 CFR 8878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 28, 2010 Received: June 1, 2010
Dear Mr. Sullivan:
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. Ilsting 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 of medical device-related
4
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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/CDRH0ffices/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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name: HALO®ULTRAAblation Catheter model 90-9200
Indications for Use:
The HALO90 ULTRA Ablation Catheter model 90-9200 (when used with HALO" Energy Generator) 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
HALO® ULTRA Ablation Catheter
510(k) Number