(49 days)
Not Found
No
The summary describes an ablation catheter system and an accessory cap. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The changes described are related to an accessory and a name change for international labeling.
Yes
The device is used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is an ablation catheter intended for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, which is a therapeutic function, not a diagnostic one.
No
The device description clearly lists hardware components including an energy generator, sizing balloon, and ablation catheter. The submission focuses on changes to a hardware accessory (HALO Cap) and a name change for a hardware component.
Based on the provided information, the HALO360+ Ablation Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- HALO360+ Function: The HALO360+ Ablation Catheter is used directly on tissue within the gastrointestinal tract to coagulate bleeding and non-bleeding sites. It is a therapeutic device that performs a physical action on the body, not a device that analyzes samples in vitro.
The description clearly states its intended use is for "coagulation of bleeding and non-bleeding sites in the gastrointestinal tract," which is an in-vivo procedure.
N/A
Intended Use / Indications for Use
The HALO360+ Ablation Catheter intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360+ Ablation Catheter 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, and Angiodysplasia.
Product codes
GEI
Device Description
The HALO360 System consists of the following components:
- HALO360 Energy Generator model 1100C-115B and 1100C-230B . and accessories (output cable, and an optional footswitch).
- A single use HALO360 Sizing Balloon model 3441B,
- A single use HALO360+ Ablation Catheter model 32041-xx with an optional accessory HALO Cap
The HALO360 System performance and mode of operation did not change. This 510 (k) addresses the addition of the optional accessory HALO Cap.
There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO360+ Ablation catheter model 32041-xx when compared with the predicate device HALO360+ Coagulation Catheter model 32041-xx. The following changes are subject to this 510k submission:
- Based on feedback received from the physician-user, BARRX Medical identified the need for an optional accessory HALO Cap for the use with HALO30 + Coagulation Catheter. This accessory will-facilitate removal of biological debris.after treatment and as result minimize the time;of the ¿ procedure.
- HALO360+ Coagulation Catheter model 32041-xx was marketed in Europe and Canada as HALO360+ Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO360+ Coagulation Catheter to HALO360+ Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K083711
FEB -2 2009
(3
510(k) SUMMARY
BÂRRX Medical's HALO860+ Ablation Catheter
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 Facsimile: (408) 328-7395
Contact Person:
December 11, 2008 Date Prepared:
Name of device and Name/Address of Sponsor: 2.
HALO360+ Ablation Catheter
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
1
5. Predicate Devices
HALO360+ Coagulation Catheter model 32041-xx (K071543) manufactured by BARRX Medical Inc;
HALO® Coagulation Catheter model 90-9100 (K062723) manufactured bv BÂRRX Medical Inc:
6. Intended Use / Indications for Use
The HALO360+ Ablation Catheter intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360+ Ablation Catheter 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, and Angiodysplasia.
Technological Characteristics 7.
The HALO360 System consists of the following components:
- HALO360 Energy Generator model 1100C-115B and 1100C-230B . and accessories (output cable, and an optional footswitch).
- A single use HALO360 Sizing Balloon model 3441B,
- A single use HALO360+ Ablation Catheter model 32041-xx with an optional accessory HALO Cap
The HALO360 System performance and mode of operation did not change. This 510 (k) addresses the addition of the optional accessory HALO Cap.
HALO360+ Coagulation Catheter
There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO360+ Ablation catheter model 32041-xx when compared with the predicate device HALO360+ Coagulation Catheter model 32041-xx. The following changes are subject to this 510k submission:
- Based on feedback received from the physician-user, BARRX Medical identified the need for an optional accessory HALO Cap for the use with HALO30 + Coagulation Catheter. This accessory will-facilitate removal of biological debris.after treatment and as result minimize the time;of the ¿ procedure.
- HALO360+ Coagulation Catheter model 32041-xx was marketed in Europe and Canada as HALO360+ Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO360+ Coagulation Catheter to HALO360+ Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.
2
KO83711
Page 3 of (3)
HALO360 Energy Generator
There are no changes associated to the HALO360 Energy Generator.
છે. Substantial Equivalence
The HALO360+ Ablation Catheter model 32041-XX and the predicate devices HALQ360+ Coagulation Catheter model 32041-xx and HALO90 Coagulation Catheter model 90-9100 are similar in construction except:
Inclusion on an optional HALO Cap accessory .
- . Name changes
- o From HALO360+ Coagulation Catheter to HALO360+ Ablation Catheter
- o From HALO360 Coagulation System to HALO360 System.
All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design that resembles an abstract representation of a human figure.
Public Health Service
FEB = 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BARRX Medical, Inc. % Ms. Viorica Filimon 530 Oakmead Parkway Sunnyvale, California 94085
Re: K083711
Trade/Device Name: HALO360+ Ablation Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 11, 2008 Received: January 12, 2009
Dear Ms. Filimon:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Ms. Viorica Filimon
This letter will allow you to begin marketing your device as described in your Section 510(k) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):_ |