(24 days)
Not Found
No
The document describes a medical device for coagulation using an energy generator and catheter. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The focus is on the physical components and their function.
Yes
The device is intended 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 described as a "Coagulation Catheter" and "Coagulation System" used for the "coagulation of bleeding and non-bleeding sites." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a catheter, energy generator, sizing balloon, output cable, and footswitch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "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 is a "Coagulation Catheter" used with an "Energy Generator." This describes a system for delivering energy to tissue for treatment.
- Lack of Diagnostic Function: 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. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The HALO360+ Coagulation Catheter is a therapeutic medical device used for treating conditions in the gastrointestinal tract, not for diagnosing them.
N/A
Intended Use / Indications for Use
The HALO360+ Coagulation Catheter model is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360+ Coagulation 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 (comma separated list FDA assigned to the subject device)
GEI
Device Description
The HALO360 Coagulation System consists of the HALO460 Energy Generator with a disposable single-use HALO360+ Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch.
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)
All these differences were evaluated on the bench and in the animal model and did not raise questions regarding safety and efficacy. Thus the devices are 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.
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
Page 1 of 2
510(k) SUMMARY
BARRX Medical's HALO360+ Coagulation Catheter
JUN 2 9 2007
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
BARRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Phone: (408) 328-7302 Facsimile: (408) 328-7395
Contact Person: Viorica Filimon
Date Prepared: June 4, 2007
Name of device and Name/Address of Sponsor:
HALO360+ Coagulation Catheter
BARRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Common or Usual Name(s):
Electrosurgical Coagulation Catheter
Classification Name:
Product code: GEI
CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II
Classification panel: General & Plastic Surgery
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K 071543
Page 2 of 2
Predicate Device(s)
K051168 HALO360 Coagulation System-BARRX Medical Inc. K062225 HALO360 Coagulation Catheter-BÂRRX Medical Inc.
Intended Use / Indications for Use
The HALO360+ Coagulation Catheter model is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360+ Coagulation 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, Dieulafov Lesions, and Angiodysplasia.
Technological Characteristics
The HALO360 Coagulation System consists of the HALO460 Energy Generator with a disposable single-use HALO360+ Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation System comprising catheter model 32041-XX performance and mode of operation is substantially equivalent to the already cleared HALO300 Coagulation System comprising catheter models 31041-XX and/or 31041-XXBR.
Substantial Equivalence
The HALO360+ Coagulation Catheter model 32041-XX and the predicate device HALO360 Coagulation Catheter models 31041-XXBR and 31041-XX manufactured by BARRX Medical Inc and Stellartech Research Co. respectively have the same intended use, indications for use, technological characteristics, and principles of operation. The technological differences between the HALO360+ Coagulation Catheter model 32041-XX and its predicates are:
-
- Changes in materials for manufacturability
-
- Changes in manufacturing processes
All these differences were evaluated on the bench and in the animal model and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized human figure with three heads and three sets of arms, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BARRX Medical % Ms. Viorica Filimon 540 Oakmead Parkway Sunnyvale, California 94085
JUN 2 9 2007
Re: K071543
Trade/Device Name: HALO360+ Coagulation Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 5, 2007 Received: June 5, 2007
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 (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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
3
Page 2 - Ms. Viorica Filimon
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
P.O.M.
Mark N. Melkerson
Director Division of General, Restorativ and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K071543
Device Name: HALO360+ Coagulation Catheter
Indications for Use:
The HALO360* Coagulation 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.
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 System Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | 10715B |
| Page | of |
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