(85 days)
No
The document describes a radiofrequency coagulation system with power control and monitoring, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract to treat various conditions, which fits the definition of a therapeutic device.
No
The device is intended for coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, which is a therapeutic function, not diagnostic.
No
The device description explicitly lists hardware components such as an energy generator, disposable catheter, output cable, and footswitch, indicating it is not a software-only device.
Based on the provided information, the HALO® Coagulation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "coagulation of bleeding and non-bleeding sites in the gastrointestinal tract." This describes a therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details an energy generator, catheter, cable, and footswitch used to deliver radiofrequency power for coagulation. This is consistent with a surgical or therapeutic device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HALO® Coagulation System's function is to treat tissue directly.
N/A
Intended Use / Indications for Use
The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO® Coagulation System 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 HALO® Coagulation System consists of the HALO® Coagulation System consists of the HALO90 Energy Generator model 90-9000 with a disposable single-use HALO® Coagulation Catheter, output cable, and a 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 bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.Bench study
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.
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510(k) SUMMARY
Page 1 of 3
BARRX Medical's HALO® Coagulation System
Submitter's Name, Address, Telephone Number, Contact 1. Person and Date Prepared:
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
NOV 1 4 2006
(408) 328-7302 Phone: Facsimile: (408) 328-7395
Viorica Filimon Contact Person:
Date Prepared: August 19, 2006
Name of device and Name/Address of Sponsor: 2.
HALO90 Coagulation System HALO®0 Coagulation Catheter HALO90 Energy Generator
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Common or Usual Name(s): 3.
Electrosurgical Coagulation System
Classification Name: 4.
Product code: GEI CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II Classification panel: General & Plastic Surgery
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Kobz44/
Page 2 of 3
5. Predicate Devices
- HALO® Energy Generator model 1100C-115C (K060169) manufactured by . Stellartech Research;
- HALO360 Energy Generator model 1100C-115B (K051168) manufactured by . Stellartech Research;
- Stellartech Coagulation System 2, model 1100C-115A (K050831) . manufactured by Stellartech Research;
Intended Use / Indications for Use 6.
The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO® Coagulation System 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 HALO® Coagulation System consists of the HALO90 Energy Generator model 90-9000 with a disposable single-use HALO® Coagulation Catheter, output cable, and a footswitch. The HALO® Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO® Coagulation System, HALO360 Coagulation System, and Stellartech Coagulation System 2.
HALO® Coagulation Catheter
There are no changes associated with the HALO® Coagulation Catheter model 1520F.
HALO90 Energy Generator
The HALO® Energy Generator model 90-9000 is configured with an output cable (model 90-9010), a footswitch (model 90-9020) and a power cord.
The HALO® Coagulation Generator supplies up to 150 watts of radiofrequency power at 460 kHz in a bipolar mode under power control while continuously monitoring and displaying power density, and energy density. Energy
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[Kob244/
density and power are displayed to allow homogeneous energy delivery equivalent to the HALO90 Energy Generator model 1100C-115C.
8. Substantial Equivalence
The HALO® Coagulation System (generator model 90-9000) and the predicate devices: HALO® Coagulation System (generator model 11000-1150), HALO360 Coagulation System and Stellartech Coagulation System 2 have the same or similar intended use, indications for use, technological characteristics and principles of operation. The technological differences between the HALO90 Coagulation System and its predicates are:
(1) Simplification of the generator and elimination of the unused pneumatic systems for inflation/deflation capability;
(2) Changes in the hardware implemented to establish an optimum RF power output for the impedance range defined for the clinical application;
(3) Minor modification of the generator software to support the changes in the hardware design.
(4) Change of the design and manufacturing facility to the Aubrey Group;
All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
3
510(K) SUMMARY v.
.
The Company's 510(k) Summary is provided in pages 19-21 below.
:
HALO® Energy Generator
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BARRX Medical, Inc. % Hogan & Hartson, L.L.P. Mr. Jonathan S. Kahan 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
NOV 1 4 2006
Re: K062441
Trade/Device Name: HALO® Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 17, 2006 Received: October 17, 2006
Dear Mr. Kahan:
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.
5
Page 2 – Mr. Jonathan S. Kahan
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 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,
Mark A. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko6244/
Indications for Use Statement 1.
510(k) Number (if known):
Device Name:
Indications for Use:
The HALO® Coagulation System 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 __ V_ (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 General, Restorative,
and Neurological Devices
510(k) Number. K062441 Page _ of _
HALO
Energy Generator