(88 days)
Not Found
No
The summary does not mention any AI or ML terms, image processing, or performance metrics typically associated with AI/ML-driven devices. The device description focuses on hardware components and its intended use is for coagulation, which is a standard medical procedure.
Yes
The device is used 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 described as a coagulation system for treating bleeding or non-bleeding sites in the gastrointestinal tract, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states that the system consists of a generator, catheter, output cable, and optional footswitch, which are all hardware components.
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 is a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The system consists of a generator, catheter, cable, and footswitch. These are all components used for delivering energy to tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, tissue, etc.), performing tests, or providing diagnostic information based on sample analysis.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The HALO® Coagulation System is a therapeutic device used for treating conditions within the body.
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 Generator with a disposable single-use HALO® Coagulation Catheter, 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)
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
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
APR 2 1 2005
510(k) SUMMARY
BÂRRX Medical's HALO® Coagulation System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
(408) 328-7302 Phone: (408) 328-7395 Facsimile:
Contact Person: Viorica Filimon
Date Prepared: January 20, 2006
Name of device and Name/Address of Sponsor:
HALO90 Coagulation System HALO® Coagulation Catheter HALO90 Coagulation Generator
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Common or Usual Name(s):
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
Predicate Device(s)
K051168 HALO360 Coagulation System-BÂRRX Medical Inc. K050831 Stellartech Coagulation System 2-Stellartech Research Corporation
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.
Technological Characteristics
The HALO® Coagulation System consists of the HALO® Coagulation Generator with a disposable single-use HALO® Coagulation Catheter, output cable, and an optional footswitch. The HALO® Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO®60 Coagulation System and Stellartech Coagulation System 2.
Substantial Equivalence
The HALO® Coagulation System and the predicate devices: 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 HALO® Coagulation System and its predicates are: (1) use of an endoscope and pivot mechanism for electrode positioning; (2) elimination of the sizing balloon and the need to select a custom size coagulation catheter; (3) additional materials; and (4) minor modification of the generator software to support the changes in the catheter design. All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
2
Image /page/2/Picture/1 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 abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 1 2006
Ms. Viorica Filimon Vice President of Quality/Regulatory Affairs BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085
Re: K060169
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: January 20, 2006 Reccived: January 27, 2006
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, the words "Promoting Public" are written in a cursive font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary. The text is black and the background is white.
3
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.
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K060 0 69
Device Name: HALO90 Coagulation System
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 _> (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)
T. Henry C. Broderick
(Division Sign-Off Division of Reproductive, Abdominal and Radiological Device 510(k) Number.
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