(58 days)
HALO90 Coagulation System (with catheter model 1520F)
Not Found
No
The summary describes a coagulation system that uses electrical energy for tissue treatment. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the hardware components and intended use for coagulation.
Yes
The device is used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, addressing medical conditions such as ulcers, tears, and lesions. This direct intervention to treat health issues classifies it as a therapeutic device.
No
The device is described as a "Coagulation System" indicated for the "coagulation of bleeding and non-bleeding sites." Its purpose is to treat or manage existing conditions, not to diagnose them.
No
The device description explicitly states it consists of a generator, disposable catheter, output cable, and optional footswitch, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used 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 description details a "Coagulation Generator" and a "Coagulation Catheter". These are 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, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to provide information about a patient's health status through the examination of these samples.
Therefore, the HALO® Coagulation System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
The HALO90 Coagulation System consists of the HALO90 Coagulation Generator with a disposable single-use HALO90 Coagulation Catheter model 90-9100, output cable, and an optional footswitch. The HALO90 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO90 Coagulation System (with catheter model 1520F).
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
K06-2723
NOV - 9 2006
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
Phone: (408) 328-7302 Facsimile: (408) 328-7395
Contact Person: Viorica Filimon
Date Prepared: September 11, 2006
Name of device and Name/Address of Sponsor:
HALO® Coagulation System HALO90 Coagulation Catheter HALO® 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
Kila 727, 737, 202
69 HALO® Coagula
l Use / Indications for Use
e HALO® Coagulation System intended use is for the
l non-bleeding sites in the gastrointestinal tract
ne HALO® Coagulation System is indicated for use in the coagulation of bleeding
ad non-blectives in the gastrointestinal tract including but not bested to, the the her
terior inglodySplasia.
ological Characteristics
The HALO90 Coagulation System consists of the HALO90 Coagulation Generator
with a disposable single-use HALO90 Coagulation Catheter model 90-9100, output
cable, and an optional footswitch. The HALO90 Coagulation System performance
and mode of operation is substantially equivalent to the already cleared HALO90
Coagulation System (with catheter model 1520F).
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Viorica Filimon VP Regulatory/Quality BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085
NOV - 9 2006
Re: K062723
Trade/Device Name: BÂRRX HALO® Coagulation Catheter, Model 90-9100 Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 14, 2006 Received: October 18, 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 is a circular seal with the text "1906-2006 FDA Centennial" arranged around the perimeter. In the center of the seal, the letters "FDA" are prominently displayed in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial".
Protecting and Promoting Public Health
3
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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 Ictter 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrlv/industry/support/index.html.
Sincerely vours.
Nancy Chrogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K062723
Device Name: HALO® 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 V (Part 21 C.F.R. 801 Subpart D)
ANDIOR
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)
Nancy C. Brogdon
(Division Sign-O Division of Reproductive, Abdominal. and Radiological Devie 510(k) Number
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