(55 days)
111115
No
The summary describes a coagulation system with a generator and catheters, and explicitly states that it is technologically identical to a previously cleared device. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.
Yes
The device is indicated for "coagulation of bleeding and non-bleeding lesions" for various conditions, directly treating a medical problem.
No
The device is indicated for the "coagulation of bleeding and non-bleeding lesions" in the gastrointestinal tract, which is a therapeutic function, not a diagnostic one. Its components are also consistent with a therapeutic device (Generator, Sizing Catheter, Coagulation Catheter).
No
The device description explicitly lists hardware components such as a Generator, Sizing Catheter, Coagulation Catheter, and Catheter Connection Cable.
Based on the provided information, the HALO360 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the HALO360 is used for the "coagulation of bleeding and non-bleeding lesions in the gastrointestinal tract". This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The components listed (Generator, Sizing Catheter, Coagulation Catheter, Catheter Connection Cable) are consistent with a device used for delivering energy (likely radiofrequency or similar) to tissue for coagulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health information. The HALO360 is a therapeutic device used to treat conditions directly within the body.
No
The provided FDA clearance letter does not contain any mention or indication of a Predetermined Change Control Plan (PCCP) for the HALO360 device. PCCPs are explicitly stated in clearance letters when authorized, and this document makes no reference to such a plan.
Intended Use / Indications for Use
The HALO360 is indicated for use in the coagulation of bleeding and non-bleeding I he firms - 11 million in tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Indications increate Loophagear - Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Product codes
GEI
Device Description
The HALO360 consists of a Generator; a Sizing Catheter; a Coagulation Catheter; The HALO™ connection Cable. A mains power cord and optional footswitch also and a Cathewer Colliestion Cashnological characteristics and principles of are available. The 111115 - - comittee cleared Stellartech Coagulation System 2.
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)
The HALO360 System is technologically identical to the cleared Stellartech The HALO® System. Accordingly, no performance testing was conducted. Clinical Coagulation bystem. Trecording:3, as provided to Instructions contained in the Instructions for Use for the HALO360 Coagulation Catheter. That data Instructions for Osciol accordance with those instructions, the HALO360 uemonstrated that, When wive as the Stellartech Coagulation System for the treatment of Barrett's Esophagus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stellartech Research Corporation's Stellartech Coagulation System 2
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
JUN 2 9 2005
51168 510(k) SUMMARY
Page 1 of 2
BARRX's HALO360 Coagulation System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
BARRX Medical, Inc. 1334 Bordeaux Drive Sunnyvale, CA 94089
(408) 745-8000 Phone: Facsimile: (408) 745-7406
Contact:, David S. Utley, M.D.
Date Prepared: May 5, 2005
Name of Device and Name/Address of Sponsor
HALO360 Coagulation System
BARRX Medical, Inc. 1334 Bordeaux Drive Sunnyvale, CA 94089
Common or Usual Name
Electrosurgical Coagulation System
Classification Name
Electrosurgical Cutting or Coagulation Device
... .
Predicate Devices
Stellartech Research Corporation's Stellartech Coagulation System 2
Intended Use / Indications for Use
The HALO360 is indicated for use in the coagulation of bleeding and non-bleeding I he firms - 11 million in tract including but not limited to the esophagus.
1
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Page 2 of (2
Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Indications increate Loophagear - Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Technological Characteristics
The HALO360 consists of a Generator; a Sizing Catheter; a Coagulation Catheter; The HALO™ connection Cable. A mains power cord and optional footswitch also and a Cathewer Colliestion Cashnological characteristics and principles of are available. The 111115 - - comittee cleared Stellartech Coagulation System 2.
Performance Data
The HALO360 System is technologically identical to the cleared Stellartech The HALO® System. Accordingly, no performance testing was conducted. Clinical Coagulation bystem. Trecording:3, as provided to Instructions contained in the Instructions for Use for the HALO360 Coagulation Catheter. That data Instructions for Osciol accordance with those instructions, the HALO360 uemonstrated that, When wive as the Stellartech Coagulation System for the treatment of Barrett's Esophagus.
Substantial Equivalence
The HALO360 is as safe and effective as the Stellartech Coagulation System. The The THISS - Is as as antended use, indications for use, technological ITALO … ias the same investion as the predicate device. The addition of Characteristics, and printerprommending specific power settings for the treatment of I hysician's finol acon (a cleared indication for use of the predicate device) is Darrews Hoophiagas (a taxand does not change the device's indications for use. Thus, the HALO360 is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Barrx Medical Incorporated C/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 13th Street, NW Washington, District of Columbia 20004
Re: K051168
Trade/Device Name: HALO360 Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 5, 2005 Received: May 5, 2005
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.
3
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ruch. An
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
KOS 1168 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The HALO360 Coagulation System is indicated for use in the coagulation of bleeding Inc IIIIo - Goagains in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Coophiague. Thateations, 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 Evaluation (ODE)
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510(k) Number K031168
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