(64 days)
No
The summary describes minor software changes to an existing energy generator for coagulation, with no mention of AI or ML capabilities.
Yes
The device is described as an "Energy Generator" for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, addressing conditions like ulcers and malformations, which falls under therapeutic intervention.
No
The device is described as an "Energy Generator" and "Coagulation System" used for the "coagulation of bleeding and non-bleeding sites." Its intended use is therapeutic (treating conditions by coagulation), not diagnostic (identifying or characterizing diseases).
No
The device description explicitly states that the system consists of an energy generator, a disposable catheter, an output cable, and an optional footswitch, all of which are hardware components. While there are software changes, the device itself is a hardware system with integrated software.
Based on the provided information, the HALO360 Energy Generator 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 device is an "Energy Generator" used with a "Coagulation Catheter." This further supports its use in a surgical or interventional procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (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 the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The HALO360 Energy Generator's function is to apply energy to tissue for coagulation, which is a treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The HALO360 Energy Generator intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360 Energy Generator 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 HALO360 Coagulation System consists of the HALO360 Energy Generator model 1100C-115B with a disposable single-use HALO®60 Coagulation Catheter, output cable, and an optional footswitch. The HALO360 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO360 Coagulation System, and Stellartech Coagulation System 2.
The HALO360 Energy Generator model 1100C-115B is configured with an output cable (model CCC-001B), an optional footswitch (model FS-100B), and a power cord.
There are no changes to the hardware associated to HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. There are minor changes implemented to the software version of the generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal tract, 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 differences were evaluated on bench and did not raise questions regarding safety and efficacy.
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
OCT 0 8 2008
510(k) SUMMARY
BÂRRX Medical's HALO360 Energy Generator
Submitter's Name, Address, Telephone Number, Contact 1. 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: August 1, 2008
Name of device and Name/Address of Sponsor: 2.
HALO360 Energy Generator
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
3. Common or Usual Name(s):
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
1
Koszco 3
- 20f 3
5. Predicate Devices
HALO360 Energy Generator model 1100C-115B software version 4.2 (K051168) manufactured by Stellartech Research;
Stellartech Coagulation System 2, model 1100C-115A (K050831) manufactured by Stellartech Research;
6. Intended Use / Indications for Use
The HALO360 Energy Generator intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360 Energy Generator 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 HALO360 Coagulation System consists of the HALO360 Energy Generator model 1100C-115B with a disposable single-use HALO®60 Coagulation Catheter, output cable, and an optional footswitch. The HALO360 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO360 Coagulation System, and Stellartech Coagulation System 2.
HALO360+ Coagulation Catheter
There are no changes associated to the HALO360+ Coagulation Catheter.
HALO360 Energy Generator
The HALO360 Energy Generator model 1100C-115B is configured with an output cable (model CCC-001B), an optional footswitch (model FS-100B), and a power cord.
There are no changes to the hardware associated to HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. There are minor changes implemented to the software version of the generator.
This submission addresses software changes for HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy.
2
KO82203
$
3.4
$
Substantial Equivalence
The HALO360 Energy Generator model 1100C-115B (software version V4.5) and the predicate devices HALO360 Energy Generator model 1100C-115B (software version 4.2), and Stellartech Energy Generator 2 have the same intended use, indications for use, technological characteristics, and principles of operation. The technological differences between the HALO360 Energy Generator model 1100C-115B software version 4.5 and its predicates are:
Modification of the coagulation catheter operating pressure .
The differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
OCT 0 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Barrx Medical. Inc. % Ms. Viorica Filimon VP of Quality/Regualtory Affairs 540 Oakmead Parkway Sunnyvale, California 94085
Re: K082202
Trade/Device Name: The HALO360 Energy Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 5, 2008 Received: September 9, 2008
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. Ilsting 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.
4
Page 2 - Ms. Viorica Filimon
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically "KO82202". The characters are handwritten and appear to be part of a code or identifier. A line is drawn underneath the sequence of characters.
$\theta \cdot 1 \circ + 1$
Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
The HALO360 Energy Generator 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 Evaluation (ODE)
N.L.R.R. Ryden for mkm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K082202 Page 1 of 1
HALO360 Energy Generator