(89 days)
No
The summary describes a radiofrequency energy generator with minor hardware and software updates for increased memory and component optimization. There is no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is indicated for the coagulation of soft tissue, including specific conditions in the gastrointestinal tract, which are therapeutic interventions.
No
The device is described as an energy generator for the coagulation of soft tissue and bleeding sites, indicating a therapeutic or procedural function rather than a diagnostic one.
No
The device description explicitly mentions modifications to hardware components such as the CPU board, Pressure Monitoring Board, RF MUX Board, and Hand Piece Interface Board, indicating it is a hardware device with associated software.
Based on the provided information, the HALOFLEX Energy Generator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "coagulation of soft tissue" and "coagulation of bleeding and non-bleeding sites in the gastrointestinal tract". This describes a therapeutic intervention performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The device is an "Energy Generator" used to deliver energy for coagulation. This is consistent with a therapeutic device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
- Measuring analytes
The HALOFLEX Energy Generator is a therapeutic device used for tissue coagulation.
N/A
Intended Use / Indications for Use
The HALOFLEX Energy Generator is indicated for use for the coagulation of soft tissue.
The HALOFLEX 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 HALOFLEX Energy Generator is a modification to the HALO360 Energy Generator and HALO® Energy Generators that have already been cleared by the Food and Drug Administration ("FDA" or the "Agency") for use in coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus (K051168 and K060169, K062441 respectively). The Generator has the same intended use and fundamental scientific technology as the cleared HALO360 and HALO90 Energy Generators. In addition, the intended use was expanded to include "coagulation of soft tissue", for this indication for use the predicate device is the RF 3000 Radiofrequency Generator (K000241).
The design changes between the HALO360 and HALO® Energy Generators and the HALOFLEX Energy Generator do not affect the clinical parameters employed in the energy delivery or the safety mechanisms that control those parameters.
The HALOFLEX Energy Generator has a limited number of design changes compared to the predicate devices. These changes are minor and do not raise no questions or effectiveness. Further, bench testing demonstrated comparable performance and safety. These modifications were as follows:
- Add to the indications for use the "coagulation of soft tissue", to reflect the . general nature of the device.
- Modification of the CPU board, for increased memory .
- Consolidation of the Pressure Monitoring Board and RF MUX Board in the Hand Piece Interface Board
- Integration on the HALO360 and HALO90 Energy Generators on the same . hardware platform as HALO360 Energy Generator
- . Update the software codes to reflect the specific performance characteristics for each Energy Generator.
- Optimization of components for reliability, and/or obsolescence
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)
Performance testing was conducted in compliance with the applicable international and domestic requirements and the certifications (for harmonized standards) and the reports for performance testing were provided to FDA to support this submission. That data demonstrated that, when used in accordance with the instructions, the HALOFLEX is at least as safe and effective as the predicate devices HALO360 and HALO90 Energy Generators.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HALO360 Energy Generator model 1100C-115B (K051168), HALO® Energy Generator model 1100C-115C (K060169), HALO90 Energy Generator model 90-9000 (K062441), RF 3000 Radiofrequency Generator (K000241)
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
NOV 1 0 2009
510(k) SUMMARY
BÂRRX Medical Inc.'s HALORLEX Energy Generator
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
BARRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
| Phone: | 408-328-7302 |
|---|---|
| Facsimile: | 408-328-7395 |
Viorica (Vivi) Filimon Contact Person:
Date Prepared: August 12, 2009
Name of Device and Name/Address of Sponsor
HALOFLEX Energy Generator
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Common or Usual Name:
Electrosurgical Coagulation System
Classification Name
878.4400 Electrosurgical, cutting & coagulation & accessories, product code GEI
Predicate Devices
HALO360 Energy Generator model 1100C-115B
HALO® Energy Generator model 1100C-115C
HALO90 Energy Generator model 90-9000
RF 3000 Radiofrequency Generator
BÂRRX Medical Inc.
BARRX Medical Inc.
BARRX Medical Inc.
Radio Therapeutics Corporation (Boston Scientific Inc)
1
Intended Use / Indications for Use
The HALOFLEX Energy Generator is indicated for use for the coagulation of soft tissue
The HALOFLEX Energy Generator intended use is for coagulation of soft tissue, and bleeding on non bleeding sites in the gastrointestinal tract.
The HALORLEX 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
The HALORLEX Energy Generator is a modification to the HALO360 Energy Generator and HALO® Energy Generators that have already been cleared by the Food and Drug Administration ("FDA" or the "Agency") for use in coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus (K051168 and K060169, K062441 respectively). The Generator has the same intended use and fundamental scientific technology as the cleared HALO360 and HALO90 Energy Generators. In addition, the intended use was expanded to include "coagulation of soft tissue", for this indication for use the predicate device is the RF 3000 Radiofrequency Generator (K000241).
The design changes between the HALO360 and HALO® Energy Generators and the HALOFLEX Energy Generator do not affect the clinical parameters employed in the energy delivery or the safety mechanisms that control those parameters.
The HALOFLEX Energy Generator has a limited number of design changes compared to the predicate devices. These changes are minor and do not raise no questions or effectiveness. Further, bench testing demonstrated comparable performance and safety. These modifications were as follows:
- Add to the indications for use the "coagulation of soft tissue", to reflect the . general nature of the device.
- Modification of the CPU board, for increased memory .
- Consolidation of the Pressure Monitoring Board and RF MUX Board in the Hand Piece Interface Board
2
- Integration on the HALO360 and HALO90 Energy Generators on the same . hardware platform as HALO360 Energy Generator
- . Update the software codes to reflect the specific performance characteristics for each Energy Generator.
- Optimization of components for reliability, and/or obsolescence
Performance Data
The HALOFLEX Energy Generator is technologically equivalent and clinically identical to the cleared HALO360 and HALO90 Energy Generators.
Performance testing was conducted in compliance with the applicable international and domestic requirements and the certifications (for harmonized standards) and the reports for performance testing were provided to FDA to support this submission. That data demonstrated that, when used in accordance with the instructions, the HALOFLEX is at least as safe and effective as the predicate devices HALO360 and HALO90 Energy Generators.
Substantial Equivalence
The HALOFLEX Energy Generator is as safe and effective as the HALO360 Energy Generator (K051168) and HALO90 Energy Generator (K060169 and K062441), RF 3000 Radiofrequency Generator (K000241) the predicate devices. The HALOFLEX Energy Generator has the same intended uses and indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the HALORLES Energy Generator and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the HALOFLEX Energy Generator is as safe and effective as HALO360 Energy Generator (K051168) and HALO90 Energy Generator (K060169 and K062441), RF 3000 Radiofrequency Generator the predicate devices. Thus, the HALOFLEX Energy Generator is substantially equivalent.
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
BARRX Medical, Inc. % Ms. Viorica Filimon Vice President of Quality/Regulatory Affairs 540 Oakmead Parkway Sunnyvale, California 94085
NOV 1 0 2009
Re: K092487
Trade/Device Name: HALOFLEX Energy Generator Model 1190A-115A Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 12, 2009 Received: August 13, 2009
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 (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The HALOFLEX Energy Generator is indicated for use for the coagulation of soft tissue.
The HALOFLEX 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, Die Hotor Lesions, and Angiodysplasia.
AND/OR
Prescription Use _ X Use (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter
(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)
FOR M. MELKERSON
Division of Surgical, Orthopedic, and Restorative Devices
Page _ of _
510(k) Number K01248