(56 days)
Not Found
No
The document explicitly states that there are no changes to the device's performance, mode of operation, principle of operation, software, or hardware. The submission is solely for a name change of the catheter. There is no mention of AI or ML in the description.
Yes
The device is indicated for use in the coagulation of various bleeding and non-bleeding sites in the gastrointestinal tract, addressing specific medical conditions like ulcers, tears, and Barrett's Esophagus, which are therapeutic interventions.
No
The device is indicated for use in the coagulation of bleeding and non-bleeding sites, which is a treatment function, not a diagnostic one.
No
The device description explicitly lists hardware components (Energy Generator, Ablation Catheter, output cable, footswitch) and the submission addresses a name change for a physical catheter.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The HALO® System is described as being 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, not an analysis of a specimen outside the body.
- Intended Use: The intended use clearly states it's for treating conditions within the gastrointestinal tract, not for analyzing samples.
The device is a therapeutic device used for tissue ablation/coagulation within the body.
N/A
Intended Use / Indications for Use
The HALO90 System (inclusive of the HALO90 Ablation Catheter) 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 (comma separated list FDA assigned to the subject device)
GEI
Device Description
The HALO90 System consists of the following components:
- HALO" Energy Generator model 1100C-115C and 90-9100 and . accessories (output cable, and an optional footswitch).
- A single use HALO90 Ablation Catheter model 90-9100 .
The HALO® System performance and mode of operation did not change. This 510 (k) addresses the name change for the catheter.
There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO® Ablation catheter model 90-9100 when compared with the predicate device HALO® Coagulation Catheter model 90-9100.
The following changes are subject to this 510k submission: HALO® Coagulation Catheter model 90-9100 was marketed in Europe and Canada as HALO90 Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO® Coagulation Catheter to HALO90 Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.
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
Prescription Use
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
BÂRRX Medical's HALO® Ablation Catheter
FEB 1 0 2009
Submitter's Name, Address, Telephone Number, Contact السندر السياري والي الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم الموسم Person, and Date Prepared:
BARRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Phone: (408) 328-7302 (408) 328-7395 Facsimile:
Contact Person: Viorica Filimon
December 15, 2008 Date Prepared:
Name of device and Name/Address of Sponsor: 2.
HALO90 Ablation Catheter
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
3. Common or Usual Name(s):
Electrosurgical Coagulation System
4. Classification Name:
Product code: GEI CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II Classification panel: General & Plastic Surgery
Predicate Devices 5.
HALO® Coagulation Catheter model 90-9100 (K062723) manufactured by BÂRRX Medical Inc.
1
K083737 page 2 of 2
6. Intended Use / Indications for Use
The HALO90 System (inclusive of the HALO90 Ablation Catheter) 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 HALO90 System consists of the following components:
- HALO" Energy Generator model 1100C-115C and 90-9100 and . accessories (output cable, and an optional footswitch).
- A single use HALO90 Ablation Catheter model 90-9100 .
The HALO® System performance and mode of operation did not change. This 510 (k) addresses the name change for the catheter.
HALO® Ablation Catheter
There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO® Ablation catheter model 90-9100 when compared with the predicate device HALO® Coagulation Catheter model 90-9100.
The following changes are subject to this 510k submission: HALO® Coagulation Catheter model 90-9100 was marketed in Europe and Canada as HALO90 Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO® Coagulation Catheter to HALO90 Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.
HALO90 Energy Generator
There are no changes associated to the HALO® Energy Generator software, hardware and accessories.
Substantial Equivalence 8.
The HALO90 Ablation Catheter model 90-9100 and the predicate devices HALO® Coagulation Catheter model 90-9100 are identical in construction except the product name changes:
o From HALO90 Coagulation Catheter to HALO90 Ablation Catheter
o From HALO90 Coagulation System to HALO90 System.
There are no differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Viorica Filimon Vice President, Quality and Regulatory Affairs BÂRRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085
FEB 1 0 2009
Re: K083737
Trade/Device Name: HALO90 Ablation Catheter (model 90-9100) Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical, cutting &coagulation & accessories Regulatory Class: II Product Code: ·GEI Dated: December 15, 2008 Received: January 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 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.
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 os 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 892.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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, 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/odrb/industry.suppor/index.html.
Sincerely yours,
Laura B. Morris
anine M. M. orri Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use Statement
510(k) Number (if known): K083737
Device Name: HALO90 Abliation Catheter (model 90-9100)
Indications for Use:
The HALO® System (inclusive of HALO® Ablation Catheter) 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)
Heiber Perez
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 08 27 3 510(k) Number _
Page _ of _
HALO® Ablation Catheter
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