(30 days)
Not Found
No
The summary describes a mechanical sizing balloon used with an energy generator and coagulation catheter, with no mention of AI/ML or data processing beyond basic sizing accuracy.
No
The device is described as a sizing balloon used in conjunction with energy generators and coagulation catheters to assess esophageal lumen size and facilitate the selection of a coagulation catheter. It itself does not directly perform the therapeutic action.
No
The device is indicated for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, which is a therapeutic function, not a diagnostic one. While it assesses the size of the esophageal lumen, this is to facilitate the selection of a coagulation catheter, serving a preparatory role for therapy rather than providing a diagnosis of a medical condition.
No
The device description explicitly states that the device is comprised of a sizing balloon, a catheter shaft with markings, and an electrical connector, 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 is 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 device is a "Sizing Balloon" used to "assess the size of the esophageal lumen" and "facilitate the selection of the disposable single-use HALO360+ Coagulation Catheter". This is a tool used during a medical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on in vitro testing. The device is used for a direct intervention on the patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HALO360+ Sizing Balloon model 3441C is intended to be used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. The HALO660+ Sizing Balloon model 3441C is indicated for use for the coagulation of bleeding and nonbleeding 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+ Sizing Balloon model 3441C is used in conjunction with either the HALO360 Energy Generator models 1100C-115B (or 1100C-230B), or HALORLEX Energy Generator model 1190A-115A (or 1190A-230A) for assessing the size of the esophageal lumen, and facilitate the selection of the disposable single-use HALO360+ Coagulation Catheter. The HALO360+ Sizing Balloon model 3441C, like the predicate device HALO360 Sizing Balloon model 3441B is comprised of a sizing balloon, a catheter shaft with markings, and an electrical connector.
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
The HALO360+ Sizing Balloon model 3441C met the same specifications requirements as the HALO360 Sizing Balloon and HALO360+ Ablation Catheter for the following characteristics:
- Sizing accuracy
- Structural strength
- Material compatibility
- Sterility
Key Metrics
Not Found
Predicate Device(s)
HALO360 Sizing Balloon model 3441B (K051168), HALO360+ Ablation Catheter model 32041-XX (K083711, K071543)
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
510(k) SUMMARY
5093855
JAN 1 5 2010
BARRX Medical's [MODIFIED DEVICE]
.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
BARRX Medical Inc. 540 Oakmead Pkwv Sunnyvale, CA 94085
Phone: 408-328-7302 Facsimile: 408-328-7395
Contact Person: Viorica Filimon
Date Prepared: December 20, 2009
Name of Device and Name/Address of Sponsor
HALO360+ Sizing Balloon
BARRX Medical Inc. 540 Oakmead Pkwy Sunnyvale, CA 94085
Common or Usual Name
Sizing Balloon
Classification Name
Product code: GEI CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II Classification panel: General & Plastic Surgery
Predicate Devices
HALO360 Sizing Balloon model 3441B (K051168) HALO360+ Ablation Catheter model 32041-XX (K083711, K071543)
Purpose of the Special 510(k) notice.
The HALO360+ Sizing Balloon model 3441C is a modification to HALO360 Sizing Balloon model 3441B and HALO360+ Ablation Catheter model 32041-XX the predicate devices.
Intended Use
510(k) HALO360+ Sizing Balloon Model 3441C
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1
The HALO360+ Sizing Balloon model 3441C is intended to be used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. The HALO660+ Sizing Balloon model 3441C is indicated for use for the coagulation of bleeding and nonbleeding 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 HALO360+ Sizing Balloon model 3441C is used in conjunction with either the HALO360 Energy Generator models 1100C-115B (or 1100C-230B), or HALORLEX Energy Generator model 1190A-115A (or 1190A-230A) for assessing the size of the esophageal lumen, and facilitate the selection of the disposable single-use HALO360+ Coagulation Catheter. The HALO360+ Sizing Balloon model 3441C, like the predicate device HALO360 Sizing Balloon model 3441B is comprised of a sizing balloon, a catheter shaft with markings, and an electrical connector. The HALO360+ Sizing Balloon model 3441B is substantially equivalent in design, performance, and mode of operation with the already cleared predicate devices: HALO360 Sizing Balloon model 3441B and HALO360+ Ablation Catheter model 32041-XX.
Performance Data
The HALO360+ Sizing Balloon model 3441C met the same specifications requirements as the HALO360 Sizing Balloon and HALO360+ Ablation Catheter for the following characteristics:
- 0 Sizing accuracy
- Structural strength .
- Material compatibility
- Sterility .
Substantial Equivalence
HALO360+ Sizing Balloon model 3441C has the same intended use and indications, principles of operation, and technological characteristics as HALO360 Sizing Balloon model 3441B and HALO360+ Ablation Catheter model 32041-XX. The minor differences in the HALO360+ Sizing Balloon model 3441C are:
- . Changes in the balloon material
- Increase the sizing balloon capability to measure esophageal diameter . higher than 33.7 mm and as result identify when the balloon migrates in the stomach.
These changes do not raise any new questions of safety or effectiveness. Performance data demonstrates that the HALO360+ Sizing Balloon is as safe and effective as HALO360 Sizing Balloon model 3441B and HALO360+ Ablation catheter model 32041-XX. Thus, the HALO360+ Sizing Balloon model 3441B is substantially equivalent to its predicate devices.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
BARRX Medical, Inc. % Ms. Viorica Filimon Vice President of Quality/Regulatory Affairs 540 Oakmead Parkway Sunnyvale, California 94085
JAN 1 5 2010
Re: K093855
Trade/Device Name: HALO360 + Sizing Balloon Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 15, 2009 Received: December 16, 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.
3
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.
Singular
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):___
Device Name: HALO360 + Sizing Balloon
Indications for Use:
HALO360 + Sizing Balloon model 3441C is indicated for 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 (Per 21 C.F.R. 801.109) Subpart C)
AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807
(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 Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093855
510(k) HALO360+ Sizing Balloon Model 3441C
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