(88 days)
The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. The HALO® Coagulation System 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.
The HALO® Coagulation System consists of the HALO® Coagulation Generator with a disposable single-use HALO® Coagulation Catheter, output cable, and an optional footswitch.
The provided text (K060169) for the BÂRRX Medical's HALO® Coagulation System is a 510(k) summary and not a comprehensive study report. Therefore, it does not contain detailed information regarding acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or direct comparative effectiveness studies with human readers.
The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with predefined acceptance criteria.
Here's an analysis based on the information available in the provided text, while acknowledging significant gaps due to the nature of the document:
Acceptance Criteria and Device Performance:
The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, or specific coagulation depth/width targets) or report performance against such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that its performance is presumed acceptable if it functions similarly and addresses the same indications for use.
The "performance" described is largely about the technological characteristics and the assertion of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy (via Substantial Equivalence) | HALO® Coagulation System has "same or similar intended use, indications for use, technological characteristics, and principles of operation" as predicate devices. |
| Technological Characteristics - Catheter Design | Uses an endoscope and pivot mechanism for electrode positioning. |
| Technological Characteristics - Sizing Balloon | Eliminates the sizing balloon and the need for custom catheter selection. |
| Technological Characteristics - Materials | Employs additional materials. |
| Technological Characteristics - Software Modifications | Minor modification of generator software to support catheter design changes. |
| Impact of Differences on Safety and Efficacy | "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy." |
| Coagulation of Bleeding and Non-Bleeding Sites (Intended Use) | Indicated for "coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus." |
| Specific Indications (Intended Use) | Indicated for Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia. |
Detailed Study Information (Based on Available Text):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document refers to "bench" evaluations for the technological differences but does not provide details on sample size, data type, or provenance for these evaluations or any clinical studies.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not explicitly stated. The document does not describe a clinical study that would involve expert-established ground truth for a test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. No clinical test set or adjudication method is described.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an electrosurgical coagulation system, not an AI-powered diagnostic or interpretive tool. Therefore, a MRMC study assessing human reader improvement with AI assistance is not relevant to this device and was not performed/reported.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not stated. This is a medical device for direct coagulation, not an algorithm. Its operation is inherently "standalone" in that it performs the coagulation directly, but its use involves a clinician (human-in-the-loop) for guidance and application. The document describes "bench" evaluations, but not a "standalone algorithm" performance study.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. Given the nature of a coagulation system, "ground truth" for performance would likely relate to objective measurements of tissue ablation/coagulation effectiveness, depth, and safety parameters, potentially animal models or in-vitro tissue models for bench testing. However, the document does not specify these details.
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The sample size for the training set:
- Not applicable/Not stated. The device is not an AI/machine learning system that requires a training set in the conventional sense.
-
How the ground truth for the training set was established:
- Not applicable/Not stated. No training set is described for this type of device.
Summary of Device Approval Process:
The document is a 510(k) Pre-market Notification, which is a process for demonstrating that a new device is "substantially equivalent" to an already legally marketed device (predicate device). In this case, BÂRRX Medical argued that the HALO® Coagulation System is substantially equivalent to:
- K051168 HALO360 Coagulation System (BÂRRX Medical Inc.)
- K050831 Stellartech Coagulation System 2 (Stellartech Research Corporation)
The "study" referenced is primarily a demonstration that the technological differences (endoscope/pivot vs. sizing balloon, additional materials, minor software modifications) were evaluated "on bench" and did not raise new questions of safety or efficacy compared to the predicate devices. This type of submission does not typically include detailed clinical studies with quantifiable acceptance criteria for diagnostic performance metrics.
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APR 2 1 2005
510(k) SUMMARY
BÂRRX Medical's HALO® Coagulation System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
(408) 328-7302 Phone: (408) 328-7395 Facsimile:
Contact Person: Viorica Filimon
Date Prepared: January 20, 2006
Name of device and Name/Address of Sponsor:
HALO90 Coagulation System HALO® Coagulation Catheter HALO90 Coagulation Generator
BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Common or Usual Name(s):
Electrosurgical Coagulation System
Classification Name:
Product code: GEI CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II Classification panel: General & Plastic Surgery
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Predicate Device(s)
K051168 HALO360 Coagulation System-BÂRRX Medical Inc. K050831 Stellartech Coagulation System 2-Stellartech Research Corporation
Intended Use / Indications for Use
The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO® Coagulation System 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 HALO® Coagulation System consists of the HALO® Coagulation Generator with a disposable single-use HALO® Coagulation Catheter, output cable, and an optional footswitch. The HALO® Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO®60 Coagulation System and Stellartech Coagulation System 2.
Substantial Equivalence
The HALO® Coagulation System and the predicate devices: HALO360 Coagulation System and Stellartech Coagulation System 2 have the same or similar intended use, indications for use, technological characteristics, and principles of operation. The technological differences between the HALO® Coagulation System and its predicates are: (1) use of an endoscope and pivot mechanism for electrode positioning; (2) elimination of the sizing balloon and the need to select a custom size coagulation catheter; (3) additional materials; and (4) minor modification of the generator software to support the changes in the catheter design. All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 1 2006
Ms. Viorica Filimon Vice President of Quality/Regulatory Affairs BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085
Re: K060169
Trade/Device Name: HALO® Coagulation System Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 20, 2006 Reccived: January 27, 2006
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, the words "Promoting Public" are written in a cursive font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary. The text is black and the background is white.
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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 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K060 0 69
Device Name: HALO90 Coagulation System
Indications for Use:
The HALO® Coagulation System 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 _> (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 System Evaluation (ODE)
T. Henry C. Broderick
(Division Sign-Off Division of Reproductive, Abdominal and Radiological Device 510(k) Number.
Page .______ of _
BARKX Medical Inc 510k
Page: 17
§ 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.