(24 days)
The HALO360+ Coagulation Catheter model is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360+ Coagulation 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.
The HALO360 Coagulation System consists of the HALO460 Energy Generator with a disposable single-use HALO360+ Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation System comprising catheter model 32041-XX performance and mode of operation is substantially equivalent to the already cleared HALO300 Coagulation System comprising catheter models 31041-XX and/or 31041-XXBR.
This 510(k) submission (K071543) is for a medical device (HALO360+ Coagulation Catheter) and appears to be a substantial equivalence submission, rather than one providing detailed clinical study data with acceptance criteria and device performance metrics in the way that would typically be described for AI/CADe devices. This type of submission relies on demonstrating similarity to legally marketed predicate devices, and therefore, does not typically include the specific performance metrics, ground truth establishment, or reader studies requested in your prompt as these are more common for novel device performance claims.
Here's a breakdown based on the provided document, addressing what can be found and noting what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or reported device performance for a clinical study in the context of diagnostic accuracy, sensitivity, specificity, etc., which would be typical for AI/CADe devices. This is a submission for a physical medical device (coagulation catheter) claiming substantial equivalence to existing devices. The evaluation focuses on changes in materials and manufacturing processes.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The submission states that "All these differences were evaluated on the bench and in the animal model." No details on the sample size of the animal model or data provenance are provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable/Not provided. This type of evaluation for a physical device typically doesn't involve expert ground truth establishment for a test set in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
5. 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 is not an AI-assisted device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The document mentions "bench and ... animal model" evaluations. For a physical device, the "ground truth" would relate to the physical and functional characteristics of the device (e.g., coagulation efficacy, safety parameters in an animal model) rather than diagnostic truth in patient data. Specific details are not provided in this summary.
8. The Sample Size for the Training Set
No training set is applicable as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of what is present:
- Acceptance Criteria (Implied): The implied acceptance criteria for this 510(k) submission are that the changes in materials and manufacturing processes do not raise new questions of safety and efficacy compared to the predicate devices. The study performed ("bench and in the animal model") aimed to demonstrate that these changes maintain substantial equivalence in performance and safety.
- Device Performance (Implied): The devices (new and predicate) are considered "equivalent," meaning the HALO360+ Coagulation Catheter performs similarly to the predicate devices in its intended use for coagulation.
- Study Type: This appears to be a design verification and validation study, including bench testing and animal model testing, to confirm that the changes made (materials and manufacturing) do not negatively impact the device's safety and effectiveness compared to its predicates.
Why this information is largely absent in the provided text:
This 510(k) summary is for a physical medical device (a catheter) seeking clearance based on substantial equivalence to already cleared predicate devices. The "study" referenced ("bench and in the animal model") is to demonstrate that minor changes in materials and manufacturing processes do not alter the fundamental safety and effectiveness of the device as established by the predicates. This is fundamentally different from the rigorous clinical trial and performance metrics often required for novel devices, especially diagnostic AI tools, which necessitate detailed information on acceptance criteria, ground truth, reader studies, and sample sizes for various datasets.
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510(k) SUMMARY
BARRX Medical's HALO360+ Coagulation Catheter
JUN 2 9 2007
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
Contact Person: Viorica Filimon
Date Prepared: June 4, 2007
Name of device and Name/Address of Sponsor:
HALO360+ Coagulation Catheter
BARRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Common or Usual Name(s):
Electrosurgical Coagulation Catheter
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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K 071543
Page 2 of 2
Predicate Device(s)
K051168 HALO360 Coagulation System-BARRX Medical Inc. K062225 HALO360 Coagulation Catheter-BÂRRX Medical Inc.
Intended Use / Indications for Use
The HALO360+ Coagulation Catheter model is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360+ Coagulation 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, Dieulafov Lesions, and Angiodysplasia.
Technological Characteristics
The HALO360 Coagulation System consists of the HALO460 Energy Generator with a disposable single-use HALO360+ Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation System comprising catheter model 32041-XX performance and mode of operation is substantially equivalent to the already cleared HALO300 Coagulation System comprising catheter models 31041-XX and/or 31041-XXBR.
Substantial Equivalence
The HALO360+ Coagulation Catheter model 32041-XX and the predicate device HALO360 Coagulation Catheter models 31041-XXBR and 31041-XX manufactured by BARRX Medical Inc and Stellartech Research Co. respectively have the same intended use, indications for use, technological characteristics, and principles of operation. The technological differences between the HALO360+ Coagulation Catheter model 32041-XX and its predicates are:
-
- Changes in materials for manufacturability
-
- Changes in manufacturing processes
All these differences were evaluated on the bench and in the animal model and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.
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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized human figure with three heads and three sets of arms, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BARRX Medical % Ms. Viorica Filimon 540 Oakmead Parkway Sunnyvale, California 94085
JUN 2 9 2007
Re: K071543
Trade/Device Name: HALO360+ Coagulation Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 5, 2007 Received: June 5, 2007
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.
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 (OS) 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
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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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
P.O.M.
Mark N. Melkerson
Director Division of General, Restorativ and Neurological 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): K071543
Device Name: HALO360+ Coagulation Catheter
Indications for Use:
The HALO360* Coagulation 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 System Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | 10715B |
| Page | of |
Page: 16BARRX Medical Inc 510k
§ 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.