(102 days)
The HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
The HALO® Ablation Catheter model 90-9100 operates in conjunction with HALO® Energy Generator model 90-9000. There are no changes to the HALO® Ablation Catheter or HALO® Energy Generator implemented since the devices were cleared by K083737, K062723 and K062441. The product is also identical in principle of operation and energy density to the treatment site with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter. HALO® is substantially equivalent in construction with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter and Microvasive Gold Probe. The product is similar in performance with Olympus Heat Probe.
The provided 510(k) summary for BARRX's HALO System (K093008) indicates that no new performance testing was conducted for this submission.
The submission focuses on expanding the indications for use for the HALO® Ablation Catheter to include Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP) based on the substantial equivalence to previously cleared devices and existing clinical data.
Therefore, the following information cannot be extracted from the provided text as the study described is a review of existing clinical data, not a new performance study with acceptance criteria.
- A table of acceptance criteria and the reported device performance: Not applicable, as no new performance testing was conducted.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for new performance testing. The clinical data supporting the expanded indications was "derived from publications and case studies." The provenance details are not specified.
- 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 applicable, as no new test set was created with expert-established ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI/device assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the expanded indications, the clinical data relied upon was from "publications and case studies" which demonstrated the safety and effectiveness of the device when used for GAVE and RP. This implies that outcomes data from these existing sources served as the basis for substantiating safety and effectiveness for these new indications.
- The sample size for the training set: Not applicable, as no new training set was explicitly mentioned for algorithmic development in this submission.
- How the ground truth for the training set was established: Not applicable.
Summary of the study that proves the device meets the acceptance criteria (expanded indications):
The submission argues for the substantial equivalence of the HALO® Ablation Catheter for the treatment of GAVE and RP by referencing:
- Technological Identity and Substantial Equivalence: The HALO® Ablation Catheter model 90-9100 is "technologically identical" to its cleared predicate (K083737, K062723). It also highlights substantial equivalence in principle of operation, energy density, construction, and performance with other predicate devices (HALO360 Ablation Catheter, Stellartech Coagulation Catheter, Microvasive Gold Probe, Olympus Heat Probe).
- Clinical Data Review: Clinical data was provided to FDA "to support the changes in the Instructions for Use associated with the use in the coagulation of bleeding sites for the HALO® Ablation Catheter for the treatment of GAVE and Radiation Proctitis." This data "demonstrated that, when used in accordance with those instructions, the HALO® Ablation Catheter used for the treatment of GAVE and Radiation Proctitis respectively is at least as safe and effective as the cleared HALO® Ablation Catheter for the treatment of bleeding sites in the gastrointestinal tract."
- Basis of Clinical Data: The clinical data supporting the additional indications (GAVE and RP) was "derived from publications and case studies" and facilitated "Physician's Instructions recommending specific treatment settings and selection criteria for the patients (Contraindications, Warnings and Cautions)."
- Similarity of Conditions: GAVE and RP are described as being similar to other already indicated bleeding conditions (esophageal ulcers, Mallory-Weiss tears, etc.) in that they are confined to the mucosal layer, associated with hemorrhage, and treated with coagulative therapy.
In essence, the "study" proving the device meets the acceptance criteria for expanded indications was a retrospective review of existing clinical data from publications and case studies, and an argument for substantial equivalence to previously cleared predicate devices for similar applications. No new pre-market performance study with defined acceptance criteria was conducted.
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510(k) SUMMARY BARRX's HALO" System
JAN - 8 2010
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
BARRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085 Phone: (408) 328-7300 Facsimile: (408) 328-7395 Contact: Viorica Filimon Date Prepared: June 2009
Name of Device and Name/Address of Sponsor
HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) BARRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085
Common or Usual Name
Electrosurgical Coagulation System
Classification Name
Electrosurgical Cutting or Coagulation Device
Predicate Devices
HALO90 Ablation Catheter model 90-9100 (K060169, K062723 and K083737) HALO360 Ablation Catheter (K050168, K062225, K083711) Stellartech Coagulation Catheter (K013139, K042909, K050831) Microvasive Gold Probe (K970278) Olympus Heat Probe (K982289)
Intended Use / Indications for Use
The HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
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K093008
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Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Technological Characteristics
The HALO® Ablation Catheter model 90-9100 operates in conjunction with HALO® Energy Generator model 90-9000. There are no changes to the HALO® Ablation Catheter or HALO® Energy Generator implemented since the devices were cleared by K083737, K062723 and K062441. The product is also identical in principle of operation and energy density to the treatment site with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter. HALO® is substantially equivalent in construction with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter and Microvasive Gold Probe. The product is similar in performance with Olympus Heat Probe. The similarities in performance and intended use with the other predicate devices are presented in Table 2.
Performance Data
The HALO® Ablation Catheter model 90-9100 is technologically identical to the cleared predicate device HALO® Ablation Catheter model 90-9100 cleared by K083737 and K062723. Accordingly, no performance testing was conducted.
Clinical data was provided to FDA to support the changes in the Instructions for Use associated with the use in the coagulation of bleeding sites for the HALO® Ablation Catheter for the treatment of GAVE and Radiation Proctitis. Clinical data demonstrated that, when used in accordance with those instructions, the HALO® Ablation Catheter used for the treatment of GAVE and Radiation Proctitis respectively is at least as safe and effective as the cleared HALO® Ablation Catheter for the treatment of bleeding sites in the gastrointestinal tract .
Substantial Equivalence
The HALO® Ablation Catheter with expanded indications for use is as safe and effective as the predicate devices HALO® Ablation Catheter, HALO360 Ablation Catheter, Microvasive Gold Probe, and Olympus Heat Probe. The HALO® has the same general intended use. general indications for use, technological characteristics, and principles of operation as the predicate devices.
The HALO® Ablation Catheter is currently cleared for the coagulation of bleeding sites in the gastrointestinal tract. In addition, physicians have elected to use the HALO® System within its indication for use for the coagulation of bleeding sites within the gastrointestinal tract, specifically gastric antral vascular ectasia (GAVE) and radiation proctitis/proctopathy (hereafter, collectively RP). GAVE and RP are similar in that they are both confined to the mucosal layer of the gastrointestinal tract, associated with hemorrhage and treated with coagulative
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therapy. In this way, they are also very much akin to the other bleeding conditions (esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, angiomata, Dieulafoy lesions, and angiodysplasia) cited as examples in the HALO® System cleared indication for use.
HALO® Ablation Catheter is substantially equivalent with several devices: HALO® Ablation Catheter (K06169, K062723 and K083737), HALO360 Ablation Catheter (substantially equivalency established in K060169 and K06223), Stellartech Coagulation Catheter (substantial equivalency established in K013139, K042909, K050831), Microvasive Gold Probe (equivalency established by K013139 and K970278), and Olympus Heat Probe (K982289).
HALO® Ablation Catheter included in this submission has identical indications for use with the HALO90 Ablation Catheter (K060169, K062723 and K083737), HALO360 Ablation Catheter (K050168, K062225, K083711) and Stellartech Coagulation Catheter 2.0 (K013139, K042909, K050831) with the exception of Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis(RP).
Based on the substantial equivalence established historically between HALO® Ablation Catheter and the predicate devices Microvasive Gold Probe (K970278) and Olympus Heat Probe (982289) we seek the expansion of the indications for use for HALO90 Ablation Catheter to include the GAVE (or Watermelon Stomach) indications for use as the Microvasive Gold Probe:
Indications for use for HALO® Ablation Catheter current submission:
The HALO® Ablation Catheter model 90-9100 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Indications for use for Microvasive Gold Probe (K970278):
The Gold Probe is indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus, stomach, duodenum, and colon. The indications include peptic ulcers, Mallory-Weiss tears, Arteriovenous Malformations (AVM), Angiomata, Dieulafoy Lesions, bleeding polyp stocks, angiomata, Watermelon Stomach(1), Barrett's Esophagus, angiodysplasia, and esophageal tumors.
ω Definition: Watermelon Stomach is the popular name for Gastric Antral Vascular Ectasia (GAVE) — a condition in which the lining of the stomach bleeds, causing it to look like the characteristic stripes of a watermelon when viewed by Endoscopy.
Indications for use for Olympus Heat Probe (K982289):
The Olympus Heat Probe Unit HPU-20 has been designed for thermal cautery with the Olympus Heat Probes.
The Olympus Heat Probe has been specifically designed to thermo-cauterize bleeding sites within the gastrointestinal tract under endoscopic observation.
The addition of Physician's Instructions recommending specific treatment settings and selection criteria for the patients (Contraindications, Warnings and
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093008 age 4 of
Cautions) for the treatment of bleeding sites in the gastrointestinal tract such as GAVE and RP is supported by clinical data derived from publications and case studies and does improve the device risk profile by providing guidance required for optimal use of the device. The risk profile of the cleared predicate device HALO®0 Ablation Catheter with the indication for use of coagulation of bleeding sites in the gastrointestinal sites is identical with the risk profile of the device in the current submission HALO® Ablation Catheter with the indication for use for coagulation of bleeding sites in the gastrointestinal tract such as Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). Thus, the HALO90 Ablation Catheter is substantially equivalent.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Viorica Filimon VP Quality/Regulatory Affairs BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085
JAN - 8 2010
Re: K093008
Trade/Device Name: HALO99 System (including HALO90 Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 8, 2009 Received: December 9, 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 of medical
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Enclosure
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K093008
Device Name: HALO® System (including HALO99 Ablation Catheter model 90-9100 and HALO90 Energy Generator model 90-9000)
Indications for Use:
The HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) is indicated for use in 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Plumer
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devi % 93008
510(k) Number
Page of of
§ 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.