(97 days)
The Habib Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract
The Habib Endoblate is a bipolar radiofrequency (RF) device that consists of a catheter with 3 contact electrodes and 1 ring electrode, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib Endoblate has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib Endoblate is designed for use in endoscopy and is a single use sterile device.
The provided text describes the Habib Endoblate device and its 510(k) clearance, but it does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria with quantitative metrics.
The document states: "Performance testing was undertaken to ensure that the Habib Endoblate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."
This is a general statement required for 510(k) submissions, indicating that some testing was performed to demonstrate substantial equivalence to a legally marketed predicate device (Gold Probe catheter, K970278). However, the specific results of this performance testing, the acceptance criteria used, or the study details are not included in this summary.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth, expert involvement, or comparative effectiveness studies, as this information is not present in the provided text.
The information that can be extracted relevant to your request is limited to:
- Predicate Device: Gold Probe catheter manufactured by Boston Scientific Inc. (K970278)
- Basis for Clearance: Substantial equivalence to the predicate device.
- Technological Characteristics: Both devices use bipolar RF energy through a number of electrodes to coagulate tissue.
To obtain the detailed performance data, acceptance criteria, and study results, one would typically need to refer to the full 510(k) submission document or supporting technical files, which are not included here.
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K072383$^{10(2}$
SECTION 3 Summary of Safety and Effectiveness
Sponsor: EMcision, Ltd.
- Contact Person: Nagy Habib, MD Chief Executive Officer Liver Surgery Section, Hammersmith Hospital Du Cane Road London, W12 0NN United Kingdom
Summary Prepared: 2007-05-01
Trade Name: Habib Endoblate
Common Name: Endoscopic Electrosurgical Unit
- Classification: Class Il per 21 CFR 878.4400
Product Code: Gastroenterology-Urology (GU) Gastro-Renal (GRDB)
GEI
Gold Probe catheter manufactured by Boston Scientific Inc. Predicate Devices: (K970278)
Intended Use:
The Habib Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract
Description:
The Habib Endoblate is a bipolar radiofrequency (RF) device that consists of a catheter with 3 contact electrodes and 1 ring electrode, introduced via an endoscope's biopsy channel and activated with bipolar RF energy.
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K072383
SECTION 3 Summary of Safety and Effectiveness
The Habib Endoblate has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib Endoblate is designed for use in endoscopy and is a single use sterile device.
Technological Differences:
The Habib Endoblate has the same basic technological characteristics as the Gold Probe. Both devices use bipolar RF energy through a number of electrodes to coagulate tissue.
Performance Data:
Performance testing was undertaken to ensure that the Habib Endoblate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
NOV 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Emcision Ltd. c/o Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230
K072383 Re:
Trade/Device Name: Habib Endoblate Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: November 8, 2007 Received: November 13, 2007
Dear Mr. Christensen:
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.
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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 (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 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 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.
Nancy C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 2 Indications for Use Statement
Indications For Use Statement
510(K) Number (if known)
Not yet Allocated
Device Name
Habib Endoblate
The Habib Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract
PLEASE DO NO WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen Lewer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(per 21 CFR 878.4400)
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).