(14 days)
Not Found
No
The description focuses on the physical components and the mechanism of action (bipolar RF coagulation) and does not mention any AI/ML terms or functionalities.
Yes
Explanation: The device is described as assisting in the coagulation of tissue, which is a therapeutic action (treating or preventing a disease/condition).
No
The device is described as assisting in coagulation of tissue during surgical procedures, which is a therapeutic function, not a diagnostic one. It uses RF energy to coagulate tissue and does not appear to collect any data for diagnostic purposes.
No
The device description explicitly states it is a bipolar radiofrequency (RF) device consisting of a handle, electrodes, and a cable, which are all hardware components.
Based on the provided information, the Habib Hexablate 10 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "to assist in coagulation of tissue during intraoperative surgical procedures." This describes a device used directly on tissue within the body during surgery.
- Device Description: The description details a bipolar radiofrequency device with electrodes inserted into tissue for coagulation. This is a surgical instrument used for therapeutic purposes.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The Habib Hexablate 10 does not perform this function.
Therefore, the Habib Hexablate 10 is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Habib Hexablate 10 is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Product codes
GEI
Device Description
The Habib Hexablate 10 is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate 10 has an attached cable which connects the device to an RF Generator. The electrodes are inserted into tissue and the tissue is coagulated using RF power. The Habib Hexablate 10 is designed for use in surgery and is a single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Performance testing was done to ensure that the Habib Hexablate 10 functions as intended and meets design specifications. Sufficient data was obtained to show that the Hexablate 10 meets safety and effectiveness criteria.
Key Metrics
Not Found
Predicate Device(s)
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.
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SECTION 3 Summary of Safety and Effectiveness
Page 1 of 2
| Sponsor: | EMcision Ltd. | MAR 2 7 2008 |
|---|---|---|
| Contact Person: | Nagy Habib, MD | |
| Chief Executive Officer | ||
| Liver Surgery Section, Hammersmith Hospital | ||
| Du Cane Road | ||
| London, W12 0HS | ||
| United Kingdom | ||
| Summary Prepared: | January 25, 2008 | |
| Trade Name: | Habib Hexablate 10 | |
| Common Name: | Electrosurgical cutting and coagulation device and accessories | |
| Classification: | Class II per 21 CFR 878.4400 | |
| Product Code: | GEI | |
| Previously cleared device: | EMcision Habib Hexablate (K071103) |
Intended Use:
The Habib Hexablate 10 is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Description:
The Habib Hexablate 10 is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate 10 has an attached cable which connects the device to an RF Generator. The electrodes are inserted into tissue and the tissue is coagulated using RF power. The Habib Hexablate 10 is designed for use in surgery and is a single use device.
Technological Differences:
The Habib Hexablate 10 has the same basic technological characteristics as the Habib Hexablate. Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue. The primary difference is in the coagulation zone created
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SECTION 3 Summary of Safety and Effectiveness
Page 2 of ②
by each device. The Habib Hexablate 10 also uses aspiration through the center electrode to remove fluids and gases from the center of the coagulation zone. The only difference between the previously cleared device and the new modified device is that the previously cleared device has a diameter of 20mm and the Hexablate 10 device has a diameter of 10mm.
Performance Data:
Performance testing was done to ensure that the Habib Hexablate 10 functions as intended and meets design specifications. Sufficient data was obtained to show that the Hexablate 10 meets safety and effectiveness criteria.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Emcision, Ltd. % Underwriters Laboratories, Inc. Mr. Morten S. Christensen 455 East Trimble Road San Jose, California 95131
MAR 2 7 2008
Re: K080717
Trade/Device Name: Habib Hexablate 10 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 27, 2008 Received: March 13, 2008
Dear Ms. 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.
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.
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Page 2 – Mr. Morten S. Christensen
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 (240) 276-0115. 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,
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological 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) K080717
Device Name Habib Hexablate 10 \
The Habib Hexablate 10 is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Prescription Use OR Over the Counter Use (per 21 CFR 801.109)
PLEASE DO NO WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yourd. Curry
att (Division Sign-Op) )
Division of General, Restorative, Division of Over and Neurological Devices
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