(69 days)
Not Found
No
The description focuses on the physical components and function of a bipolar RF device for tissue coagulation, with no mention of AI/ML terms, image processing, or data-driven algorithms.
No.
Explanation: The device is used to assist in coagulation of tissue during intraoperative surgical procedures, which is a surgical tool, not a therapeutic device.
No
The device is described as assisting in the coagulation of tissue using radiofrequency power during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a bipolar radiofrequency (RF) device consisting of a handle, electrodes, and cables, which are all hardware components.
Based on the provided information, the Habib Hexablate is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to assist in coagulation of tissue during intraoperative surgical procedures." This describes a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a device that applies radiofrequency energy directly to tissue for coagulation. This is a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Habib Hexablate's function is to directly treat tissue during surgery.
N/A
Intended Use / Indications for Use
The Habib Hexablate is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Habib Hexablate 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 has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Hexablate 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
tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was done to ensure that the Habib Hexablate 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Habib 4X (K051420)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
| SECTION 3 | |
|---|---|
| Summary of Safety and Effectiveness | |
| Sponsor: | EMcision, Ltd. |
| K071103 | |
| Contact Person: | Nagy Habib, MD |
| Chief Executive Officer | |
| Liver Surgery Section, Hammersmith Hospital | |
| Du Cane Road | |
| London, W12 0NN | |
| United Kingdom | |
| Summary Prepared: | April 10, 2006 |
| JUN 27 2007 | |
| Trade Name: | Habib Hexablate |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II per 21 CFR 878.4400 |
| Product Code: | GEI |
| Predicate Devices: | Habib 4X (K051420) |
Page 1 of 2Intended Use:
The Habib Hexablate is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Description:
The Habib Hexablate 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 has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Hexablate is designed for use in surgery and is a single use device.
Technological Differences:
The Habib Hexablate has the same basic technological characteristics as the Habib 4X. Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue. The primary difference is in the size and shape of the coagulation zone created by each
1
K071103
SECTION 3
Page 2 of 2
Summary of Safety and Effectiveness
device. The Habib Hexablate also uses aspiration through the center electrode to remove fluids and gases from the center of the coagulation zone.
Performance Data:
Performance testing was done to ensure that the Habib Hexablate 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.
2
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EMcision, Ltd. % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen 455 East Trimble Road San Jose, California 95131-1230
JUN 2 7 2007
Re: K071103
Trade/Device Name: Habib Hexablate Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 7, 2007 Received: June 12, 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. Iisting 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.
3
Page 2 - Mr. Morten Simon 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 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,
For Peter Rummell
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 2 Indications for Use Statement
Indications For Use Statement
510(K) Number (if known) K071103
Habib Hexablate Device Name
The Habib Hexablate 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | |
|---|---|
| --------------- | -- |
Habib Hexablate 510(k) Section 2, Indications for Use Statement EMcision, Ltd. Page 2-1