(12 days)
Not Found
No
The device description focuses on the physical components and the mechanism of action (bipolar radiofrequency coagulation) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to assist in coagulation of tissue during surgical procedures, which is a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures," which is a treatment function, not a diagnostic one.
No
The device description clearly outlines physical hardware components including a handle, laparoscopic shaft, introducer, electrodes, and connecting cables, indicating it is a hardware-based medical device.
Based on the provided information, the Habib Laparoscopic Hexablate is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "assist in coagulation of tissue during laparoscopic intraoperative surgical procedures." This describes a surgical intervention performed directly on a patient's tissue, not a test performed on a sample (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The description details a surgical instrument with electrodes that are inserted into tissue to apply radiofrequency power for coagulation. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Habib Laparoscopic Hexablate does not fit this description.
N/A
Intended Use / Indications for Use
The Habib Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Habib Laparoscopic Hexablate is a bipolar radiofrequency (RF) device that consists of a handle, laparoscopic shaft and introducer and an array of seven parallel electrodes which extend out from the laparoscopic shaft. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Laparoscopic 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 Laparoscopic Hexablate is designed for use in laparoscopic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was done to ensure that the Habib Laparoscope 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 Hexablate (K071103), Habib 4X Laparoscopic (K062935)
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. | |
|---|---|---|
| Contact Person: | Nagy Habib, MD | |
| Chief Executive Officer | ||
| Liver Surgery Section, Hammersmith Hospital | ||
| Du Cane Road | ||
| London, W12 0NN | ||
| United Kingdom | JAN - 9 2008 | |
| Summary Prepared: | August 20, 2007 | |
| Trade Name: | Habib Laparoscopic Hexablate | |
| Common Name: | Electrosurgical cutting and coagulation device and accessories | |
| Classification: | Class II per 21 CFR 878.4400 | |
| Product Code: | GEI | |
| Predicate Devices: | Habib Hexablate (K071103) - EMcision | |
| Habib 4X Laparoscopic (K062935) RITA Medical |
Intended Use:
The Habib Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures.
Description:
The Habib Laparoscopic Hexablate is a bipolar radiofrequency (RF) device that consists of a handle, laparoscopic shaft and introducer and an array of seven parallel electrodes which extend out from the laparoscopic shaft. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Laparoscopic 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 Laparoscopic Hexablate is designed for use in laparoscopic surgery and is a single use device.
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Technological Differences:
The Habib Laparoscopic Hexablate has the same basic technological characteristics as the Habib Hexablate (K071103). Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue. The primary difference is that the Habib Laparoscopic Hexablate is used via a laparoscopic port. The size and shape of the coagulation zone created by each device is similar. Both devices uses aspiration through the center electrode to remove fluids and gases from the center of the coagulation zone.
The Laparoscopic Hexablate is fitted with an introducer which allows the electrodes to pass through a standard Ø12mm laparoscopic port without damaging the seals.
The Habib 4X Laparoscopic (K062935) has the same basic technological characteristics as the Habib Laparoscopic Hexablate. Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue during laparoscopic procedures. The primary difference is that the Habib 4X Laparoscopic and the Habib Laparoscopic Hexablate is the number of electrodes. The Habib 4X Laparoscopic has 4 electrodes on a fixed 10mm diameter, whilst the Habib Laparoscopic has 7 electrodes (six outer array and 1 centre) which deploy upon exit of the introducer port to 20mm diameter.
Performance Data:
Performance testing was done to ensure that the Habib Laparoscope 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol to the right, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the bird. The bird symbol is composed of three curved lines that suggest the shape of a bird in flight. The logo is in black and white.
Public Health Service
JAN - 9 2008
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
Re: K073687
Trade/Device Name: Habib Laparoscopic Hexablate Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 27, 2007 Received: December 28, 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.
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 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 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 M. Millman
- 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) K073687
Device Name
Habib Laparoscopic Hexablate
The Habib Laparoscopic Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures
Prescription Use ﻬﺎ 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)
MD, MPH
Division of General, Restorative,
and Neurological Devices
510(k) Number
1