(14 days)
The Habib Hexablate 10 is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
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.
The provided text is a 510(k) premarket notification for the Habib Hexablate 10, an electrosurgical cutting and coagulation device. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive de novo clinical studies with detailed acceptance criteria and standalone performance metrics.
Based on the provided text, the following can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states:
| Criterion | Reported Performance |
|---|---|
| Functionality | Device functions as intended. |
| Design Specifications | Device meets design specifications. |
| Safety and Effectiveness | Sufficient data was obtained to show that the Hexablate 10 meets safety and effectiveness criteria. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set. It mentions "Performance testing" but does not elaborate on the methodology, number of samples, or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) where the focus is often on bench testing and comparison to an existing device rather than a new clinical trial.
3. 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)
No information is provided regarding experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information is provided regarding an adjudication method.
5. 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
No MRMC comparative effectiveness study was performed or mentioned, as this device is not an AI-powered diagnostic tool. It is an electrosurgical device for tissue coagulation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done in the sense that the device itself was tested for its ability to function as intended and meet design specifications. However, this is not in the context of an "algorithm only" or "AI" standalone performance, as the device is a physical electrosurgical tool. The "Performance Data" section indicates that the device was evaluated to ensure it "functions as intended and meets design specifications."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth. Given the nature of the device (electrosurgical for tissue coagulation), ground truth would likely be established through objective measurements of coagulation zone size, tissue necrosis, temperature profiles, and potentially histological examination of treated tissue in preclinical models, but these details are not provided in the summary.
8. The sample size for the training set
No information is provided regarding a training set. This is not applicable as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model.
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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, MDChief Executive OfficerLiver Surgery Section, Hammersmith HospitalDu Cane RoadLondon, W12 0HSUnited 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.
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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
Rev0
. 47
§ 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.