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.

AI/ML Overview

The provided text describes a medical device, the "Habib Laparoscopic Hexablate," and its 510(k) submission to the FDA. However, the document does not include detailed acceptance criteria or a specific study that proves the device meets those criteria in the context of device performance as one might expect for a robust clinical trial.

Instead, the "Performance Data" section states: "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."

This indicates that the device's performance was evaluated primarily against its predicate devices (Habib Hexablate (K071103) and Habib 4X Laparoscopic (K062935)) to demonstrate substantial equivalence for regulatory approval, rather than through a separate study with predefined acceptance criteria for novel clinical efficacy. The FDA's letter confirms this is a substantial equivalence determination.

Therefore, many of your specific questions cannot be answered from the provided text, as the focus is on regulatory equivalence rather than a clinical effectiveness study with defined performance metrics.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria for performance (e.g., coagulation depth, accuracy, etc.) and corresponding reported device performance values are NOT explicitly stated.

The "Performance Data" section generally states:

Acceptance Criteria (Implied): The device functions as intended and meets design specifications. It is substantially equivalent to the predicate device, and meets safety and effectiveness criteria.
Reported Device Performance: "Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

The "Technological Differences" section provides some comparative details, implying performance equivalence:

Habib Laparoscopic Hexablate vs. 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."
Habib Laparoscopic Hexablate vs. Habib 4X Laparoscopic (K062935): "Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue during laparoscopic procedures." The main difference is the number and deployment of electrodes.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Device functions as intended.	"Performance testing was done to ensure that the Habib Laparoscope Hexablate functions as intended and meets design specifications."
Meets design specifications.	"Performance testing was done to ensure that the Habib Laparoscope Hexablate functions as intended and meets design specifications."
Substantially equivalent to predicate device(s).	"Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria." This is further supported by the comparison: "The size and shape of the coagulation zone created by each device [Habib Laparoscopic Hexablate and Habib Hexablate] is similar." and "Both devices [Habib Laparoscopic Hexablate and Habib 4X Laparoscopic] use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue during laparoscopic procedures."
Meets safety and effectiveness criteria (as defined by predicate device's performance).	"Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. The document refers to "Performance testing" but does not detail the nature of these tests (e.g., in vitro, ex vivo, animal studies) or any human subject data, test set size, or data provenance. Given the nature of a 510(k) for substantial equivalence, clinical trials with large human test sets are often not required if bench and possibly animal testing support the claims relative to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the given text. The document doesn't describe a ground truth establishment process by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given text.

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. The provided text describes an electrosurgical device, not an AI or imaging diagnostic device. Therefore, an MRMC study involving human readers' improvement with AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an electrosurgical instrument for direct surgical application, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" in the context of diagnostic or interpretive AI/imaging is not applicable to this device. The performance evaluation would likely involve engineering parameters, tissue coagulation studies (which might use histology/pathology as a "ground truth" for coagulation depth/volume, but this is not specified), and comparison to predicate device performance.

8. The sample size for the training set

This information is not provided and is not applicable as this is not a machine learning/AI device.

9. How the ground truth for the training set was established

This information is not provided and is not applicable as this is not a machine learning/AI device.

Summary

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SECTION 3 Summary of Safety and Effectiveness

Sponsor:	EMcision, Ltd.
Contact Person:	Nagy Habib, MDChief Executive OfficerLiver Surgery Section, Hammersmith HospitalDu Cane RoadLondon, W12 0NNUnited 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) - EMcisionHabib 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:

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Page 2 of 2

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.

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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<073687

Habib Laparoscopic Hexablate 510(k) Section 2, Indications for Use Statement

Revision 1

Regulation Number and Section

§ 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.