The Habib EndoHPB is a bipolar radiofrequency (RF) device that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib EndoHPB has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device.

AI/ML Overview

The provided K083292 submission for the Habib EndoHPB does not include detailed acceptance criteria or a specific study that proves the device meets such criteria in the way typically associated with AI/ML device performance evaluation.

Instead, this submission is for a conventional electrosurgical unit and relies on a demonstration of substantial equivalence to a predicate device (Habib Endoblate catheter, K072383).

Here's an analysis based on the provided text, highlighting what is and isn't present regarding acceptance criteria and performance studies:

Acceptance Criteria and Reported Device Performance

The submission focuses on the device functioning "as intended" and meeting "design specifications" to establish substantial equivalence, rather than defining specific, quantifiable acceptance criteria like sensitivity, specificity, or AUC which are common for AI/ML devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Functions as Intended (Coagulate tissue in GI tract)	"Performance testing was undertaken to ensure that the Habib EndoHPB functions as intended..."
Meets Design Specifications	"...and meets design specifications."
Substantially Equivalent to Predicate Device (K072383)	"Sufficient data was obtained to show that the device is substantially equivalent to the predicate device..."
Meets Safety and Effectiveness Criteria (General)	"...and meets safety and effectiveness criteria."
Bipolar RF energy for tissue coagulation	"Both devices use bipolar RF energy through a number of electrodes to coagulate tissue."
Single-use sterile device	"The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device."

No specific quantitative metrics or thresholds (e.g., specific coagulation depth, lesion size uniformity, power output ranges) are explicitly stated as acceptance criteria in the provided text. The evaluation is qualitative and comparative against the predicate.

Study Information (as applicable to this type of device submission)

Sample size used for the test set and the data provenance:
- Not explicitly stated. The submission mentions "Performance testing was undertaken," but does not detail the nature of this testing (e.g., in vitro, ex vivo, animal studies, human trials), the number of samples/cases tested, or their origin. For a device like this, testing might involve bench testing on tissue phantoms or ex vivo tissue samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. Given that this is an electrosurgical device for tissue coagulation, the "ground truth" would likely be objectively measurable physical effects (e.g., tissue temperature, lesion depth, lack of charring, power delivery metrics) rather than subjective expert interpretation of images or clinical findings. The submission does not specify the involvement of experts in establishing ground truth for performance testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None stated. Adjudication methods are typically used for establishing ground truth in AI/ML performance studies where human interpretation is involved. For this device, performance is likely assessed through objective measurements against design specifications and physical properties.
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, an MRMC study was not done. This is not an AI/ML device, and therefore this type of study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The performance of the device ("algorithm only") would be its physical output and effect on tissue, which was assessed through "performance testing." However, the term "standalone" in this context is typically reserved for AI/ML algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied objective measurements against design specifications and functional intent. For an electrosurgical device, ground truth would relate to the physical effects of energy delivery on tissue (e.g., measurable coagulation, temperature profiles, impedance changes) rather than diagnostic interpretations. The submission doesn't explicitly state the methodology for establishing "ground truth," but it would involve standard engineering and biological testing.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.

In summary: The K083292 submission for the Habib EndoHPB demonstrates safety and effectiveness through substantial equivalence to a predicate device, supported by general "performance testing" to ensure it functions as intended and meets design specifications. It does not provide the detailed, quantitative acceptance criteria and study methodologies, particularly those related to a test set and ground truth establishment, that would be expected for an AI/ML-driven medical device.

Summary

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K083292

SECTION 3

Summary of Safety and Effectiveness

Sponsor:	EMcision, Ltd.	JUN 10 2009
Contact Person:	Nagy Habib, MDChief Executive OfficerLiver Surgery Section, Hammersmith HospitalDu Cane RoadLondon, W12 0NNUnited Kingdom
Summary Prepared:	2007-05-01
Trade Name:	Habib EndoHPB
Common Name:	Endoscopic Electrosurgical Unit
Classification:	Class II per 21 CFR 876.4300
Product Code:	Gastroenterology-Urology (GU)KNS
Predicate Device:(K072383.)	Habib Endoblate catheter manufactured by EMcision Ltd

Intended Use:

The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract.

Description:

The Habib EndoHPB is a bipolar radiofrequency (RF) device that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel and activated with bipolar RF energy.

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SECTION 3

Summary of Safety and Effectiveness

The Habib EndoHPB has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device.

Technological Differences:

The Habib EndoHPB has the same basic technological characteristics as the Habib Endoblate. Both devices use bipolar RF energy through a number of electrodes to coagulate tissue.

Performance Data:

Performance testing was undertaken to ensure that the Habib EndoHPB 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2009

EMcision Ltd. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA. 95131

Re: K083292

Trade/Device Name: Habib EndoHPB

Regulation Number: 21 CFR 876.4300

Regulation Name: Endoscopic electrosurgical unit and accessories

Regulatory Class: II Product Code: KNS Dated: May 20, 2009 Received: May 26, 2009

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.

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 (OS) regulation (21 CFR Part 820); and if avplicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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 one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological 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)

Not yet Allocated

Device Name

Habib EndoHPB

The Habib EndoHPB is intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.

PLEASE DO NO WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ OR Over the Counter Use X

(per 21 CFR 878.4400)

Coles n Pollard

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Habib EndoHPB 510(k) Section 2, Indications for Use Statement Revision 2 2009-06-09 EMcision, Ltd. Page 2-1

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).