The HET™ Bipolar Electrocautery Forceps and Monitor are intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.

The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.

The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT II RF energy generators.

Device Description

The HET™ Bipolar Electrocautery System is comprised of the HET™ Bipolar Forceps and the HET™ Monitor.

The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cable to the bipolar output of an electrosurgical generator.

When connected to the HET™ Monitor, the HET™ Bipolar Forceps has an integrated tissue illumination feature and a temperature probe. The HET™ Monitor is an accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.

AI/ML Overview

The provided 510(k) summary for the HET™ Bipolar Electrocautery Forceps and Monitor (K121085) does not explicitly detail acceptance criteria in a quantitative table or the specific performance metrics used in the human clinical evaluations. The information focuses on establishing substantial equivalence to predicate devices rather than proving a set of pre-defined acceptance criteria with specific performance values.

However, based on the description, we can infer the intent of the acceptance criteria was to demonstrate clinical performance "substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device" for the treatment of symptomatic Grade I and Grade II internal hemorrhoids, and general grasping, manipulating, and coagulating soft tissue.

Below is an attempt to structure the requested information based on the available text, with caveats regarding the missing specifics:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Inferred from substantial equivalence)	Reported Device Performance
Clinical Efficacy for Symptomatic Grade I & II Internal Hemorrhoids	Clinical outcomes demonstrating similar efficacy to the Redfield Infrared Coagulator (K950836) as reported in literature.	The two human clinical evaluations "demonstrated outcomes substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device."
Tissue Coagulation (General Surgery)	Effective grasping, manipulating, and coagulating soft tissue during general surgery.	This is stated as an intended use, implicitly confirmed by substantial equivalence.
Safety (Biocompatibility, Electrical Safety)	Meeting established standards for biocompatibility and electrical safety.	"Biocompatibility studies, software validations, and electrical safety studies were conducted and reported in the 510(k) Notice for the predicate HET Systems device [K110143]. Because the two devices are essentially the same, the information reported for the predicate HET device is applicable."
In Vivo Performance	Performance comparable to the predicate device in an animal model.	"A study (in an animal model) was conducted to evaluate the in vivo performance and histological effects of the device as compared to the predicate device [K110143]."

2. Sample Size Used for the Test Set and Data Provenance

Human Clinical Evaluations: Two human clinical evaluations were conducted. The specific sample size for these studies is not provided in the summary.
Data Provenance: The origin of the data (country of origin, retrospective or prospective) for the human clinical evaluations is not specified.
Animal Model Study: One animal model study was conducted. The specific sample size (number of animals) is not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. The context of "substantially equivalent to clinical outcomes reported in the literature" suggests a comparison to published data, but it doesn't detail how ground truth for the specific clinical evaluations conducted was established or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the focus on substantial equivalence to literature outcomes, a formal adjudication process for the conducted human studies is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This review is for an electrosurgical device, not an AI-powered diagnostic or imaging interpretation device. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not applicable and was not performed.

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

This is an electrosurgical device with a monitor displaying temperature. It is not an algorithm-only device, and standalone algorithm performance is not applicable. The device is intended for human-in-the-loop operation.

7. Type of Ground Truth Used

Clinical Efficacy (Human Clinical Evaluations): The ground truth for the human clinical evaluations appears to be clinical outcomes observed in patients and compared to published literature on the predicate IRC device.
In Vivo Performance: The ground truth for the animal study involved evaluating "in vivo performance and histological effects."

8. Sample Size for the Training Set

This is an electrosurgical device, not a machine learning or AI algorithm in the context of device approval. Therefore, the concept of a "training set" for an algorithm is not applicable. The device's design and manufacturing rely on engineering principles, material science, and established medical device testing, not data-driven machine learning models.

9. How the Ground Truth for the Training Set was Established

As explained above, the concept of a "training set" and its associated ground truth is not applicable to this type of medical device for regulatory approval.

Summary

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K121085

NOV 2 0 2012 1

510(k) SUMMARY (Per 21 CFR 807.92)

General Company Information

HET Systems, LLC Name: Howard Schrayer Contact: Regulatory Affairs Consultant
113 Laredo Drive Address: Morganville, NJ 07751
(609) 924-9510 Telephone: hs.ss@verizon.net E-mail:
November 20, 2012 Date Prepared

General Device Information

HET™ Bipolar Electrocautery Forceps and Monitor Product Name:

"Electrosurgical cutting and coagulation device and Classification: accessories" Product code: GEI - Class II 21 CFR 878.4400

Predicate Devices

HET™ Bipolar Electrocautery Forceps and Monitor HET Systems, Inc. 510(k) K110143

Redfield Infrared Coagulator Redfield, Inc. 510(k) K950836

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Description

The HET™ Bipolar Electrocautery System is comprised of the HET™ Bipolar Forceps and the HET™ Monitor.

Intended Use (Indications)

The HET™ Bipolar Electrocautery Forceps and Monitor is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.

The HET™ Bipolar Electrocautery System may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.

Substantial Equivalence

This submission supports the position that the HET™ Bipolar Electrocautery Forceps is substantially equivalent to a number of previously cleared devices, including the previously cleared HET Bipolar Electrocautery Forceps and Monitor (K110143) and the Redfield Infrared Coagulator (K950836).

The technological characteristics of the device are unchanged (exactly the same as) the characteristics of the predicate HET Systems device that was cleared under 510(k) K110143, with the exception that the timing indicator has been removed from the Monitor. Specifically, the materials, software, and treatment mechanism (i.e., bipolar energy used to produce heat) are unchanged.

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The technological characteristics of the device differ from those of the Redfield Infrared Coagulator (IRC) predicate that was cleared under 510(k) K950836 in regard to the materials used and energy source. The IRC device uses infrared light to produce heat, instead of high frequency bipolar energy. However, both predicate systems and the subject device use thermal energy to achieve the treatment effect (tissue coagulation). The IRC predicate is indicated for the treatment of internal hemorrhoids.

The 510(k) Notice contains a report of a study (in an animal model) that was conducted to evaluate the in vivo performance and histological effects of the device as compared to the predicate device. Biocompatibility studies, software validations, and electrical safety studies were conducted and reported in the 510(k) Notice for the predicate HET Systems device. Because the two devices are essentially the same, the information reported for the predicate HET device is applicable.

The 510(k) Notice also contains reports of two human clinical evaluations that were conducted to evaluate the clinical performance of the device. These studies demonstrated outcomes substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device.

Conclusions

HET Systems, LLC believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the indications for the HET™ Bipolar Electrocautery Forceps and Monitor. The material from which the HET Systems device is fabricated has an established history of use in medical applications; and devices produced by HET Systems have been tested in accordance with applicable guidelines and standards.

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three curved lines that suggest a person in motion. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 20, 2012

HET Systems, LLC % HET Bipolar Ligator System Mr. Howard Schrayer Regulatory Affairs Consultant 113 Laredo Drive Morganville, NJ 07751

Re: K121085

Trade/Device Name: HET™ Bipolar Electrocautery Forceps and Monitor Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 09, 2012 Received: November 13, 2012

Dear Mr. Schraver:

We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Howard Schrayer

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K121085

Device Name: HET™ Bipolar Electrocautery Forceps and Monitor

Indications For Use:

The HET™ Bipolar Electrocautery Forceps and Monitor are intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.

The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division sign-off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K 121085

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.