The Epix® Electrosurgical Probes with Smoke Evacuation (spatula, L-hook, needle tips) are intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic (inclusive of endoscopic) surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.

Device Description

Electrosurgical probes are designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures. The device also has a smoke evacuation feature. The subject device has an angled shaft that fits through 10mm trocar cannulas and must be connected to a standard electrosurgical generator and a vacuum source in order to operate according to its intended use. The shaft can be rotated 360 degrees using a knob on the handpiece.

The probes are available in the following tip configurations:

Spatula Tip
L-Hook Tip
Needle Tip

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Epix Electrosurgical Probe with Smoke Evacuation, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
Safety Standards Adherence	IEC 60601-1: General requirements for safety of medical electrical equipment.	Designed/evaluated to meet this standard.
	IEC 60601-1-2: Electromagnetic compatibility requirements and tests.	Designed/evaluated to meet this standard.
	IEC 60601-2-2: Particular requirements for basic safety and essential performance of high-frequency surgical equipment.	Designed/evaluated to meet this standard.
	ISO 10993: Biological Evaluation of Medical Devices.	Designed/evaluated to meet this standard.
Functional Performance (Electrosurgery)	Thermal spread during electrosurgical cutting and coagulation should be similar to predicate and reference devices.	Thermal spread was found to be similar between the subject device (Epix Electrosurgical Probe), the predicate (Microline™ Electrosurgical Cautery Probes K981188), and the reference device (Applied Medical Epix Electrosurgical S/I Probes K132300). This was tested across high, medium, and low settings on a monopolar generator.
Functional Performance (Smoke Evacuation)	Aspiration flow rate (for smoke evacuation) should be comparable to a reference device.	Aspiration flow rate (smoke evacuation feature) comparison testing showed the subject device was comparable to the reference device (Applied Medical Suction/Irrigator cleared in K003443).
Substantial Equivalence	Overall safety and effectiveness should be substantially equivalent to the predicate device.	The device was found to be substantially equivalent in safety and effectiveness to the Microline™ Electrosurgical Cautery Probes (K981188), with the additional capability of removing smoke from the operative site.

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

The document does not explicitly state a numerical sample size for the test set used in the performance testing. However, it indicates:

Sample Size: "Testing was performed in vitro using tissue that is representative of what the device may encounter during general laparoscopic procedures." This implies the use of a sufficient amount of tissue samples to conduct the comparison testing across various electrosurgical settings. Specific numbers of tissue samples are not provided.
Data Provenance: The testing was "in vitro." The document does not specify a country of origin for the data beyond that it was performed in vitro. It is a retrospective study in the sense that it's a submission for a pre-market notification, relying on data collected for this purpose, not a prospective clinical trial.

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

The document does not mention the use of experts to establish a "ground truth" for the performance testing. The comparison was based on objective measurements of thermal spread and aspiration flow rate against established predicate and reference device performance.

4. Adjudication Method for the Test Set

Not applicable. The testing was objective performance testing (thermal spread, aspiration flow rate) and comparison against predicate/reference devices, not a diagnostic or interpretive task requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes in-vitro performance testing comparing the new device to existing predicate and reference devices. It does not describe a MRMC comparative effectiveness study involving human readers or assessing improvement with AI assistance.

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

Yes, in a sense. The performance testing described is standalone in that it evaluates the physical device's performance characteristics (thermal spread, smoke aspiration) directly, without human interpretation in a diagnostic context. It's not an "algorithm" in the AI sense, but the device's functional performance was assessed on its own merits and in comparison to other devices.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was:

Measured physical properties: Direct measurements of thermal spread in tissue and aspiration flow rate.
Comparison to established predicate/reference performance: The performance of the predicate (Microline™ Electrosurgical Cautery Probes K981188) and reference devices (Applied Medical Suction/Irrigator K003443 and Applied Medical Epix Electrosurgical S/I Probes K132300) served as the benchmark for "truth." The claim is that the subject device performs similarly or comparably to these legally marketed devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. It is a physical electrosurgical probe.

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

Not applicable, as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2016

Applied Medical Resources Ms. Jessica Cho.MS Manager, Regulatory Affairs 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K151480

Trade/Device Name: Epix Electrosurgical Probe with Smoke Evacuation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation Device & Accessories Regulatory Class: Class II Product Code: GEI Dated: January 26, 2016 Received: January 27, 2016

Dear Ms. Cho:

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 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 of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerelv vours.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K151480

Device Name

Epix® Electrosurgical Probes with Smoke Evacuation

Indications for Use (Describe)

The Epix® Electrosurgical Probes with Smoke Evacuation (spatula, L-hook, needle tips) are intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic (inclusive of endoscopic) surgical procedures where is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

510(K) Submitter:	Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA, 92688(949) 713-8000
Contact Person:	Ms. Jessica Cho, MSManager, Regulatory AffairsApplied Medical Resourcesjcho@appliedmedical.comTel: (949) 713-7958Fax: (949) 713-8205
Date of Preparation:	January 26, 2016
Trade Name:	Epix® Electrosurgical Probes with Smoke Evacuation
Common Name:	Electrosurgical Probes
Classification:	Electrosurgical cutting and coagulation device and accessories.Class II, Product Code: GEI, Regulation: 21 CFR 878.4400
Primary PredicateDevice:	Microline™ Pentax Inc Electrosurgical Cautery Probes510(k): K981188Product Code: GEI
Reference Device:	Applied Medical Suction/Irrigator510(k): K003443Product Code: FHFApplied Medical Epix Electrosurgical S/I Probes510(k): K132300Product Code: GEI
Intended Use:	The Epix® Electrosurgical Probes with Smoke Evacuation (spatula,L-hook, needle tips) are intended to deliver energy from anindependent monopolar electrosurgical generator to cut andcoagulate tissue during laparoscopic (inclusive of endoscopic)surgical procedures where the device is introduced into the bodythrough a cannula. The device may be used for the evacuation ofsmoke created by electrosurgery at the surgical site.
Device Description:	Electrosurgical probes are designed for electrosurgical cutting andcoagulation of tissue during general laparoscopic procedures. Thedevice also has a smoke evacuation feature. The subject device hasan angled shaft that fits through 10mm trocar cannulas and must beconnected to a standard electrosurgical generator and a vacuumsource in order to operate according to its intended use. The shaft

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can be rotated 360 degrees using a knob on the handpiece.

The probes are available in the following tip configurations:

Spatula Tip
L-Hook Tip ●
Needle Tip

Summary of Technological Characteristics:

The subject electrosurgical probes feature a monopolar connector post at the base of the pistol grip handle, which may be connected to the monopolar port of an electrosurgical generator (ESG), via a standard 4mm cable, to perform electrosurgery.

When the ESG is activated by its footswitch(es), RF energy is conducted from the connector, along the shaft, and delivered at the tip. Cutting and coagulation using the subject device is fully dependent on the output waveform from the connected ESG.

A long flexible tube extends from the handpiece and connects the device to a vacuum source available in most operating suites. The smoke aspiration rate is fully dependent on the pressure of the vacuum source.

The subject and the predicate Microline™ Electrosurgical Cautery Probes (K981188) devices are similar in tip-configuration, size, materials, technology, and performance. Both are devices designed for electrosurgical cutting and coagulation during general laparoscopic procedures and function when connected to a standard electrosurgical generator.

The main difference between subject and predicate is that the subject device has a smoke evacuation capability.

Discussion of Performance Testing:

The Epix Electrosurgical Probes are designed/evaluated to the following safety and performance standards/tests:

IEC 60601-1 Medical electrical equipment General requirements for safety ●
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety -● Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ISO 10993 Biological Evaluation of Medical Devices.
Aspiration flow rate (smoke evacuation feature) comparison testing against a reference device: the Applied Medical Suction/Irrigator cleared in K003443. This device is also marketed by Applied Medical and contains a smoke evacuation feature when connected to the hospital vacuum source.

Thermal spread during electrosurgical cutting and coagulation was evaluated side-by-side

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with the predicate Microline™ Electrosurgical Cautery Probes (K981188) and also against a reference device, the Applied Medical Epix Electrosurgical S/I Probes (K132300). Testing was performed in vitro using tissue that is representative of what the device may encounter during general laparoscopic procedures. All applicable functions (i.e., electrosurgical cut and coagulation) were tested using high, medium, and low settings on a monopolar generator. Thermal spread was found to be similar between the subject, predicate, and reference devices.

Conclusions Drawn from Testing:

The subject Epix Electrosurgical Probes with Smoke Evacuation are substantially equivalent to the predicate Microline™ Electrosurgical Cautery Probes (K981188) with the additional capability of removing smoke from the operative site. Thermal spread was found to be substantially equivalent to the predicate Microline device. The smoke evacuation feature was found to be comparable to a separate reference device, the Applied Medical Suction/Irrigator cleared in K003443.

The Epix® Electrosurgical Probes with Smoke Evacuation are substantially equivalent in safety and effectiveness to the Microline™ Electrosurgical Cautery Probes (K981188).

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.