Epix Electrosurgical Probe with Smoke Evacuation

K151480 · Applied Medical Resources · GEI · Feb 19, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K151480
• Device Name: Epix Electrosurgical Probe with Smoke Evacuation
• Applicant: Applied Medical Resources
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Monopolar electrosurgical probe for laparoscopic surgery; features spatula, L-hook, or needle tips. Device connects to independent monopolar electrosurgical generator (ESG) for RF energy delivery and hospital vacuum source for smoke evacuation. Operated by surgeon in OR; shaft rotates 360 degrees via handpiece knob. RF energy conducts from connector through shaft to tip for tissue cutting/coagulation; vacuum draws smoke from site. Provides surgical access and smoke clearance; benefits include improved visualization and reduced smoke inhalation risk for OR staff.

Clinical Evidence

Bench testing only. In vitro testing evaluated thermal spread using tissue representative of laparoscopic procedures across high, medium, and low generator settings. Aspiration flow rate for smoke evacuation was compared against a reference device (K003443). Results demonstrated thermal spread similar to predicate and reference devices; smoke evacuation performance was found comparable to the reference device.

Technological Characteristics

Monopolar electrosurgical probe with pistol grip handle and 360-degree rotating shaft. Materials evaluated per ISO 10993. Energy source: external monopolar ESG. Connectivity: 4mm cable to ESG, flexible tube to vacuum source. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. No software or algorithm.

Indications for Use

Indicated for patients undergoing laparoscopic or endoscopic surgical procedures requiring tissue cutting and coagulation via monopolar electrosurgical energy, with optional smoke evacuation at the surgical site.

Regulatory Classification

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.

Predicate Devices

• Microline™ Pentax Inc Electrosurgical Cautery Probes (K981188)

Reference Devices

• Applied Medical Suction/Irrigator (K003443)
• Applied Medical Epix Electrosurgical S/I Probes (K132300)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 510(k) Summary

| 510(K) Submitter: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA, 92688<br>[phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Jessica Cho, MS<br>Manager, Regulatory Affairs<br>Applied Medical Resources<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| 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.<br>Class II, Product Code: GEI, Regulation: 21 CFR 878.4400 |
| Primary Predicate<br>Device: | Microline™ Pentax Inc Electrosurgical Cautery Probes<br>510(k): K981188<br>Product Code: GEI |
| Reference Device: | Applied Medical Suction/Irrigator<br>510(k): K003443<br>Product Code: FHF<br>Applied Medical Epix Electrosurgical S/I Probes<br>510(k): K132300<br>Product Code: GEI |
| Intended Use: | The Epix® Electrosurgical Probes with Smoke Evacuation (spatula,<br>L-hook, needle tips) are intended to deliver energy from an<br>independent monopolar electrosurgical generator to cut and<br>coagulate tissue during laparoscopic (inclusive of endoscopic)<br>surgical procedures where the device is introduced into the body<br>through a cannula. The device may be used for the evacuation of<br>smoke created by electrosurgery at the surgical site. |
| Device Description: | Electrosurgical probes are designed for electrosurgical cutting and<br>coagulation of tissue during general laparoscopic procedures. The<br>device also has a smoke evacuation feature. The subject device has<br>an angled shaft that fits through 10mm trocar cannulas and must be<br>connected to a standard electrosurgical generator and a vacuum<br>source 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).