Epix Electrosurgical Probe with Smoke Evacuation

K171684 · Applied Medical Resources Corporation · GEI · Aug 7, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171684
• Device Name: Epix Electrosurgical Probe with Smoke Evacuation
• Applicant: Applied Medical Resources Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic 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 Story

Sterile, single-use monopolar electrosurgical probe; used in laparoscopic surgery. Device connects to user-provided independent monopolar electrosurgical generator via standard 4mm connector to deliver RF energy for tissue cutting and coagulation. Features integrated suction channel for smoke evacuation at surgical site to improve visualization. Available in various tip geometries (spatula, L-hook, needle) and shaft lengths (20cm-45cm). Operated by surgeons in clinical/OR settings. Output is thermal energy for tissue effect and suction for smoke removal. Benefits include enhanced surgical site visibility and management of surgical smoke.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence and safety/efficacy were demonstrated through bench testing, including biocompatibility, mechanical testing, electrical safety, electromagnetic compatibility (EMC), and smoke evacuation performance testing.

Technological Characteristics

Materials: Stainless steel and polymers. Energy: Monopolar RF (user-provided generator). Dimensions: 20cm-45cm shaft lengths; spatula, L-hook, or needle tips. Connectivity: Standard 4mm monopolar female connector. Standards: ISO 10993, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ISO 11137-2, AAMI TIR 33.

Indications for Use

Indicated for patients undergoing laparoscopic surgical procedures requiring tissue cutting and coagulation via monopolar electrosurgical energy, with concurrent 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

• Epix Electrosurgical Probes (K132300)

Reference Devices

• Medtronic ForceTriad generator (K110268)
• ConMed System 5000 generator (K020186)
• Karl Storz AUTOCON II 400 SCB generator (K062464)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

August 7, 2017

Applied Medical Resources Corporation Aditi Iyengar Regulatory Affairs Analyst 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K171684

Trade/Device Name: Epix Electrosurgical Probe with Smoke Evacuation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 6, 2017 Received: June 7, 2017

Dear Aditi Iyengar:

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

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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 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. Jennifer R. Stevenson -S3

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

K171684

510(k) Number (if known)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### Device Name

Epix® Electrosurgical Probe with Smoke Evacuation

Indications for Use (Describe)

The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: | Aditi Iyengar<br>Regulatory Affairs Analyst<br>Applied Medical Resources<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] | | |
| Date of Preparation: | June 6, 2017 | | |
| Trade Name: | Epix® Electrosurgical Probes with Smoke Evacuation | | |
| Common Name: | Smoke Evacuation Electrosurgery Probes | | |
| Classification: | Electrosurgical cutting and coagulation device and accessories.<br>Regulation: 21 CFR 878.4400<br>Device Class: Class II<br>Product Code: GEI | | |
| Predicate Device: | Epix® Electrosurgical Probes<br>510(k)#: K132300<br>Product Code: GEI | | |
| Device Description: | The Epix Electrosurgical Probe with Smoke Evacuation is a sterile,<br>single-use monopolar instrument equipped with a smoke<br>evacuation feature. The proposed device uses RF energy provided<br>by a generator to electrosurgically cut and/or coagulate tissue<br>during general laparoscopic procedures. The electrosurgical<br>probes are available in three different tip geometries with probe<br>lengths ranging between 20cm - 45cm. All models are constructed<br>of the same materials and by similar manufacturing assembly<br>processes. The following configurations will be available: | | |
| | Probe Length | Probe Configuration | Model Number |
| | 20 cm | Spatula Tip<br>L-Hook Tip<br>Needle Tip | CW011<br>CW012<br>CW013 |
| Probe Length | Probe Configuration | Model Number | |
| 35 cm | Spatula Tip | CW031 | |
| | L-Hook Tip | CW032 | |
| | Needle Tip | CW033 | |
| 42cm | Spatula Tip | CW001 | |
| | L-Hook Tip | CW002 | |
| | Needle Tip | CW003 | |
| 45cm | Spatula Tip | CW041 | |
| | L-Hook Tip | CW042 | |
| | Needle Tip | CW043 | |

27 cm

Spatula Tip

L-Hook Tip Needle Tip

CW021

CW022

CW023

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Intended Use: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic 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.

## Comparison of Technological Characteristics with the Predicate Device

The subject and predicate electrosurgical probes are similar in technological characteristics, materials, performance, and method of operation. They are designed to deliver RF energy via connection to an independent monopolar generator to electrosurgically cut and coagulate tissue during general laparoscopic procedures. The subject and predicate probes are both compatible with standard monopolar electrosurgical generators such as the Medtronic® ForceTriad® generator (K110268), ConMed® System 5000™ generator (K020186), or Karl Storz ® AUTOCON ® II 400 SCB generator (K062464), using a standard 4mm monopolar female connector. Additionally, both subject and predicate probes are also equipped with a suction feature to aid in visualization of the surgical site.

The following technological differences exist between the subject and predicate electrosurgical probes:

- The suction feature on the subject device is intended to evacuate smoke while the ● suction feature on the predicate device is intended to aspirate fluid.
- . The subiect product line is available in an additional tip configuration, needle tip, and the shaft length of the subject probe is available in the range of 20cm - 45cm where the predicate probe was cleared with a 33cm length.

Table 1 below provides a more detailed comparison of the subject and predicate electrosurgical probes.

| | Predicate<br>Epix Electrosurgical Probes | Subject<br>Epix Electrosurgical Probes<br>with Smoke Evacuation |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Epix Electrosurgical Probes | Epix Electrosurgical Probe with<br>Smoke Evacuation |
| | Predicate<br>Epix Electrosurgical Probes | Subject<br>Epix Electrosurgical Probes<br>with Smoke Evacuation |
| Probe Tip<br>Configurations | • Spatula Tip<br>• L-Hook Tip<br>• J-Hook Tip | • Spatula Tip<br>• L-Hook Tip<br>• Needle Tip |
| 510(k) Holder | Applied Medical Resources<br>Corporation | Same as predicate |
| 510(k) Number | K132300 | K171684 |
| Regulation | 21 CFR §878.4400 | Same as predicate |
| FDA Product Code | GEI | Same as predicate |
| Device<br>Classification | FDA Class II | Same as predicate |
| Type of Use | Prescription Use Only | Same as predicate |
| Energy Type | Monopolar | Same as predicate |
| Energy source | Electrosurgical generator<br>provided by user | Same as predicate |
| Cable<br>compatibility | Standard 4mm monopolar<br>cables | Same as predicate |
| Materials | Stainless Steel, polymers | Same as predicate |
| Shaft Properties | • 33cm working length<br>• 360 ° rotation<br>• Straight | • 20cm - 45cm working lengths<br>• 360 ° rotation<br>• Angled at distal end |
| Single Use | No | Yes |
| Standards | Conforms to:<br>• ISO 10993-series<br>• IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-2-2<br>• IEC 60601-2-18<br>• AAMI TIR 17 | Conforms to:<br>• ISO 10993-series<br>• IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-2-2<br>• IEC 60601-2-18<br>• ISO 11137-2<br>• AAMI TIR 33 |

#### Table 1: Comparison of Characteristics

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## Performance Data

The performance data in Table 2 is provided in support of the substantial equivalence determination.

### Table 2: Substantial Equivalence Tests

| Test | Result |
|------------------------------|--------------------------|
| Electrosurgical Performance | Substantially Equivalent |
| Smoke Evacuation Performance | Substantially Equivalent |

The performance data in Table 3 is provided to demonstrate safety and efficacy of the subject devices.

#### Table 3: Performance Tests

| Test | Result |
|---------------------------------------------|-------------------------|
| Biocompatibility | Met Acceptance Criteria |
| Mechanical Testing | Met Acceptance Criteria |
| Electrical Safety Testing | Met Acceptance Criteria |
| Electromagnetic Compatibility (EMC) Testing | Met Acceptance Criteria |

No animal or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance. The non-clinical performance data detailed in this submission supports the substantial equivalence of the subject device.

## Conclusion

Based on the intended use, technological characteristics, and performance testing results, the subject Epix Electrosurgical Probes with Smoke Evacuation are substantially equivalent to the predicate Epix Electrosurgical Probes and do not raise any new issues of safety and efficacy.