K Number
K171684
Device Name
Epix Electrosurgical Probe with Smoke Evacuation
Date Cleared
2017-08-07

(61 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The Epix Electrosurgical Probe with Smoke Evacuation is a sterile, single-use monopolar instrument equipped with a smoke evacuation feature. The proposed device uses RF energy provided by a generator to electrosurgically cut and/or coagulate tissue during general laparoscopic procedures. The electrosurgical probes are available in three different tip geometries with probe lengths ranging between 20cm - 45cm. All models are constructed of the same materials and by similar manufacturing assembly processes.
More Information

No
The summary describes a standard electrosurgical probe with smoke evacuation and does not mention any AI or ML capabilities.

Yes
The device is described as an electrosurgical probe intended to cut and coagulate tissue, which directly contributes to treating a medical condition or disease by facilitating surgical procedures.

No

Explanation: The device is described as an electrosurgical probe intended for cutting and coagulating tissue and evacuating smoke during laparoscopic procedures. Its function is to perform surgical actions, not to diagnose conditions.

No

The device description clearly states it is a physical instrument (probe) used in laparoscopic surgery, not a software application.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for delivering energy to cut and coagulate tissue during laparoscopic surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically on biological samples) diagnostic test.
  • Device Description: The description reinforces its use as a surgical instrument for electrosurgery.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on surgical intervention within the body.

N/A

Intended Use / Indications for 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.

Product codes

GEI

Device Description

The Epix Electrosurgical Probe with Smoke Evacuation is a sterile, single-use monopolar instrument equipped with a smoke evacuation feature. The proposed device uses RF energy provided by a generator to electrosurgically cut and/or coagulate tissue during general laparoscopic procedures. The electrosurgical probes are available in three different tip geometries with probe lengths ranging between 20cm - 45cm. All models are constructed of the same materials and by similar manufacturing assembly processes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Table 2: Substantial Equivalence Tests
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
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.

Key Metrics

Not Found

Predicate Device(s)

K132300

Reference Device(s)

K110268, K020186, K062464

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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 (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. 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

| 510(K) Submitter: | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------|
| Contact Person: | Aditi Iyengar
Regulatory Affairs Analyst
Applied Medical Resources
aiyengar@appliedmedical.com
Tel: (949) 713-8007
Fax: (949) 713-8205 | | |
| 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.
Regulation: 21 CFR 878.4400
Device Class: Class II
Product Code: GEI | | |
| Predicate Device: | Epix® Electrosurgical Probes
510(k)#: K132300
Product Code: GEI | | |
| Device Description: | The Epix Electrosurgical Probe with Smoke Evacuation is a sterile,
single-use monopolar instrument equipped with a smoke
evacuation feature. The proposed device uses RF energy provided
by a generator to electrosurgically cut and/or coagulate tissue
during general laparoscopic procedures. The electrosurgical
probes are available in three different tip geometries with probe
lengths ranging between 20cm - 45cm. All models are constructed
of the same materials and by similar manufacturing assembly
processes. The following configurations will be available: | | |
| | Probe Length | Probe Configuration | Model Number |
| | 20 cm | Spatula Tip
L-Hook Tip
Needle Tip | CW011
CW012
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
Epix Electrosurgical Probes | Subject
Epix Electrosurgical Probes
with Smoke Evacuation |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Epix Electrosurgical Probes | Epix Electrosurgical Probe with
Smoke Evacuation |
| | Predicate
Epix Electrosurgical Probes | Subject
Epix Electrosurgical Probes
with Smoke Evacuation |
| Probe Tip
Configurations | • Spatula Tip
• L-Hook Tip
• J-Hook Tip | • Spatula Tip
• L-Hook Tip
• Needle Tip |
| 510(k) Holder | Applied Medical Resources
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
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
provided by user | Same as predicate |
| Cable
compatibility | Standard 4mm monopolar
cables | Same as predicate |
| Materials | Stainless Steel, polymers | Same as predicate |
| Shaft Properties | • 33cm working length
• 360 ° rotation
• Straight | • 20cm - 45cm working lengths
• 360 ° rotation
• Angled at distal end |
| Single Use | No | Yes |
| Standards | Conforms to:
• ISO 10993-series
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-2
• IEC 60601-2-18
• AAMI TIR 17 | Conforms to:
• ISO 10993-series
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-2
• IEC 60601-2-18
• ISO 11137-2
• 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

TestResult
Electrosurgical PerformanceSubstantially Equivalent
Smoke Evacuation PerformanceSubstantially Equivalent

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

Table 3: Performance Tests

TestResult
BiocompatibilityMet Acceptance Criteria
Mechanical TestingMet Acceptance Criteria
Electrical Safety TestingMet Acceptance Criteria
Electromagnetic Compatibility (EMC) TestingMet 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.