EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE

K132300 · Applied Medical Resources Corp. · GEI · Jan 24, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132300
• Device Name: EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
• Applicant: Applied Medical Resources Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epix® electrosurgical probes are indicated for irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures.

Device Story

Epix Electrosurgical Probes are reusable suction and irrigation devices used during general laparoscopic procedures. The device connects to a suction/irrigation tubing set and an electrosurgical generator. It functions by delivering electrosurgical energy for tissue cutting and coagulation while simultaneously providing suction and irrigation capabilities. Operated by surgeons in an OR setting, the device facilitates tissue management and fluid control. The probe's design allows for integration with standard electrosurgical equipment, aiding the surgeon in performing laparoscopic interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was evaluated via side-by-side laboratory testing against the predicate device to confirm functional equivalence of suction and irrigation features. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and ISO 10993 standards was demonstrated.

Technological Characteristics

Reusable unipolar electrosurgical probe; suction and irrigation functionality; connects to external electrosurgical generator and tubing set. Materials and tip configuration similar to predicate. Safety/performance standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993.

Indications for Use

Indicated for irrigation, fluid evacuation, and electrosurgical cutting/coagulation during general laparoscopic procedures.

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

• Modulap™ Reusable Unipolar Electrosurgical Probes (K983623)

Submission Summary (Full Text)

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## 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| 510(K) Submitter: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA, 92688<br>[phone] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jessica Cho<br>Regulatory Affairs Specialist<br>Applied Medical Resources<br>[e-mail]<br>Tel: [phone] ext. 6697<br>Fax: [phone] |
| Date of Preparation: | July 22, 2013 |
| Trade Name: | Epix® Electrosurgical Probes |
| Common Name: | Electrosurgical Probes |
| Classification: | Class II<br>Product Code: GEI<br>Regulation: 21 CFR 878.4400 |
| Predicate Device: | Modulap™ Reusable Unipolar Electrosurgical Probes<br>510(k)#: K983623<br>Product Code: GCJ |
| Device Description: | Electrosurgical probes are reusable suction and irrigation devices<br>designed for electrosurgical cutting and coagulation of tissue during<br>general laparoscopic procedures. |
| Intended Use: | The Epix® electrosurgical probes are indicated for irrigation,<br>evacuation of fluids, and electrosurgical cutting and coagulation during<br>general laparoscopic procedures. |

#### Summary of Technological Characteristics:

The Epix® Electrosurgical Probes are substantially equivalent in safety and effectiveness to the Modulap™ Reusable Unipolar Electrosurgical Probes (K983623).

The subject and predicate device are similar in tip-configuration, size, materials, technology, and Priveres They are reusable, suction and irrigation devices designed for electrosurgical cutting and coagulation during general laparoscopic procedures. The subject and predicate electrosurgical probes are each designed to interface and function when connected to a suction irrigation tubing set and electrosurgical generator.

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#### Discussion of Performance Testing:

The Epix Electrosurgical Probes are designed to the following safety and performance standards: 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, and ISO 10993 Biological Evaluation of Medical Devices.

Applied Medical created a testing protocol to confirm substantial equivalency between the subject and predicate. The devices were tested side-by-side to evaluate substantial equivalence of performance in a laboratory setting. The bench top tests were designed to focus on the functional performance of the suction and irrigation features.

#### Conclusions Drawn from Testing:

Testing demonstrates that the subject Epix Electrosurgical Probes are substantially equivalent to the predicate Modulap Reusable Unipolar Electrosurgical Probes.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

January 24, 2014

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

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

Re: K132300

Trade/Device Name: Epix® Electrosurgical Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 14, 2014 Received: January 16, 2014

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 (reporting of medical device-related 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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Page 2 - Ms. Jessica Cho

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joshuaj@JWipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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: K132300

Device Name: Epix® Electrosurgical Probes

Indications for Use: The Epix® Electrosurgical Probes are indicated for irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Long H. Chen -A

2.19200300.100.1.1=130038 4:24:42 -05-00

for BSA

(Division Sign-Off)

Division of Surgical Devices

510(k) Number: K132300