SERFAS 90-S Electrosurgical Probe

K160050 · Stryker Corporation · GEI · May 3, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160050
• Device Name: SERFAS 90-S Electrosurgical Probe
• Applicant: Stryker Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker SERFAS 90-S Electrosurgical Probe is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.

Device Story

The SERFAS 90-S Electrosurgical Probe is a disposable, single-use accessory for the SERFAS Energy System; used in arthroscopic orthopedic procedures. The device delivers radiofrequency (RF) energy to soft tissue for resection, ablation, and coagulation; also provides hemostasis for blood vessels. Operated by surgeons in clinical settings; the probe connects to a compatible Stryker RF generator console. The device features a redesigned ceramic tip, electrode face suction path, and handle to improve mechanical robustness and prevent unintentional activation. Surgeons use the probe to remove tissue and control bleeding during joint surgery; the device benefits patients by facilitating minimally invasive arthroscopic interventions. The probe is provided sterile via ethylene oxide.

Clinical Evidence

Bench testing only. Testing included aggressive use, tip cantilever strength, electrode bend testing, thermal expansion, leak testing, and system compatibility with Stryker consoles. Biocompatibility was assessed per ISO 10993-1:2009. Sterilization validation followed ISO 11135:2014 and residuals were assessed per ISO 10993-7. All tests passed.

Technological Characteristics

RF electrosurgical probe; disposable; ethylene oxide sterilized. Materials: ceramic and handle components (biocompatible per ISO 10993-1). Features: suction path, electrode face. Energy source: RF generator (external). Connectivity: compatible with Stryker RF consoles.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic joint procedures (knee, shoulder, elbow, hip, ankle, wrist).

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

• SERFAS Energy System (K041810)

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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

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

May 3, 2016

Stryker Corporation Somi Ekwealor Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95138

Re: K160050

Trade/Device Name: SERFAS 90-S Electrosurgical Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: April 1, 2016 Received: April 4, 2016

Dear Somi Ekwealor:

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.

Sincerely yours,

Jennifer R. Stevenson -A

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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| K160050 | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Page 1 of 1 | Page 19 of 681 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------|
| | <b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | |
| 510(k) Number (if known) | K160050 | | |
| Device Name | Stryker® SERFAS 90-S Electrosurgical Probe | | |
| Indications for Use (Describe) | The Stryker SERFAS 90-S Electrosurgical Probe is indicated for resection, ablation, and coagulation of soft tissue and<br>hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip,<br>ankle, and wrist. | | |
| Type of Use (Select one or both, as applicable) | | | |
| | <div> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> | <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> | |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |

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## 1. General Information

| 510(k) Sponsor | Stryker Corporation |
|-------------------------|-----------------------------------------------------------------------------------|
| Address | 5900 Optical Court<br>San Jose, CA 95138 |
| FDA Registration Number | 2936485 |
| Correspondence Person | Mr. Somi Ekwealor, MSRS, RAC<br>Regulatory Affairs Analyst<br>Stryker Corporation |
| Contact Information | Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared | 08 Jan 2016 |

# 2. Device Identification

Proposed Device:

| Proprietary Name | Stryker® SERFAS 90-S Electrosurgical Probe |
|---------------------|-------------------------------------------------------------------|
| Common Name | RF Probe |
| Classification Name | Electrosurgical Cutting and Coagulation Device<br>and Accessories |
| Regulation Number | 21 CFR 878.4400 |
| Product Code | GEI |
| Regulatory Class | II |

### Predicate Device:

| Proprietary Name | SERFAS Energy System (probe only*) |
|------------------------|----------------------------------------------------------------|
| Common Name | RF System, RF Generator, RF Probe, RF Footswitch |
| Premarket Notification | K041810 |
| Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Number | 21 CFR 878.4400 |
| Product Code | GEI |
| Regulatory Class | II |

* The predicate device includes the entire energy system and accessories while the Proposed device includes the electrosurgical probe (90-S Redesign) only. This premarket notification refers to the SERFAS 90-S Redesign unless Original SERFAS 90-S is stated.

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### Device Description

The Stryker SERFAS 90-S Electrosurgical Probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810, which is intended for resection, ablation, and coagulation of soft tissue via radiofrequency (RF) ablation. RF ablation probes are the main tool used in most arthroscopic procedures for the removal of tissue and the coagulation of bleeding vessels. The Proposed device is a disposable single-use electrosurgical device provided sterile via Ethylene Oxide sterilization.

### 3. Indication for Use

The Stryker SERFAS 90-S electrosurgical probe is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.

### 4. Comparison of Technological Characteristics with the Predicate Device

The Stryker SERFAS 90-S electrosurgical probe and predicate device are similar in technological characteristics and design. The predicate device includes the entire SERFAS Energy system while the Proposed device includes the probe only.

The differences between the Proposed device and the predicate are minor and raise no new questions of safety and effectiveness, therefore supporting that the SERFAS 90-S electrosurgical probe is substantially equivalent to the predicate device currently on the market. The following differences exist between the Proposed and predicate device:

- 트 Ceramic and Electrode Key Feature Design
- Electrode Face Suction Path
- 트 Handle Design

### Ceramic and Electrode Key Feature Design

Both the Proposed device and predicate device ceramic raw materials are identical but the devices have slightly different dimensional specifications. The intent of this change is to increase the mechanical robustness of the probe's tip and thereby address the failure mode of tip breakage. This difference is not critical to the intended surgical use of the device and does not impact the effectiveness of the device when used as labeled, however the safety of this product will be improved as a result of this change given the reduction in occurrence of tip breakage.

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This minor difference in the Proposed device does not introduce additional risks and raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device.

#### Electrode Face Suction Path

The Proposed device contains minor electrode face suction path design differences compared to the predicate device. Both the Proposed device and predicate device electrode raw materials are identical but the devices have slightly different dimensional specifications.

This minor difference in the Proposed device does not introduce additional risks and raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device.

#### Handle Design

The patient contacting raw materials of the Proposed device and predicate device handle are identical. The Proposed device has a slightly different design specification for improved safety. This difference is not critical to the intended surgical use of the device and does not affect the effectiveness of the device when used as labeled. however the safety of this product will be improved as a result of this change because the occurrence of unintentional activation will be decreased.

This minor difference in the Proposed device does not introduce additional risks and raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device.

#### 5. Performance Testing

The Stryker SERFAS 90-S Electrosurgical probe was tested for performance in accordance with internal design specification and with the applicable performance standards, which established the substantial equivalence determination. The following non-clinical tests were conducted and are summarized in this premarket notification:

| Test Name | Description | Results |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Aggressive Use | Determines if a probe can last its full lifetime without failure<br>while being subjected to an extended activation period on<br>tissue at the highest power setting. | Pass |
| Tip Cantilever | Determines if the probe tip can withstand the normal, side,<br>and back force required to permanently deform the lumen | Pass |

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| Test Name | Description | Results |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Electrode Bend | Verifies the electrode can withstand a 7lb force for a worst<br>case scenario. | Pass |
| Thermal<br>Expansion (Heat)<br>Test | Verifies that the SERFAS probe tip assembly does not<br>experience thermal expansion capable of causing catastrophic<br>failure when subject to excessive heat | Pass |
| Leak | Verifies the condition of the ceramic-outer lumen assembly<br>and the condition of the suction clamp of all styles of Stryker<br>and non-Stryker RF ablation probes. | Pass |
| System<br>Compatibility | Verifies that the electrosurgical probe is compatible with<br>Stryker's legally marketed consoles | Pass |

Biocompatibility was assessed in accordance with ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and related collateral standards for patient contacting materials (see Section 15 -Biocompatibility).

Sterilization was assessed in accordance with ISO 11135:2014 - Sterilization of health-care products - Ethylene Oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. Sterilization residuals were assessed in accordance with ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (see Section 14 - Sterilization and Shelf Life).

Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria. Test results obtained verified the safety and effectiveness of the device per design specifications and applicable standards (see Section 18 - Performance Testing - Bench).

#### 6. Conclusion

Based on the intended use, technological characteristics, performance testing, and nonclinical testing in comparison to the predicate device, the Stryker SERFAS 90-S Electrosurgical Probe does not introduce additional risks and raises no new questions of safety and effectiveness, thus demonstrating substantial equivalence.