RESPROCESSED SERFAS ENERGY PROBE

K121855 · Stryker Sustainability Solutions · NUJ · Aug 16, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121855
• Device Name: RESPROCESSED SERFAS ENERGY PROBE
• Applicant: Stryker Sustainability Solutions
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Aug 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reprocessed SERFAS Energy Probe is a disposable, radio-frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery for the knee, shoulder, ankle, hip, elbow and wrist.

Device Story

Reprocessed SERFAS Energy Probe is a disposable radio-frequency electrosurgical device. Input: electrical energy from compatible electrosurgical generator. Operation: energy-transferring cable delivers RF energy to probe tip for soft tissue resection, ablation, coagulation, and hemostasis; simultaneous fluid aspiration capability. Used in arthroscopic procedures (knee, shoulder, ankle, hip, elbow, wrist) by surgeons. Device is a reprocessed version of original OEM probes; involves cleaning, decontamination, and functional testing of components. Output: thermal effect on tissue. Benefit: enables minimally invasive surgical tissue management.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, functional testing, and packaging validation to demonstrate safety and effectiveness.

Technological Characteristics

Radio-frequency electrosurgical probe; includes energy-transferring cable, various tip configurations, and suction channels. Materials and mechanical design identical to predicate devices. Reprocessed via cleaning and decontamination. Class II device.

Indications for Use

Indicated for patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, or wrist requiring soft tissue resection, ablation, coagulation, or hemostasis of blood vessels.

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

• IMPULSE Energy System (K041810)
• SERFAS Energy System (K991960)

Submission Summary (Full Text)

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K12/855

#### 510(k) SUMMARY

AUG 16 2012

### Submitter:

Stryker Sustainability Solutions 1810 W Drake Dr Tempe, Arizona 85283

## Contact:

Eric Varty Vice President Research & Development 888-888-3433, ext. 5400 480.763.6078 (o) 480.496.1942(f) [e-mail]

## Date of preparation: 21 June 2012

#### Name of device:

| Trade/Proprietary Name: | Reprocessed SERFAS Energy Probe |
|-------------------------|-----------------------------------------------------------------------------------------------|
| Regulation Name: | Electrosurgical, Cutting & Coagulation Accessories,<br>Laparoscopic & Endoscopic, Reprocessed |
| Regulation Number: | 21 CFR 878.4400 |
| Regulatory Class: | Class II |
| Product Code: | NUJ |

#### Predicate Device:

| Predicate Device | 510(k) Title | Manufacturer |
|------------------|-----------------------|-------------------|
| K041810 | IMPULSE Energy System | Stryker Endoscopy |
| K991960 | SERFAS Energy System | Stryker Endoscopy |

### Device Description:

The Reprocessed SERFAS Energy Probe includes an energy-transferring cable as well as several different tip configurations and suction probes which are capable of providing simultaneous fluid aspirations.

#### Indications for Use:

The Reprocessed SERFAS Energy Probe is a disposable, radio-frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery for the knee, shoulder, ankle, hip, elbow and wrist.

## Technological Characteristics:

l

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The design, materials, and intended use of Reprocessed SERFAS Energy Probe are identical to the predicate devices. The mechanism of action of the Reprocessed SERFAS Energy Probe is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of SERFAS Energy Probes includes removal of adherent visible soil and decontamination. Each individual Probe is tested for appropriate function of its components prior to packaging and labeling operations. components prior to packaging and labeling operations.

## Performance data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed SERFAS Energy Probes. This included the following tests:

- � Biocompatibility
- . Validation of reprocessing
- Sterilization Validation .
- ◆ Function test(s)
- Packaging Validation .

Performance testing demonstrates that Reprocessed SERFAS Energy Probes perform as originally intended.

#### Conclusion:

Stryker Sustainability Solutions concludes that the modified devices (Reprocessed SERFAS Energy Probes) are safe, effective, and substantially equivalent to the predicate devices as described herein.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

AUG 16 2012

Stryker Sustainability Solutions % Mr. Eric Varty Vice President 1810 West Drake Drive Tempe, Arizona 85283

Re: K121855

Trade/Device Name: Reprocessed SERFAS Energy Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accesories Regulatory Class: Class II Product Code: NUJ Dated: June 21, 2012 Received: June 25, 2012

Dear Mr. Varty:

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

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## Page 2 - Mr. Eric Varty

forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

## 510(k) Number (if known): K121855

Device Name: Reprocessed SERFAS Energy Probe

Indications For Use: The Reprocessed SERFAS Energy Probe is a disposable, radiofrequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery for the knee, shoulder, ankle, hip, elbow and wrist.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diph
Der Xua Dr

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121855