DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS

K110924 · Synergetics, Inc. · GEI · Dec 7, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110924
• Device Name: DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
• Applicant: Synergetics, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

Device Story

Sterile, single-use bayonet-style bipolar forceps; used in electrosurgery for tissue coagulation and irrigation. Device features dual inlet irrigation pathways running from proximal to distal end, allowing surgeon to irrigate surgical field without obstruction. Operated by surgeons in clinical settings; connects to external electrosurgical generators, irrigation modules, and tubing via Luer connector. Provides controlled fluid delivery to distal tip to maintain clear visualization and manage tissue temperature during coagulation. Benefits include reduced risk of cross-contamination due to single-use design and improved surgical field visibility.

Clinical Evidence

Bench testing only. Comparative performance testing against the predicate device and electrical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) were performed. Results indicate performance is substantially equivalent to the predicate.

Technological Characteristics

Bayonet-style bipolar forceps. Materials: Silver-plated Aluminum base, PVDF insulation. Connectivity: Luer connector for irrigation tubing. Energy: Electrosurgical (high frequency). Sterilization: Ethylene Oxide (EtO) per AAMI/ISO 11135. Packaging: Rigid PETG tray with Tyvek lid, validated per ISO 11607-1.

Indications for Use

Indicated for use in electrosurgery for coagulation and irrigation of tissue during surgical procedures. Intended for prescription use only.

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

• Olsen Medical Single Use Bayonet Bipolar Irrigating Bipolar Forceps (K080187)

Submission Summary (Full Text)

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DEC - 7 2011

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# 510 (k) Summary of Safety and Effectiveness Synergetics Single Use Irrigating Bipolar Forceps Submitted in accordance with the requirements of 21 CFR 807.92

| Applicant's Name and Address: | Synergetics, Inc.<br>3845 Corporate Centre Drive<br>O'Fallon, MO 63368 | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Gary Oliveros<br>Synergetics, Inc.<br>Regulatory Affairs/ Compliance Manager<br>Telephone Number: [phone]<br>Fax Number: [phone]<br>Email: [e-mail]) | |
| Date Prepared: | March 31, 2011 | |
| Device Trade Name: | Synergetics™ Disposable Spetzler™ Malis® Dual Irrigating<br>Bipolar Forceps | |
| Common Name: | Single Use Irrigating Bipolar Forceps | |
| Device Classification: | 21 CFR Part 878.4400, Electrosurgical Cutting and Coagulation<br>Devices and Accessories are Class II devices | |
| Classification Name: | Electrosurgical, Cutting and Coagulation and Accessories | |
| Product Code: | GEI | |
| FDA Panel: | General and Plastic Surgery | |
| Predicate Device: | Olsen Medical Single Use Bayonet Bipolar Irrigating Bipolar<br>Forceps, K080187 | |

## Device Description:

The Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps is a sterile single use device. It consists of dual inlet irrigating pathways that run along side of the forceps from the proximal end the distal end. This allows the surgeon to view the surgical field without obstruction allowing the fluid to irrigate through the irrigation module through the forceps.

### Intended Use:

The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

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## Comparison of Technical Characteristics:

| Criteria | Predicate Device - Olsen Medical<br>Single Use Bayonet Irrigating<br>Bipolar Forceps, K080187 | Synergetics Dual Irrigating<br>Bipolar Forceps |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | Sterile single use, for use in<br>electrosurgery for coagulation and<br>irrigation of tissue. | Sterile single use, for use in<br>electrosurgery for coagulation<br>and irrigation of tissue. |
| For Use With | Electrosurgical generators,<br>irrigation modules and irrigation<br>tubing | Electrosurgical generators,<br>irrigation modules and irrigation<br>tubing |
| Forceps Design | Bayonet Style | Bayonet Style |
| Patient Contact Material | Stainless Steel base, with Nylon<br>insulation | Biocompatible Silver plated<br>Aluminum base with PVDF<br>insulation |
| Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 |
| Latex Free | Yes | Yes |
| Luer connector for connection<br>to irrigation tubing | Yes | Yes |
| Delivery line for fluid to distal<br>end of forceps | Yes | Yes |
| Single Use | Yes | Yes |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Packaging | Tyvek Pouch | Rigid PETG Tray, Tyvek lid |
| Note 1: Synergetics packaging configuration has been validated in accordance with ISO 11607-1:2006, Packaging<br>for Terminally Sterilized Medical Devices- Part 1: Requirements for Materials, Sterile Barrier Systems and<br>Packaging Systems | | |

#### Risk Management:

Risk Management has been implemented and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices.

#### Sterilization Method:

Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps are sterilized in accordance with AAMINSO 11135 Medical Devices - Validation and routine control of ethylene oxide sterilization (EtO), Overkill Method.

#### Summary of Non-clinical Testing:

Bench testing, comparative performance testing to the predicate device, and relevant electrical safety testing to IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility, and IEC 60601-2-2, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment was performed on the Synergetics Disposable Spetzler Malis Dual Irigating Bipolar Forceps. The non-clinical testing indicates the device performance is substantially equivalent to the predicate and the slight differences raise no new issues of safety and effectiveness.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Synergetics, Inc. % Mr. Gary Oliveros 3845 Corporate Centre Drive O'Fallon, MO 63368

DEC - 7 2011

Re: K110924

Trade/Device Name: Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 3, 2011 Received: November 7, 2011

Dear Mr. Oliveros:

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 - Mr. Gary Oliveros

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 yours,

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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# Synergetics™ 510 (k) Submission Synergetics Disposable Spetzler ™ Malis ® Dual-Irrigating Bipolar Forceps Section 4 - Indications for Use

510(k) Number (if known):

Device Name:

Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps

Indications for Use:

The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

X Prescription Use (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)

(Division Sign-Off)

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

510(k) Number K110924

Section 4 - Page 1 of 1