AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS

K121426 · Synergetics, Inc. · GEI · Jul 10, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121426
• Device Name: AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
• Applicant: Synergetics, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

Device Story

Sterile, single-use bayonet-style bipolar forceps; used in electrosurgery for tissue coagulation. Device connects to Malis bipolar electrosurgical generator via integrated proximal cord. Operated by surgeons in clinical/surgical settings. Provides electrical current to target tissue to achieve hemostasis. Benefits include reduced risk of cross-contamination due to single-use design.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate device and electrical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) performed. No clinical data.

Technological Characteristics

Bayonet-style bipolar forceps. Materials: silver-plated aluminum base, PVDF insulation. Energy: high-frequency electrosurgical current. Connectivity: wired connection to electrosurgical generator. Sterilization: Ethylene Oxide (EtO) per ISO 11135. Packaging: rigid PETG tray with Tyvek lid per ISO 11607-1.

Indications for Use

Indicated for use in electrosurgery for coagulation of tissue. Intended for single use by clinicians in a surgical setting.

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

• Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps (K110924)

Submission Summary (Full Text)

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510 (k) Summary of Safety and Effectiveness Synergetics Disposable Spetzler-Malis Standard 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 | JUL 10 2012 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Gary Oliveros<br>Synergetics, Inc.<br>Senior Regulatory Affairs Specialist<br>Telephone Number: [phone]<br>Fax Number: [phone]<br>Email: [e-mail] | |
| Date Prepared: | May 11, 2012 | |
| Device Trade Name: | Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar<br>Forceps | |
| Common Name: | Single Use 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: | Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar<br>Forceps, K110924 | |

#### Device Description:

The Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps are sterile single use devices for use in electrosurgery. The forceps are a bayonet style and include a cord at the proximal end which allows for connection to a Malis bipolar electrosurgical generator.

#### Intended Use:

The Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

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Image /page/1/Picture/1 description: The image shows the logo for "Synergetics". The logo consists of a geometric shape resembling a diamond made up of smaller squares on the left, followed by the word "Synergetics" in bold, black font. The letters are connected, and there is a curved line above the "i" in "Synergetics", and the letters "TM" are in the upper right corner of the word.

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Comparison of Technical Characteristics:

| Criteria | Predicate Device - Synergetics<br>Single Use Dual Irrigating<br>Bipolar Forceps, K110924 | Synergetics Disposable<br>Standard 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 of<br>tissue. |
| For Use With | Electrosurgical generators,<br>irrigation modules and irrigation<br>tubing | Electrosurgical generators |
| Forceps Design | Bayonet Style | Bayonet Style |
| Patient Contact Material | Biocompatible Silver plated<br>Aluminum base with PVDF<br>insulation | Biocompatible Silver plated<br>Aluminum base with PVDF<br>insulation |
| Electrical Safety Testing | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 |
| Latex Free | Yes | Yes |
| Single Use | Yes | Yes |
| Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Packaging | Rigid PETG Tray, Tyvek lid | 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 Standard Bipolar Forceps are sterilized in accordance with AMINSO 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 Standard 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings, positioned to the right of a circular emblem. Encircling the emblem are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters.

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

Synergetics, Incorporated % Mr. Gary Oliveros Senior Regulatory Affairs Specialist 3845 Corporate Centre Drive O'Fallon, Missouri 63368

JUL 10 2012

Re: K121426

> Trade/Device Name: Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 11, 2012 Received: May 17, 2012

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.

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Page 2- Mr. Gary Oliveros

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 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.

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/CDRH0ffices/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.

Edward V. Carey.

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric shape that looks like a diamond made up of smaller squares. The letters are black, and the geometric shape is outlined in black. There is a trademark symbol to the right of the word.

# K121 426

Synergetics™ 510 (k) Submission Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps Section 4 - Indications for Use

510(k) Number (if known):

Device Name:

Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps

Indications for Use:

The Synergetics Disposable Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

' AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilfred for mxm

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

510(k) Number K121426

Section 4 - Page 1 of 1

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