Spetzler Malis Dual Illuminating Bipolar Forceps

K160103 · Synergetics · GEI · Oct 12, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160103
• Device Name: Spetzler Malis Dual Illuminating Bipolar Forceps
• Applicant: Synergetics
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.

Device Story

The Spetzler™ Malis® Dual Illuminating Bipolar Forceps are bayonet-style, single-use, sterile electrosurgical instruments. They function by connecting to a bipolar electrosurgical generator via a twin-pin cord for tissue coagulation and to an endoscopic light source via a fiberoptic cable bonded to each tine for surgical site illumination. Used by surgeons in clinical settings, the device provides both coagulation and light delivery simultaneously. The integration of fiberoptics allows for localized illumination at the surgical site, potentially improving visibility during delicate procedures. The device is designed to be substantially equivalent to standard bipolar forceps while adding the illumination feature, which is validated against reference endoscopic telescopes to ensure safe thermal output and light transmission levels. The healthcare provider uses the forceps to perform coagulation while benefiting from the integrated light, which aids in visualizing the target tissue.

Clinical Evidence

Bench testing only. Comparative performance testing evaluated non-stick coagulation efficacy (500+ events), illumination output (200-204 mW), and thermal safety (tip temperature and surface temperature rise on beef liver). Results demonstrated equivalence to the predicate for coagulation and to the reference device for illumination safety, with tip temperatures and light transmission levels remaining within acceptable limits (<110% of reference scope).

Technological Characteristics

Materials: Silver-plated aluminum base, PVDF insulation. Design: Bayonet-style bipolar forceps with integrated fiberoptic cables. Energy: Bipolar electrosurgical (RF) and fiberoptic light transmission. Connectivity: Twin-pin electrical connector; proprietary fiberoptic connector for light source adapter. Sterilization: Ethylene Oxide (ETO) to 10^-6 SAL. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2.

Indications for Use

Indicated for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures in patients undergoing surgical procedures requiring bipolar electrosurgical coagulation and illumination.

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

• Spetzler™ Malis® Standard Bipolar Forceps (K121426)

Reference Devices

• Karl Storz Xenon Light Source and Telescope (K962595)

Submission Summary (Full Text)

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

October 12, 2016

Synergetics Mr. Dan Regan Regulatory Affairs Director 3845 Corporate Centre Drive O' Fallon, Missouri 63368

Re: K160103

Trade/Device Name: Spetzler Malis Dual Illuminating 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: September 7, 2016 Received: September 9, 2016

Dear Mr. Regan:

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 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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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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# Indications for Use

510(k) Number (if known) K160103

Device Name

Spetzler™ Malis® Dual Illuminating Bipolar Forceps

#### Indications for Use (Describe)

The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image contains the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric design composed of several squares and lines, creating a diamond shape. To the right of the word "Synergetics" is the trademark symbol, "TM", in a smaller font size.

## Section 5 - 510(k) Summary

#### Submitted in accordance with the requirements of 21 CFR 807.92

#### I. SUBMITTER

| Applicant's Name<br>and Address: | Synergetics<br>3845 Corporate Centre Drive<br>O'Fallon, MO 63368 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dan Regan, Regulatory Affairs Director |
| Date Prepared: | October 11, 2016 |
| II. DEVICE | |
| Device Trade<br>Name: | Spetzler™ Malis® Dual Illuminating Bipolar Forceps |
| Common Name: | Illuminating Bipolar Forceps |
| Device<br>Classification: | 21 CFR Part 878.4400, Electrosurgical Cutting and Coagulation<br>Devices and Accessories are Class II devices. |
| Class Name: | Electrosurgical, Cutting and Coagulation and Accessories |
| Product Code: | GEI |
| FDA Panel: | General and Plastic Surgery |
| III. PREDICATE DEVICE | |

Predicate Devices: Spetzler™ Malis® Standard Bipolar Forceps, K121426 (primary predicate)

> Karl Storz Xenon Light Source and Telescope, K962595 (reference device)

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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 made up of smaller squares and triangles. The letters are black, and the geometric shape is outlined in black. The trademark symbol is located to the right of the word.

## Section 5 - 510(k) Summary

## Submitted in accordance with the requirements of 21 CFR 807.92

# IV. DEVICE DESCRIPTION

The Spetzler™ Malis® Dual Illuminating Bipolar Forceps are sterile, single-use devices for use in electrosurgery. The forceps are a bayonet style and incorporates a twin pin cord in the proximal end for connection to a bipolar electrosurgical generator via a generic twin pin, female socket receptacle cord set. A fiberoptic cable is bonded to each tine and mates to a proprietary connector at the proximal end. The connector mates with an adaptor that is inserted in the illumination port of an endoscopic ligthsource.

## V. INDICATIONS FOR USE

The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual llluminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.

| Element<br>510(k) Number | Subject Device<br>Spetzler™ Malis®<br>Dual Illuminating<br>Bipolar Forceps<br>K160103 | Predicate Device<br>Spetzler™ Malis®<br>Standard Bipolar<br>Forceps<br>K121426 | Reference Device<br>Karl Storz Xenon<br>Light source with<br>Telescope<br>K962595 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Spetzler™ Malis®<br>Dual Illuminating<br>Bipolar Forceps are<br>single use devices<br>sold sterile and are<br>intended for use in<br>electrosurgery for<br>coagulation of tissue | The Spetzler™<br>Malis® Standard<br>Bipolar Forceps<br>are single use<br>devices sold<br>sterile and are<br>intended for use<br>in electrosurgery<br>for coagulation of<br>tissue. | This device is<br>designed to supply<br>light for<br>endoscopic<br>diagnostic and<br>surgical<br>procedures. |

#### VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS:

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Image /page/5/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric logo consisting of several squares arranged to form a larger diamond shape. To the right of the word "Synergetics" is the trademark symbol, "™".

#### Section 5 - 510(k) Summary

# Submitted in accordance with the requirements of 21 CFR 807.92

## VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS:

| | Subject Device | Predicate Device | Reference Device |
|----------------------------------|----------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------|
| | Spetzler™ Malis®<br>Dual Illuminating<br>Bipolar Forceps | Spetzler™ Malis®<br>Standard Bipolar<br>Forceps | Karl Storz Xenon<br>Light source with<br>Telescope |
| Element | | | |
| Product Code | GEI | GEI | FFS |
| Forceps Design | Bayonet Style | Bayonet Style | Not applicable |
| Patient Contact Material | Silver Plated<br>aluminum base with<br>PVDF insulation | Silver Plated<br>aluminum base<br>with PVDF<br>insulation | Not applicable |
| 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 | Not Known |
| Size Offerings Overall<br>Length | 8 inches and 9 inches | 7 inches, 8 inches<br>and<br>9 inches | Not applicable |
| Size Offerings Distal Tip | 0.5 mm<br>1.0 mm<br>1.5mm | 0.5 mm<br>1.0 mm<br>1.5mm | Not applicable |
| Packaging Configuration | Rigid PETG Tray with<br>a Tyvek 1073B Lid | Rigid PETG Tray<br>with a Tyvek<br>1073B Lid | Not applicable |
| Method of sterilization | ETO | ETO | Not applicable |
| Sterility Assurance Level | 10-6 | 10-6 | Not applicable |

# VII. SUMMARY OF NON-CLINICAL TESTS:

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Image /page/6/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric design made up of squares and lines. The letters are black, and there is a trademark symbol to the right of the word.

## Section 5 - 510(k) Summary

## Submitted in accordance with the requirements of 21 CFR 807.92

A series of bench tests were performed to assess the non-stick and illumination features of the forceps. The results are summarized below.

| Substantial Equivalence Testing, Primary Function, Non Stick Coagulation | | |
|--------------------------------------------------------------------------|----------------------|----------------------|
| Parameter | Subject Device | Predicate Device |
| 80-7621 | 80-7621 | 80-1273 |
| COAG Setting | 25 Malis Units | 25 Malis Units |
| Illumination Output | 200-204 mW | N/A |
| Accessory Cord | 80-1184 (Single Use) | 80-1184 (Single Use) |
| Non-Stick COAG Events | 500+ | 500+ |
| Results | Pass/Equivalent | Pass/Equivalent |

| Comparison of Beef Liver surface temperature rise<br>after 30 minutes of continuous illumination | | Reference<br>Device | Analysis |
|--------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------|------------------------------------------------------------------------|
| Parameter | Subject<br>Device | | |
| Device Catalog<br>Number | Synergetics Forceps<br>80-7621 | Karl Storz Telescope<br>27023ABA | Unique |
| Source Connection<br>Means | Synergetics Adapter<br>80-7630 | Karl Storz Fiber Cable<br>495NE | Equivalent |
| Lightsource | Karl Storz 300W<br>Xenon | Karl Storz 300W<br>Xenon | Identical |
| Adapter/Cable<br>Output [mW] | 1230<br>(non-standard<br>adapter @ 75%<br>setting) | 3400<br>100% output | Equivalent<br>( |
| Device Output [mW]<br>MAX | 335-340<br>(1.5x Typ. Max) | 326 | Equivalent<br>( |
| Liver Steady State<br>Temperature Rise<br>over Ambient [°F]<br>after 30 min.<br>exposure | 4 degrees F | 6-8 degrees F | Equivalent<br>(<110% of Scope<br>& < 10 degrees F<br>after 30 minutes) |

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Image /page/7/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric logo made up of squares and lines. To the upper right of the word is the trademark symbol, "TM", in a smaller font.

## Section 5 - 510(k) Summary

## Submitted in accordance with the requirements of 21 CFR 807.92

| Illumination Transmission Levels for Subject Device and Reference Device | | | |
|--------------------------------------------------------------------------|--------------------------------|----------------------------------|-------------------------|
| Parameter | Subject Device | Reference Device | Analysis |
| Device Catalog Number | Synergetics Forceps<br>80-7621 | Karl Storz Telescope<br>27023ABA | Unique |
| Source Connection Means | Synergetics Adapter<br>80-7630 | Karl Storz Fiber<br>Cable 495NE | Equivalent |
| Lightsource | Karl Storz 300W<br>Xenon | Karl Storz 300W<br>Xenon | Identical |
| Adapter/Cable Output [mW]<br>100% output | 400<br>(Standard Adapter) | 3400 | Equivalent<br>(<Cable) |
| Device Output [mW]<br>MAX, 100% Setting | 220 | 326 | Equivalent<br>(<Scopes) |
| Device Output [mW]<br>AVG, 100% Setting | 207 | 326 | Equivalent<br>(<Scopes) |

| Comparative Light Output Readings from Subject Forceps and Reference Device | | | |
|-----------------------------------------------------------------------------|--------------------------------|------------------------------------|--------------------------------|
| Parameter | Subject<br>Device | Reference<br>Device | Analysis |
| Device Catalog<br>Number | Synergetics Forceps<br>80-7621 | Karl Storz Telescope<br>27023ABA | Unique |
| Source Connection<br>Means | Synergetics Adapter<br>80-7630 | Karl Storz<br>Fiber Cable<br>495NE | Equivalent |
| Lightsource | Karl Storz 300W<br>Xenon | Karl Storz 300W<br>Xenon | Identical |
| Adapter/Cable<br>Output [mW] | 400 | 3400 | Equivalent<br>( |
| Device Output<br>[mW] MAX | 220 | 326 | Equivalent<br>( |
| Tip Temperature<br>[°F] MAX | 186 | 171 | Equivalent<br>(<110% of Scope) |

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Image /page/8/Picture/0 description: The image contains the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric logo consisting of a square divided into smaller squares and triangles. A trademark symbol is located to the right of the word.

#### Section 5 - 510(k) Summary

#### Submitted in accordance with the requirements of 21 CFR 807.92

| Comparative Light Output Readings from Subject Forceps and Reference Device | | | |
|-----------------------------------------------------------------------------|-----------------------|----------------------|--------------------------------|
| Parameter | Subject<br>Device | Reference<br>Device | Analysis |
| Device Output<br>[mW] AVG | 207<br>(6pc sample) | 326<br>(1 pc sample) | Equivalent<br>(<Scope) |
| Tip Temperature<br>[°F] AVG | 164.5<br>(6pc sample) | 171<br>(1pc sample) | Equivalent<br>(<110% of Scope) |

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 Spetzler™ Malis® Dual Illuminating Bipolar Forceps.

The non-clinical testing supports a determination of substantially equivalency to the predicate device.

#### VIII. SUBSTANTIAL EQUIVALENCE BASIS:

The conclusions performed by independent laboratories and internal comparative bench testing provide objective evidence to substantiate the Spetzler™ Malis® Dual Illuminating Bipolar Forceps is as safe and effective as the predicate device, the Spetzler™ Malis® Standard Bipolar Forceps.